A protocol for treatment of unstable ankle fractures using transarticular fixation in patients with diabetes mellitus and loss of protective sensibility.

PubMed

Jani, Mihir M; Ricci, William M; Borrelli, Joseph; Barrett, Susan E; Johnson, Jeffrey E

2003-11-01

Surgical treatment of ankle fractures in patients with diabetes mellitus is associated with a high complication rate. Diabetic patients with peripheral neuropathy are a particularly difficult group to treat because of their inability to sense deep infection, repeat trauma, and wound complications. The purpose of this study was to evaluate a protocol that included transarticular fixation and prolonged, protected weightbearing in the treatment of unstable ankle fractures in diabetic patients with peripheral neuropathy and loss of protective sensibility. The authors retrospectively reviewed the records of 15 patients with diabetes mellitus, unstable ankle fractures (AO classification 44B), and loss of protective sensibility confirmed via testing with a 5.07 Semmes-Weinstein monofilament. Retrograde transcalcaneal-talar-tibial fixation using large Steinmann pins or screws in conjunction with standard techniques of open reduction and internal fixation was used. The postoperative treatment protocol included: 1) short leg, total contact casting and nonweightbearing status for 12 weeks; 2) removal of the intramedullary implants between 12 and 16 weeks; 3) application of a walker boot or short leg cast with partial weightbearing for an additional 12 weeks; and 4) transition to a custom-molded ankle-foot orthosis (AFO) or custom total-contact inserts in appropriate diabetic footwear. The major complication rate for all fractures was 25% (4/16) and for closed fractures was 23% (3/13). These are lower than previously reported rates between 30% (3/10) and 43% (9/21) for diabetic patients with and without neuropathy. The amputation rate for all fractures was 13% (2/16) and for closed fractures alone was 8% (1/13). These are similar to previously reported rates of 10% (2/10) to 20% (2/21). There were no deaths or Charcot malunions in this series. The combination of transarticular fixation and prolonged, protected weightbearing provided 13 of 15 patients with a stable ankle for weightbearing. Although these fractures remain a treatment challenge, this study presents a successful, multidisciplinary protocol for treatment of unstable ankle fractures in the most challenging group of diabetic patients - those with loss of protective sensibility.

Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation.

PubMed

Manousaki, Despoina; Deladoëy, Johnny; Geoffroy, Louis; Olivier, Patricia

2017-01-01

The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children. The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (±3 days). After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p  = 0.52, 95% CI 0.52-1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p  = 0.56, 95% CI 0.75-1.68). We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p  = 0.06, 95% CI 0.97-2.35). Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children. www.ClinicalTrials.gov, identifier NCT01840358.

Epidemiology of diabetic foot disease and diabetes-related lower-extremity amputation in Australia: a systematic review protocol.

PubMed

van Netten, Jaap J; Baba, Mendel; Lazzarini, Peter A

2017-05-18

Diabetic foot disease is associated with major morbidity, mortality, costs, and reduction of a person's quality of life. Investigating the epidemiology of diabetic foot disease is the backbone of diabetic foot research and clinical practice, yet the full burden of diabetic foot disease in Australia is unknown. This study aims to describe the protocol for a systematic review of the epidemiology of diabetic foot disease and diabetes-related lower-extremity amputation in Australia. The systematic review will be performed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. PubMed and EMBASE will be searched for publications in any language and without restrictions to date. Two independent investigators will screen publications for eligibility, with publications reporting Australian population-based incidence or prevalence of diabetic foot disease or diabetes-related lower-extremity amputation to be included. Additionally, a forward literature search will be performed in Google Scholar, and a grey literature search will be performed to identify government publications. Quality assessment will be performed using customised checklists. The summary statistic used for each study will be an incidence or prevalence proportion of diabetic foot disease or diabetes-related lower-extremity amputation. The standard error for each proportion will be calculated. A meta-analysis will be performed when three or more publications of adequate quality, reporting on similar outcomes and in similar populations, are identified. The results of this systematic review can be used to adequately inform stakeholders in the field of diabetic foot disease on the extent of the problem in incidence and prevalence of diabetic foot disease in Australia, and to help guide appropriate use of resources to reduce the burden of this disease. PROSPERO CRD42016050740.

The Association between Medicare Advantage Market Penetration and Diabetes in the United States

PubMed Central

Howard, Steven W.; Bernell, Stephanie Lazarus; Wilmott, Jennifer; Casim, M. Faizan; Wang, Jing; Pearson, Lindsey; Byler, Caitlin M.; Zhang, Zidong

2015-01-01

The objective of this study is to explore the extent to which managed care market penetration in the United States is associated with the presence of chronic disease. Diabetes was selected as the chronic disease of interest due to its increasing prevalence as well as the disease management protocols that can lessen disease complications. We hypothesized that greater managed care market penetration would be associated with (1) lower prevalence of diabetes and (2) lower prevalence of diabetes-related comorbidities (DRCs) among diabetics. Data for this analysis came from two sources. We merged Medicare Advantage (MA) market penetration data from the Centers for Medicare and Medicaid Services (CMS) with data from the Medical Expenditure Panel Survey (MEPS) (2004–2008). Results suggest that county-level MA market penetration is not significantly associated with prevalence of diabetes or DRCs. That finding is quite interesting in that managed care market penetration has been shown to have an effect on utilization of inpatient services. It may be that managed care protocols do not offer the same benefits beyond the inpatient setting. PMID:26501052

The Association between Medicare Advantage Market Penetration and Diabetes in the United States.

PubMed

Howard, Steven W; Bernell, Stephanie Lazarus; Wilmott, Jennifer; Casim, M Faizan; Wang, Jing; Pearson, Lindsey; Byler, Caitlin M; Zhang, Zidong

2015-01-01

The objective of this study is to explore the extent to which managed care market penetration in the United States is associated with the presence of chronic disease. Diabetes was selected as the chronic disease of interest due to its increasing prevalence as well as the disease management protocols that can lessen disease complications. We hypothesized that greater managed care market penetration would be associated with (1) lower prevalence of diabetes and (2) lower prevalence of diabetes-related comorbidities (DRCs) among diabetics. Data for this analysis came from two sources. We merged Medicare Advantage (MA) market penetration data from the Centers for Medicare and Medicaid Services (CMS) with data from the Medical Expenditure Panel Survey (MEPS) (2004-2008). Results suggest that county-level MA market penetration is not significantly associated with prevalence of diabetes or DRCs. That finding is quite interesting in that managed care market penetration has been shown to have an effect on utilization of inpatient services. It may be that managed care protocols do not offer the same benefits beyond the inpatient setting.

Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

PubMed

Beime, Beate; Krüger, Ralf; Hammel, Gertrud; Bramlage, Peter; Deutsch, Cornelia

2018-02-01

The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol. In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis. The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol. The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.

Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey.

PubMed

Egan, Aoife M; Smith, Valerie; Devane, Declan; Dunne, Fidelma P

2015-08-14

Women with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who are planning pregnancy and is associated with improved outcomes. However, there is significant heterogeneity in the outcomes measured and reported in studies evaluating the effects of prepregnancy care, which makes meaningful comparison difficult. The aim of this article is to present a protocol for a study to develop a Core Outcome Set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus. This study will include a systematic review of the literature to identify outcomes that have previously been reported in studies evaluating prepregnancy care for women with pregestational diabetes. We will then prioritise these outcomes from the perspective of key stakeholders, including women with pregestational diabetes as well as clinicians, using a Delphi survey. A final consensus meeting will be held with stakeholders to review and finalise the outcomes. The expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prepregnancy care programs for women with pregestational diabetes. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved patient care.

Cerebral microbleeds, cognitive impairment, and MRI in patients with diabetes mellitus.

PubMed

Zhou, Hong; Yang, Juan; Xie, Peihan; Dong, Yulan; You, Yong; Liu, Jincai

2017-07-01

Cerebral microbleeds (CMBs), a typical imaging manifestation marker of sporadic cerebral small vessel disease, play a critical role in vascular cognitive impairment, which is often accompanied by diabetes mellitus (DM). Hence, CMBs may, in part, be responsible for the occurrence and development of cognitive impairment in patients with diabetes. Novel magnetic resonance imaging (MRI) sequences, such as susceptibility-weighted imaging and T2*-weighted gradient-echo, have the capability of noninvasively revealing CMBs in the brain. Moreover, a correlation between CMBs and cognitive impairment in patients with diabetes has been suggested in applications of functional MRI (fMRI). Since pathological changes in the brain occur prior to observable decline in cognitive function, neuroimaging may help predict the progression of cognitive impairment in diabetic patients. In this article, we review the detection of CMBs using MRI in diabetic patients exhibiting cognitive impairment. Future studies should emphasize the development and establishment of a novel MRI protocol, including fMRI, for diabetic patients with cognitive impairment to detect CMBs. A reliable MRI protocol would also be helpful in understanding the pathological mechanisms of cognitive impairment in this important patient population. Copyright © 2017. Published by Elsevier B.V.

Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

PubMed

Kluding, Patricia M; Singleton, J Robinson; Pasnoor, Mamatha; Dimachkie, Mazen M; Barohn, Richard J; Smith, A Gordon; Marcus, Robin L

2017-01-01

Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration. The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression and quality of life in individuals with DPN. The study will be a randomized controlled trial. The study will be conducted at 2 academic medical centers. The participants will be 140 individuals with type 2 diabetes and mild to moderate DPN. The intervention group will receive 18 months of supervised exercise training, actigraphy-based counseling to reduce sedentary behavior, and individualized dietary counseling. Control group participants will receive diet and activity counseling at baseline and at 9 months. The primary outcomes are neuropathy progression as measured by intraepidermal nerve fiber density in a distal thigh skin biopsy and the Norfolk Quality of Life-Diabetic Neuropathy score. Secondary outcomes include pain, gait, balance, and mobility measures. Due to the combined intervention approach, this protocol will not be able to determine which intervention components influence outcomes. There also may be difficulty with participant attrition during the 18-month study intervention. The Activity for Diabetic Polyneuropathy (ADAPT) protocol resulted from a collaboration between physical therapists and neurologist researchers that includes as primary outcomes both a quality-of-life measure (NQOL-DN) and a physiologic biomarker (IENFD). It has the potential to demonstrate that an intensive lifestyle intervention may be a sustainable, clinically effective approach for people with DPN that improves patient outcomes and can have an immediate impact on patient care and future clinical trials. © 2017 American Physical Therapy Association

Rationale for the Diabetic Retinopathy Clinical Research Network Treatment Protocol for Center-involved Diabetic Macular Edema

PubMed Central

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M.; Browning, David J.; Chalam, KV; Davis, Matthew; Ferris, Frederick L; Glassman, Adam; Maturi, Raj; Stockdale, Cynthia R.; Topping, Trexler

2011-01-01

Objective Describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Design Discussion of treatment protocol for DME. Participants Subjects with vision loss from DME involving the center of the macula. Methods The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser in eyes with vision loss from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes, compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. In order to share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Main Outcome Measures Clinical guidelines based on a DRCR.net protocol. Results The treatment protocol required real time feedback from a web-based data entry system for intravitreal injections, focal/grid laser, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month, or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Conclusions Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. PMID:22136692

Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.

PubMed

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M; Browning, David J; Chalam, K V; Davis, Matthew; Ferris, Frederick L; Glassman, Adam R; Maturi, Raj K; Stockdale, Cynthia R; Topping, Trexler M

2011-12-01

To describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Discussion of treatment protocol for DME. Subjects with vision loss resulting from DME involving the center of the macula. The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser treatment in eyes with vision loss resulting from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. To share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Clinical guidelines based on a DRCR.net protocol. The treatment protocol required real-time feedback from a web-based data entry system for intravitreal injections, focal/grid laser treatment, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes. Methods/Design A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109. Discussion The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index – normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2. Data will be published after the study is completed. PMID:24716713

Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Gomes, Cid André Fidelis de Paula; Leal-Junior, Ernesto Cesar Pinto; Biasotto-Gonzalez, Daniela Aparecida; El-Hage, Yasmin; Politti, Fabiano; Gonzalez, Tabajara de Oliveira; Dibai-Filho, Almir Vieira; de Oliveira, Adriano Rodrigues; Frigero, Marcelo; Antonialli, Fernanda Colella; Vanin, Adriane Aver; de Tarso Camillo de Carvalho, Paulo

2014-04-09

Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes. A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109. The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index - normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2. Data will be published after the study is completed.

Development and feasibility testing of an intervention to support active lifestyles in youths with type 1 diabetes-the ActivPals programme: a study protocol.

PubMed

Mitchell, Fiona; Kirk, Alison; Robertson, Kenneth; Reilly, John J

2016-01-01

The global incidence of type 1 diabetes is rising, and youths with type 1 diabetes continue to suffer poorer health than peers without diabetes. Evidence suggests youths with type 1 diabetes have physical activity (PA) levels well below the recommendations for health and have high levels of sedentary behaviour. An active lifestyle is therefore recommended to improve health. There is limited research showing effective lifestyle behaviour change in this population; therefore, an evidence gap exists between the need to promote physical activity in type 1 diabetes care and lack of understanding on how to do this. This protocol paper describes a feasibility and pilot study of the ActivPals programme-an intervention to support active lifestyles in youths with type 1 diabetes. Key intervention components have been identified from preliminary work (individual and family focus, peer mentoring, technology integration and improved communication and understanding) and are being developed into a pragmatic randomised controlled trial (RCT) supported by recruitment pathways. A steering group of health care professionals and managers will refine the intervention to patient needs. A pilot trial is providing data on intervention implementation, acceptability and feasibility. Twenty youths with type 1 diabetes are being recruited and randomised into an intervention or control group. Physical activity is being measured objectively using the Actigraph GT3X+ monitor at baseline and 1-month follow-up. Contextual factors associated with intervention delivery are being explored. This study will contribute to the development of evidence-based, user-informed and pragmatic interventions leading to healthier lifestyles in youths with type 1 diabetes.

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

PubMed

Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

2016-04-27

Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693 .

An approach for setting evidence-based and stakeholder-informed research priorities in low- and middle-income countries.

PubMed

Rehfuess, Eva A; Durão, Solange; Kyamanywa, Patrick; Meerpohl, Joerg J; Young, Taryn; Rohwer, Anke

2016-04-01

To derive evidence-based and stakeholder-informed research priorities for implementation in African settings, the international research consortium Collaboration for Evidence-Based Healthcare and Public Health in Africa (CEBHA+) developed and applied a pragmatic approach. First, an online survey and face-to-face consultation between CEBHA+ partners and policy-makers generated priority research areas. Second, evidence maps for these priority research areas identified gaps and related priority research questions. Finally, study protocols were developed for inclusion within a grant proposal. Policy and practice representatives were involved throughout the process. Tuberculosis, diabetes, hypertension and road traffic injuries were selected as priority research areas. Evidence maps covered screening and models of care for diabetes and hypertension, population-level prevention of diabetes and hypertension and their risk factors, and prevention and management of road traffic injuries. Analysis of these maps yielded three priority research questions on hypertension and diabetes and one on road traffic injuries. The four resulting study protocols employ a broad range of primary and secondary research methods; a fifth promotes an integrated methodological approach across all research activities. The CEBHA+ approach, in particular evidence mapping, helped to formulate research questions and study protocols that would be owned by African partners, fill gaps in the evidence base, address policy and practice needs and be feasible given the existing research infrastructure and expertise. The consortium believes that the continuous involvement of decision-makers throughout the research process is an important means of ensuring that studies are relevant to the African context and that findings are rapidly implemented.

RN Diabetes Virtual Case Management: A New Model for Providing Chronic Care Management.

PubMed

Brown, Nancy N; Carrara, Barbara E; Watts, Sharon A; Lucatorto, Michelle A

2016-01-01

The U.S. chronic disease health care system has substantial gaps in delivery of services. New models of care change traditional delivery of care and explore new settings for care. This article describes a new model of diabetes chronic care delivery: nurse-delivered care that includes protocol-based insulin titration and patient education delivered solely in a virtual environment. In phase 1, the clinical outcome of time to achievement of glycated hemoglobin (A(1C)) goals (P < .001; 95% confidence interval, 1.68-2.24) was significantly improved by registered nurse (RN) standing order intervention (n = 24) as compared with historical controls (n = 28). In phase 2, patients who were referred to an RN-managed insulin titration protocol with individualized A(1C) goals had a significant (P < .001; 95% confidence interval, 1.680-2.242) reduction in results from a mean of 9.6% at baseline to 7.7% at completion. Average patient age was 66 years, with a mean duration of 11 years diagnosed with diabetes. Safety was demonstrated by the absence of hypoglycemia related to RN protocol adjustment. There were no admissions or emergency room (ER) visits for hypoglycemia. This study demonstrates safety and efficacy of RN virtual chronic disease management for an older population of patients with long-standing diabetes.

Effect of Trelagliptin on Quality of Life in Patients with Type 2 Diabetes Mellitus: Study Protocol.

PubMed

Ishii, Hitoshi; Suzaki, Yuki; Miyata, Yuko

2017-12-01

Long-term glycemic control in type 2 diabetes is critical to prevent or delay the onset of macrovascular and microvascular complications. Medication adherence is an integral component of type 2 diabetes management. Minimizing the dosing frequency of antidiabetic drugs may reduce treatment burden for patients and improve medication adherence. This study has been proposed to assess the reduction in treatment burden during 12 weeks' administration of trelagliptin, a weekly dosing dipeptidyl peptidase-4 (DPP-4) inhibitor, compared with a daily dosing DPP-4 inhibitor in patients with type 2 diabetes. This is a multicenter, randomized, open-label, parallel-group, comparative study to be conducted at approximately 15 sites across Japan. A total of 240 patients are to be randomized 1:1 to receive trelagliptin or a daily DPP-4 inhibitor for 12 weeks. Efficacy and safety will be compared between the two groups. The primary endpoint is the change in total score for all items of the diabetes-therapy-related QOL questionnaire from treatment start to treatment end. The study will be conducted with the highest respect for the individual participants in accordance with the protocol, the Declaration of Helsinki, the Ethical Guidelines for Clinical Research, the ICH Consolidated Guideline for Good Clinical Practice, and applicable local laws and regulations. Takeda Pharmaceutical Company Limited. Japic CTI-173482.

Hypoglycemic effects of Acacia nilotica in type II diabetes: a research proposal.

PubMed

Roozbeh, Nasibeh; Darvish, Leili; Abdi, Fatemeh

2017-07-26

Diabetes mellitus is a common metabolic disorder throughout the world which can negatively affect the function of various body organs. Due to their availability and few side effects, herbal medicines have been proposed as suitable alternatives in the management of diabetes. Previous studies have confirmed the anti diabetic properties of Acacia nilotica. The hypoglycemic effects of this plant have been attributed to its role in stimulating the islets of Langerhans to produce more insulin. The present paper describes a systematic review protocol for the assessment of the hypoglycemic effects of A. nilotica. Randomized and non-randomized placebo-controlled clinical trials, performed during 1999-2016 will be included. The outcomes will be measured through FBS, GCT, GTT, and OGTT in all of studies and in addition to these tests, will be measured 2HPP and HbA1c level in human study. Well-known databases will be searched for selected key terms A. nilotica, type II diabetes and hypoglycemia. The quality assessment of the selected papers will be evaluated based on SYRCLE and Cochrane Risk of Bias Tool. We believe that our findings will provide details about difficulties researchers face during the design of protocols or implementation of scientific studies. Ultimately, the publication of our findings will facilitate the development of effective treatment strategies to promote the health of people with type II DM. PROSPERO registration CRD42016053141.

Quality, efficiency, and cost of a physician-assistant-protocol system for managment of diabetes and hypertension.

PubMed

Komaroff, A L; Flatley, M; Browne, C; Sherman, H; Fineberg, S E; Knopp, R H

1976-04-01

Briefly trained physicians assistants using protocols (clinical algorithms) for diabetes, hypertension, and related chronic arteriosclerotic and hypertensive heart disease abstrated information from the medical record and obtained history and physical examination data on every patient-visit to a city hospital chronic disease clinic over a 18-month period. The care rendered by the protocol system was compared with care rendered by a "traditional" system in the same clinic in which physicians delegated few clinical tasks. Increased thoroughness in collecting clinical data in the protocol system led to an increase in the recognition of new pathology. Outcome criteria reflected equivalent quality of care in both groups. Efficiency time-motion studies demonstrated a 20 per cent saving in physician time with the protocol system. Coct estimates, based on the time spent with patients by various providers and on the laboratory-test-ordering patterns, demonstrated equivalent costs of the two systems, given optimal staffing patterns. Laboratory tests were a major element of the cost of patient care,and the clinical yield per unit cost of different tests varied widely.

Rapid Evidence Review of Mobile Applications for Self-management of Diabetes.

PubMed

Veazie, Stephanie; Winchell, Kara; Gilbert, Jennifer; Paynter, Robin; Ivlev, Ilya; Eden, Karen B; Nussbaum, Kerri; Weiskopf, Nicole; Guise, Jeanne-Marie; Helfand, Mark

2018-05-08

Patients with diabetes lack information on which commercially available applications (apps) improve diabetes-related outcomes. We conducted a rapid evidence review to examine features, clinical efficacy, and usability of apps for self-management of type 1 and type 2 diabetes in adults. Ovid/Medline and the Cochrane Database of Systematic Reviews were searched for systematic reviews and technology assessments. Reference lists of relevant systematic reviews were examined for primary studies. Additional searches for primary studies were conducted online, through Ovid/Medline, Embase, CINAHL, and ClinicalTrials.gov . Studies were evaluated for eligibility based on predetermined criteria, data were extracted, study quality was assessed using a risk of bias tool, information on app features was collected, and app usability was assessed. Results are summarized qualitatively. Fifteen articles evaluating 11 apps were identified: six apps for type 1 and five apps for type 2 diabetes. Common features of apps included setting reminders and tracking blood glucose and hemoglobin A1c (HbA1c), medication use, physical activity, and weight. Compared with controls, use of eight apps, when paired with support from a healthcare provider or study staff, improved at least one outcome, most often HbA1c. Patients did not experience improvements in quality of life, blood pressure, or weight, regardless of app used or type of diabetes. Study quality was variable. Of the eight apps available for usability testing, two were scored "acceptable," three were "marginal," and three were "not acceptable." Limited evidence suggests that use of some commercially available apps, when combined with additional support from a healthcare provider or study staff, may improve some short-term diabetes-related outcomes. The impact of these apps on longer-term outcomes is unclear. More rigorous and longer-term studies of apps are needed. This review was funded by the Agency for Healthcare Research and Quality (AHRQ). The protocol is available at: http://www.effectivehealthcare.ahrq.gov/topics/diabetes-mobile-devices/research-protocol .

Empowering Staff Nurses as Primary Educators to Children with Type 1 Diabetes.

PubMed

Sy, Virginia

2016-01-01

Patient and family education is a critical element of diabetes management. Manychildren with new onset type 1 diabetes present with symptoms of diabeticketoacidosis (DKA) and are hospitalized at diagnosis. These children and theirfamilies receive their initial education in the hospital setting. As soon as bloodglucose levels are stabilized and the acidosis is corrected, the patient is dischargedhome, usually within three days (Nettles, 2005). There is little time toprovide the skills and education, as well as emotional support, for a smooth transitionto home. It is a challenge to achieve these goals if the only resource personfor diabetes education is the clinical nurse specialist (CNS). The CNS for a 14-bed pediatric unit sought to expand the role of the bedside nurse to being the primaryeducator of patients with diabetes through education and support. All nursesattended an eight-hour workshop on diabetes. A DKA protocol was developedthrough multidisciplinary collaboration, and nurses were educated on this protocol.Additionally, the CNS organized a diabetes resource cart that contains thetools for diabetes education. The protocol and education materials wereuploaded in the Pediatric SharePoint site to make them accessible to nurses. Most importantly, the CNS developed a structured patient education plan that isoutcome-oriented, and based on review of current literature and practices in theunit. This initiative resulted in an increase in nursing confidence and expertiserelated to diabetes care as demonstrated by competencies met by nurses andanecdotal evidence from nurses and patients’ caregivers.

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

PubMed Central

Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

2018-01-01

Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. Trial registration number NCT0280469; Pre-results. PMID:29530914

Bio-Engineering tissue and V.A.C. therapy: A new method for the treatment of extensive necrotizing infection in the diabetic foot.

PubMed

Armenio, Andrea; Cutrignelli, Daniela Anna; Nardulli, Maria Luisa; Maggio, Giulio; Memeo, Giuseppe; De Santis, Valerio; Giudice, Giuseppe; Ressa, Cosmo Maurizio

2017-01-01

The aim of the study is to compare the standard care for progressive necrotizing infection in diabetic foot with a treatment protocol based on the association between autologous fibroblast grafts and vacuum-assisted closure therapy (V.A.C.). A retrospective matched Case-Control study was carried out on 20 patients with diabetic foot infection, 10 treated with the standard care and 10 with our new protocol. Inclusion criteria were: acute diabetic foot necrosis (Wagner III and IV), ulcer size (30 to 80 cm2), tendon and bone exposure. Success in the treatment was evaluated as: percentage of healing at the 20th week, time of healing, deambulation, recurrence and major amputation rate. A 90% healing rate was observed after 20 weeks in the study group, compared to a 28.6% in the control group. The recurrence rate in the treated areas was 20% in the study group and 100% in the control group. None of the patients in either group required major amputations. We achieved very promising results by associating autologous fibroblasts grafts and V.A.C. therapy, in comparison with standard care. V.A.C. therapy seems to improve the growth rate of the fibroblasts, probably by sealing the wound and providing a moist environment following the fibroblast graft. The improved neoangiogenesis of the neo-dermis could explain the reduced recurrence rate of the study group. Despite the low number of patients involved and the retrospective nature of the analysis, this study showed a reliable, safe and cost-effective method of treating extensive infection in the diabetic foot. Bio-Engineered Tissue, Diabetic foot, Fibroblast graft, V.A.C.

Diabetic foot infection treatment and care.

PubMed

Cigna, Emanuele; Fino, Pasquale; Onesti, Maria G; Amorosi, Vittoria; Scuderi, Nicolò

2016-04-01

Foot infections in diabetic patients are a common, complex and costly problem. They are potentially adverse with progression to deeper spaces and tissues and are associated with severe complications. The management of diabetic foot infection (DFI) requires a prompt and systematic approach to achieve more successful outcomes and to ultimately avoid amputations. This study reviews a multi-step treatment for DFIs. Between September 2010 and September 2012, a total of about 37 patients were consulted for DFI. The treatment algorithm included four steps, that is, several types of debridement according to the type of wound, the application of negative pressure therapy (NPT), other advanced dressings, a targeted antibiotic therapy local or systemic as the case may, and, if necessary, reconstructive surgery. This treatment protocol showed excellent outcomes, allowing us to avoid amputation in most difficult cases. Only about 8% of patients require amputation. This treatment protocol and a multidisciplinary approach with a specialised team produced excellent results in the treatment of DFI and in the management of diabetic foot in general, allowing us to improve the quality of life of diabetic patients and also to ensure cost savings. © 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Ranasinghe, Priyanga; Galappaththy, Priyadarshani; Constantine, Godwin Roger; Jayawardena, Ranil; Weeratunga, Hasitha Dhananjaya; Premakumara, Sirimal; Katulanda, Prasad

2017-09-29

Previous studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA 1 c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14. We describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes. Sri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 ( http://slctr.lk/trials/714 ). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.

Patient Engagement and Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol.

PubMed

Young, Doris; Furler, John; Vale, Margarite; Walker, Christine; Segal, Leonie; Dunning, Patricia; Best, James; Blackberry, Irene; Audehm, Ralph; Sulaiman, Nabil; Dunbar, James; Chondros, Patty

2007-04-11

The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice. In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures. Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH study. This study explores the potential role for PNs to help reduce the treatment and outcomes gap in people with T2D by using telephone coaching. The intervention, if found to be effective, has potential to be sustained and embedded within real world General Practice.

Morphine hyposensitivity in streptozotocin-diabetic rats: Reversal by dietary l-arginine treatment.

PubMed

Lotfipour, Shahrdad; Smith, Maree T

2018-01-01

Painful diabetic neuropathy (PDN) is a long-term complication of diabetes. Defining symptoms include mechanical allodynia (pain due to light pressure or touch) and morphine hyposensitivity. In our previous work using the streptozotocin (STZ)-diabetic rat model of PDN, morphine hyposensitivity developed in a temporal manner with efficacy abolished at 3 months post-STZ and maintained for 6 months post-STZ. As this time course mimicked that for the temporal development of hyposensitivity to the pain-relieving effects of the furoxan nitric oxide (NO) donor, PRG150 (3-methylfuroxan-4-carbaldehyde) in STZ-diabetic rats, we hypothesized that progressive depletion of endogenous NO bioactivity may underpin the temporal loss of morphine sensitivity in STZ-diabetic rats. Furthermore, we hypothesized that replenishment of NO bioactivity may restore morphine sensitivity in these animals. Diabetes was induced in male Dark Agouti rats by intravenous injection of STZ (85 mg/kg). Diabetes was confirmed on day 7 if blood glucose concentrations were ≥15 mmol/L. Mechanical allodynia was fully developed in the bilateral hindpaws by 3 weeks of STZ-diabetes in rats and this was maintained for the study duration. Morphine hyposensitivity developed in a temporal manner with efficacy abolished by 3 months post-STZ. Administration of dietary l-arginine (NO precursor) at 1 g/d to STZ-diabetic rats according to a 15-week prevention protocol initiated at 9 weeks post-STZ prevented abolition of morphine efficacy. When given as an 8-week intervention protocol in rats where morphine efficacy was abolished, dietary l-arginine at 1 g/d progressively rescued morphine efficacy and potency. Our findings implicate NO depletion in the development of morphine hyposensitivity in STZ-diabetic rats. © 2017 John Wiley & Sons Australia, Ltd.

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial.

PubMed

Zgibor, Janice C; Maloney, Maura A; Malmi, Markku; Fabio, Anthony; Kuo, Shihchen; Solano, Francis X; Tilves, Debra; Tu, Lichuan; Davidson, Mayer B

2018-01-01

To evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care. This clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n=175) or usual care (n=65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups. The population was 50.8% male with a mean age of 61years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p=0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p=0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication. Findings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control. Copyright © 2017 Elsevier Inc. All rights reserved.

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

PubMed

Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-04-02

Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association-recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A 1c levels, weight, and the usability of the connected system. An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5). ©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Yusof, Barakatun-Nisak Mohd

2016-02-27

Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT02322268.

Integrating cardiovascular diseases, hypertension, and diabetes with HIV services: a systematic review.

PubMed

Haldane, Victoria; Legido-Quigley, Helena; Chuah, Fiona Leh Hoon; Sigfrid, Louise; Murphy, Georgina; Ong, Suan Ee; Cervero-Liceras, Francisco; Watt, Nicola; Balabanova, Dina; Hogarth, Sue; Maimaris, Will; Buse, Kent; McKee, Martin; Piot, Peter; Perel, Pablo

2018-01-01

Non-communicable diseases (NCDs), including cardiovascular diseases (CVD), hypertension and diabetes together with HIV infection are among the major public health concerns worldwide. Health services for HIV and NCDs require health systems that provide for people's chronic care needs, which present an opportunity to coordinate efforts and create synergies between programs to benefit people living with HIV and/or AIDS and NCDs. This review included studies that reported service integration for HIV and/or AIDS with coronary heart diseases, chronic CVD, cerebrovascular diseases (stroke), hypertension or diabetes. We searched multiple databases from inception until October 2015. Articles were screened independently by two reviewers and assessed for risk of bias. 11,057 records were identified with 7,616 after duplicate removal. After screening titles and abstracts, 14 papers addressing 17 distinct interventions met the inclusion criteria. We categorized integration models by diseases (HIV with diabetes, HIV with hypertension and diabetes, HIV with CVD and finally HIV with hypertension and CVD and diabetes). Models also looked at integration from micro (patient focused integration) to macro (system level integrations). Most reported integration of hypertension and diabetes with HIV and AIDS services and described multidisciplinary collaboration, shared protocols, and incorporating screening activities into community campaigns. Integration took place exclusively at the meso-level, with no micro- or macro-level integrations described. Most were descriptive studies, with one cohort study reporting evaluative outcomes. Several innovative initiatives were identified and studies showed that CVD and HIV service integration is feasible. Integration should build on existing protocols and use the community as a locus for advocacy and health services, while promoting multidisciplinary teams, including greater involvement of pharmacists. There is a need for robust and well-designed studies at all levels - particularly macro-level studies, research looking at long-term outcomes of integration, and research in a more diverse range of countries.

Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol

PubMed Central

2010-01-01

Background An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours. Methods/Design A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned. Discussion Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore, the study will provide insight into the potential for more widespread uptake of automated telehealth interventions, globally. Trial Registration Number ACTRN12607000594426 PMID:20937148

From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program.

PubMed

Ko, Gary T; So, Wing-Yee; Tong, Peter C; Le Coguiec, Francois; Kerr, Debborah; Lyubomirsky, Greg; Tamesis, Beaver; Wolthers, Troels; Nan, Jennifer; Chan, Juliana

2010-05-13

The Joint Asia Diabetes Evaluation (JADE) Program is a web-based program incorporating a comprehensive risk engine, care protocols, and clinical decision support to improve ambulatory diabetes care. The JADE Program uses information technology to facilitate healthcare professionals to create a diabetes registry and to deliver an evidence-based care and education protocol tailored to patients' risk profiles. With written informed consent from participating patients and care providers, all data are anonymized and stored in a databank to establish an Asian Diabetes Database for research and publication purpose. The JADE electronic portal (e-portal: http://www.jade-adf.org) is implemented as a Java application using the Apache web server, the mySQL database and the Cocoon framework. The JADE e-portal comprises a risk engine which predicts 5-year probability of major clinical events based on parameters collected during an annual comprehensive assessment. Based on this risk stratification, the JADE e-portal recommends a care protocol tailored to these risk levels with decision support triggered by various risk factors. Apart from establishing a registry for quality assurance and data tracking, the JADE e-portal also displays trends of risk factor control at each visit to promote doctor-patient dialogues and to empower both parties to make informed decisions. The JADE Program is a prototype using information technology to facilitate implementation of a comprehensive care model, as recommended by the International Diabetes Federation. It also enables health care teams to record, manage, track and analyze the clinical course and outcomes of people with diabetes.

A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion--a study protocol.

PubMed

Brorsson, Anna Lena; Leksell, Janeth; Viklund, Gunnel; Lindholm Olinder, Anna

2013-12-20

Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrollment. This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12-18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used: Disabkids, 'Check your health', the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment. In this study, we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family.

Cost-effectiveness analysis of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.

PubMed

Dewan, Vinay; Lambert, Dennis; Edler, Joshua; Kymes, Steven; Apte, Rajendra S

2012-08-01

Perform a cost-effectiveness analysis of the treatment of diabetic macular edema (DME) with ranibizumab plus prompt or deferred laser versus triamcinolone plus prompt laser. Data for the analysis were drawn from reports of the Diabetic Retinopathy Clinical Research Network (DRCRnet) Protocol I. Computer simulation based on Protocol I data. Analyses were conducted from the payor perspective. Simulated participants assigned characteristics reflecting those seen in Protocol I. Markov models were constructed to replicate Protocol I's 104-week outcomes using a microsimulation approach to estimation. Baseline characteristics, visual acuity (VA), treatments, and complications were based on Protocol I data. Costs were identified by literature search. One-way sensitivity analysis was performed, and the results were validated against Protocol I data. Direct cost of care for 2 years, change in VA from baseline, and incremental cost-effectiveness ratio (ICER) measured as cost per additional letter gained from baseline (Early Treatment of Diabetic Retinopathy Study). For sham plus laser (S+L), ranibizumab plus prompt laser (R+pL), ranibizumab plus deferred laser (R+dL), and triamcinolone plus laser (T+L), effectiveness through 104 weeks was predicted to be 3.46, 7.07, 8.63, and 2.40 letters correct, respectively. The ICER values in terms of dollars per VA letter were $393 (S+L vs. T+L), $5943 (R+pL vs. S+L), and $20 (R+dL vs. R+pL). For pseudophakics, the ICER value for comparison triamcinolone with laser versus ranibizumab with deferred laser was $14 690 per letter gained. No clinically relevant changes in model variables altered outcomes. Internal validation demonstrated good similarity to Protocol I treatment patterns. In treatment of phakic patients with DME, ranibizumab with deferred laser provided an additional 6 letters correct compared with triamcinolone with laser at an additional cost of $19 216 over 2 years. That would indicate that if the gain in VA seen at 2 years is maintained in subsequent years, then the treatment of phakic patients with DME using ranibizumab may meet accepted standards of cost-effectiveness. For pseudophakic patients, first-line treatment with triamcinolone seems to be the most cost-effective option. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial.

PubMed

Hilliard, Marisa E; Eshtehardi, Sahar S; Minard, Charles G; Saber, Rana; Thompson, Debbe; Karaviti, Lefkothea P; Rojas, Yuliana; Anderson, Barbara J

2018-03-13

Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen's most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents' engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. ClinicalTrials.gov NCT02877680; https://clinicaltrials.gov/ct2/show/NCT02877680 (Archived by WebCite at http://www.webcitation.org/6xTAMN5k2). ©Marisa E Hilliard, Sahar S Eshtehardi, Charles G Minard, Rana Saber, Debbe Thompson, Lefkothea P Karaviti, Yuliana Rojas, Barbara J Anderson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.03.2018.

Undulatory physical resistance training program increases maximal strength in elderly type 2 diabetics.

PubMed

Santos, Gilberto Monteiro dos; Montrezol, Fábio Tanil; Pauli, Luciana Santos Souza; Sartori-Cintra, Angélica Rossi; Colantonio, Emilson; Gomes, Ricardo José; Marinho, Rodolfo; Moura, Leandro Pereira de; Pauli, José Rodrigo

2014-01-01

To investigate the effects of a specific protocol of undulatory physical resistance training on maximal strength gains in elderly type 2 diabetics. The study included 48 subjects, aged between 60 and 85 years, of both genders. They were divided into two groups: Untrained Diabetic Elderly (n=19) with those who were not subjected to physical training and Trained Diabetic Elderly (n=29), with those who were subjected to undulatory physical resistance training. The participants were evaluated with several types of resistance training's equipment before and after training protocol, by test of one maximal repetition. The subjects were trained on undulatory resistance three times per week for a period of 16 weeks. The overload used in undulatory resistance training was equivalent to 50% of one maximal repetition and 70% of one maximal repetition, alternating weekly. Statistical analysis revealed significant differences (p<0.05) between pre-test and post-test over a period of 16 weeks. The average gains in strength were 43.20% (knee extension), 65.00% (knee flexion), 27.80% (supine sitting machine), 31.00% (rowing sitting), 43.90% (biceps pulley), and 21.10% (triceps pulley). Undulatory resistance training used with weekly different overloads was effective to provide significant gains in maximum strength in elderly type 2 diabetic individuals.

Undulatory physical resistance training program increases maximal strength in elderly type 2 diabetics

PubMed Central

dos Santos, Gilberto Monteiro; Montrezol, Fábio Tanil; Pauli, Luciana Santos Souza; Sartori-Cintra, Angélica Rossi; Colantonio, Emilson; Gomes, Ricardo José; Marinho, Rodolfo; de Moura, Leandro Pereira; Pauli, José Rodrigo

2014-01-01

Objective To investigate the effects of a specific protocol of undulatory physical resistance training on maximal strength gains in elderly type 2 diabetics. Methods The study included 48 subjects, aged between 60 and 85 years, of both genders. They were divided into two groups: Untrained Diabetic Elderly (n=19) with those who were not subjected to physical training and Trained Diabetic Elderly (n=29), with those who were subjected to undulatory physical resistance training. The participants were evaluated with several types of resistance training’s equipment before and after training protocol, by test of one maximal repetition. The subjects were trained on undulatory resistance three times per week for a period of 16 weeks. The overload used in undulatory resistance training was equivalent to 50% of one maximal repetition and 70% of one maximal repetition, alternating weekly. Statistical analysis revealed significant differences (p<0.05) between pre-test and post-test over a period of 16 weeks. Results The average gains in strength were 43.20% (knee extension), 65.00% (knee flexion), 27.80% (supine sitting machine), 31.00% (rowing sitting), 43.90% (biceps pulley), and 21.10% (triceps pulley). Conclusion Undulatory resistance training used with weekly different overloads was effective to provide significant gains in maximum strength in elderly type 2 diabetic individuals. PMID:25628192

A nurse-guided, basal-prandial insulin treatment protocol for achieving glycaemic control of hospitalized, non-critically ill diabetes patients, is non-inferior to physician-guided therapy: A pivotal, nurse-empowerment study.

PubMed

Segal, Gad; Karniel, Eli; Mahagna, Ahmed; Kaa'dan, Fadi; Levi, Zehava; Balik, Chaya

2015-12-01

Basal-prandial insulin is established for glycaemic control for hospitalized, type 2 diabetes patients. Empowering nurses to guide such protocols could be advantageous.The study aims to comparatively assess the efficacy and safety of glycaemic control by a nurse-guided protocol with physician-guided therapy. It also aims to assess the impact of empowerment on the nurses' sense of competence. This is a prospective, controlled, randomized, single-blinded study. Validated protocol utilizing basal-prandial insulin was used. Glycaemic control was the primary efficacy outcome, whereas hypoglycaemia and laboratory parameters were followed for safety. Assessment of nurses' psychological empowerment was done. One hundred fifty-eight treatment days of 53 patients were included. Patients were randomized to either study group (n = 27) or control group (n = 26). Glycaemia deviation from liberal range (60-300 mg/dL) was 7.4% of days for nurse-guided, basal-prandial insulin treatment protocol (NGP) and 7.84% for physician-guided therapy (PGT), P = 0.901. Rate of glycaemia deviation from the strict range (100-180 mg/dL) was 49.76% for NGP and 47.38% for PGT, P = 0.703. Mean range of daily deviation was similar (77.05 mg/dL for NGP and 76.04 mg/dL for PGT, P = 0.93). There were no significant differences in safety parameters. An empowerment questionnaire showed tendency for increased nurses' sense of competence. Nurse-guided protocol is non-inferior to physician-guided treatment in efficacy and safety parameters. Nurses' sense of competence was positively influenced. © 2014 Wiley Publishing Asia Pty Ltd.

IMITS: Information and Clinical Technologies for the Advancement of Healthcare

DTIC Science & Technology

2008-12-01

a model to evaluate the efficacy of Platelet Gel Therapy on non-healing diabetic foot wounds... the safety and efficacy of Platelet Gel Therapy on non-healing diabetic lower extremity wounds. The implementation of the study protocol, “ A Randomized...prototype for select MTFs. One of the initial steps within Phase Two will be for the DWA project team to provide a project review at SGR

Pediatric Diabetic Ketoacidosis, Fluid Therapy and Cerebral Injury: The Design of a Factorial Randomized Controlled Trial

PubMed Central

Glaser, Nicole S.; Ghetti, Simona; Casper, T. Charles; Dean, J. Michael; Kuppermann, Nathan

2013-01-01

Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the United States and worldwide. The optimal protocol for intravenous fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of intravenous fluid infusion and the development of cerebral edema, the most common and most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and cerebral edema have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (Fluid Therapies Under Investigation in DKA) Study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial-design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically-overt CE, and long-term neurocognitive outcomes following DKA. PMID:23490311

Live Birth after Rescue In vitro Maturation-intracytoplasmic Sperm Injection in Type 1 Diabetes, Polycystic Ovary Syndrome Patient Using Clomiphene-antagonist Protocol.

PubMed

Sankari, Samundi; Elanchezhian, M; Selvamani, Divya; Nagarajan, M; Gopikrishnan, D

2018-01-01

Infertility in patients with polycystic ovary syndrome (PCOS) associated with diabetes leads to challenging situations seeking alternative treatments. In vitro maturation (IVM) followed by intracytoplasmic sperm injection (ICSI) could overcome the challenges with promising pregnancies in such patients. In the treatment of a 32-year-old diabetic woman who also had PCOS, single immature oocyte was retrieved. Rescue IVM followed by ICSI yielded a grade 1 day 3 embryo which on transferring resulted in pregnancy and a healthy infant was delivered. Rescue IVM-ICSI could help in achieving pregnancy and live birth. Stimulation involving clomiphene and gonadotropin-releasing hormone antagonist is an effective and patient-friendly protocol for women with PCOS and diabetes and also for poor responders.

Agreement between automated and manual quantification of corneal nerve fiber length: Implications for diabetic neuropathy research.

PubMed

Scarr, Daniel; Lovblom, Leif E; Ostrovski, Ilia; Kelly, Dylan; Wu, Tong; Farooqi, Mohammed A; Halpern, Elise M; Ngo, Mylan; Ng, Eduardo; Orszag, Andrej; Bril, Vera; Perkins, Bruce A

2017-06-01

Quantification of corneal nerve fiber length (CNFL) by in vivo corneal confocal microscopy represents a promising diabetic neuropathy biomarker, but applicability is limited by resource-intensive image analysis. We aimed to evaluate, in cross-sectional analysis of non-diabetic controls and patients with type 1 and type 2 diabetes with and without neuropathy, the agreement between manual and automated analysis protocols. Sixty-eight controls, 139 type 1 diabetes, and 249 type 2 diabetes participants underwent CNFL measurement (N=456). Neuropathy status was determined by clinical and electrophysiological criteria. CNFL was determined by manual (CNFL Manual , reference standard) and automated (CNFL Auto ) protocols, and results were compared for correlation and agreement using Spearman coefficients and the method of Bland and Altman (CNFL Manual subtracted from CNFL Auto ). Participants demonstrated broad variability in clinical characteristics associated with neuropathy. The mean age, diabetes duration, and HbA1c were 53±18years, 15.9±12.6years, and 7.4±1.7%, respectively, and 218 (56%) individuals with diabetes had neuropathy. Mean CNFL Manual was 15.1±4.9mm/mm 2 , and mean CNFL Auto was 10.5±3.7mm/mm 2 (CNFL Auto underestimation bias, -4.6±2.6mm/mm 2 corresponding to -29±17%). Percent bias was similar across non-diabetic controls (-33±12%), type 1 (-30±20%), and type 2 diabetes (-28±16%) subgroups (ANOVA, p=0.068), and similarly in diabetes participants with and without neuropathy. Levels of CNFL Auto and CNFL Manual were both inversely associated with neuropathy status. Although CNFL Auto substantially underestimated CNFL Manual , its bias was non-differential between diverse patient groups and its relationship with neuropathy status was preserved. Determination of diagnostic thresholds specific to CNFL Auto should be pursued in diagnostic studies of diabetic neuropathy. Copyright © 2016 Elsevier Inc. All rights reserved.

External validation of type 2 diabetes computer simulation models: definitions, approaches, implications and room for improvement-a protocol for a systematic review.

PubMed

Ogurtsova, Katherine; Heise, Thomas L; Linnenkamp, Ute; Dintsios, Charalabos-Markos; Lhachimi, Stefan K; Icks, Andrea

2017-12-29

Type 2 diabetes mellitus (T2DM), a highly prevalent chronic disease, puts a large burden on individual health and health care systems. Computer simulation models, used to evaluate the clinical and economic effectiveness of various interventions to handle T2DM, have become a well-established tool in diabetes research. Despite the broad consensus about the general importance of validation, especially external validation, as a crucial instrument of assessing and controlling for the quality of these models, there are no systematic reviews comparing such validation of diabetes models. As a result, the main objectives of this systematic review are to identify and appraise the different approaches used for the external validation of existing models covering the development and progression of T2DM. We will perform adapted searches by applying respective search strategies to identify suitable studies from 14 electronic databases. Retrieved study records will be included or excluded based on predefined eligibility criteria as defined in this protocol. Among others, a publication filter will exclude studies published before 1995. We will run abstract and full text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives. We will pay special attention to aspects of quality of these models in regard to the external validation based upon ISPOR and ADA recommendations as well as Mount Hood Challenge reports. All critical stages within the screening, data extraction and synthesis processes will be conducted by at least two authors. This protocol adheres to PRISMA and PRISMA-P standards. The proposed systematic review will provide a broad overview of the current practice in the external validation of models with respect to T2DM incidence and progression in humans built on simulation techniques. PROSPERO CRD42017069983 .

Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.

PubMed

Lernmark, Barbro; Lynch, Kristian; Baxter, Judith; Roth, Roswith; Simell, Tuula; Smith, Laura; Swartling, Ulrica; Johnson, Suzanne Bennett

2016-01-01

To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial.

PubMed

Jeandidier, Nathalie; Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-04-19

Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Here, we present the protocol for a new study (Suivi A Grande Echelle d'une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. TELESAGE is a multicenter, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist's task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd). ©Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2018.

Digital retinal imaging in a residency-based patient-centered medical home.

PubMed

Newman, Robert; Cummings, Doyle M; Doherty, Lisa; Patel, Nick R

2012-03-01

Diabetic retinopathy is the leading cause of blindness in adults in the United States, and early screening/treatment may preserve vision. This study examined the feasibility of using non-mydriatic digital retinal imaging (DRI) for retinopathy screening in a busy family medicine residency program at the point of care using a nurse-driven protocol. We compared the number of diabetics screened during a 1-year period before and after DRI protocol implementation. We also determined the prevalence of retinopathy, assessed patient satisfaction with the alternative screening process, and tracked ophthalmologic appointment compliance for patients referred because of abnormal screening results. Screening approximately doubled from 161 patients/year before the protocol to 330 patients/year after protocol implementation. However, DRI screening had no impact on ophthalmologic appointment compliance; only 58% of 153 patients referred for ophthalmologic evaluation because of positive screening findings completed their referral appointment. Seven cases needing urgent ophthalmologic treatment were identified. Satisfaction with primary care retinopathy screening was high. Use of a nurse-driven protocol for digital retinal imaging at the point of care dramatically improves rates of annual retinopathy screening in academic family medicine practice and can identify patients who require subspecialty referral. However, DRI screening does not improve visit compliance rates with ophthalmologists for evaluation and management.

[Optimizing the managment of patients with diabetes mellitus: selected clinical trials from the 2004 Congress of the American Diabetes Association].

PubMed

Scheen, A J; Radermecker, R P; Philips, J C

2004-06-01

The 64th scientific congress of the American Diabetes Association had a special session devoted to the presentation of the results from three clinical trials: 1) the first multicentre international trial of pancreatic islet transplantation according to the so-called Edmonton protocol with the primary endpoint of restoring insulin independence in type 1 diabetic patients; 2) three pivotal studies of 30 weeks testing both the efficacy and safety of exenatide (exendin-4), a new insulin secretagogue that is a long-acting analogue of glucagon-like peptide-1, in patients with type 2 diabetes treated with either metformin, or a sulfonylurea, or a metformin-sulfonylurea combination; and 3) the "Collaborative AtoRvastatin Diabetes Study" (CARDS), a placebo-controlled primary prevention trial of cardiovascular complications using atorvastatin 10 mg in 2 838 at risk patients with type 2 diabetes. The main results and conclusions of these trials are briefly presented as they open new perspectives in the management of patients with type 1 or type 2 diabetes mellitus.

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

PubMed

Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B

2018-03-12

Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. NCT0280469; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Interpreting the results of the Semmes-Weinstein monofilament test: accounting for false-positive answers in the international consensus on the diabetic foot protocol by a new model.

PubMed

Slater, Robert A; Koren, Shlomit; Ramot, Yoram; Buchs, Andreas; Rapoport, Micha J

2014-01-01

The Semmes-Weinstein monofilament is the most widely used test to diagnose the loss of protective sensation. The commonly used protocol of the International Consensus on the Diabetic Foot includes a 'sham' application that allows for false-positive answers. We sought to study the heretofore unexamined significance of false-positive answers. Forty-five patients with diabetes and a history of pedal ulceration (Group I) and 81 patients with diabetes but no history of ulceration (Group II) were studied. The three original sites of the International Consensus on the Diabetic Foot at the hallux, 1st metatarsal and 5th metatarsal areas were used. At each location, the test was performed three times: 2 actual and 1 "sham" applications. Scores were graded from 0 to 3 based upon correct responses. Determination of loss of protective sensation was performed with and without calculating a false-positive answer as a minus 1 score. False-positive responses were found in a significant percentage of patients with and without history of ulceration. Introducing false-positive results as minus 1 into the test outcome significantly increased the number of patients diagnosed with loss of protective sensation in both groups. False-positive answers can significantly affect Semmes-Weinstein monofilament test results and the diagnosis of LOPS. A model that accounts for false-positive answers is offered. Copyright © 2013 John Wiley & Sons, Ltd.

Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care.

PubMed

Askew, Deborah A; Jackson, Claire L; Ware, Robert S; Russell, Anthony

2010-05-24

Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Australian New Zealand Clinical Trials Registry ACTRN12608000010392.

From design to implementation - The Joint Asia Diabetes Evaluation (JADE) program: A descriptive report of an electronic web-based diabetes management program

PubMed Central

2010-01-01

Background The Joint Asia Diabetes Evaluation (JADE) Program is a web-based program incorporating a comprehensive risk engine, care protocols, and clinical decision support to improve ambulatory diabetes care. Methods The JADE Program uses information technology to facilitate healthcare professionals to create a diabetes registry and to deliver an evidence-based care and education protocol tailored to patients' risk profiles. With written informed consent from participating patients and care providers, all data are anonymized and stored in a databank to establish an Asian Diabetes Database for research and publication purpose. Results The JADE electronic portal (e-portal: http://www.jade-adf.org) is implemented as a Java application using the Apache web server, the mySQL database and the Cocoon framework. The JADE e-portal comprises a risk engine which predicts 5-year probability of major clinical events based on parameters collected during an annual comprehensive assessment. Based on this risk stratification, the JADE e-portal recommends a care protocol tailored to these risk levels with decision support triggered by various risk factors. Apart from establishing a registry for quality assurance and data tracking, the JADE e-portal also displays trends of risk factor control at each visit to promote doctor-patient dialogues and to empower both parties to make informed decisions. Conclusions The JADE Program is a prototype using information technology to facilitate implementation of a comprehensive care model, as recommended by the International Diabetes Federation. It also enables health care teams to record, manage, track and analyze the clinical course and outcomes of people with diabetes. PMID:20465815

A multi-center prospective cohort study to evaluate the effect of differential pricing and health systems strengthening on access to medicines and management of hypertension and diabetes in Ghana: A study protocol.

PubMed

Mobula, Linda Meta; Sarfo, Stephen; Arthur, Lynda; Burnham, Gilbert; Plange-Rhule, Jacob; Ansong, Daniel; Gavor, Edith; Ofori-Adjei, David

2018-02-07

Background: There is evidence to suggest that the prevalence of non-communicable diseases (NCDs), in particular cardiovascular diseases and diabetes, are being recognized as forming a substantial proportion of the burden of disease among populations in Low- and Middle-Income Countries (LMICs).  Access to treatment is likely a key barrier to the control and prevention of NCD outcomes.  Differential pricing, an approach used to price drugs based on the purchasing power of patients in different socioeconomic segments, has been shown to be beneficial and leads to improved access and affordability. Methods: This is a quasi-experimental study, with a pragmatic trial design, to be conducted over the course of three years. A mixed methods design will be used to evaluate the effects of health systems strengthening and differential pricing on the management of diabetes, hypertension and selected cancers in Ghana. A public private partnership was established between all sites that will receive multi-level interventions, including health systems strengthening  and access to medicines interventions. Study populations and sites: Study participants will include individuals with new or recently diagnosed hypertension and diabetes (n=3,300), who present to two major referral hospitals, Komfo Anokye Teaching Hospital and Tamale Teaching Hospital, as well as three district hospitals, namely Kings Medical Centre, Agogo Presbyterian District Hospital, and Atua Government Hospital. Discussion: The objective of this study aims to test approaches intended to improve access to drugs for the treatment of hypertension and diabetes, and improve disease control. Patients with these conditions will benefit from health systems strengthening interventions (education, counseling, improved management of disease), and increased access to innovative medicines via differential pricing. Pilot programs also will facilitate health system strengthening at the participating institutions, which includes training of clinicians and updating of guidelines and production of protocols for the treatment of diabetes, hypertension and cancer.

Intervention mapping protocol for developing a theory-based diabetes self-management education program.

PubMed

Song, Misoon; Choi, Suyoung; Kim, Se-An; Seo, Kyoungsan; Lee, Soo Jin

2015-01-01

Development of behavior theory-based health promotion programs is encouraged with the paradigm shift from contents to behavior outcomes. This article describes the development process of the diabetes self-management program for older Koreans (DSME-OK) using intervention mapping (IM) protocol. The IM protocol includes needs assessment, defining goals and objectives, identifying theory and determinants, developing a matrix to form change objectives, selecting strategies and methods, structuring the program, and planning for evaluation and pilot testing. The DSME-OK adopted seven behavior objectives developed by the American Association of Diabetes Educators as behavioral outcomes. The program applied an information-motivation-behavioral skills model, and interventions were targeted to 3 determinants to change health behaviors. Specific methods were selected to achieve each objective guided by IM protocol. As the final step, program evaluation was planned including a pilot test. The DSME-OK was structured as the 3 determinants of the IMB model were intervened to achieve behavior objectives in each session. The program has 12 weekly 90-min sessions tailored for older adults. Using the IM protocol in developing a theory-based self-management program was beneficial in terms of providing a systematic guide to developing theory-based and behavior outcome-focused health education programs.

A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

PubMed

Adolfsson, Annsofie; Linden, Karolina; Sparud-Lundin, Carina; Larsson, Per-Göran; Berg, Marie

2014-12-29

Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden. The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05. The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management. ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

Modern retinal laser therapy

PubMed Central

Kozak, Igor; Luttrull, Jeffrey K.

2014-01-01

Medicinal lasers are a standard source of light to produce retinal tissue photocoagulation to treat retinovascular disease. The Diabetic Retinopathy Study and the Early Treatment Diabetic Retinopathy Study were large randomized clinical trials that have shown beneficial effect of retinal laser photocoagulation in diabetic retinopathy and have dictated the standard of care for decades. However, current treatment protocols undergo modifications. Types of lasers used in treatment of retinal diseases include argon, diode, dye and multicolor lasers, micropulse lasers and lasers for photodynamic therapy. Delivery systems include contact lens slit-lamp laser delivery, indirect ophthalmocope based laser photocoagulation and camera based navigated retinal photocoagulation with retinal eye-tracking. Selective targeted photocoagulation could be a future alternative to panretinal photocoagulation. PMID:25892934

Predictors of study completion and withdrawal in a randomized clinical trial of a pediatric diabetes adherence intervention.

PubMed

Driscoll, Kimberly A; Killian, Michael; Johnson, Suzanne Bennett; Silverstein, Janet H; Deeb, Larry C

2009-05-01

Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study completion status throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child's regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n=41) and Late Completers (n=39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants' completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group.

Transcultural Endocrinology: Adapting Type-2 Diabetes Guidelines on a Global Scale.

PubMed

Nieto-Martínez, Ramfis; González-Rivas, Juan P; Florez, Hermes; Mechanick, Jeffrey I

2016-12-01

Type-2 diabetes (T2D) needs to be prevented and treated effectively to reduce its burden and consequences. White papers, such as evidence-based clinical practice guidelines (CPG) and their more portable versions, clinical practice algorithms and clinical checklists, may improve clinical decision-making and diabetes outcomes. However, CPG are underused and poorly validated. Protocols that translate and implement these CPG are needed. This review presents the global dimension of T2D, details the importance of white papers in the transculturalization process, compares relevant international CPG, analyzes cultural variables, and summarizes translation strategies that can improve care. Specific protocols and algorithmic tools are provided. Copyright © 2016 Elsevier Inc. All rights reserved.

Using the intervention mapping protocol to develop a maintenance programme for the SLIMMER diabetes prevention intervention.

PubMed

Elsman, Ellen B M; Leerlooijer, Joanne N; Ter Beek, Josien; Duijzer, Geerke; Jansen, Sophia C; Hiddink, Gerrit J; Feskens, Edith J M; Haveman-Nies, Annemien

2014-10-27

Although lifestyle interventions have shown to be effective in reducing the risk for type 2 diabetes mellitus, maintenance of achieved results is difficult, as participants often experience relapse after the intervention has ended. This paper describes the systematic development of a maintenance programme for the extensive SLIMMER intervention, an existing diabetes prevention intervention for high-risk individuals, implemented in a real-life setting in the Netherlands. The maintenance programme was developed using the Intervention Mapping protocol. Programme development was informed by a literature study supplemented by various focus group discussions and feedback from implementers of the extensive SLIMMER intervention. The maintenance programme was designed to sustain a healthy diet and physical activity pattern by targeting knowledge, attitudes, subjective norms and perceived behavioural control of the SLIMMER participants. Practical applications were clustered into nine programme components, including sports clinics at local sports clubs, a concluding meeting with the physiotherapist and dietician, and a return session with the physiotherapist, dietician and physical activity group. Manuals were developed for the implementers and included a detailed time table and step-by-step instructions on how to implement the maintenance programme. The Intervention Mapping protocol provided a useful framework to systematically plan a maintenance programme for the extensive SLIMMER intervention. The study showed that planning a maintenance programme can build on existing implementation structures of the extensive programme. Future research is needed to determine to what extent the maintenance programme contributes to sustained effects in participants of lifestyle interventions.

Treat-to-target trials in diabetes.

PubMed

Wangnoo, Subhash K; Sethi, Bipin; Sahay, Rakesh K; John, Mathew; Ghosal, Samit; Sharma, Surendra K

2014-03-01

Treat-to-target is a therapeutic concept that considers well defined and specific physiologic targets as aims in controlling the pathophysiology of the disease. It has been widely used in diseases that pathophysiology includes, chronic metabolic and physiological disturbances, namely rheumatic conditions, vascular medicine and diabetes. In diabetes, the availability of "gold-standard" quantitative measures like fasting plasma glucose and glycated hemoglobin make the application of treat-to-target trials especially pertinent. Treatment modalities which have used single therapeutic agents or combinations or in combination with a variety of titration algorithms and implementation protocols have broadened our understanding of diabetes management with specific reference to insulin initiation and maintenance. Treat-to-target trials have been used to investigate a wide variety of questions including efficacy, safety, effect of treatment on comorbidities and patient satisfaction, ideal mechanisms to implement insulin initiation etc. A more generalized acceptance and implementation of treat-to-target trials may finally revolutionize diabetes management by combining aspects of individual care with standard treatment protocols.

The Diabetic Foot Attack: "'Tis Too Late to Retreat!"

PubMed

Vas, Prashanth R J; Edmonds, Michael; Kavarthapu, Venu; Rashid, Hisham; Ahluwalia, Raju; Pankhurst, Christian; Papanas, Nikolaos

2018-03-01

The "diabetic foot attack" is one of the most devastating presentations of diabetic foot disease, typically presenting as an acutely inflamed foot with rapidly progressive skin and tissue necrosis, at times associated with significant systemic symptoms. Without intervention, it may escalate over hours to limb-threatening proportions and poses a high amputation risk. There are only best practice approaches but no international protocols to guide management. Immediate recognition of a typical infected diabetic foot attack, predominated by severe infection, with prompt surgical intervention to debride all infected tissue alongside broad-spectrum antibiotic therapy is vital to ensure both limb and patient survival. Postoperative access to multidisciplinary and advanced wound care therapies is also necessary. More subtle forms exist: these include the ischemic diabetic foot attack and, possibly, in a contemporary categorization, acute Charcot neuroarthropathy. To emphasize the importance of timely action especially in the infected and ischemic diabetic foot attack, we revisit the concept of "time is tissue" and draw parallels with advances in acute myocardial infarction and stroke care. At the moment, international protocols to guide management of severe diabetic foot presentations do not specifically use the term. However, we believe that it may help increase awareness of the urgent actions required in some situations.

The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) study: expected outcome from the DD2 project and two intervention studies

PubMed Central

Beck-Nielsen, Henning; Solomon, Thomas PJ; Lauridsen, Jørgen; Karstoft, Kristian; Pedersen, Bente K; Johnsen, Søren P; Nielsen, Jens Steen; Kryger, Tine Bjerregaard; Sortsø, Camilla; Vaag, Allan

2012-01-01

The overall aim of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) is to near-normalize metabolic control in newly diagnosed patients with type 2 diabetes (T2D) using an individualized treatment approach. We hypothesize that this will not only prevent complications and improve quality of life for T2D patients but also result in increased cost efficiency compared with current treatment modalities. This paper provides an overview of the expected outcomes from DD2, focusing on the two main intervention studies. The main data for the DD2 project are collected during patient enrollment and stored using the individual civil registration number. This enables subsequent linking to other national databases where supplemental data can be obtained. All data will be used for designing treatment guidelines and continuously monitoring the development of diabetic complications, thereby obtaining knowledge about predictors for the long-term outcome and identifying targets for new interventions. Further data are being collected from two intervention studies. The aim of the first intervention study is to improve T2D treatment using an individualized treatment modality optimizing medication according to individual metabolic responses and phenotypic characteristics. The aim of the second intervention study is to develop an evidence-based training protocol to be implemented as a treatment modality for T2D and used for initiating lifelong changes in physical activity levels in patients with T2D. An initial pilot study evaluating an interval-based walking protocol is ongoing, and preliminary results indicate that this protocol is an optimal “free-living” training intervention. An initial health-economic analysis will also be performed as a basis for analysis of the data collected during the project. A cost-benefit analysis of the two intervention studies will be conducted. The DD2 project is expected to lead to improved treatment modalities and increased knowledge about existing treatment guidelines, and will also provide a solid base for health-economic decision-making. PMID:23071408

Delivering diabetes care in the Philippines and Vietnam: policy and practice issues.

PubMed

Beran, David; Higuchi, Michiyo

2013-01-01

The aim of this study is the comparison of 2 studies looking at the barriers to access of diabetes care and medicines in the Philippines and Vietnam. These studies used the Rapid Assessment Protocol for Insulin Access. Diabetes care is provided in specialized facilities and appropriate referral systems are lacking. In Vietnam, no problems were reported with regard to diagnostic tools, whereas this was a concern in the public sector in the Philippines. Both countries had high prices for medicines in comparison to international standards. Availability of medicines was better in Vietnam than in the Philippines, especially with regard to insulin. This affected adherence as did a lack of patient education. As countries aim to provide health care to the majority of their populations through universal coverage, the challenge of diabetes cannot be neglected. Trying to achieve universal coverage in parallel to decentralization, national and local governments need adapted guidance for this.

Electroretinographic evidence suggesting that the type 2 diabetic retinopathy of the sand rat Psammomys obesus is comparable to that of humans

PubMed Central

Dellaa, Ahmed; Benlarbi, Maha; Hammoum, Imane; Gammoudi, Nouha; Dogui, Mohamed; Messaoud, Riadh; Azaiz, Rached; Charfeddine, Ridha; Khairallah, Moncef; Lachapelle, Pierre

2018-01-01

Purpose Type 2 diabetic retinopathy is the main cause of acquired blindness in adults. The aim of this work was to examine the retinal function of the sand rat Psammomys obesus as an animal model of diet-induced type 2 diabetes when subjected to a hypercaloric regimen. Materials and methods Hyperglycemia was induced in Psammomys obesus by high caloric diet (4 kcal/g). The visual function of control (n = 7) and diabetic (n = 7) adult rodents were followed up during 28 consecutive weeks with full-field electroretinogram(ERG) recordings evoked to flashes of white light according to the standard protocol of the International Society for Clinical Electrophysiology of Vision protocol (ISCEV). Results Twenty-eight weeks following the induction of diabetes, results revealed significantly reduced and delayed photopic and scotopic ERG responses in diabetic rats compared to control rats. More specifically, we noted a significant decrease in the amplitude of the dark-adapted 0.01ERG (62%), a- and b-wave amplitudes of the dark-adapted 3.0 ERG (33.6%, 55.1%) and the four major oscillatory potentials components (OP1-OP4) (39.0%, 75.2%, 54.8% and 53.7% respectively). In photopic conditions, diabetic rats showed a significant decrease in a- and b-wave (30.4%, 43.4%), photopic negative response (55.3%), 30 Hz flicker (63.7%), OP1-OP4(51.6%, 61.8%, 68.3% and 47.5% respectively) and S-cone (34.7%). Significantly delayed implicit times were observed for all ERG components in the diabetic animals. Results obtained are comparable to those characterizing the retinal function of patients affected with advanced stage of diabetic retinopathy. Conclusion Psammomys obesus is a useful translational model to study the pathophysiology of diabetic retinopathy in order to explore new therapeutic avenues in human patients. PMID:29420665

Delivery of integrated diabetes care using logistics and information technology--the Joint Asia Diabetes Evaluation (JADE) program.

PubMed

Chan, Juliana C N; Ozaki, Risa; Luk, Andrea; Kong, Alice P S; Ma, Ronald C W; Chow, Francis C C; Wong, Patrick; Wong, Rebecca; Chung, Harriet; Chiu, Cherry; Wolthers, Troels; Tong, Peter C Y; Ko, Gary T C; So, Wing-Yee; Lyubomirsky, Greg

2014-12-01

Diabetes is a global epidemic, and many affected individuals are undiagnosed, untreated, or uncontrolled. The silent and multi-system nature of diabetes and its complications, with complex care protocols, are often associated with omission of periodic assessments, clinical inertia, poor treatment compliance, and care fragmentation. These barriers at the system, patient, and care-provider levels have resulted in poor control of risk factors and under-usage of potentially life-saving medications such as statins and renin-angiotensin system inhibitors. However, in the clinical trial setting, use of nurses and protocol with frequent contact and regular monitoring have resulted in marked differences in event rates compared to epidemiological data collected in the real-world setting. The phenotypic heterogeneity and cognitive-psychological-behavioral needs of people with diabetes call for regular risk stratification to personalize care. Quality improvement initiatives targeted at patient education, task delegation, case management, and self-care promotion had the largest effect size in improving cardio-metabolic risk factors. The Joint Asia Diabetes Evaluation (JADE) program is an innovative care prototype that advocates a change in clinic setting and workflow, coordinated by a doctor-nurse team and augmented by a web-based portal, which incorporates care protocols and a validated risk engine to provide decision support and regular feedback. By using logistics and information technology, supported by a network of health-care professionals to provide integrated, holistic, and evidence-based care, the JADE Program aims to establish a high-quality regional diabetes database to reflect the status of diabetes care in real-world practice, confirm efficacy data, and identify unmet needs. Through collaborative efforts, we shall evaluate the feasibility, acceptability, and cost-effectiveness of this "high tech, soft touch" model to make diabetes and chronic disease care more accessible, affordable, and sustainable. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Rebound hyperglycaemia in diabetic cats.

PubMed

Roomp, Kirsten; Rand, Jacquie

2016-08-01

Rebound hyperglycaemia (also termed Somogyi effect) is defined as hyperglycaemia caused by the release of counter-regulatory hormones in response to insulin-induced hypoglycaemia, and is widely believed to be common in diabetic cats. However, studies in human diabetic patients over the past quarter century have rejected the common occurrence of this phenomenon. Therefore, we evaluated the occurrence and prevalence of rebound hyperglycaemia in diabetic cats. In a retrospective study, 10,767 blood glucose curves of 55 cats treated with glargine using an intensive blood glucose regulation protocol with a median of five blood glucose measurements per day were evaluated for evidence of rebound hyperglycaemic events, defined in two different ways (with and without an insulin resistance component). While biochemical hypoglycaemia occurred frequently, blood glucose curves consistent with rebound hyperglycaemia with insulin resistance was confined to four single events in four different cats. In 14/55 cats (25%), a median of 1.5% (range 0.32-7.7%) of blood glucose curves were consistent with rebound hyperglycaemia without an insulin resistance component; this represented 0.42% of blood glucose curves in both affected and unaffected cats. We conclude that despite the frequent occurrence of biochemical hypoglycaemia, rebound hyperglycaemia is rare in cats treated with glargine on a protocol aimed at tight glycaemic control. For glargine-treated cats, insulin dose should not be reduced when there is hyperglycaemia in the absence of biochemical or clinical evidence of hypoglycaemia. © ISFM and AAFP 2015.

Bio-engineering inslulin-secreting cells from embryonic stem cells: a review of progress.

PubMed

Roche, E; Sepulcre, M P; Enseñat-Waser, R; Maestre, I; Reig, J A; Soria, B

2003-07-01

According to the Edmonton protocol, human islet transplantation can result in insulin independency for periods longer than 3 years. However, this therapy for type 1 diabetes is limited by the scarcity of cadaveric donors. Owing to the ability of embryonic stem cells to expand in vitro and differentiate into a variety of cell types, research has focused on ways to manipulate these cells to overcome this problem. It has been demonstrated that mouse embryonic stem cells can differentiate into insulin-containing cells, restoring normoglycaemia in diabetic mice. To this end, mouse embryonic stem cells were transfected with a DNA construct that provides resistance to neomycin under the control of the regulatory regions of the human insulin gene. However, this protocol has a very low efficiency, needing improvements for this technology to be transferred to human stem cells. Optimum protocols will be instrumental in the production of an unlimited source of cells that synthesise, store and release insulin in a physiological manner. The review focuses on the alternative source of tissue offered by embryonic stem cells for regenerative medicine in diabetes and some key points that should be considered in order for a definitive protocol for in vitro differentiation to be established.

Evaluation of a Non-Invasive Alternative Glucose Monitor System in Patients with Diabetes Mellitus

DTIC Science & Technology

2008-01-07

Diabetes Mellitus New Protocol Title: Evaluation of a Non-Invasive Alternative Glucose Monitor System in Patients with Diabetes Mellitus PRINCIPAL...Invasive Alternative Glucose Monitor System in Patients with Diabetes Mellitus 5b. GRANT NUMBER Coop Agreement # 05216002 5c. PROGRAM ELEMENT NUMBER...Flexible Medical Systems was approved by the Department of Clinical Investigation at WRAMC in January 2008. FY08 AAMTI funding will support the

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

PubMed

Taylor, Johanna; Böhnke, Jan R; Wright, Judy; Kellar, Ian; Alderson, Sarah L; Hughes, Tom; Holt, Richard I G; Siddiqi, Najma

2017-02-14

People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Evaluation of an adult insulin infusion protocol at an academic medical center.

PubMed

Petrov, Katerina I; Burns, Tammy L; Drincic, Andjela

2012-05-01

Acknowledging evidence of possible detrimental effects of tightly controlled blood glucose levels, the American Association of Clinical Endocrinologists and the American Diabetes Association published a consensus statement recommending less strict control for most diabetic patients. As a result of these recommendations, our academic center at Creighton University Medical Center revised its adult insulin infusion protocol to target blood glucose levels ranging from 120 to 180 mg/dL for regular (standard) glycemic control and 80 to 120 mg/dL for tight control; previous targets had ranged from 80 to 180 mg/dL and 70 to 110 mg/dL, respectively. The primary objective was to evaluate the time that blood glucose values were within the target range for patients receiving the new protocol, compared with patients receiving the previous protocol. Our study was designed to evaluate the effectiveness and safety of the revised protocol. Using a retrospective chart review, we collected data for 4 months from patients on the old insulin protocol (May to August 2009) and for 4 months from patients on the new protocol (September to December 2009). Secondary endpoints included the number of hypoglycemic episodes (blood glucose below 70 mg/dL) and severe hypoglycemic episodes (blood glucose 40 mg/dL or lower) experienced by patients receiving the new insulin protocol compared with those receiving the former protocol. Patient characteristics were similar at baseline. Blood glucose values stayed within the target range for a significantly shorter time with the new protocol than with the former protocol (44.6% vs. 56.8%, respectively; P < 0.001), probably because of the narrower target range in the revised protocol. No statistically significant differences in hypoglycemia were observed after the protocol was changed. Hypoglycemia occurred in 31% of the former-protocol patients compared with 18% of the revised-protocol patients. Severe hypoglycemia was experienced by 2.1% of patients on the old protocol and by 3.1% of patients on the new protocol. Rates of severe hypoglycemia were low (2.6%) with the original protocol. Patients' blood glucose levels were within the target range for a shorter time with the new protocol. Fewer episodes of hypoglycemia were recorded with the new protocol, but rates of severe hypoglycemia were similar with both protocols.

Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care

PubMed Central

2010-01-01

Background Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Methods/Design Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). Discussion This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000010392. PMID:20492731

Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial.

PubMed

van Puffelen, Anne L; Rijken, Mieke; Heijmans, Monique J W M; Nijpels, Giel; Rutten, Guy E H M; Schellevis, François G

2014-04-01

The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated. We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome. Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients' partners in effective diabetes care is also acknowledged in the study. Netherlands National Trial Register (NTR) NTR3302.

Pediatric diabetic ketoacidosis, fluid therapy, and cerebral injury: the design of a factorial randomized controlled trial.

PubMed

Glaser, Nicole S; Ghetti, Simona; Casper, T Charles; Dean, J Michael; Kuppermann, Nathan

2013-09-01

Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the USA and worldwide. The optimal protocol for intravenous (IV) fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of IV fluid infusion and the development of cerebral edema (CE), the most common and the most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and CE have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently, there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (FLuid therapies Under Investigation in DKA) study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically overt CE and long-term neurocognitive outcomes following DKA. © 2013 John Wiley & Sons A/S.

A Practical and Time-Efficient High-Intensity Interval Training Program Modifies Cardio-Metabolic Risk Factors in Adults with Risk Factors for Type II Diabetes.

PubMed

Phillips, Bethan E; Kelly, Benjamin M; Lilja, Mats; Ponce-González, Jesús Gustavo; Brogan, Robert J; Morris, David L; Gustafsson, Thomas; Kraus, William E; Atherton, Philip J; Vollaard, Niels B J; Rooyackers, Olav; Timmons, James A

2017-01-01

Regular physical activity (PA) can reduce the risk of developing type 2 diabetes, but adherence to time-orientated (150 min week -1 or more) PA guidelines is very poor. A practical and time-efficient PA regime that was equally efficacious at controlling risk factors for cardio-metabolic disease is one solution to this problem. Herein, we evaluate a new time-efficient and genuinely practical high-intensity interval training (HIT) protocol in men and women with pre-existing risk factors for type 2 diabetes. One hundred eighty-nine sedentary women ( n  = 101) and men ( n  = 88) with impaired glucose tolerance and/or a body mass index >27 kg m -2 [mean (range) age: 36 (18-53) years] participated in this multi-center study. Each completed a fully supervised 6-week HIT protocol at work-loads equivalent to ~100 or ~125% [Formula: see text]. Change in [Formula: see text] was used to monitor protocol efficacy, while Actiheart™ monitors were used to determine PA during four, weeklong, periods. Mean arterial (blood) pressure (MAP) and fasting insulin resistance [homeostatic model assessment (HOMA)-IR] represent key health biomarker outcomes. The higher intensity bouts (~125% [Formula: see text]) used during a 5-by-1 min HIT protocol resulted in a robust increase in [Formula: see text] (136 participants, +10.0%, p  < 0.001; large size effect). 5-by-1 HIT reduced MAP (~3%; p  < 0.001) and HOMA-IR (~16%; p  < 0.01). Physiological responses were similar in men and women while a sizeable proportion of the training-induced changes in [Formula: see text], MAP, and HOMA-IR was retained 3 weeks after cessation of training. The supervised HIT sessions accounted for the entire quantifiable increase in PA, and this equated to 400 metabolic equivalent (MET) min week -1 . Meta-analysis indicated that 5-by-1 HIT matched the efficacy and variability of a time-consuming 30-week PA program on [Formula: see text], MAP, and HOMA-IR. With a total time-commitment of <15 min per session and reliance on a practical ergometer protocol, 5-by-1 HIT offers a new solution to modulate cardio-metabolic risk factors in adults with pre-existing risk factors for type 2 diabetes while approximately meeting the MET min week -1 PA guidelines. Long-term randomized controlled studies will be required to quantify the ability for 5-by-1 HIT to reduce the incidence of type 2 diabetes, while strategies are required to harmonize the adaptations to exercise across individuals.

Quality improvement for integrated management of patients with type 2 diabetes (PRIHTA project stage 1).

PubMed

Paccagnella, Agostino; Mauri, Alessandra; Spinella, Nello

2012-01-01

The purpose of the study was to show how a different collaborative relationship with family doctors and increasingly specialized diabetologists could lead to a 50% reduction in recurrent appointments due to procedural errors and a 50% reduction in the average waiting times for a specialist medical visit. A qualitative and quantitative definition of the problem was made using the Lean Six Sigma method: (Define); process indicators were observed that might interfere with the objectives of this study (Measure); descriptive statistics were used to confirm the validity and significance of the results (Analyze); and finally strategies were established to intervene on these variables (Improve). Four groups of action led to optimization of the objectives: (1) establishing clinical protocols for primary care physicians for treating hospitalized patients with type 2 diabetes and hyperglycemia; (2) increasing the autonomy of nursing care staff; (3) reorganizing the appointments booking office; and (4) making diabetes clinics more specialized. Thanks to this project, primary care physicians have rediscovered their role and defined their diagnostic-therapeutic function under a shared scientific protocol. The model presented in this study provides scope for reflection on the role of the diabetologist, proposing an "alternative" that concerns only the care of patients with metabolic decompensation.

Maturation and function of human embryonic stem cell-derived pancreatic progenitors in macroencapsulation devices following transplant into mice.

PubMed

Bruin, Jennifer E; Rezania, Alireza; Xu, Jean; Narayan, Kavitha; Fox, Jessica K; O'Neil, John J; Kieffer, Timothy J

2013-09-01

Islet transplantation is a promising cell therapy for patients with diabetes, but it is currently limited by the reliance upon cadaveric donor tissue. We previously demonstrated that human embryonic stem cell (hESC)-derived pancreatic progenitor cells matured under the kidney capsule in a mouse model of diabetes into glucose-responsive insulin-secreting cells capable of reversing diabetes. However, the formation of cells resembling bone and cartilage was a major limitation of that study. Therefore, we developed an improved differentiation protocol that aimed to prevent the formation of off-target mesoderm tissue following transplantation. We also examined how variation within the complex host environment influenced the development of pancreatic progenitors in vivo. The hESCs were differentiated for 14 days into pancreatic progenitor cells and transplanted either under the kidney capsule or within Theracyte (TheraCyte, Laguna Hills, CA, USA) devices into diabetic mice. Our revised differentiation protocol successfully eliminated the formation of non-endodermal cell populations in 99% of transplanted mice and generated grafts containing >80% endocrine cells. Progenitor cells developed efficiently into pancreatic endocrine tissue within macroencapsulation devices, despite lacking direct contact with the host environment, and reversed diabetes within 3 months. The preparation of cell aggregates pre-transplant was critical for the formation of insulin-producing cells in vivo and endocrine cell development was accelerated within a diabetic host environment compared with healthy mice. Neither insulin nor exendin-4 therapy post-transplant affected the maturation of macroencapsulated cells. Efficient differentiation of hESC-derived pancreatic endocrine cells can occur in a macroencapsulation device, yielding glucose-responsive insulin-producing cells capable of reversing diabetes.

Implementing an intravenous insulin protocol in your practice: practical advice to overcome clinical, administrative, and financial barriers.

PubMed

Kelly, Janet L; Hirsch, Irl B; Furnary, Anthony P

2006-01-01

Diabetes mellitus is the fourth most common comorbid condition among hospitalized patients, and 30% of patients undergoing open-heart surgery have diabetes. The link between hyperglycemia and poor outcome has been well described, and large clinical trials have shown that aggressive control of blood glucose with an insulin infusion can improve these outcomes. The barriers to implementing an insulin infusion protocol are numerous, despite the fact that doing so is paramount to clinical success. Barriers include safety concerns, such as fear of hypoglycemia, insufficient nursing staff to patient ratios, lack of administrative and physician support, various system and procedural issues, and resistance to change. Key steps to overcome the barriers include building support with multidisciplinary champions, involving key staff, educating staff, and administrators of the clinical and economic benefits of improving glycemic control, setting realistic goals, selecting a validated insulin infusion protocol, and internally marketing the success of the protocol.

The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

PubMed Central

Sturt, Jackie; Hearnshaw, Hilary; Farmer, Andrew; Dale, Jeremy; Eldridge, Sandra

2006-01-01

Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes. PMID:16846517

The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411].

PubMed

Sturt, Jackie; Hearnshaw, Hilary; Farmer, Andrew; Dale, Jeremy; Eldridge, Sandra

2006-07-17

The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

PubMed Central

Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-01-01

Background Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) PMID:29674306

Analysis of 43 cases of Langerhans cell histiocytosis (LCH)-induced central diabetes insipidus registered in the JLSG-96 and JLSG-02 studies in Japan.

PubMed

Shioda, Yoko; Adachi, Souichi; Imashuku, Shinsaku; Kudo, Kazuko; Imamura, Toshihiko; Morimoto, Akira

2011-12-01

To determine the ability of recent systemic chemotherapy protocols to reduce the incidence of central diabetes insipidus (CDI) in Langerhans cell histiocytosis (LCH), 43 CDI cases that belonged to a cohort of 348 pediatric patients with multi-focal LCH who were treated with the JLSG-96/-02 protocols were analyzed. The overall incidence of CDI was 12.4%, but in 24 cases CDI was already present at the time LCH was diagnosed. Thus, CDI developed during or after systemic chemotherapy over a follow-up period of 5.0 (0.2-14.7) years in only 19 patients (5.9%), with 7.4% at 5-year cumulative risk by Kaplan-Meier analysis. In two cases, complete resolution of CDI was noted. Anterior pituitary hormone deficiency was detected in 13 cases, while CDI-associated neurodegenerative disease was observed in six cases. The JLSG-96/-02 protocol appears to effectively reduce the occurrence of CDI. However, novel therapeutic measures are required to reverse pre-existing CDI and to prevent CDI-associated neurological complications.

Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

PubMed Central

2012-01-01

Background Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed. Methods A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12609000469213 PMID:23035666

A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial

PubMed Central

Mahon, Lewis W; Klar, Neil S; Schulz, David C; Gonder, John R; Hramiak, Irene M; Mahon, Jeffrey L

2017-01-01

Introduction Suboptimal screening for diabetic eye disease is a major cause of preventable vision loss. Screening barriers include mydriasis and the extra time patients need to attend dedicated eye screening appointments. In the Clearsight trial, we are testing whether screening by non-mydriatic ultra-wide field (NM UWF) imaging on the day patients attend their diabetes outpatient clinic visit improves detection of clinically important eye disease compared with usual screening. Methods and analysis Patients with diabetes due for a screening eye exam by the 2013 Canadian Diabetes Association (CDA) practice guidelines are being randomised to on-site screening by NM UWF imaging on the day of their clinic visit or to usual screening where, per CDA guidelines, they are encouraged to arrange an exam by an optometrist. The primary outcome is actionable eye disease (AED) based on a need for referral to ophthalmology and/or increased ocular surveillance. The primary analysis will use an intention-to-screen approach that compares the proportions of detected AED between on-site and usual screening groups under a superiority hypothesis in favour of on-site screening. With 740 randomised participants, the study will have 80% power to detect ≥5% absolute increase in the AED rate among on-site screening versus usual screening participants. This difference translates into a number-needed-to-screen by on-site screening of 20 to detect 1 additional person with AED. Ethics and dissemination The protocol was approved by the institutional review board of Western University. The findings of the trial will be disseminated directly to participants and through peer-reviewed publications and conference presentations. Trial registration number ClinicalTrials.Gov NCT02579837 (registered 16 October 2015). Protocol issue date 18 November 2015. PMID:28775182

Intraoperative blood glucose management: impact of a real-time decision support system on adherence to institutional protocol.

PubMed

Nair, Bala G; Grunzweig, Katherine; Peterson, Gene N; Horibe, Mayumi; Neradilek, Moni B; Newman, Shu-Fang; Van Norman, Gail; Schwid, Howard A; Hao, Wei; Hirsch, Irl B; Patchen Dellinger, E

2016-06-01

Poor perioperative glycemic management can lead to negative surgical outcome. Improved compliance to glucose control protocol could lead to better glucose management. An Anesthesia Information Management System based decision support system-Smart Anesthesia Manager™ (SAM) was used to generate real-time reminders to the anesthesia providers to closely adhere to our institutional glucose management protocol. Compliance to hourly glucose measurements and correct insulin dose adjustments was compared for the baseline period (12 months) without SAM and the intervention period (12 months) with SAM decision support. Additionally, glucose management parameters were compared for the baseline and intervention periods. A total of 1587 cases during baseline and 1997 cases during intervention met the criteria for glucose management (diabetic patients or non-diabetic patients with glucose level >140 mg/dL). Among the intervention cases anesthesia providers chose to use SAM reminders 48.7 % of the time primarily for patients who had diabetes, higher HbA1C or body mass index, while disabling the system for the remaining cases. Compliance to hourly glucose measurement and correct insulin doses increased significantly during the intervention period when compared with the baseline (from 52.6 to 71.2 % and from 13.5 to 24.4 %, respectively). In spite of improved compliance to institutional protocol, the mean glucose levels and other glycemic management parameters did not show significant improvement with SAM reminders. Real-time electronic reminders improved intraoperative compliance to institutional glucose management protocol though glycemic parameters did not improve even when there was greater compliance to the protocol.

Social and economic impact of diabetics in Bangladesh: protocol for a case-control study.

PubMed

Shariful Islam, Sheikh Mohammed; Lechner, Andreas; Ferrari, Uta; Froeschl, Guenter; Niessen, Louis W; Seissler, Jochen; Alam, Dewan Shamsul

2013-12-21

Diabetes affects both individuals and their families and has an impact on economic and social development of a country. Information on the availability, cost, and quality of medical care for diabetes is mostly not available for many low- and middle-income countries including Bangladesh. Complications from diabetes, which can be devastating, could largely be prevented by wider use of several inexpensive generic medicines, simple tests and monitoring and can be a cost saving intervention. This study will provide an in-depth and comprehensive picture of social and economic impacts of diabetes in Bangladesh and propose clear recommendations for improving prevention and management of diabetes. The objectives of the study are: 1) To study the association between diabetes and other health problems and its social impacts. 2) To estimate the economic impact of diabetes including total direct and indirect costs. 3) To measure the impact of diabetes on quality of life among diabetes patients in Bangladesh. 4) To study the impact of diabetes on the health care system This is a case-control study comparing cases with type 2 diabetes to controls without diabetes matched on age, sex and place of residence. 564 cases and 564 controls will be selected from the outpatient department of a tertiary hospital in Dhaka, Bangladesh. Data on socioeconomic status, health utility index, direct and indirect costs for diabetes, medication adherence, quality of life, treatment satisfaction, diet, physical activity, mental state examination, weight, height, hip and waist circumference, blood pressure, pulse, medication history, laboratory data and physical examination will be conducted. The primary outcome measures will be association between diabetes and other health problems, cost of diabetes, impact of diabetes on quality of life and secondary outcome measures are impact of diabetes on healthcare systems in Bangladesh. This study will provide an in-depth and comprehensive picture of social and economic impacts of diabetics in Bangladesh and propose clear recommendations for improving prevention and management of diabetics. It will help to develop programs and policies for better management of Diabetics and cost effective strategies in Bangladesh context.

Social and economic impact of diabetics in Bangladesh: protocol for a case–control study

PubMed Central

2013-01-01

Background Diabetes affects both individuals and their families and has an impact on economic and social development of a country. Information on the availability, cost, and quality of medical care for diabetes is mostly not available for many low- and middle-income countries including Bangladesh. Complications from diabetes, which can be devastating, could largely be prevented by wider use of several inexpensive generic medicines, simple tests and monitoring and can be a cost saving intervention. This study will provide an in-depth and comprehensive picture of social and economic impacts of diabetes in Bangladesh and propose clear recommendations for improving prevention and management of diabetes. The objectives of the study are: 1) To study the association between diabetes and other health problems and its social impacts 2) To estimate the economic impact of diabetes including total direct and indirect costs 3) To measure the impact of diabetes on quality of life among diabetes patients in Bangladesh 4) To study the impact of diabetes on the health care system Methods This is a case–control study comparing cases with type 2 diabetes to controls without diabetes matched on age, sex and place of residence. 564 cases and 564 controls will be selected from the outpatient department of a tertiary hospital in Dhaka, Bangladesh. Data on socioeconomic status, health utility index, direct and indirect costs for diabetes, medication adherence, quality of life, treatment satisfaction, diet, physical activity, mental state examination, weight, height, hip and waist circumference, blood pressure, pulse, medication history, laboratory data and physical examination will be conducted. Outcome measures: The primary outcome measures will be association between diabetes and other health problems, cost of diabetes, impact of diabetes on quality of life and secondary outcome measures are impact of diabetes on healthcare systems in Bangladesh. Discussion This study will provide an in-depth and comprehensive picture of social and economic impacts of diabetics in Bangladesh and propose clear recommendations for improving prevention and management of diabetics. It will help to develop programs and policies for better management of Diabetics and cost effective strategies in Bangladesh context. PMID:24359558

Strengths-based behavioral intervention for parents of adolescents with type 1 diabetes using an mHealth app (Type 1 Doing Well): Protocol for a pilot randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desire...

Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial.

PubMed

Schein, Aso; Correa, Aps; Casali, Karina Rabello; Schaan, Beatriz D

2016-01-20

Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes. This study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load). Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability. ClinicalTrials.gov NCT02292810 .

Protocol for a systematic review and individual patient data meta-analysis of prognostic factors of foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS).

PubMed

Crawford, Fay; Anandan, Chantelle; Chappell, Francesca M; Murray, Gordon D; Price, Jacqueline F; Sheikh, Aziz; Simpson, Colin R; Maxwell, Martin; Stansby, Gerard P; Young, Matthew J; Abbott, Caroline A; Boulton, Andrew J M; Boyko, Edward J; Kastenbauer, Thomas; Leese, Graham P; Monami, Matteo; Monteiro-Soares, Matilde; Rith-Najarian, Stephen J; Veves, Aristidis; Coates, Nikki; Jeffcoate, William J; Leech, Nicola; Fahey, Tom; Tierney, Jayne

2013-02-15

Diabetes-related lower limb amputations are associated with considerable morbidity and mortality and are usually preceded by foot ulceration. The available systematic reviews of aggregate data are compromised because the primary studies report both adjusted and unadjusted estimates. As adjusted meta-analyses of aggregate data can be challenging, the best way to standardise the analytical approach is to conduct a meta-analysis based on individual patient data (IPD).There are however many challenges and fundamental methodological omissions are common; protocols are rare and the assessment of the risk of bias arising from the conduct of individual studies is frequently not performed, largely because of the absence of widely agreed criteria for assessing the risk of bias in this type of review. In this protocol we propose key methodological approaches to underpin our IPD systematic review of prognostic factors of foot ulceration in diabetes.Review questions;1. What are the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes?2. Can the data from each study be adjusted for a consistent set of adjustment factors?3. Does the model accuracy change when patient populations are stratified according to demographic and/or clinical characteristics? MEDLINE and EMBASE databases from their inception until early 2012 were searched and the corresponding authors of all eligible primary studies invited to contribute their raw data. We developed relevant quality assurance items likely to identify occasions when study validity may have been compromised from several sources. A confidentiality agreement, arrangements for communication and reporting as well as ethical and governance considerations are explained.We have agreement from the corresponding authors of all studies which meet the eligibility criteria and they collectively possess data from more than 17000 patients. We propose, as a provisional analysis plan, to use a multi-level mixed model, using "study" as one of the levels. Such a model can also allow for the within-patient clustering that occurs if a patient contributes data from both feet, although to aid interpretation, we prefer to use patients rather than feet as the unit of analysis. We intend to only attempt this analysis if the results of the investigation of heterogeneity do not rule it out and the model diagnostics are acceptable. This review is central to the development of a global evidence-based strategy for the risk assessment of the foot in patients with diabetes, ensuring future recommendations are valid and can reliably inform international clinical guidelines.

Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.

PubMed

Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal D

2018-06-01

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m 2 , mean eGFR was 80.7 ml/min/1.73 m 2 , and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided. NCT01829256. Copyright © 2018 Elsevier Inc. All rights reserved.

Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations

PubMed Central

Jansink, Renate; Braspenning, Jozé; van der Weijden, Trudy; Niessen, Louis; Elwyn, Glyn; Grol, Richard

2009-01-01

Background The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. Methods/Design A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm) starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids), lifestyle (diet, physical activity, smoking, and alcohol), health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months. Discussion Applying motivational interviewing for patients with diabetes in primary care has been studied, but to our knowledge, no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice. If this intervention proves to be effective and cost-effective, large-scale implementation of this nurse-oriented intervention will be considered and anticipated. Trial registration Current Controlled Trials ISRCTN68707773. PMID:19183462

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial

PubMed Central

Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-01-01

Background Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. Objective The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. Methods A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association–recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators’ monitoring of patients’ adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A1c levels, weight, and the usability of the connected system. Results An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) PMID:29610111

Appearance Investment, Quality of Life, and Metabolic Control Among Women with Type 1 Diabetes.

PubMed

Gawlik, Nicola R; Elias, Anna J; Bond, Malcolm J

2016-06-01

Concomitants of Type 1 diabetes management include weight gain and dietary restraint. Body image concerns, particularly among women, are therefore common. The study evaluated associations between the appearance investment component of body image, age, quality of life and self-reported metabolic control were examined, along with the practice of insulin restriction as a weight control strategy. A questionnaire comprising demographic and diabetes-related information, the Appearance Schemas Inventory, and Diabetes Quality of Life Brief Clinical Inventory was completed by Australian women diagnosed with type 1 diabetes (N = 177). Self-evaluative salience was higher among younger participants, those with a lower quality of life, and those with better metabolic control of their diabetes, with the relationships between metabolic control and all of age, quality of life, and self-evaluative salience noted to be non-linear. Among participants who reported restricting insulin for weight control, self-evaluative salience was particularly relevant. Motivational salience was not related to other study variables. Clinically, the provision of information regarding appearance changes that might arise in order to mitigate later body image difficulties is a potentially beneficial adjunct to standard diabetes management protocols that may lead to more successful disease adjustment.

Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: protocol for a randomized controlled trial.

PubMed

Ribu, Lis; Holmen, Heidi; Torbjørnsen, Astrid; Wahl, Astrid Klopstad; Grøttland, Astrid; Småstuen, Milada Cvancarova; Elind, Elisabeth; Bergmo, Trine Strand; Breivik, Elin; Arsand, Eirik

2013-08-26

The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project-REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients' registrations on the application are recorded continuously and are sent securely to a server. The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients' health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

PubMed Central

Holmen, Heidi; Torbjørnsen, Astrid; Wahl, Astrid Klopstad; Grøttland, Astrid; Småstuen, Milada Cvancarova; Elind, Elisabeth; Bergmo, Trine Strand; Breivik, Elin; Årsand, Eirik

2013-01-01

Background The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Trial Registration Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH). PMID:23978690

Improving outcomes in patients with coexisting multimorbid conditions-the development and evaluation of the combined diabetes and renal control trial (C-DIRECT): study protocol.

PubMed

Griva, Konstadina; Mooppil, Nandakumar; Khoo, Eric; Lee, Vanessa Yin Woan; Kang, Augustine Wee Cheng; Newman, Stanton P

2015-02-12

Diabetes mellitus (DM) is the most common cause of end-stage renal disease (ESRD). Patients with diabetes on dialysis have worse clinical outcomes and increased psychological burden. The need to manage the combined treatment demands for both conditions is particularly challenging yet there is paucity of data of the barriers preventing optimal management to combined therapy for diabetes and kidney failure. The study aims to explore needs of patients and develop an intervention to enable people with diabetes and ESRD to better manage both their conditions. A two-phase study comprising a mixed method observational study (phase I) and a feasibility trial (phase II). Phase I will seek to document outcomes and needs of the population (patients with DM-ESRD) and seek input on preferred delivery/implementation for the programme. Data will be collected with in-depth interviews with patients, caregivers and healthcare providers (N=50), and from a questionnaire-based survey (N=170). Phase 2 will build on these data to design and test the feasibility of a practical, low-intensity, clinic-integrated intervention using a self-management paradigm. The intervention will primarily seek to support behavioural change so as to improve adherence and clinical outcomes for DM as well as for ESRD. For the feasibility trial, we will be evaluating acceptability, retention and completion rates of the programme. The study protocol has been approved by the local ethics committee and written informed consent is required from every participant. Findings will be disseminated through journals, conferences and will be used to create a fully manualised intervention (materials) and training course for facilitators. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Client perceptions of group education in the management of type 2 diabetes mellitus in South Australia.

PubMed

Smith, Cynthia; McNaughton, Darlene A; Meyer, Samantha

2016-01-01

Type 2 diabetes mellitus (T2DM) is a progressive chronic disease that requires significant self-surveillance and adherence to the treatment protocols for successful management and future health. There is a growing body of evidence suggesting that diabetes education is beneficial for patient outcomes. However, there is some debate about how best to deliver diabetes education, whether individually or in groups. Although several studies have investigated the role of group education in improving the management of T2DM, few studies have examined this issue from the client's perspective. It is here that this study makes a contribution to understanding diabetes management. Drawing on systematic observation of group education sessions provided by diabetic resource nurses and in-depth interviews with clients, this paper describes the experiences, perspectives and significance of these sessions to clients. Our results suggest that group education sessions were seen as valuable to the clients for: the opportunity they provided to meet others living with diabetes; to improve motivation for managing the disease; and to enhance knowledge of diabetes, its management and long-term implications. In short, this study demonstrates that the clients value group education sessions for the social contact, increasing knowledge about the disease for self-management and support they provide; factors recognised as important to maintaining health. In addition, group education sessions appear to be a cost-effective method for diabetes self-management that funders need to consider.

Information needs in people with diabetes mellitus: a systematic review.

PubMed

Biernatzki, Lisa; Kuske, Silke; Genz, Jutta; Ritschel, Michaela; Stephan, Astrid; Bächle, Christina; Droste, Sigrid; Grobosch, Sandra; Ernstmann, Nicole; Chernyak, Nadja; Icks, Andrea

2018-02-14

The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors. Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically. In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including 'treatment-process', 'course of disease', 'abnormalities of glucose metabolism' and 'diabetes through the life cycle'. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums. Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course. The review protocol has been registered at Prospero ( CRD42015029610 ).

Social support systems as determinants of self-management and quality of life of people with diabetes across Europe: study protocol for an observational study.

PubMed

Koetsenruijter, Jan; van Lieshout, Jan; Vassilev, Ivaylo; Portillo, Mari Carmen; Serrano, Manuel; Knutsen, Ingrid; Roukova, Poli; Lionis, Christos; Todorova, Elka; Foss, Christina; Rogers, Anne; Wensing, Michel

2014-03-04

Long-term conditions pose major challenges for healthcare systems. Optimizing self-management of people with long-term conditions is an important strategy to improve quality of life, health outcomes, patient experiences in healthcare, and the sustainability of healthcare systems. Much research on self-management focuses on individual competencies, while the social systems of support that facilitate self-management are underexplored. The presented study aims to explore the role of social systems of support for self-management and quality of life, focusing on the social networks of people with diabetes and community organisations that serve them. The protocol concerns a cross-sectional study in 18 geographic areas in six European countries, involving a total of 1800 individuals with diabetes and 900 representatives of community organisations. In each country, we include a deprived rural area, a deprived urban area, and an affluent urban area. Individuals are recruited through healthcare practices in the targeted areas. A patient questionnaire comprises measures for quality of life, self-management behaviours, social network and social support, as well as individual characteristics. A community organisations' survey maps out interconnections between community and voluntary organisations that support patients with chronic illness and documents the scope of work of the different types of organisations. We first explore the structure of social networks of individuals and of community organisations. Then linkages between these social networks, self-management and quality of life will be examined, taking deprivation and other factors into account. This study will provide insight into determinants of self-management and quality of life in individuals with diabetes, focusing on the role of social networks and community organisations.

Protocol of GLUcose COntrol Safety and Efficacy in type 2 DIabetes, a NETwork meta-analysis: GLUCOSE DINET protocol-Rational and design.

PubMed

Grenet, Guillaume; Lajoinie, Audrey; Ribault, Shams; Nguyen, Gia Bao; Linet, Thomas; Metge, Augustin; Cornu, Catherine; Cucherat, Michel; Moulin, Philippe; Gueyffier, François

2017-06-01

The aim of this study was to propose a ranking of the currently available antidiabetic drugs, regarding vascular clinical outcomes, in patients with type 2 diabetes, through a network meta-analysis approach. Randomized clinical trials, regardless of the blinding design, testing contemporary antidiabetic drugs, and considering clinically relevant outcomes in patients with type 2 diabetes mellitus will be included. The primary outcomes of this analysis will be overall mortality, cardiovascular mortality, and major cardiovascular events. Diabetic microangiopathy will be a secondary outcome. Adverse events, hypoglycemia, weight evolution, bariatric surgery, and discontinuation of the treatment will also be recorded. Each drug will be analyzed according to its therapeutic class: biguanide, alpha-glucosidase inhibitors, sulfonylureas, glitazones, glinides, insulin, DPP-4 inhibitors, GLP-1 analogs, and gliflozins. The treatment effect of each drug class will be compared using pairwise meta-analysis and a Bayesian random model network meta-analysis. Sensitivity analyses will be conducted according to the quality of the studies and the glycemic control. The report will follow the PRISMA checklist for network meta-analysis. Results of the search strategy and of the study selection will be presented in a PRISMA compliant flowchart. The treatment effects will be summarized with odds ratio (OR) estimates and their 95% credible intervals. A ranking of the drugs will be proposed. Our network meta-analysis should allow a clinically relevant ranking of the contemporary antidiabetic drugs. © 2016 Société Française de Pharmacologie et de Thérapeutique.

Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.

PubMed

Padwal, Raj; McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

2016-06-24

Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension. A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).

Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

PubMed Central

McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

2016-01-01

Background Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc) PMID:27343147

Improving mental health of adolescents with Type 1 diabetes: protocol for a randomized controlled trial of the Nothing Ventured Nothing Gained online adolescent and parenting support intervention

PubMed Central

2013-01-01

Background Management of Type 1 diabetes comes with substantial personal and psychological demands particularly during adolescence, placing young people at significant risk for mental health problems. Supportive parenting can mitigate these risks, however the challenges associated with parenting a child with a chronic illness can interfere with a parent’s capacity to parent effectively. Interventions that provide support for both the adolescent and their parents are needed to prevent mental health problems in adolescents; to support positive parent-adolescent relationships; and to empower young people to better self-manage their illness. This paper presents the research protocol for a study evaluating the efficacy of the Nothing Ventured Nothing Gained online adolescent and parenting intervention which aims to improve the mental health outcomes of adolescents with Type 1 diabetes. Method/Design A randomized controlled trial using repeated measures with two arms (intervention and wait-list control) will be used to evaluate the efficacy and acceptability of the online intervention. Approximately 120 adolescents with Type 1 diabetes, aged 13–18 years and one of their parents/guardians will be recruited from pediatric diabetes clinics across Victoria, Australia. Participants will be randomized to receive the intervention immediately or to wait 6 months before accessing the intervention. Adolescent, parent and family outcomes will be assessed via self-report questionnaires at three time points (baseline, 6 weeks and 6 months). The primary outcome is improved adolescent mental health (depression and anxiety). Secondary outcomes include adolescent behavioral (diabetes self-management and risk taking behavior), psychosocial (diabetes relevant quality of life, parent reported child well-being, self-efficacy, resilience, and perceived illness benefits and burdens); metabolic (HbA1c) outcomes; parent psychosocial outcomes (negative affect and fatigue, self-efficacy, and parent experience of child illness); and family outcomes (parent and adolescent reported parent-adolescent communication, responsibility for diabetes care, diabetes related conflict). Process variables including recruitment, retention, intervention completion and intervention satisfaction will also be assessed. Discussion The results of this study will provide valuable information about the efficacy, acceptability and therefore the viability of delivering online interventions to families affected by chronic illnesses such as Type 1 diabetes. Trial registration Australian New Zealand clinical trials registry (ANZCTR); ACTRN12610000170022 PMID:24341465

The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial).

PubMed

Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal; Ascione, Raimondo

2017-06-19

Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to "fit for discharge", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were "fit for discharge", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK). ©Madeleine Clout, Tracy Harris, Chris Rogers, Lucy Culliford, Jodi Taylor, Gianni Angelini, Pradeep Narayan, Barnaby Reeves, James Hillier, Kate Ashton, Kunal Sarkar, Raimondo Ascione. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.06.2017.

MANAGEMENT OF DIABETES DURING AIR TRAVEL: A SYSTEMATIC LITERATURE REVIEW OF CURRENT RECOMMENDATIONS AND THEIR SUPPORTING EVIDENCE.

PubMed

Pavela, James; Suresh, Rahul; Blue, Rebecca S; Mathers, Charles H; Belalcazar, L Maria

2018-02-01

Individuals with diabetes are increasingly seeking pretravel advice, but updated professional recommendations remain scant. We performed a systematic review on diabetes management during air travel to summarize current recommendations, assess supporting evidence, and identify areas of future research. A systematic review of the English literature on diabetes management during air travel was undertaken utilizing PubMed and MEDLINE. Publications regarding general travel advice; adjustment of insulin and noninsulin therapies; and the use of insulin pumps, glucometers and subcutaneous glucose sensors at altitude were included. Gathered information was used to create an updated summary of glucose-lowering medication adjustment during air travel. Sixty-one publications were identified, most providing expert opinion and few offering primary data (47 expert opinion, 2 observational studies, 2 case reports, 10 device studies). General travel advice was uniform, with increasing attention to preflight security. Indications for oral antihyperglycemic therapy adjustments varied. There were few recommendations on contemporary agents and on nonhypoglycemic adverse events. There was little consensus on insulin adjustment protocols, many antedating current insulin formulations. Most publications advocated adjusting insulin pump time settings after arrival; however, there was disagreement on timing and rate adjustments. Glucometers and subcutaneous glucose sensors were reported to be less accurate at altitude, but not to an extent that would preclude their clinical use. Recommendations for diabetes management during air travel vary significantly and are mostly based on expert opinion. Data from systematic investigation on glucose-lowering medication adjustment protocols may support the development of a future consensus statement. CSII = continuous subcutaneous insulin infusion (device) DPP-4 = dipeptidyl peptidase 4 EGA = error grid analysis GDH = glucose dehydrogenase GOX = glucose oxidase GLP1 = glucagon-like peptide-1 NPH = neutral protamine Hagedorn SGLT2 = sodium-glucose cotransporter-2.

The INTERPRET-DD study of diabetes and depression: a protocol.

PubMed

Lloyd, C E; Sartorius, N; Cimino, L C; Alvarez, A; Guinzbourg de Braude, M; Rabbani, G; Uddin Ahmed, H; Papelbaum, M; Regina de Freitas, S; Ji, L; Yu, X; Gaebel, W; Müssig, K; Chaturvedi, S K; Srikanta, S S; Burti, L; Bulgari, V; Musau, A; Ndetei, D; Heinze, G; Romo Nava, F; Taj, R; Khan, A; Kokoszka, A; Papasz-Siemieniuk, A; Starostina, E G; Bobrov, A E; Lecic-Tosevski, D; Lalic, N M; Udomratn, P; Tangwongchai, S; Bahendeka, S; Basangwa, D; Mankovsky, B

2015-07-01

People with diabetes are at an increased risk of developing depression and other psychological disorders. However, little is known about the prevalence, correlates or care pathways in countries other than the UK and the USA. A new study, the International Prevalence and Treatment of Diabetes and Depression Study (INTERPRET-DD) aims to address this dearth of knowledge and identify optimal pathways to care across the globe. INTERPRET-DD is a 2-year longitudinal study, taking place in 16 countries' diabetes outpatients' facilities, investigating the recognition and management of depressive disorders in people with Type 2 diabetes. Clinical interviews are used to diagnose depression, with clinical and other data obtained from medical records and through patient interviews. Pathways to care and the impact of treatment for previously unrecognized (undocumented) depression on clinical outcomes and emotional well-being are being investigated. Initial evidence indicates that a range of pathways to care exist, with few of them based on available recommendations for treatment. Pilot data indicates that the instruments we are using to measure both the symptoms and clinical diagnosis of depression are acceptable in our study population and easy to use. Our study will increase the understanding of the impact of comorbid diabetes and depression and identify the most appropriate (country-specific) pathways via which patients receive their care. It addresses an important public health problem and leads to recommendations for best practice relevant to the different participating centres with regard to the identification and treatment of people with comorbid diabetes and depression. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

Nurse-patient communication in primary care diabetes management: an exploratory study

PubMed Central

2013-01-01

Background Diabetes is a major health issue for individuals and for health services. There is a considerable literature on the management of diabetes and also on communication in primary care consultations. However, few studies combine these two topics and specifically in relation to nurse communication. This paper describes the nature of nurse-patient communication in diabetes management. Methods Thirty-five primary health care consultations involving 18 patients and 10 nurses were video-recorded as part of a larger multi-site study tracking health care interactions between health professionals and patients who were newly diagnosed with Type 2 diabetes. Patients and nurses were interviewed separately at the end of the 6-month study period and asked to describe their experience of managing diabetes. The analysis used ethnography and interaction analysis. In addition to analysis of the recorded consultations and interviews, the number of consultations for each patient and total time spent with nurses and other health professionals were quantified and compared. Results This study showed that initial consultations with nurses often incorporated completion of extensive checklists, physical examination, referral to other health professionals and distribution of written material, and were typically longer than consultations with other health professionals. The consultations were driven more by the nurses’ clinical agenda than by what the patient already knew or wanted to know. Interactional analysis showed that protocols and checklists both help and hinder the communication process. This contradictory outcome was also evident at a health systems level: although organisational targets may have been met, the patient did not always feel that their priorities were attended to. Both nurses and patients reported a sense of being overwhelmed arising from the sheer volume of information exchanged along with a mismatch in expectations. Conclusions Conscientious nursing work was evident but at times misdirected in terms of optimal use of time. The misalignment of patient expectations and clinical protocols highlights a common dilemma in clinical practice and raises questions about the best ways to balance the needs of individuals with the needs of a health system. Video- recording can be a powerful tool for reflection and peer review. PMID:24028348

Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study

PubMed Central

Stidsen, Jacob Volmer; Nielsen, Jens Steen; Henriksen, Jan Erik; Friborg, Søren Gunnar; Olesen, Thomas Bastholm; Olsen, Michael Hecht; Beck-Nielsen, Henning

2017-01-01

Introduction We present the protocol for a multifactorial intervention study designed to test whether individualised treatment, based on pathophysiological phenotyping and individualised treatment goals, improves type 2 diabetes (T2D) outcomes. Methods and analysis We will conduct a prospective controlled multicentre open-label intervention study, drawing on the longitudinal cohort of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2). New clinically diagnosed patients with T2D in the intervention group will be assigned to receive individualised treatment by their general practitioner. Intervention patients will be compared with a matched control cohort of DD2 patients receiving routine clinical care. Among intervention patients, we will first do pathophysiological phenotyping to classify patients into WHO-defined T2D or other specific types of diabetes (monogenic diabetes, secondary diabetes etc). Patients with WHO-defined T2D will then be further subcharacterised by their beta-cell function (BCF) and insulin sensitivity (IS), using the revised homeostatic assessment model, as having either insulinopaenic T2D (high IS and low BCF), classical T2D (low IS and low BCF) or hyperinsulinaemic T2D (low IS and high BCF). For each subtype, a specific treatment algorithm will target the primary pathophysiological defect. Similarly, antihypertensive treatment will be targeted at the specific underlying pathophysiology, characterised by impedance cardiography (relative importance of vascular resistance, intravascular volume and cardiac inotropy). All treatment goals will be based on individual patient assessment of expected positive versus adverse effects. Web-based and face-to-face individualised lifestyle intervention will also be implemented to empower patients to make a sustainable improvement in daily physical activity and to change to a low-carbohydrate diet. Ethics and dissemination The study will use well-known pharmacological agents according to their labels; patient safety is therefore considered high. Study results will be published in international peer-reviewed journals. Trial registration number NCT02015130; Pre-results. PMID:29229652

β-Glucans (Saccharomyces cereviseae) Reduce Glucose Levels and Attenuate Alveolar Bone Loss in Diabetic Rats with Periodontal Disease

PubMed Central

2015-01-01

The objective of this study was to assess the effects of oral ingestion of β-glucans isolated from Saccharomyces cereviseae on the metabolic profile, expression of gingival inflammatory markers and amount of alveolar bone loss in diabetic rats with periodontal disease. Diabetes mellitus was induced in 48 Wistar rats by intraperitoneal injection of streptozotocin (80 mg/kg). After confirming the diabetes diagnosis, the animals were treated with β-glucans (by gavage) for 28 days. On the 14th day of this period, periodontal disease was induced using a ligature protocol. β-glucans reduced the amount of alveolar bone loss in animals with periodontal disease in both the diabetic and non-diabetic groups (p < 0.05). β-glucans reduced blood glucose, cholesterol and triacylglycerol levels in diabetic animals, both with and without periodontal disease (p < 0.05). Furthermore, treatment with β-glucans reduced the expression of cyclooxygenase-2 and receptor activator of nuclear factor kappa-B ligand and increased osteoprotegerin expression in animals with diabetes and periodontal disease (p < 0.05). It was concluded that treatment with β-glucans has beneficial metabolic and periodontal effects in diabetic rats with periodontal disease. PMID:26291983

Acute Changes in Heart Rate Variability in Subjects With Diabetes Following a Highway Traffic Exposure

PubMed Central

Laumbach, Robert J.; Rich, David Q.; Gandhi, Sampada; Amorosa, Louis; Schneider, Stephen; Zhang, Junfeng; Ohman-Strickland, Pamela; Gong, Jicheng; Lelyanov, Oleksiy; Kipen, Howard M.

2014-01-01

Objective To pilot a protocol to evaluate acute cardiovascular effects in in-vehicle exposure to traffic air pollutants in people with diabetes. Methods Twenty-one volunteers with type 2 diabetes were passengers on 90- to 110-minute car rides on a busy highway. We measured in-vehicle particle number and mass (PM2.5) nitrogen dioxide, and carbon monoxide and heart rate, heart rate variability (HRV), and blood pressure. Results Compared with pre-ride measurements, we found a decrease in high frequency (HF) HRV from pre-ride to next day (ratio 0.66, 95% CI = 0.47 to 0.93) and an increase in low frequency to HF ratio at post-ride (ratio 1.92, 95% CI = 1.21 to 3.05) at post-ride. Interquartile range increases in measured pollutants were associated with next-day decreases in HR HRV. Conclusions This protocol appears useful for assessing acute adverse cardiovascular effects of in-vehicle exposures among people who have diabetes. PMID:20190650

Gestational diabetes insipidus, HELLP syndrome and eclampsia in a twin pregnancy: a case report.

PubMed

Woelk, J L; Dombroski, R A; Brezina, P R

2010-02-01

We report a case of eclampsia in a twin pregnancy complicated by HELLP syndrome and diabetes insipidus. This confluence of disease processes suggests that a modification of common magnesium sulfate treatment protocols may be appropriate in a certain subset of patients.

Quantitative assessment of early diabetic retinopathy using fractal analysis.

PubMed

Cheung, Ning; Donaghue, Kim C; Liew, Gerald; Rogers, Sophie L; Wang, Jie Jin; Lim, Shueh-Wen; Jenkins, Alicia J; Hsu, Wynne; Li Lee, Mong; Wong, Tien Y

2009-01-01

Fractal analysis can quantify the geometric complexity of the retinal vascular branching pattern and may therefore offer a new method to quantify early diabetic microvascular damage. In this study, we examined the relationship between retinal fractal dimension and retinopathy in young individuals with type 1 diabetes. We conducted a cross-sectional study of 729 patients with type 1 diabetes (aged 12-20 years) who had seven-field stereoscopic retinal photographs taken of both eyes. From these photographs, retinopathy was graded according to the modified Airlie House classification, and fractal dimension was quantified using a computer-based program following a standardized protocol. In this study, 137 patients (18.8%) had diabetic retinopathy signs; of these, 105 had mild retinopathy. Median (interquartile range) retinal fractal dimension was 1.46214 (1.45023-1.47217). After adjustment for age, sex, diabetes duration, A1C, blood pressure, and total cholesterol, increasing retinal vascular fractal dimension was significantly associated with increasing odds of retinopathy (odds ratio 3.92 [95% CI 2.02-7.61] for fourth versus first quartile of fractal dimension). In multivariate analysis, each 0.01 increase in retinal vascular fractal dimension was associated with a nearly 40% increased odds of retinopathy (1.37 [1.21-1.56]). This association remained after additional adjustment for retinal vascular caliber. Greater retinal fractal dimension, representing increased geometric complexity of the retinal vasculature, is independently associated with early diabetic retinopathy signs in type 1 diabetes. Fractal analysis of fundus photographs may allow quantitative measurement of early diabetic microvascular damage.

Retinal microaneurysm count predicts progression and regression of diabetic retinopathy. Post-hoc results from the DIRECT Programme.

PubMed

Sjølie, A K; Klein, R; Porta, M; Orchard, T; Fuller, J; Parving, H H; Bilous, R; Aldington, S; Chaturvedi, N

2011-03-01

To study the association between baseline retinal microaneurysm score and progression and regression of diabetic retinopathy, and response to treatment with candesartan in people with diabetes. This was a multicenter randomized clinical trial. The progression analysis included 893 patients with Type 1 diabetes and 526 patients with Type 2 diabetes with retinal microaneurysms only at baseline. For regression, 438 with Type 1 and 216 with Type 2 diabetes qualified. Microaneurysms were scored from yearly retinal photographs according to the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Retinopathy progression and regression was defined as two or more step change on the ETDRS scale from baseline. Patients were normoalbuminuric, and normotensive with Type 1 and Type 2 diabetes or treated hypertensive with Type 2 diabetes. They were randomized to treatment with candesartan 32 mg daily or placebo and followed for 4.6 years. A higher microaneurysm score at baseline predicted an increased risk of retinopathy progression (HR per microaneurysm score 1.08, P < 0.0001 in Type 1 diabetes; HR 1.07, P = 0.0174 in Type 2 diabetes) and reduced the likelihood of regression (HR 0.79, P < 0.0001 in Type 1 diabetes; HR 0.85, P = 0.0009 in Type 2 diabetes), all adjusted for baseline variables and treatment. Candesartan reduced the risk of microaneurysm score progression. Microaneurysm counts are important prognostic indicators for worsening of retinopathy, thus microaneurysms are not benign. Treatment with renin-angiotensin system inhibitors is effective in the early stages and may improve mild diabetic retinopathy. Microaneurysm scores may be useful surrogate endpoints in clinical trials. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Outcomes in the offspring of mothers with pre-diabetes during pregnancy: a protocol for a systematic review.

PubMed

Swaleh, Rukia; Zeng, Ling; Mbuagbaw, Lawrence; Morrison, Katherine M

2015-05-10

Despite the increasing prevalence of pre-diabetes worldwide, there is insufficient literature on the impact of gestational pre-diabetes on offspring outcomes. The objective of this systematic review is to determine the risk of developing adverse outcomes for the offspring in women with pre-diabetes compared to women with normal glucose levels and women with gestational diabetes mellitus. A systematic search of the published literature will be conducted for experimental and observational studies that report outcomes in the offspring of mothers with pre-diabetes during pregnancy. Databases including EMBASE, PsycINFO, and PubMed will be searched from 1979 (the year when the terms impaired glucose tolerance and pre-diabetes were coined) to December 2014. Screening of identified articles and data extraction will be conducted in duplicate and independently. Methodological quality of the included studies will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus or by consulting a third author. Meta-analyses will be performed, and findings will be reported according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) and the meta-analysis of observational studies in epidemiology (MOOSE) guidelines. Determining the effect of pre-diabetes on offspring outcome will be important for clinicians providing care to pregnant women and their offspring. This review will also identify any gaps in the current literature on this topic and provide direction for future research in this area of study. PROSPERO CRD42015015536.

Evaluation of current trends and recent development in insulin therapy for management of diabetes mellitus.

PubMed

Nawaz, Muhammad Sarfraz; Shah, Kifayat Ullah; Khan, Tahir Mehmood; Rehman, Asim Ur; Rashid, Haroon Ur; Mahmood, Sajid; Khan, Shahzeb; Farrukh, Muhammad Junaid

2017-12-01

Diabetes mellitus is a major health problem in developing countries. There are various insulin therapies to manage diabetes mellitus. This systematic review evaluates various insulin therapies for management of diabetes mellitus worldwide. This review also focuses on recent developments being explored for better management of diabetes mellitus. We reviewed a number of published articles from 2002 to 2016 to find out the appropriate management of diabetes mellitus. The paramount parameters of the selected studies include the insulin type & its dose, type of diabetes, duration and comparison of different insulin protocols. In addition, various newly developed approaches for insulin delivery with potential output have also been evaluated. A great variability was observed in managing diabetes mellitus through insulin therapy and the important controlling factors found for this therapy include; dose titration, duration of insulin use, type of insulin used and combination therapy of different insulin. A range of research articles on current trends and recent advances in insulin has been summarized, which led us to the conclusion that multiple daily insulin injections or continuous subcutaneous insulin infusion (insulin pump) is the best method to manage diabetes mellitus. In future perspectives, development of the oral and inhalant insulin would be a tremendous breakthrough in Insulin therapy. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Generation of high-yield insulin producing cells from human bone marrow mesenchymal stem cells.

PubMed

Jafarian, Arefeh; Taghikhani, Mohammad; Abroun, Saeid; Pourpak, Zahra; Allahverdi, Amir; Soleimani, Masoud

2014-07-01

Allogenic islet transplantation is a most efficient approach for treatment of diabetes mellitus. However, the scarcity of islets and long term need for an immunosuppressant limits its application. Recently, cell replacement therapies that generate of unlimited sources of β cells have been developed to overcome these limitations. In this study we have described a stage specific differentiation protocol for the generation of insulin producing islet-like clusters from human bone marrow mesenchymal stem cells (hBM-MSCs). This specific stepwise protocol induced differentiation of hMSCs into definitive endoderm, pancreatic endoderm and pancreatic endocrine cells that expressed of sox17, foxa2, pdx1, ngn3, nkx2.2, insulin, glucagon, somatostatin, pancreatic polypeptide, and glut2 transcripts respectively. In addition, immunocytochemical analysis confirmed protein expression of the above mentioned genes. Western blot analysis discriminated insulin from proinsulin in the final differentiated cells. In derived insulin producing cells (IPCs), secreted insulin and C-peptide was in a glucose dependent manner. We have developed a protocol that generates effective high-yield human IPCs from hBM-MSCs in vitro. These finding suggest that functional IPCs generated by this procedure can be used as a cell-based approach for insulin dependent diabetes mellitus.

The comparison of muscle strength and short-term endurance in the different periods of type 2 diabetes

PubMed Central

2014-01-01

Background Patients with type 2 diabetes (T2DM) are subjected to reduction in the quality and oxidative capacity of muscles. The effect of duration of diabetes on the muscle endurance response is not clear and strength as well. Objective The aim of this study was the assessment of strength and endurance of knee extensor and flexor in the patients with T2DM < 10 and T2DM > 10 years in comparison with age, sex, BMI, ABI and PAI-matched health control subjects. Methods Isometric maximal peak torque (MPT) of knee extensor and flexor before and after 40 isokinetic repetitions with velocity of 150 degree/s were recorded in 18 patients with T2DM < 10 Y , 12 patients with T2DM > 10 Y and 20 matched health control (HC) groups. Results Both diabetic patient groups had significant lower isometric and isotonic knee extensor and flexor strength than HC. The endurance indices indicated that whereas the isometric MPT of flexor movement was reduced after isokinetic protocol in the both patient groups in comparison with HC, the less decline was seen in the isotonic torque and work during isokinetic protocol in the T2DM > 10 Y group in comparison with two other groups. The HbA1c and FPG were significantly correlated with strength not with endurance indices. Conclusions It seems the progression of diabetes accompanied with vascular, neural and muscular deficits activate, some adaptive and compensatory processes which can maintain muscle performance. PMID:24476108

Protocol for Psychopharmacologic Management of Behavioral Health Comorbidity in Adult Patients with Diabetes and Soft Tissue Infections in a Tertiary Care Hospital Setting.

PubMed

Pinkhasov, Aaron; Singh, Deepan; Kashan, Benjamin; DiGregorio, Julie; Criscitelli, Theresa M; Gorenstein, Scott; Brem, Harold

2016-11-01

To provide information about the effect of psychiatric comorbidities on wound healing in patients with diabetes mellitus (DM). This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. After participating in this educational activity, the participant should be better able to:1. Discuss the connection between DM and the development of psychiatric comorbidities.2. Identify the drugs recommended in the treatment of these psychiatric comorbidities.3. List cautions and contraindications related to the drugs discussed. In patients with diabetes mellitus type 2, psychiatric comorbidities such as depressive and anxiety disorders are 60% or more prevalent than in the general population. The severity of mental illness and the duration of diabetes have been shown to correlate with worsening glycemic control, thus impeding wound healing. A retrospective chart review was conducted in all patients with diabetes mellitus admitted to the wound service with prior or current psychiatric symptoms of anxiety, depression, or cognitive impairment. A psychopharmacologic protocol was developed based on the clinical data collected and treatment parameters used by the behavioral health consultation liaison service.

CAN ULTRASOUND ABDOMEN HELP IN EARLY DIAGNOSIS OF DIABETES MELLITUS? AN OBSERVATIONAL STUDY.

PubMed

Anwar, Javed; Aamir, Muhammad Omer; Sanaullah; Imdad, Zeeshan ul Hasnain; Parveen, Ishrat; Yousaf, Nasreen

2015-01-01

Diabetes mellitus is a common disease. Similarly, ultrasound findings of fatty change and renal crystals are commonly seen on ultrasound. In the personal observation of the main author over the past so many years it was noticed that Diabetes Mellitus, Fatty liver and renal crystals all sit well together. This study tries to establish a relationship between diabetes mellitus renal echogenic foci and fatty liver. This study is first of its kind, as nobody has ever before investigated an association between the renal echogenic foci and fatty liver in relation to diabetes mellitus. This cross-sectional, observational study was conducted at Radiology Department Combined Military Hospital, Kohat From 2nd June 2013 to 30th May 2014. Three hundred patients were collected on the basis of having fatty liver and renal echogenic foci on ultrasound and three hundred more patients were collected who had no fatty liver or renal echogenic foci on ultrasound. Their labs were done for diabetes mellitus. The patients having renal echogenic foci together with fatty liver had 83% positive rate of being diabetics, while patients with no fatty liver and no echogenic foci on ultrasonography had only 0.6% Positive rate of being diabetics. Our results provided the first demonstration of an association between renal echogenic foci together with fatty liver with the diabetes mellitus. Thus ultrasound examination of abdomen can be helpful in its early diagnosis if we make a protocol of doing fasting and random blood sugars in all those patients who have positive renal echogenic foci and fatty liver on their ultrasound examination.

Maternal and fetal outcome of mothers with gestational diabetes mellitus attending BIRDEM Hospital.

PubMed

Sajani, T T; Rahman, M T; Karim, M R

2014-04-01

Gestational diabetes mellitus, most of which progress to type-2 diabetes mellitus is increasing worldwide. Identification of gestational diabetes and control of glucose can reduce such complications and improve maternal and neonatal health. A hospital based cross sectional study was conducted to find out maternal and fetal outcome of gestational diabetes from January to July 2011. Data were collected from 109 gestational diabetes mothers attending Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) hospital for delivery. Study revealed that gestational diabetes was more common among mothers aged >25 years old and multiparaous women. Mean gestational age of diagnosis was 16.82±9.54 weeks. Sixty eight (68%) mothers were diagnosed before 20 weeks of gestation and more than 90% mothers with gestational diabetes delivered by caesarean section. Mean pregnancy weight gain was 6.8±1.18kg. Adverse maternal outcome observed in 24% cases and adverse fetal outcome was present in 34% cases. In univariate analysis weeks of delivery and fasting blood sugar were statistically significantly associated with adverse pregnancy outcome. Babies born to mothers with only diet restriction had less birth weight than mothers with insulin therapy. Pregnancy thought to be the most vulnerable stage of women's life and protecting her health along with her fetus during this period yields a positive impact on the health of future generation. Particular attention should be given during antenatal period to initiate screening programme and treatment protocol for gestational diabetic mothers.

Nephrogenic diabetes insipidus: treat with caution.

PubMed

Boussemart, Thierry; Nsota, Jacqueline; Martin-Coignard, Dominique; Champion, Gérard

2009-09-01

Current therapy for congenital nephrogenic diabetes insipidus consists of appropriate water intake coupled with decreased urine output obtained by means of a low-sodium diet and a combination of thiazide diuretics with renal prostaglandins inhibitors or amiloride. We report a case of congenital nephrogenic diabetes insipidus that was complicated by paradoxical water intoxication secondary to liberal water intake and the initiation of hydrochlorothiazide and indomethacin combination therapy. This report emphasizes the importance of evaluating the water balance and of a quick response with strict protocols following the initiation of indomethacin and thiazide diuretics in nephrogenic diabetes insipidus.

Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

PubMed

Muralidharan, Shruti; Mohan, Viswanathan; Anjana, Ranjit Mohan; Jena, Sidhant; Tandon, Nikhil; Allender, Steven; Ranjani, Harish

2017-12-12

The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television-based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http://www.webcitation.org/6urCS5kMB). ©Shruti Muralidharan, Viswanathan Mohan, Ranjit Mohan Anjana, Sidhant Jena, Nikhil Tandon, Steven Allender, Harish Ranjani. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.12.2017.

Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study.

PubMed

Chan, Juliana C; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K; Yeung, Vincent T; Leung, Wilson Y; Tong, Peter C

2009-06-01

Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150-350 micromol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 micromol/l or dialysis). Of these 205 patients (mean +/- SD age 65 +/- 7.2 years; disease duration 14 +/- 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 +/- 12 vs. 71 +/- 12 mmHg, respectively, P = 0.02; A1C 7.3 +/- 1.3 vs. 8.0 +/- 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained >or=3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained >or=3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21-0.86] compared with that of those who attained

Nitric oxide and oxidative stress is associated with severity of diabetic retinopathy and retinal structural alterations.

PubMed

Sharma, Shashi; Saxena, Sandeep; Srivastav, Khushboo; Shukla, Rajendra K; Mishra, Nibha; Meyer, Carsten H; Kruzliak, Peter; Khanna, Vinay K

2015-07-01

The aim of the study was to determine plasma nitric oxide (NO) and lipid peroxide (LPO) levels in diabetic retinopathy and its association with severity of disease. Prospective observational study. A total of 60 consecutive cases and 20 healthy controls were included. Severity of retinopathy was graded according to early treatment diabetic retinopathy study (ETDRS) classification. Photoreceptor inner segment ellipsoid band (ISel) disruption and retinal pigment epithelium (RPE) alteration were graded using spectral domain optical coherence tomography. Data were statistically analyzed. Plasma thiobarbituric acid reactive substances, NO assay and reduced glutathione (GSH) were measured using standard protocol. Increased severity of diabetic retinopathy was significantly associated with increase in plasma levels of LPO (P < 0.05), NO (P < 0.001) and decrease in plasma levels of GSH (P < 0.0001), ISel disruption (P < 0.001) and RPE topographic alteration (P < 0.01). Increased plasma NO levels are associated with increased severity of diabetic retinopathy. For the first time, it has been demonstrated that increased plasma LPO, NO and decreased GSH levels are associated with in vivo structural changes in inner segment ellipsoid and RPE. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

Evaluation of Visual Acuity Measurements after Autorefraction versus Manual Refraction in Eyes with and without Diabetic Macular Edema

PubMed Central

Sun, Jennifer K.; Qin, Haijing; Aiello, Lloyd Paul; Melia, Michele; Beck, Roy W.; Andreoli, Christopher M.; Edwards, Paul A.; Glassman, Adam R.; Pavlica, Michael R.

2012-01-01

Objective To compare visual acuity (VA) scores after autorefraction versus research protocol manual refraction in eyes of patients with diabetes and a wide range of VA. Methods Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) VA Test© letter score (EVA) was measured after autorefraction (AR-EVA) and after Diabetic Retinopathy Clinical Research Network (DRCR.net) protocol manual refraction (MR-EVA). Testing order was randomized, study participants and VA examiners were masked to refraction source, and a second EVA utilizing an identical manual refraction (MR-EVAsupl) was performed to determine test-retest variability. Results In 878 eyes of 456 study participants, median MR-EVA was 74 (Snellen equivalent approximately 20/32). Spherical equivalent was often similar for manual and autorefraction (median difference: 0.00, 5th and 95th percentiles −1.75 to +1.13 Diopters). However, on average, MR-EVA results were slightly better than AR-EVA results across the entire VA range. Furthermore, variability between AR-EVA and MR-EVA was substantially greater than the test-retest variability of MR-EVA (P<0.001). Variability of differences was highly dependent on autorefractor model. Conclusions Across a wide range of VA at multiple sites using a variety of autorefractors, VA measurements tend to be worse with autorefraction than manual refraction. Differences between individual autorefractor models were identified. However, even among autorefractor models comparing most favorably to manual refraction, VA variability between autorefraction and manual refraction is higher than the test-retest variability of manual refraction. The results suggest that with current instruments, autorefraction is not an acceptable substitute for manual refraction for most clinical trials with primary outcomes dependent on best-corrected VA. PMID:22159173

Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist--protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol.

PubMed

Ishøy, Pelle L; Knop, Filip K; Broberg, Brian V; Baandrup, Lone; Fagerlund, Birgitte; Jørgensen, Niklas R; Andersen, Ulrik B; Rostrup, Egill; Glenthøj, Birte Y; Ebdrup, Bjørn H

2014-01-08

Antipsychotic medication is widely associated with dysmetabolism including obesity and type 2 diabetes, cardiovascular-related diseases and early death. Obesity is considered the single most important risk factor for cardiovascular morbidity and mortality. Interventions against antipsychotic-associated obesity are limited and insufficient. Glucagon-like peptide-1 (GLP-1) receptor agonists are approved for the treatment of type 2 diabetes, but their bodyweight-lowering effects have also been recognised in patients with non-diabetes. The primary endpoint of this trial is weight loss after 3 months of treatment with a GLP-1 receptor agonist (exenatide once weekly) in patients with non-diabetic schizophrenia with antipsychotic-associated obesity. Secondary endpoints include physiological and metabolic measurements, various psychopathological and cognitive measures, and structural and functional brain MRI. 40 obese patients with schizophrenia or schizoaffective disorder treated with antipsychotic drugs will be randomised to subcutaneous injection of exenatide once weekly (2 mg) or placebo for 3 months, adjunctive to their antipsychotic treatment. The trial has been approved by the Danish Health and Medicines Authority, the National Committee on Health Research Ethics and the Danish Data Protection Agency. Trial participation presupposes theoral and written patient informed consent. An external, independent monitoring committee (Good Clinical Practice Unit at Copenhagen University Hospital) will monitor the study according to the GCP Guidelines. Trial data, including positive, negative and inconclusive results, will be presented at national and international scientific meetings and conferences. Papers will be submitted to peer-reviewed journals. ClinicalTrials.gov identifier: NCT01794429; National Committee on Health Research Ethics project number: 36378; EudraCT nr: 2012-005404-17; The Danish Data Protection Agency project number: RHP-2012-027.

Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial.

PubMed

Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

2012-01-01

Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).

Increased serum level of homocysteine correlates with retinal nerve fiber layer thinning in diabetic retinopathy

PubMed Central

Srivastav, Khushboo; Mahdi, Abbas A.; Shukla, Rajendra K.; Meyer, Carsten H.; Akduman, Levent; Khanna, Vinay K.

2016-01-01

Purpose To study the correlation between serum levels of vitamin B12, folic acid, and homocysteine and the severity of diabetic retinopathy and the correlation with retinal nerve fiber layer (RNFL) thinning on spectral domain optical coherence tomography (SD-OCT). Methods In a tertiary care center–based prospective cross-sectional study, 60 consecutive cases and 20 healthy controls in the age group of 40–65 years were included. The eyes of the cases were divided into three groups according to Early Treatment Diabetic Retinopathy Study (ETDRS) classification: diabetes mellitus without retinopathy (n = 20), non-proliferative diabetic retinopathy with macular edema (n = 20), and proliferative diabetic retinopathy with macular edema (n = 20). The serum levels of vitamin B12 and folic acid were measured using a standard protocol. The serum homocysteine assay was performed using an enzyme-linked immunosorbent assay (ELISA) kit. Average RNFL thickness was measured using SD-OCT. Statistical analysis was used to assess the correlations between the study variables. Results Increased severity of diabetic retinopathy was found to correlate with an increase in the serum levels of homocysteine (F = 53.79; p<0.001). The mean serum levels of vitamin B12 and folic acid were found to be within the normal reference range. A positive correlation was found between retinal nerve fiber layer thinning and serum levels of homocysteine (p<0.001). Conclusions This study, for the first time, demonstrated a correlation between increased homocysteine with a decrease in RNFL thickness and increased severity of diabetic retinopathy. PMID:27994434

A model protocol for a diabetes and other noncommunicable disease field survey.

PubMed

Dowse, G K; Zimmet, P

1992-01-01

Field surveys of diabetes and other noncommunicable diseases and their risk factors are increasingly being performed in both developed and developing countries. Although individual priorities and circumstances will influence survey design, a model survey manual and protocol is described which might assist investigators in formulating plans and preparing manuals for their own surveys. The model presented has been successfully used in developing countries, for both rural and urban communities, over more than a decade. It describes examples of survey objectives, and gives specific details of survey procedures and measurement techniques which may be utilized. It contains sufficient flexibility to allow its adaptation to local circumstances.

Less fat reduction per unit weight loss in type 2 diabetic compared with nondiabetic obese individuals completing a very-low-calorie diet program.

PubMed

Baker, Scott T; Jerums, George; Prendergast, Luke A; Panagiotopoulos, Sianna; Strauss, Boyd J; Proietto, Joseph

2012-06-01

The objective was to compare weight loss and change in body composition in obese subjects with and without type 2 diabetes mellitus during a very-low-calorie diet (VLCD) program. Seventy weight-matched subjects with diabetes or normal fasting glucose (controls) participated in a 24-week VLCD study. Primary end points were changes in anthropometry, body composition, and fasting plasma insulin and β-hydroxybutyrate concentrations. Fifty-one subjects (24 with diabetes) completed the study. No difference in weight loss between the 2 groups at 24 weeks was found by intention-to-treat analysis. Both groups completing the study per protocol had near-identical weight change during the program, with similar weight loss at 24 weeks (diabetes: 8.5 ± 1.3 kg vs control: 9.4 ± 1.2 kg, P = .64). Change in fat mass index correlated with change in body mass index (BMI) in both groups (diabetes: r = 0.878, control: r = 0.920, both P < .001); but change in fat mass index per unit change in BMI was less in the diabetic group compared with controls (0.574 vs 0.905 decrease, P = .003), which persisted after adjusting for age, sex, and baseline BMI (P = .008). Insulin concentrations remained higher and peak β-hydroxybutyrate concentrations were lower in the diabetic compared with the control group. While following a 24-week VLCD program, obese subjects with and without diabetes achieved comparable weight loss; but the decrease in adiposity per unit weight loss was attenuated in diabetic subjects. Hyperinsulinemia may have inhibited lipolysis in the diabetic group; however, further investigation into other factors is needed. Copyright © 2012 Elsevier Inc. All rights reserved.

Study methodology and diabetes control in patients from the non-English diabetes management project (NEDMP).

PubMed

Dirani, Mohamed; Dang, Trung M; Xie, Jing; Gnanasekaran, Sivashanth; Nicolaou, Theona; Rees, Gwyneth; Fenwick, Eva; Lamoureux, Ecosse L

2017-03-01

To describe the clinical characteristics of non-English speaking patients from the Diabetes Management Project (NEDMP), and compare their diabetes management and severity of diabetic retinopathy (DR) with the English-speaking DMP sample (EDMP). A prospective study was conducted on non-English speaking adults with diabetes who attended the Royal Victorian Eye and Ear Hospital. 136 (90.1%) non-English speaking adults were assessed, with a mean age of 72.2 years (range: 50-88 years); 74 (54.4%) were male. Participants completed interviewer-administered questionnaires and underwent visual acuity, fundus photography, optical coherence tomography, biochemistry and anthropometric measurements. The EDMP assessed 609 patients in 2009 using a similar protocol. Type and duration of diabetes, diabetes control and diabetic retinopathy. A total of 127 (93.4%) and 8 (5.9%) participants reported having type 2 and type 1 diabetes, respectively, with a median (IQR) duration of 17 (14) years. The proportion of patients with poor diabetes control (HbA1c ≥ 7%) in the NEDMP was similar to the EDMP (64.0% and 68.2%, respectively; P = 0.411). A significantly higher proportion of patients with DR in the NEDMP were found to have poor diabetes control (HbA1c ≥ 7%) compared to those without DR (80.9% vs. 50.0%, P = 0.003). Almost two-thirds of NEDMP patients (74/118) had DR and 23% (27/115) had diabetic macular edema. The prevalence of DR was similar between the NEDMP and EDMP studies, ranging from 25-30% and 28-29%. The clinical characteristics, diabetes control, and DR severity of English and non-English-speaking patients were similar. The high proportion of poor diabetes management in non-English speaking patients with DR suggests educational and behavioural interventions to improve glycaemic control are warranted. © 2016 Royal Australian and New Zealand College of Ophthalmologists.

SUGAR: spotting undiagnosed glucose abnormal results--a new protocol to increase postpartum testing among women with gestational diabetes mellitus.

PubMed

Carson, Michael P; Morgan, Benjamin; Gussman, Debra; Brown, Monica; Rothenberg, Karen; Wisner, Theresa A

2015-02-01

Over 70% of women with gestational diabetes mellitus (GDM) will develop diabetes mellitus (DM), but only 30% follow through with the recommended postpartum oral glucose tolerance testing (OGTT). HbA1c is approved to diagnose DM, and combined with a fasting plasma glucose it can identify 93% of patients with dysglycemia. We tested the hypothesis that a single blood draw to assess for dysglycemia at the postpartum visit could improve testing rates compared with those required to obtain an OGTT at an outside laboratory. Prospective cohort study of all women with GDM who delivered between July 2010 and December 2011. When insurance status required testing at an outside laboratory an OGTT was ordered, when insurance allowed testing at our center a random sugar and HbA1c were drawn at the postpartum visit (SUGAR Protocol). Of the 40 women, 36 attended a postpartum visit. In the SUGAR arm, 19 of 19 (100%) were tested versus 9 of 17 (53%) in the OGTT arm; relative risk of testing was 1.9 (95% confidence interval, 1.2-3.0). 36% were glucose intolerant. This pilot study found that an in-office testing model doubled the rate of postpartum testing in this clinic population, and was reasonably sensitive at detecting dysglycemia. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A Preliminary Study of the Effects of a Multitheory-Driven Intervention in Adults With Prediabetes Mellitus.

PubMed

Tsai, Fu-Mian; Lin, Chiu-Chu; Lin, Huey-Shyan; Liu, Yi

2018-06-01

Prediabetes mellitus (pre-DM) is an important predictive indicator of Type 2 diabetes. A person with pre-DM is eight times more likely to develop diabetes than a person without pre-DM. Prior research suggests that proactive interventions may delay the progression of this disease and reduce the rate of disease development. The purposes of this preliminary study were to develop a multitheory-driven lifestyle intervention protocol for adults with pre-DM and to evaluate its feasibility and impacts on knowledge regarding pre-DM, dietary behaviors, and physical activity (primary outcomes) as well as to describe the disease progression indicators (secondary outcomes). A single-group, longitudinal study design was used. Thirty-nine participants were included in the analysis. A generalized estimating equation model was used to determine the trends in changes in the outcomes. All of the participants underwent testing at baseline (T0) and at 3 (T1), 6 (T2), and 12 (T3) months after the 4-week lifestyle intervention. There were significantly increasing trends for each study parameter (Pre-DM Knowledge Assessment Form-12, p < .01; Dietary Behavior Scale, p < .01) and significantly positive changes in body weight (p < .01), body mass index (p < .01), fasting glucose level (p < .01), and glycated hemoglobin level (p < .01) over the 12-month study period. This study supports the feasibility of the developed multitheory-driven lifestyle intervention protocol and suggests that its application may improve the effectiveness of diabetes prevention programs in clinical settings. Further randomized controlled trials are needed.

Regenerative medicine for diabetes: differentiation of human pluripotent stem cells into functional β-cells in vitro and their proposed journey to clinical translation.

PubMed

Bose, Bipasha; Katikireddy, Kishore Reddy; Shenoy, P Sudheer

2014-01-01

Diabetes is a group of metabolic diseases, rising globally at an alarming rate. Type 1 (juvenile diabetes) is the autoimmune version of diabetes where the pancreas is unable to produce insulin, whereas type 2 (adult onset diabetes) is caused due to insulin resistance of the cells. In either of the cases, elevated blood glucose levels are observed which leads to progressive comorbidity like renal failure, cardiovascular disease, retinopathy, etc. Metformin, sulphonyl urea group of drugs, as well as insulin injections are the available therapies. In advanced cases of diabetes, the drug alone or drug in combination with insulin injections are not able to maintain a steady level of blood glucose. Moreover, frequent insulin injections are rather cumbersome for the patient. So, regenerative medicine could be a permanent solution for fighting diabetes. Islet transplantation has been tried with a limited amount of success on a large population of diabetics because of the shortage of cadaveric pancreas. Therefore, the best proposed alternative is regenerative medicine involving human pluripotent stem cell (hPSC)-derived beta islet transplantation which can be obtained in large quantities. Efficient protocols for in vitro differentiation of hPSC into a large number of sustained insulin-producing beta cells for transplantation will be considered to be a giant leap to address global rise in diabetic cases. Although most of the protocols mimic in vivo pancreatic development in humans, considerable amount of lacuna persists for near-perfect differentiation strategies. Moreover, beta islets differentiated from hPSC have not yet been successfully translated under clinical scenario. © 2014 Elsevier Inc. All rights reserved.

Previous Exercise Training Reduces Markers of Renal Oxidative Stress and Inflammation in Streptozotocin-Induced Diabetic Female Rats.

PubMed

Amaral, Liliany Souza de Brito; Souza, Cláudia Silva; Volpini, Rildo Aparecido; Shimizu, Maria Heloisa Massola; de Bragança, Ana Carolina; Canale, Daniele; Seguro, Antonio Carlos; Coimbra, Terezila Machado; de Magalhães, Amélia Cristina Mendes; Soares, Telma de Jesus

2018-01-01

The aim of this study is to evaluate the effects of regular moderate exercise training initiated previously or after induction of diabetes mellitus on renal oxidative stress and inflammation in STZ-induced diabetic female rats. For this purpose, Wistar rats were divided into five groups: sedentary control (SC), trained control (TC), sedentary diabetic (SD), trained diabetic (TD), and previously trained diabetic (PTD). Only the PTD group was submitted to treadmill running for 4 weeks previously to DM induction with streptozotocin (40 mg/kg, i.v). After confirming diabetes, the PTD, TD, and TC groups were submitted to eight weeks of exercise training. At the end of the training protocol, we evaluated the following: glycosuria, body weight gain, plasma, renal and urinary levels of nitric oxide and thiobarbituric acid reactive substances, renal glutathione, and immunolocalization of lymphocytes, macrophages, and nuclear factor-kappa B (NF- κ B/p65) in the renal cortex. The results showed that exercise training reduced glycosuria, renal TBARS levels, and the number of immune cells in the renal tissue of the TD and PTD groups. Of note, only previous exercise increased weight gain and urinary/renal NO levels and reduced NF- κ B (p65) immunostaining in the renal cortex of the PTD group. In conclusion, our study shows that exercise training, especially when initiated previously to diabetes induction, promotes protective effects in diabetic kidney by reduction of renal oxidative stress and inflammation markers in female Wistar rats.

Previous Exercise Training Reduces Markers of Renal Oxidative Stress and Inflammation in Streptozotocin-Induced Diabetic Female Rats

PubMed Central

Souza, Cláudia Silva; Volpini, Rildo Aparecido; Shimizu, Maria Heloisa Massola; de Bragança, Ana Carolina; Canale, Daniele; Seguro, Antonio Carlos; Coimbra, Terezila Machado; de Magalhães, Amélia Cristina Mendes

2018-01-01

The aim of this study is to evaluate the effects of regular moderate exercise training initiated previously or after induction of diabetes mellitus on renal oxidative stress and inflammation in STZ-induced diabetic female rats. For this purpose, Wistar rats were divided into five groups: sedentary control (SC), trained control (TC), sedentary diabetic (SD), trained diabetic (TD), and previously trained diabetic (PTD). Only the PTD group was submitted to treadmill running for 4 weeks previously to DM induction with streptozotocin (40 mg/kg, i.v). After confirming diabetes, the PTD, TD, and TC groups were submitted to eight weeks of exercise training. At the end of the training protocol, we evaluated the following: glycosuria, body weight gain, plasma, renal and urinary levels of nitric oxide and thiobarbituric acid reactive substances, renal glutathione, and immunolocalization of lymphocytes, macrophages, and nuclear factor-kappa B (NF-κB/p65) in the renal cortex. The results showed that exercise training reduced glycosuria, renal TBARS levels, and the number of immune cells in the renal tissue of the TD and PTD groups. Of note, only previous exercise increased weight gain and urinary/renal NO levels and reduced NF-κB (p65) immunostaining in the renal cortex of the PTD group. In conclusion, our study shows that exercise training, especially when initiated previously to diabetes induction, promotes protective effects in diabetic kidney by reduction of renal oxidative stress and inflammation markers in female Wistar rats. PMID:29785400

Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol.

PubMed

Kutyifa, Valentina; Beck, Christopher; Brown, Mary W; Cannom, David; Daubert, James; Estes, Mark; Greenberg, Henry; Goldenberg, Ilan; Hammes, Stephen; Huang, David; Klein, Helmut; Knops, Reinoud; Kosiborod, Mikhail; Poole, Jeanne; Schuger, Claudio; Singh, Jagmeet P; Solomon, Scott; Wilber, David; Zareba, Wojciech; Moss, Arthur J

2017-07-01

Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post-myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Disease management for the diabetic foot: effectiveness of a diabetic foot prevention program to reduce amputations and hospitalizations.

PubMed

Lavery, Lawrence A; Wunderlich, Robert P; Tredwell, Jeffrey L

2005-10-01

To demonstrate the effectiveness of a diabetic foot disease management program in a managed care organization. We implemented a lower extremity disease management program consisting of screening and treatment protocols for diabetic members in a managed care organization. Screening consisted of evaluation of neuropathy, peripheral vascular disease, deformities, foot pressures, and history of lower extremity pathology. We stratified patients into low and high-risk groups, and implemented preventive or acute care protocols. Utilization was tracked for 28 months and compared to 12 months of historic data prior to implementation of the disease management program. After we implemented the disease management program, the incidence of amputations decreased 47.4% from 12.89 per 1000 diabetics per year to 6.18 (p<0.05). The number of foot-related hospital admissions decreased 37.8% from 22.86 per 1000 members per year to 14.23 (37.8%). The average inpatient length-of-stay (LOS) was reduced 21.7% from 4.75 to 3.72 days (p<0.05). In addition, there was a 69.8% reduction in the number of skilled nursing facility (SNF) admissions per 1000 members per year (Table 1) and a 38.2% reduction in the average SNF LOS from 8.72 to 6.52 days (p<0.05). A population-based screening and treatment program for the diabetic foot can dramatically reduce hospitalizations and clinical outcomes.

Variability of DKA Management Among Pediatric Emergency Room and Critical Care Providers: A Call for More Evidence-Based and Cost-Effective Care?

PubMed

Clark, Matthew G; Dalabih, Abdallah

2014-09-01

Management protocols have been shown to be effective in the pediatric emergency medicine (PEM) and pediatric critical care (PCC) settings. Treatment protocols define clear goals which are achieved with consistency in implementation. Over the last decade, many new recommendations have been proposed on managing diabetic ketoacidosis (DKA). Although no perfect set of guidelines exist, many institutions are developing DKA treatment protocols. We sought to determine the variability between institutions in implementation of these protocols.

Diabetic Macular Edema: Options for Adjunct Therapy.

PubMed

Calvo, Pilar; Abadia, Beatriz; Ferreras, Antonio; Ruiz-Moreno, Oscar; Verdes, Guayente; Pablo, Luis E

2015-09-01

Diabetes mellitus (DM) is a chronic disease that affects 387 million people worldwide. Diabetic retinopathy (DR), a common complication of DM, is the main cause of blindness in the active population. Diabetic macular edema (DME) may occur at any stage of DR, and is characterized by vascular hyperpermeability accompanied by hard exudates within the macula. Medical and surgical therapies have dramatically reduced the progression of DR, and timely intervention can reduce the risk of severe vision loss by more than 90 %. In 2012, intravitreal ranibizumab became the first antivascular endothelial growth factor (anti-VEGF) agent approved for DME and, since then, many reports of the use of ranibizumab for DME have been promising. Randomized, prospective, multicenter clinical trials-most notably, RESOLVE, READ-2, RISE/RIDE, RESTORE, DRCR.net protocol I, and RETAIN-reported improvements in best-corrected visual acuity and decreased central retinal thickness as measured with optical coherence tomography in patients with DME. Similar treatment benefits have also been noted in clinical trials evaluating intravitreal aflibercept and bevacizumab (DAVINCI, VISTA/VIVID, and BOLT) and more recently DRCR.net protocol T. Intravitreal steroids (dexamethasone intravitreal implant and fluocinolone acetonide), particularly in refractory cases, also play a significant role in the management of DME (MEAD/CHAMPLAIN and FAMOUS/FAME studies). In summary, over the last 5 years, blocking VEGF and inflammation has been shown to improve visual outcomes in patients with macular edema due to DM, revolutionizing the treatment of center-involved DME and establishing a new standard of care.

The impact of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) fasting glucose diagnostic criterion on the prevalence and outcomes of gestational diabetes mellitus in Han Chinese women.

PubMed

Liao, S; Mei, J; Song, W; Liu, Y; Tan, Y-D; Chi, S; Li, P; Chen, X; Deng, S

2014-03-01

The International Association of Diabetes and Pregnancy Study Groups (IADPSG) proposed that a one-time value of fasting plasma glucose of 5.1 mmol/l or over at any time of the pregnancy is sufficient to diagnose gestational diabetes. We evaluated the repercussions of the application of this threshold in pregnant Han Chinese women. This is a retrospective study of 5360 (72.3% of total) consecutively recruited pregnant Han Chinese women in one centre from 2008 to 2011. These women underwent a two-step gestational diabetes diagnostic protocol according to the previous American Diabetes Association criteria. The IADPSG fasting plasma glucose criterion was used to reclassify these 5360 women. The prevalence, clinical characteristics and obstetric outcomes were compared among the women classified as having gestational diabetes by the previous American Diabetes Association criteria (approximately 90% were treated), those reclassified as having gestational diabetes by the single IADPSG fasting plasma glucose criterion (untreated), but not as having gestational diabetes by the previous American Diabetes Association criteria, and those with normal glucose tolerance. There were 626 cases of gestational diabetes defined by the previous American Diabetes Association criteria (11.7%) and these cases were associated with increased risks of maternal and neonatal outcomes when compared with the women with normal glucose tolerance. With the IADPSG fasting plasma glucose criterion, another 1314 (24.5%) women were reclassified as having gestational diabetes. Gestational diabetes classified by the IADPSG fasting plasma glucose criterion was associated with gestational hypertension (P = 0.0094) and neonatal admission to nursery (P = 0.035) prior to adjustment for maternal age and BMI, but was no longer a predictor for adverse pregnancy outcomes after adjustment. The simple IADPSG fasting plasma glucose criterion increased the Chinese population with gestational diabetes by 200%. The increased population with gestational diabetes was not significantly associated with excess obstetric and neonatal morbidity. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial.

PubMed

Yu, Ying; Sun, Qian; Yan, Lin-Feng; Hu, Yu-Chuan; Nan, Hai-Yan; Yang, Yang; Liu, Zhi-Cheng; Wang, Wen; Cui, Guang-Bin

2016-08-24

Type 2 diabetes mellitus (T2DM) is a risk factor for dementia. Mild cognitive impairment (MCI), an intermediary state between normal cognition and dementia, often occurs during the prodromal diabetic stage, making early diagnosis and intervention of MCI very important. Latest neuroimaging techniques revealed some underlying microstructure alterations for diabetic MCI, from certain aspects. But there still lacks an integrated multimodal MRI system to detect early neuroimaging changes in diabetic MCI patients. Thus, we intended to conduct a diagnostic trial using multimodal MRI techniques to detect early diabetic MCI that is determined by the Montreal Cognitive Assessment (MoCA). In this study, healthy controls, prodromal diabetes and diabetes subjects (53 subjects/group) aged 40-60 years will be recruited from the physical examination center of Tangdu Hospital. The neuroimaging and psychometric measurements will be repeated at a 0.5 year-interval for 2.5 years' follow-up. The primary outcome measures are 1) Microstructural and functional alterations revealed with multimodal MRI scans including structure magnetic resonance imaging (sMRI), resting state functional magnetic resonance imaging (rs-fMRI), diffusion kurtosis imaging (DKI), and three-dimensional pseudo-continuous arterial spin labeling (3D-pCASL); 2) Cognition evaluation with MoCA. The second outcome measures are obesity, metabolic characteristics, lifestyle and quality of life. The study will provide evidence for the potential use of multimodal MRI techniques with psychometric evaluation in diagnosing MCI at prodromal diabetic stage so as to help decision making in early intervention and improve the prognosis of T2DM. This study has been registered to ClinicalTrials.gov ( NCT02420470 ) on April 2, 2015 and published on July 29, 2015.

Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

PubMed

Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

2014-01-01

In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

Rationale and Design of the Vitamin D and Type 2 Diabetes (D2d) Study: A Diabetes Prevention Trial

PubMed Central

Pittas, Anastassios G.; Dawson-Hughes, Bess; Rosen, Clifford J.; Ware, James H.; Knowler, William C.; Staten, Myrlene A.

2014-01-01

OBJECTIVE Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100–125 mg/dL (5.5–6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140–199 mg/dL (7.7–11.0 mmol/L), hemoglobin A1c 5.7–6.4% (39–46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes. PMID:25205139

Hospital protocols for targeted glycemic control: Development, implementation, and models for cost justification.

PubMed

Magee, Michelle F

2007-05-15

Evolving elements of best practices for providing targeted glycemic control in the hospital setting, clinical performance measurement, basal-bolus plus correction-dose insulin regimens, components of standardized subcutaneous (s.c.) insulin order sets, and strategies for implementation and cost justification of glycemic control initiatives are discussed. Best practices for targeted glycemic control should address accurate documentation of hyperglycemia, initial patient assessment, management plan, target blood glucose range, blood glucose monitoring frequency, maintenance of glycemic control, criteria for glucose management consultations, and standardized insulin order sets and protocols. Establishing clinical performance measures, including desirable processes and outcomes, can help ensure the success of targeted hospital glycemic control initiatives. The basal-bolus plus correction-dose regimen for insulin administration will be used to mimic the normal physiologic pattern of endogenous insulin secretion. Standardized insulin order sets and protocols are being used to minimize the risk of error in insulin therapy. Components of standardized s.c. insulin order sets include specification of the hyperglycemia diagnosis, finger stick blood glucose monitoring frequency and timing, target blood glucose concentration range, cutoff values for excessively high or low blood glucose concentrations that warrant alerting the physician, basal and prandial or nutritional (i.e., bolus) insulin, correction doses, hypoglycemia treatment, and perioperative or procedural dosage adjustments. The endorsement of hospital administrators and key physician and nursing leaders is needed for glycemic control initiatives. Initiatives may be cost justified on the basis of the billings for clinical diabetes management services and/or the return- on-investment accrued to reductions in hospital length of stay, readmissions, and accurate documentation and coding of unrecognized or uncontrolled diabetes, and diabetes complications. Standardized insulin order sets and protocols may minimize risk of insulin errors. The endorsement of these protocols by administrators, physicians, nurses, and pharmacists is also needed for success.

Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial

PubMed Central

Eshtehardi, Sahar S; Minard, Charles G; Saber, Rana; Thompson, Debbe; Karaviti, Lefkothea P; Rojas, Yuliana; Anderson, Barbara J

2018-01-01

Background Supportive parent involvement for adolescents’ type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Methods Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). Results The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Trial Registration ClinicalTrials.gov NCT02877680; https://clinicaltrials.gov/ct2/show/NCT02877680 (Archived by WebCite at http://www.webcitation.org/6xTAMN5k2) PMID:29535081

Evaluating the implementation of a national clinical programme for diabetes to standardise and improve services: a realist evaluation protocol.

PubMed

McHugh, S; Tracey, M L; Riordan, F; O'Neill, K; Mays, N; Kearney, P M

2016-07-28

Over the last three decades in response to the growing burden of diabetes, countries worldwide have developed national and regional multifaceted programmes to improve the monitoring and management of diabetes and to enhance the coordination of care within and across settings. In Ireland in 2010, against a backdrop of limited dedicated strategic planning and engrained variation in the type and level of diabetes care, a national programme was established to standardise and improve care for people with diabetes in Ireland, known as the National Diabetes Programme (NDP). The NDP comprises a range of organisational and service delivery changes to support evidence-based practices and policies. This realist evaluation protocol sets out the approach that will be used to identify and explain which aspects of the programme are working, for whom and in what circumstances to produce the outcomes intended. This mixed method realist evaluation will develop theories about the relationship between the context, mechanisms and outcomes of the diabetes programme. In stage 1, to identify the official programme theories, documentary analysis and qualitative interviews were conducted with national stakeholders involved in the design, development and management of the programme. In stage 2, as part of a multiple case study design with one case per administrative region in the health system, qualitative interviews are being conducted with frontline staff and service users to explore their responses to, and reasoning about, the programme's resources (mechanisms). Finally, administrative data will be used to examine intermediate implementation outcomes such as service uptake, acceptability, and fidelity to models of care. This evaluation is using the principles of realist evaluation to examine the implementation of a national programme to standardise and improve services for people with diabetes in Ireland. The concurrence of implementation and evaluation has enabled us to produce formative feedback for the NDP while also supporting the refinement and revision of initial theories about how the programme is being implemented in the dynamic and unstable context of the Irish healthcare system.

Identifying clinical criteria to predict Type 1 diabetes, as defined by absolute insulin deficiency: a systematic review protocol.

PubMed

Shields, Beverley M; Peters, Jaime L; Cooper, Chris; Powell, Roy J; Knight, Bridget A; Hyde, Christopher; Hattersley, Andrew T

2012-01-01

Management of a patient's diabetes is entirely dependent upon the type of diabetes they are deemed to have. Patients with Type 1 diabetes are insulin deficient so require multiple daily insulin injections, whereas patients with Type 2 diabetes still have some endogenous insulin production so insulin treatment is only required when diet and tablets do not establish good glycaemic control. Despite the importance of a correct diagnosis, classification of diabetes is based on aetiology and relies on clinical judgement. There are no clinical guidelines on how to determine whether a patient has Type 1 or Type 2 diabetes. We aim to systematically review the literature to derive evidence-based clinical criteria for the classification of the major subtypes of diabetes. We will perform a systematic review of diagnostic accuracy studies to establish clinical criteria that predict the subsequent development of absolute insulin deficiency seen in Type 1 diabetes. Insulin deficiency will be determined by reference standard C-peptide concentrations. Synthesis of criteria identified will be undertaken using hierarchical summary receiver operating characteristic curves. As this is a systematic review, there will be no ethical issues. We will disseminate results by writing up the final systematic review and synthesis for publication in a peer-reviewed journal and will present at national and international diabetes-related meetings.

The Effectiveness of a Peer Coaching Education on Control and Management of Type 2 Diabetes in Women: A Protocol for a Randomized Controlled Trial.

PubMed

Aalaa, Maryam; Sanjari, Mahnaz; Aghaei Meybodi, Hamid Reza; Amini, Mohammad Reza; Qorbani, Mostafa; Adibi, Hossien; Mehrdad, Neda

2017-04-01

Diabetes Education by Peer Coaching is a strategy which helps the patients with diabetes in the field of behavioral and emotional problems. However, the results of studies in this field in other countries could not be generalized in our context. So, the current study aimed to examine the effectiveness of Diabetes Education by Peer Coaching on Diabetes Management. Outcome variables for patients and peer coaches are measured at baseline and in3,6 and 12 months. The primary outcome consisted of Fasting Blood Sugar (FBS) and HbA1c. Secondary outcomes included Blood Pressure (BP), Body Mass Index (BMI,) Waist-Hip Ratio (WHR), Lipid Profile, diabetes self-care activities, diabetes-related quality of life, depression, and Social Capital levels.Initial analyses compared the frequency of baseline levels of outcome and other variables using a simple Chi-square test, t-test and the Mann-Whitney- U test. Sequential measurements in each group were evaluated by two-way analysis of variance. If significant differences in baseline characteristics were found, analyses were repeated adjusting for these differences using ANOVA and logistic regression for multivariate analyses. Additional analyses were conducted to look for the evidence of effect modification by pre-specified subgroups. The fact is that self-control and self-efficacy in diabetes management and treatment of diabetes could be important components. It seems that this research in this special setting with cultural differences would provide more evidence about peer-coaching model. It seems that if the peer-coaching model improves learning situations between patients with diabetes by offering one-on-one Diabetes Self Management Education, it could be an interactive approach to diabetic education. Trial Registration Number: IRCT201501128175N3.

Subcutaneous regular insulin for the treatment of diabetic ketoacidosis in children.

PubMed

Cohen, Michal; Leibovitz, Noa; Shilo, Smadar; Zuckerman-Levin, Nehama; Shavit, Itai; Shehadeh, Naim

2017-06-01

Diabetic ketoacidosis (DKA) treatment protocols vary, however low-dose intravenous administration of regular insulin is the standard care for replacing insulin in most centers. Few studies, the majority in adults, demonstrated subcutaneous injection of rapid-acting insulin every 1-2 hours to be a valid alternative. To evaluate the efficacy and safety of subcutaneous regular insulin administered every 4 hours in pediatric DKA in a clinical setting. A retrospective chart review was conducted. Charts of all children treated with subcutaneous regular insulin for DKA and pH ≥ 7.0, between 2007 and 2010, were reviewed. Seventy-six DKA episodes in 52 patients were included. Data regarding clinical characteristics, response to treatment, and the occurrence of complications were analyzed. DKA episodes in patients with new-onset diabetes and in those with established diabetes were compared. Mean age was 11.6 ± 4.0 yr. Eighteen episodes occurred in children with new-onset diabetes. In all episodes, our protocol resulted in recovery from DKA. Median time to DKA resolution (pH > 7.30, HCO3 > 15) was 10.3 (5.5, 14.2) h. The median total insulin dose was 0.05 (0.04, 0.06) (unit/kg/h). During DKA treatment, hypoglycemia occurred in one episode and hypokalemia, mostly mild, was documented in 14. No cardiac arrhythmias, incidents of cerebral edema, or mortality occurred. Subcutaneous regular insulin administered every 4 hours is an effective and safe alternative for the insulin treatment of DKA with pH > 7.0 in children. Such treatment has the potential to simplify insulin administration when compared to either intravenous regular insulin or q1-2 hour subcutaneous rapid insulin and reduce both patient inconvenience and admission costs. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Parental perspectives of diabetes management in Alabama public schools.

PubMed

Skelley, Jason P; Luthin, David R; Skelley, Jessica W; Kabagambe, Edmond K; Ashraf, Ambika P; Atchison, Joycelyn A

2013-04-01

The purpose of this study was to assess parental perceptions of the current state of care for children with diabetes in the Alabama public school system, identify existing disparities, and determine what resources would most improve diabetes management in this setting. There is a significant need for such information because of the paucity of published data on the current state of diabetes care in Alabama public schools. We based our survey on the American Diabetes Association guidelines and collected responses on the Internet via SurveyMonkey and by paper surveys. We distributed surveys to parents of children with diabetes through the Children's Hospital endocrinology clinic, a diabetes camp, and through the Alabama Association of School Nurses e-mail listserv. A majority of children had type 1 diabetes mellitus. Students who could conveniently check their blood glucose levels (BGLs) at school were significantly more likely to participate in all school activities and their parents were significantly more likely to be satisfied with their child's diabetes care at school. Compared with minority students (defined as all races other than white), white students were more likely to be able to conveniently check their BGLs at school. The accommodation and care for children with diabetes is highly variable within much of the Alabama public school system. The ability to conveniently check BGLs at school is key for participation in all school activities and for parental satisfaction with diabetes care at school. Institution of a uniform, statewide diabetes training protocol for school personnel could improve care and parental satisfaction.

The DISC (Diabetes in Social Context) Study-evaluation of a culturally sensitive social network intervention for diabetic patients in lower socioeconomic groups: a study protocol

PubMed Central

2012-01-01

Background Compared to those in higher socioeconomic groups, diabetic patients in lower socioeconomic groups have less favourable metabolic control and experience more diabetes-related complications. They encounter specific barriers that hinder optimal diabetes self-management, including a lack of social support and other psychosocial mechanisms in their immediate social environments. Powerful Together with Diabetes is a culturally sensitive social network intervention specifically targeted to ethnic Dutch, Moroccan, Turkish, and Surinamese diabetic patients in lower socioeconomic groups. For ten months, patients will participate in peer support groups in which they will share experiences, support each other in maintaining healthy lifestyles, and learn skills to resist social pressure. At the same time, their significant others will also receive an intervention, aimed at maximizing support for and minimizing the negative social influences on diabetes self-management. This study aims to test the effectiveness of Powerful Together with Diabetes. Methods/Design We will use a quasi-experimental design with an intervention group (Group 1) and two comparison groups (Groups 2 and 3), N = 128 in each group. Group 1 will receive Powerful Together with Diabetes. Group 2 will receive Know your Sugar, a six-week group intervention that does not focus on the participants' social environments. Group 3 receives standard care only. Participants in Groups 1 and 2 will be interviewed and physically examined at baseline, 3, 10, and 16 months. We will compare their haemoglobin A1C levels with the haemoglobin A1C levels of Group 3. Main outcome measures are haemoglobin A1C, diabetes-related quality of life, diabetes self-management, health-related, and intermediate outcome measures. We will conduct a process evaluation and a qualitative study to gain more insights into the intervention fidelity, feasibility, and changes in the psychosocial mechanism in the participants' immediate social environments. Discussion With this study, we will assess the feasibility and effectiveness of a culturally sensitive social network intervention for lower socioeconomic groups. Furthermore, we will study how to enable these patients to optimally manage their diabetes. This trial is registered in the Dutch Trial Register: NTR1886 PMID:22429263

The DISC (Diabetes in Social Context) Study-evaluation of a culturally sensitive social network intervention for diabetic patients in lower socioeconomic groups: a study protocol.

PubMed

Vissenberg, Charlotte; Nierkens, Vera; Uitewaal, Paul J M; Geraci, Diana; Middelkoop, Barend J C; Nijpels, Giel; Stronks, Karien

2012-03-19

Compared to those in higher socioeconomic groups, diabetic patients in lower socioeconomic groups have less favourable metabolic control and experience more diabetes-related complications. They encounter specific barriers that hinder optimal diabetes self-management, including a lack of social support and other psychosocial mechanisms in their immediate social environments. Powerful Together with Diabetes is a culturally sensitive social network intervention specifically targeted to ethnic Dutch, Moroccan, Turkish, and Surinamese diabetic patients in lower socioeconomic groups. For ten months, patients will participate in peer support groups in which they will share experiences, support each other in maintaining healthy lifestyles, and learn skills to resist social pressure. At the same time, their significant others will also receive an intervention, aimed at maximizing support for and minimizing the negative social influences on diabetes self-management. This study aims to test the effectiveness of Powerful Together with Diabetes. We will use a quasi-experimental design with an intervention group (Group 1) and two comparison groups (Groups 2 and 3), N = 128 in each group. Group 1 will receive Powerful Together with Diabetes. Group 2 will receive Know your Sugar, a six-week group intervention that does not focus on the participants' social environments. Group 3 receives standard care only. Participants in Groups 1 and 2 will be interviewed and physically examined at baseline, 3, 10, and 16 months. We will compare their haemoglobin A1C levels with the haemoglobin A1C levels of Group 3. Main outcome measures are haemoglobin A1C, diabetes-related quality of life, diabetes self-management, health-related, and intermediate outcome measures. We will conduct a process evaluation and a qualitative study to gain more insights into the intervention fidelity, feasibility, and changes in the psychosocial mechanism in the participants' immediate social environments. With this study, we will assess the feasibility and effectiveness of a culturally sensitive social network intervention for lower socioeconomic groups. Furthermore, we will study how to enable these patients to optimally manage their diabetes.

Global prevalence of diabetes mellitus in patients with tuberculosis: a systematic review and meta-analysis protocol.

PubMed

Tankeu, Aurel T; Bigna, Jean Joël; Nansseu, Jobert Richie; Endomba, Francky Teddy A; Wafeu, Guy Sadeu; Kaze, Arnaud D; Noubiap, Jean Jacques

2017-06-09

Diabetes mellitus (DM) is an important risk factor for active tuberculosis (TB), which also adversely affect TB treatment outcomes. The escalating global DM epidemic is fuelling the burden of TB and should therefore be a major target in the strategy for ending TB. This review aims to estimate the global prevalence of DM in patients with TB. This systematic review will include cross-sectional, case-control or cohort studies of populations including patients diagnosed with TB that have reported the prevalence of DM using one of the fourth standard recommendations for screening and diagnosis. This protocol is written in accordance with recommendations from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement. Relevant abstracts published in English/French from inception to 31 December 2016 will be searched in PubMed, Excerpta Medica Database and online journals. Two investigators will independently screen, select studies, extract data and assess the risk of bias in each study. The study-specific estimates will be pooled through a random-effects meta-analysis model to obtain an overall summary estimate of the prevalence of diabetes across the studies. Heterogeneity will be assessed, and we will pool studies judged to be clinically homogenous. On the other hand, statistical heterogeneity will be evaluated by the χ² test on Cochrane's Q statistic. Funnel-plots analysis and Egger's test will be used to investigate publication bias. Results will be presented by continent or geographic regions. This study is based on published data. An ethical approval is therefore not required. This systematic review and meta-analysis is expected to inform healthcare providers as well as general population on the co-occurrence of DM and TB. The final report will be published as an original article in a peer-reviewed journal, and will also be presented at conferences and submitted to relevant health authorities. We also plan to update the review every 5 years. PROSPERO International Prospective Register of Systematic Reviews (CRD42016049901). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct--a study protocol [ISRCTN08471887].

PubMed

Joos, Stefanie; Rosemann, Thomas; Heiderhoff, Marc; Wensing, Michel; Ludt, Sabine; Gensichen, Jochen; Kaufmann-Kolle, Petra; Szecsenyi, Joachim

2005-10-04

Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt). The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed. This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states.

ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct – a study protocol [ISRCTN08471887

PubMed Central

Joos, Stefanie; Rosemann, Thomas; Heiderhoff, Marc; Wensing, Michel; Ludt, Sabine; Gensichen, Jochen; Kaufmann-Kolle, Petra; Szecsenyi, Joachim

2005-01-01

Background Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt). Methods/Design The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed. Discussion This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states. PMID:16202151

Association of serum levels of anti-myeloperoxidase antibody with retinal photoreceptor ellipsoid zone disruption in diabetic retinopathy.

PubMed

Sinha, Shivani; Saxena, Sandeep; Prasad, Senthamizh; Mahdi, Abbas Ali; Bhasker, Shashi Kumar; Das, Siddharth; Krasnik, Vladimir; Caprnda, Martin; Opatrilova, Radka; Kruzliak, Peter

2017-05-01

To study the association of serum levels of anti-myeloperoxidase (MPO) antibody with retinal photoreceptor ellipsoid zone (EZ) disruption in diabetic retinopathy. Consecutive patients with type 2 DM [diabetes mellitus with no retinopathy (NODR; n=20); non-proliferative diabetic retinopathy (NPDR; n=18); proliferative diabetic retinopathy (PDR; n=16)] and healthy controls (n=20) between the ages of 40 and 65years were included. Disruption of EZ was graded by spectral domain optical coherence tomography as no disruption of EZ and disrupted EZ. The serum levels of anti-MPO antibody was analyzed using standard protocol. Association between the variables was evaluated using multiple regression analysis. A significant difference was found between the serum levels of anti-MPO antibody in various study groups (p<0.001). A positive association was found between EZ disruption and levels of anti-MPO antibody [adjusted odd's ratio (AOR)=1.079, CI 1.010-1.124, p=0.04]. A significant positive correlation was found between logMAR visual acuity and grade of disruption (AOR=1.008, CI 1.006-5.688, p=0.04). An increased serum anti-MPO antibody levels is associated with retinal photoreceptor EZ disruption and decreased visual acuity in diabetic retinopathy. Copyright © 2017 Elsevier Inc. All rights reserved.

[Management of glycemia: an audit in 66 ICUs].

PubMed

Orban, J-C; Scarlatti, A; Lefrant, J-Y; Molinari, N; Leone, M; Jaber, S; Constantin, J-M; Allaouchiche, B; Ichai, C

2013-02-01

The interest of tight glucose control in ICU is still debated. In France, no data are available regarding this therapy and the implementation of its guidelines. Sub-study of a one-day audit performed between January and May 2009. During a one-day audit performed in 66 ICUs, trained residents collected data regarding the presence of a formal glucose control protocol and its practical application. A formalized glucose control protocol was found in 88% of patients. During the day before the audit, 3645 glycemia measurements were performed accounting for six measurements [4-9] per patient with a median higher value of 1.6 [1.4-2.1]. Hypoglycemia (<0.8 g/L) and hyperglycemia (>1.4 g/L in non-diabetic and >1.8 g/L in diabetic patients) were found in 81 (15%) and 326 (58%) patients respectively. Two episodes (0.36%) of severe hypoglycemia (<0.4 g/L) were reported. Factors associated with glucose control protocol application were: a high SOFA score, cardioversion, mechanical ventilation, intracranial pressure monitoring, steroid use and nurse to patient ratio less than 1/2.5. Hepatic failure was the only factor associated with hypoglycemia. Glucose control protocols are available in more than 80% ICUs but their implementation is still imperfect. However, the median glycemia meets international current recommendations. Severe hypoglycemia is a very rare event in ICU. Copyright © 2012 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

Simple calculator to estimate the medical cost of diabetes in sub-Saharan Africa

PubMed Central

Alouki, Koffi; Delisle, Hélène; Besançon, Stéphane; Baldé, Naby; Sidibé-Traoré, Assa; Drabo, Joseph; Djrolo, François; Mbanya, Jean-Claude; Halimi, Serge

2015-01-01

AIM: To design a medical cost calculator and show that diabetes care is beyond reach of the majority particularly patients with complications. METHODS: Out-of-pocket expenditures of patients for medical treatment of type-2 diabetes were estimated based on price data collected in Benin, Burkina Faso, Guinea and Mali. A detailed protocol for realistic medical care of diabetes and its complications in the African context was defined. Care components were based on existing guidelines, published data and clinical experience. Prices were obtained in public and private health facilities. The cost calculator used Excel. The cost for basic management of uncomplicated diabetes was calculated per person and per year. Incremental costs were also computed per annum for chronic complications and per episode for acute complications. RESULTS: Wide variations of estimated care costs were observed among countries and between the public and private healthcare system. The minimum estimated cost for the treatment of uncomplicated diabetes (in the public sector) would amount to 21%-34% of the country’s gross national income per capita, 26%-47% in the presence of retinopathy, and above 70% for nephropathy, the most expensive complication. CONCLUSION: The study provided objective evidence for the exorbitant medical cost of diabetes considering that no medical insurance is available in the study countries. Although the calculator only estimates the cost of inaction, it is innovative and of interest for several stakeholders. PMID:26617974

[Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers].

PubMed

Lázaro-Martínez, José Luis; García-Morales, Esther; Beneit-Montesinos, Juan V; Martínez-de-Jesús, Fermín R; Aragón-Sánchez, Francisco Javier

2007-07-01

Diabetic foot is a complication of diabetes mellitus that manifests with the development of ulcers that frequently precede amputation. Several studies have verified that the environment of the diabetic neuropathic foot ulcer contains a high concentration of metalloproteinases. The aim of the present study was to evaluate the efficacy of a protease-modulating dressing in the treatment of neuropathic diabetic foot ulcers. A randomized controlled trial was conducted in 40 patients with a 6-week or longer history of neuropathic diabetic foot ulcer. The patients were randomized to two groups: group 1 (n = 20) received treatment with the protease-modulating dressing while the control group (group 2; n = 20) received the treatment specified in the standardized protocol for good wound care. The patients were then followed-up for 6 weeks. After 6 weeks, healing was achieved in 12 patients (63% of n = 19) in group 1 under treatment with the protease-modulating dressing versus three patients (15% of n = 19) in the control group (p < 0.03). The mean time to healing was 23.3 +/- 9.9 days in group 1 and 40.6 +/- 1.15 days in group 2 (p < 0.01). The results confirm the hypothesis that the use of protease-modulating dressings in patients with neuropathic diabetic foot ulcers leads to better tissue regeneration than good wound care.

Nerve decompression and neuropathy complications in diabetes: Are attitudes discordant with evidence?

PubMed Central

Nickerson, D. Scott

2017-01-01

ABSTRACT External neurolysis of the nerve at fibro-osseous tunnels has been proprosed to treat or prevent signs, symptoms, and complications in the lower extremity of diabetes patients with sensorimotor polyneuropathy. Nerve decompression is justified in the presence of symptomatic compressed nerves in the several fibro-osseous tunnels of the extremities, which are known to be frequent in diabetes. Quite a body of literature has accumulated reporting results after such nerve decompression in the leg, describing pain relief and sensibility improvement, as well as balance recovery, diabetic foot ulcer prevention, curtailed ulcer recurrence risk, and amputation avoidance. Historical academic hesitance to endorse surgical treatments for pain and numbness in diabetes was based primarily on the early retrospective reports’ potential for bias and placebo effects, and that the hypothetical basis for surgery lies outside the traditional etiology paradigm of length-dependent axonopathy. This reticence is here critiqued in view of recent studies using objective, measured outcome protocols which nullify such potential confounders. Pain relief is now confirmed with Level 1 studies, and Level 2 prospective information suggests protection from initial diabetic foot ulceration and most neuropathic ulcer recurrences. In view of the potential for nerve decompression to be useful in addressing some of the more difficult, expensive, and life altering complications of diabetic neuropathy, this secondary compression thesis and operative treatment methodology may deserve reassessment. PMID:28959382

Comparison the effects of two types of therapeutic exercises Frenkele vs. Swiss ball on the clinical balance measures in patients with type II diabetic neuropathy.

PubMed

Rojhani-Shirazi, Zahra; Barzintaj, Fatemeh; Salimifard, Mohamad Reza

2017-11-01

The number of diabetic patients is increasing in the world. Peripheral neuropathy is the most important problem of diabetes. Neuropathy eventually leads to balance impairment which is the main cause of falling down in these patients However, not sufficient evidences available to compare different protocols for improving balance in diabetic patients. This study aimed to compare the effects of two therapeutic exercises on clinical balance measures in patients with type II diabetic peripheral neuropathy. The study was performed on 60 patients with diabetes categorized randomly into three groups: an intervention group (N=20) that received ball training exercise, another intervention group (N=20) that received Frenkel exercise and a control group (N=20) that received no interventions. Exercise training session was performed for 3 weeks. Then, clinical balance measures were computed in the three groups. Paired t-test and one-way ANOVA were used to analyze the collected data. Both types of therapeutic exercise programs significantly improved balance in single leg stance, star excursion test, and Berg balance scale test (P˂0.05) compared to the control group. Besides, this was more significant in the ball training group (P˂0.05). To improve balance in diabetic neuropathy, Swiss ball exercise is preferred compared to Frenkel training. Copyright © 2016. Published by Elsevier Ltd.

Bilateral Ossified Chronic Subdural Hematoma Presenting as Diabetes Insipidus-Case Report and Literature Review.

PubMed

Siddiqui, Saquib A; Singh, Pankaj Kumar; Sawarkar, Dattaraj; Singh, Manmohanjit; Sharma, Bhawani S

2017-02-01

Calcified chronic subdural hematomas are an occurrence rarely seen in neurosurgical clinical practice. And when they occur bilaterally, the radiologic image they present is fascinating, as is the clinical presentation, but their management may be challenging. They have been reported to present with a multitude of neurologic deficits but never with diabetes insipidus, which is described here. Due to the rarity of this pathology, the management protocol is not well defined, though there have been quite a few papers on this condition. This review article gathers information published over the years on this rare entity to suggest a treatment protocol. Copyright © 2016 Elsevier Inc. All rights reserved.

New Diagnostic and Therapeutic Approaches for Preventing the Progression of Diabetic Retinopathy

PubMed Central

Park, Young Gun; Roh, Young-Jung

2016-01-01

Diabetic retinopathy (DR) is a severe sight-threatening complication of diabetes mellitus. Retinal laser photocoagulation, antivascular endothelial growth factors, steroid therapy, and pars plana vitrectomy are now used extensively to treat advanced stages of diabetic retinopathy. Currently, diagnostic devices like ultrawide field fundus fluorescein angiography and the improvement of optical coherence tomography have provided quicker and more precise diagnosis of early diabetic retinopathy. Thus, treatment protocols have been modified accordingly. Various types of lasers, including the subthreshold micropulse laser and RPE-targeting laser, and selective targeted photocoagulation may be future alternatives to conventional retinal photocoagulation, with fewer complications. The new developed intravitreal medications and implants have provided more therapeutic options, with promising results. PMID:26881240

Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study

PubMed Central

Chan, Juliana C.; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T.; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K.; Yeung, Vincent T.; Leung, Wilson Y.; Tong, Peter C.

2009-01-01

OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 μmol/l or dialysis). RESULTS Of these 205 patients (mean ± SD age 65 ± 7.2 years; disease duration 14 ± 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg, respectively, P = 0.02; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained ≥3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained ≥3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21–0.86] compared with that of those who attained ≤2 targets (n = 114). CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes. In addition to protocol, audits and feedback are needed to improve outcomes. PMID:19460913

Ambulatory screening of diabetic neuropathy and predictors of its severity in outpatient settings.

PubMed

Qureshi, M S; Iqbal, M; Zahoor, S; Ali, J; Javed, M U

2017-04-01

Diabetic neuropathy is one of the most common causes of chronic neuropathic symptomatology and the most disabling and difficult-to-treat diabetic microangiopathic complication. The neuropathies associated with diabetes are typically classified into generalized, focal and multifocal varieties. There exists a scarcity of literature studying the correlation of different patient- and disease-related variables with severity of neuropathy. This study aims to delineate the prevalence of diabetic neuropathy in type 2 diabetes, describe its characteristics and find out predictors of its severity. Eight hundred consecutive diabetic patients presenting to outpatient department (OPD) of Khan Research Labs (KRL) General Hospital and Centre for Diabetes and Liver diseases, Islamabad, during March-June, 2015 were made to complete a self-administered questionnaire (Michigan Neuropathy Screening Instrument-MNSI) and underwent a thorough physical examination according to MNSI protocols. A score of >2 was considered to be diagnostic for DPN. Patient and disease variables were noted. MNSI score was used as an index of severity of diabetic peripheral neuropathy (DPN). Correlation of several patient- and disease-related variables with the severity of DPN was determined using multivariate regression. Out of a total 800 patients screened, 90 (11.25%) were found to have diabetic neuropathy. Of these 90, 45.5% were males, the median age was 54.47 ± 10.87 years and the median duration of diabetes was 11.12 ± 9.8 years. The most common symptom was found to be numbness (63.6%) followed by generalized body weakness (61.5%). The common findings on physical examination were dry skin/callus (38.7%) and deformities (14.7%). Duration of diabetes was found to be the strongest predictor for development and severity of diabetic neuropathy followed by glycemic controls (HbA1c values) and age. Duration of diabetes rather than diabetic controls predicts better the development and severity of diabetic neuropathy indicating a failure of intensive treatment to avert such complications.

Effect of Rebound Exercises and Circuit Training on Complications Associated with Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

PubMed

Kaka, Bashir; Maharaj, Sonill Sooknunan

2018-05-07

The incidence of type 2 diabetes mellitus, a chronic lifestyle disease, and its complications are on the rise. Exercise has been documented as being effective in the management of musculoskeletal pain, depression, and reduction of hyperglycemia in diabetic patients. However, there is no consensus regarding the types of exercise that reduce musculoskeletal pain and depression and improve quality of life as well as respiratory function among individuals with type 2 diabetes. The objective of this study is to determine the effects of rebound and circuit training on musculoskeletal pain, blood glucose level, cholesterol level, quality of life, depression, and respiratory parameters in patients with type 2 diabetes mellitus. A total of 70 participants are expected to be recruited in this single blind randomized controlled trial. Computer-generated random numbers will be used to randomize the participants into 3 groups, namely, the rebound exercise group, the circuit exercise group, and the control group. Measurements will be taken at baseline and at the end of the 8 weeks of the study. Participants' musculoskeletal pain will be assessed using the visual analog scale, quality of life will be assessed using the SF 12 Health Survey Questionnaire, depression using the Beck Depression Inventory, respiratory parameters using the spirometer, and biochemical parameters such as glucose level and cholesterol level using the glucometer. Data will be analyzed using descriptive statistics and inferential statistics of multivariate analysis of variance between the groups and paired t test within the group. Alpha will be set at .05. The results of this study will identify the effectiveness of rebound exercise and circuit training, compared with the control, in the management of type 2 diabetes mellitus and on quality of life, musculoskeletal pain, depression, glycemic control, cholesterol level, as well as improvement in respiratory function. Though different additional strategies such as exercise and dietary and lifestyle modifications exist for the control of type 2 diabetes, they are mostly applied for the control of glucose level. No strategies have been identified for the control of complications associated with diabetes such as musculoskeletal pain, depression, and reduction in quality of life. Clinicaltrials.gov NCT03200795; https://clinicaltrials.gov/ct2/show/NCT03200795 (Archived by WebCite at http://www.webcitation.org/6mBgcj6z7). ©Bashir Kaka, Sonill Sooknunan Maharaj. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.05.2018.

Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial.

PubMed

Lee, Jun Yang; Chan, Carina Ka Yee; Chua, Siew Siang; Ng, Chirk Jenn; Paraidathathu, Thomas; Lee, Kenneth Kwing-Chin; Lee, Shaun Wen Huey

2016-09-29

The high market penetration of mobile phones has triggered an opportunity to combine mobile technology with health care to overcome challenges in today's health care setting. Although Malaysia has a high Internet and mobile penetration rate, evaluations of the efficacy of incorporating this technology in diabetes care is not common. We report the development of a telemonitoring coaching system, using the United Kingdom (UK) Medical Research Council (MRC) framework, for patients with type 2 diabetes mellitus. The Intervention for Diabetes with Education, Technological Advancement and Support (IDEAS) study is a telemonitoring programme based on an empowerment philosophy to enable participants to be responsible for their own health decision and behaviour. An iterative cycle of development, piloting, and collating qualitative and quantitative data will be used to inform and refine the intervention. To increase compliance, the intervention will be designed to encourage self-management using simple, non-technical knowledge. The primary outcomes will be HbA1c, blood pressure, total cholesterol, and quality of life and diabetes self-efficacy. In addition, an economic analysis on health service utilisation will be collected. The mixed-method approach in this study will allow for a holistic overview of using telemonitoring in diabetes care. This design enables researchers to understand the effectiveness of telemonitoring as well as provide insights towards the receptiveness of incorporating information technology amongst type 2 diabetes patients in a community setting. ClinicalTrials.gov NCT02466880 Registered 2 June 2015.

Physiotherapy treatment of the diabetic shoulder: a longitudinal study following patients with diabetes and shoulder pain using a pre-post treatment design.

PubMed

Kyhlbäck, Maria; Schröder Winter, Helena; Thierfelder, Tomas; Söderlund, Anne

2014-01-01

The aim of this study was to describe and evaluate a physiotherapy program targeted to reduce pain intensity and improve the daily functioning of diabetics with shoulder problems. It was hypothesized that patients receiving specific physiotherapy treatment improved more frequently and rapidly than diabetic patients followed up without specific physiotherapeutic intervention. A pre-post treatment design was completed for a group of 10 subjects. The treatment protocol, also applied during the daily activities of the subjects, was aiming at reducing pain intensity and shoulder stiffness and improving impaired functioning in daily activities by muscle relaxation, light-load exercise and enhancing proper shoulder co-ordination. The group analysis showed significant decrease of pain intensity level as well as improved shoulder functioning and sustained level of subject self-efficacy beliefs throughout the study period. The results suggest that it is possible to relieve shoulder pain intensity and improve daily activities of patients with diabetes-related shoulder problems by employing a physiotherapy program focusing on muscle relaxation, light-load exercise and on the enhancement of proper shoulder co-ordination in daily activities. A physiotherapy program can be effective in reducing pain and improving shoulder function in diabetics with shoulder problems. The treatment should focus on muscle relaxation, light-load exercise and on the enhancement of proper shoulder co-ordination in daily activities.

An ethnographic study of diabetes health beliefs and practices in Sri Lankan adults.

PubMed

Amarasekara, A A T D; Fongkaew, W; Turale, S; Wimalasekara, S W; Chanprasit, C

2014-12-01

Globally, type 2 diabetes is increasingly prevalent; however, unique cultural contexts in each country might affect these diabetes control behaviours. Diabetes is a serious health issue in Sri Lanka and little is known about the impact of sociocultural context on diabetes health behaviours. This first-time qualitative Sri Lankan study explored the health beliefs and practices of adults with diabetes to enhance current nursing care and medical treatment. An ethnographic approach was used to collect data through participant observations, in-depth interviews with 14 key informants in their homes and field notes. Data were analysed by thematic analysis. Findings revealed unique, informative insights into sociocultural worlds of the participants from three Sinhalese, Tamils and Moor ethnic groups. Findings are described under five themes: gaining religious support, changing food habits is a struggle, exercising is challenging, Western medicine causes long-term consequences and Ayurveda/traditional treatments can cure. In Sri Lankans, the impact of sociocultural context on glycaemic control behaviours is significant and should be taken in consideration when health professionals provide care, treatment and health education. Study informants were selected from three ethnic groups and just two communities. Further in-depth research is required using both qualitative and quantitative approaches in individual groups. Culturally relevant policies and protocols for community care and treatment of people with diabetes are urgently required in Sri Lanka to enhance cultural treatment and care and reduce the epidemic of diabetes. These policies need to take into account traditional beliefs and practices of various ethnic groups. © 2014 International Council of Nurses.

Cardioprotective potential of N-acetyl cysteine against hyperglycaemia-induced oxidative damage: a protocol for a systematic review.

PubMed

Dludla, Phiwayinkosi V; Nkambule, Bongani B; Dias, Stephanie C; Johnson, Rabia

2017-05-12

Hyperglycaemia-induced oxidative damage is a well-established factor implicated in the development of diabetic cardiomyopathy (DCM) in diabetic individuals. Some of the well-known characteristics of DCM include increased myocardial left ventricular wall thickness and remodelling that result in reduced cardiac efficiency. To prevent this, an increasing number of pharmacological compounds such as N-acetyl cysteine (NAC) are explored for their antioxidant properties. A few studies have shown that NAC can ameliorate hyperglycaemia-induced oxidative damage within the heart. Hence, the objective of this review is to synthesise the available evidence pertaining to the cardioprotective role of NAC against hyperglycaemia-induced oxidative damage and thus prevent DCM. This systematic review protocol will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. We will perform a comprehensive search on major databases such as EMBASE, Cochrane Library, PubMed and Google scholar for original research articles published from January 1960 to March 2017. We will only report on literature that is available in English. Two authors will independently screen for eligible studies using pre-defined criteria, and data extraction will be done in duplicate. All discrepancies will be resolved by consensus or consultation of a third reviewer. The quality of studies will be checked using Cochrane Risk of Bias Assessment Tool and The Joanna Briggs Institute (JBI) Critical Appraisal tools for non-randomised experimental studies. Heterogeneity across studies will be assessed using the Cochrane Q statistic and the inconsistency index (I 2 ). We will use the random effects model to calculate a pooled estimate. Although several studies have shown that NAC can ameliorate hyperglycaemia-induced oxidative damage within the heart, this systematic review will be the first pre-registered synthesis of data to identify the cardioprotective potential of NAC against hyperglycaemia-induced oxidative damage. This result will help guide future research evaluating the cardioprotective role of NAC against DCM and better identify possible mechanisms of action for NAC to prevent oxidative damage with a diabetic heart. PROSPERO CRD42017055851 .

Analyzing Unstructured Communication in a Computer-Mediated Environment for Adults With Type 2 Diabetes: A Research Protocol.

PubMed

Lewinski, Allison A; Anderson, Ruth A; Vorderstrasse, Allison A; Fisher, Edwin B; Pan, Wei; Johnson, Constance M

2017-04-24

Individuals with type 2 diabetes have an increased risk for comorbidities such as heart disease, lower limb amputations, stroke, and renal failure. Multiple factors influence development of complications in a person living with type 2 diabetes; however, an individual's self-management behaviors may delay the onset of, or lessen the severity of, these complications. Social support provides personal, informal advice and knowledge that helps individuals initiate and sustain self-management and adherence. Our aim was to gain an understanding of type 2 diabetes social interaction in a virtual environment, one type of computer-mediated environment (CME), and the social support characteristics that increase and sustain self-management in adults living with chronic illness. This study is a secondary analysis of longitudinal data collected in a CME study, Second Life Impacts Diabetes Education & Self-Management (1R21-LM010727-01). This virtual environment replicated a real-life community where 6 months of naturalistic synchronous voice conversations, emails, and text chats were recorded among participants and providers. This analysis uses a mixed-methods approach to explore and compare qualitative and quantitative findings. This analysis is guided by two theories: Strong/Weak Ties Theory and Social Penetration Theory. Qualitative data will be analyzed using content analysis, and we will complete descriptive statistics on the quantified variables (eg, average number of ties). Institutional review board approval was obtained in June 2016. This study is in progress. Interventions provided through virtual environments are a promising solution to increasing self-management practices. However, little is known of the depth, breadth, and quality of social support that is exchanged and how interaction supports self-management and relates to health outcomes. This study will provide knowledge that will help guide clinical practice and policy to enhance social support for chronic illness via the Internet. ©Allison A Lewinski, Ruth A Anderson, Allison A Vorderstrasse, Edwin B Fisher, Wei Pan, Constance M Johnson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2017.

Beneficial effects of previous exercise training on renal changes in streptozotocin-induced diabetic female rats

PubMed Central

Amaral, Liliany S de Brito; Silva, Fernanda A; Correia, Vicente B; Andrade, Clara EF; Dutra, Bárbara A; Oliveira, Márcio V; de Magalhães, Amélia CM; Volpini, Rildo A; Seguro, Antonio C; Coimbra, Terezila M

2016-01-01

This study evaluated the effects of aerobic exercise performed both previously and after the induction of diabetes mellitus on changes of renal function and structure in streptozotocin-induced diabetic rats. Female wistar rats were divided into five groups: sedentary control (C + Se); trained control (C + Ex); sedentary diabetic (D + Se); trained diabetic (D + Ex) and previously trained diabetic (D + PEx). The previous exercise consisted of treadmill running for four weeks before the induction of diabetes mellitus. After induction of diabetes mellitus with streptozotocin, the D + PEx, D + Ex and C + Ex groups were submitted to eight weeks of aerobic exercise. At the end of the training protocol, we evaluate the serum glucose, insulin and 17β-estradiol levels, renal function and structure, proteinuria, and fibronectin, collagen IV and transforming growth factor beta 1 (TGF-β1) renal expressions. Induction of diabetes mellitus reduced the insulin and did not alter 17β-estradiol levels, and exercise did not affect any of these parameters. Previous exercise training attenuated the loss of body weight, the blood glucose, the increase of glomerular filtration rate and prevented the proteinuria in the D + PEx group compared to D + Se group. Previous exercise also reduced glomerular hypertrophy, tubular and glomerular injury, as well as the expressions of fibronectin and collagen IV. These expressions were associated with reduced expression of TGF-β1. In conclusion, our study shows that regular aerobic exercise especially performed previously to induction of diabetes mellitus improved metabolic control and has renoprotective action on the diabetic kidney. PMID:26490345

Beneficial effects of previous exercise training on renal changes in streptozotocin-induced diabetic female rats.

PubMed

Amaral, Liliany S de Brito; Silva, Fernanda A; Correia, Vicente B; Andrade, Clara E F; Dutra, Bárbara A; Oliveira, Márcio V; de Magalhães, Amélia C M; Volpini, Rildo A; Seguro, Antonio C; Coimbra, Terezila M; Soares, Telma de J

2016-02-01

This study evaluated the effects of aerobic exercise performed both previously and after the induction of diabetes mellitus on changes of renal function and structure in streptozotocin-induced diabetic rats. Female wistar rats were divided into five groups: sedentary control (C + Se); trained control (C + Ex); sedentary diabetic (D + Se); trained diabetic (D + Ex) and previously trained diabetic (D + PEx). The previous exercise consisted of treadmill running for four weeks before the induction of diabetes mellitus. After induction of diabetes mellitus with streptozotocin, the D + PEx, D + Ex and C + Ex groups were submitted to eight weeks of aerobic exercise. At the end of the training protocol, we evaluate the serum glucose, insulin and 17β-estradiol levels, renal function and structure, proteinuria, and fibronectin, collagen IV and transforming growth factor beta 1 (TGF-β1) renal expressions. Induction of diabetes mellitus reduced the insulin and did not alter 17β-estradiol levels, and exercise did not affect any of these parameters. Previous exercise training attenuated the loss of body weight, the blood glucose, the increase of glomerular filtration rate and prevented the proteinuria in the D + PEx group compared to D + Se group. Previous exercise also reduced glomerular hypertrophy, tubular and glomerular injury, as well as the expressions of fibronectin and collagen IV. These expressions were associated with reduced expression of TGF-β1. In conclusion, our study shows that regular aerobic exercise especially performed previously to induction of diabetes mellitus improved metabolic control and has renoprotective action on the diabetic kidney. © 2016 by the Society for Experimental Biology and Medicine.

Insulin-producing Cells from Adult Human Bone Marrow Mesenchymal Stromal Cells Could Control Chemically Induced Diabetes in Dogs: A Preliminary Study.

PubMed

Gabr, Mahmoud M; Zakaria, Mahmoud M; Refaie, Ayman F; Ismail, Amani M; Khater, Sherry M; Ashamallah, Sylvia A; Azzam, Maha M; Ghoneim, Mohamed A

2018-01-01

Ten mongrel dogs were used in this study. Diabetes was chemically induced in 7 dogs, and 3 dogs served as normal controls. For each diabetic dog, 5 million human bone marrow-derived mesenchymal stem cells/kg were differentiated to form insulin-producing cells using a trichostatin-based protocol. Cells were then loaded in 2 TheraCyte capsules which were transplanted under the rectus sheath. One dog died 4 d postoperatively from pneumonia. Six dogs were followed up with for 6 to 18 mo. Euglycemia was achieved in 4 dogs. Their glucose tolerance curves exhibited a normal pattern demonstrating that the encapsulated cells were glucose sensitive and insulin responsive. In the remaining 2 dogs, the fasting blood sugar levels were reduced but did not reach normal values. The sera of all transplanted dogs contained human insulin and C-peptide with a negligible amount of canine insulin. Removal of the transplanted capsules was followed by prompt return of diabetes. Intracytoplasmic insulin granules were seen by immunofluorescence in cells from the harvested capsules. Furthermore, all pancreatic endocrine genes were expressed. This study demonstrated that the TheraCyte capsule or a similar device can provide adequate immunoisolation, an important issue when stem cells are considered for the treatment of type 1 diabetes mellitus.

Distinct clinical characteristics and therapeutic modalities for diabetic ketoacidosis in type 1 and type 2 diabetes mellitus.

PubMed

Kamata, Yuji; Takano, Koji; Kishihara, Eriko; Watanabe, Michiko; Ichikawa, Raishi; Shichiri, Masayoshi

2017-02-01

Patients with type 1 diabetes often develop diabetic ketoacidosis (DKA). Reportedly, DKA in type 2 diabetes has higher mortality despite its limited occurrence. The exact clinical characteristics and therapeutic modalities yielding successful outcomes in DKA type 2 diabetes remain unknown. This retrospective study compared the clinical features and detailed treatment of consecutive type 1 and type 2 diabetes patients hospitalized with DKA between January 2001 and December 2014. We report on 127 patients with type 1 and 74 patients with type 2 diabetes whose DKA was successfully treated. The most frequent precipitating cause for DKA was infectious disease for patients with type 1 diabetes and consumption of sugar-containing beverages for those with type 2 diabetes. Type 2 diabetes patients showed higher mean plasma glucose levels than those with type 1 diabetes (48.4±21.6, vs. 37.1±16.4mmol/l, P<0.01) and higher serum creatinine, blood urea nitrogen, and hemoglobin levels, which normalized after DKA resolution. Compared with type 1 diabetes patients, those with type 2 diabetes required distinctly higher daily total insulin dosage (35.9±37.0U, vs. 20.2±23.3U, P<0.01), larger replacement fluid volumes (4.17±2.69L, vs. 2.29±1.57L, P<0.01) and greater potassium supplementation (23.9±36.5mEq, vs. 11.2±17.9mEq, P<0.01) to resolve DKA and reduce plasma glucose level to ≤16.7mmol/l. DKA patients with type 2 diabetes required management with a modified treatment protocol to resolve their profound hyperglycemia and dehydration compared with those with type 1 diabetes. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical Components of Telemedicine Programs for Diabetic Retinopathy.

PubMed

Horton, Mark B; Silva, Paolo S; Cavallerano, Jerry D; Aiello, Lloyd Paul

2016-12-01

Diabetic retinopathy is a leading cause of new-onset vision loss worldwide. Treatments supported by large clinical trials are effective in preserving vision, but many persons do not receive timely diagnosis and treatment of diabetic retinopathy, which is typically asymptomatic when most treatable. Telemedicine evaluation to identify diabetic retinopathy has the potential to improve access to care, but there are no universal standards regarding camera choice or protocol for ocular telemedicine. We review the literature regarding the impact of imaging device, number and size of retinal images, pupil dilation, type of image grader, and diagnostic accuracy on telemedicine assessment for diabetic retinopathy. Telemedicine assessment of diabetic retinopathy has the potential to preserve vision, but further development of telemedicine specific technology and standardization of operations are needed to better realize its potential.

Do non-communicable diseases such as hypertension and diabetes associate with primary open-angle glaucoma? Insights from a case-control study in Nepal.

PubMed

Shakya-Vaidya, Suraj; Aryal, Umesh Raj; Upadhyay, Madan; Krettek, Alexandra

2013-11-04

Non-communicable diseases (NCDs) such as hypertension and diabetes are rapidly emerging public health problems worldwide, and they associate with primary open-angle glaucoma (POAG). POAG is the most common cause of irreversible blindness. The most effective ways to prevent glaucoma blindness involve identifying high-risk populations and conducting routine screening for early case detection. This study investigated whether POAG associates with hypertension and diabetes in a Nepalese population. To explore the history of systemic illness, our hospital-based case-control study used non-random consecutive sampling in the general eye clinics in three hospitals across Nepal to enroll patients newly diagnosed with POAG and controls without POAG. The study protocol included history taking, ocular examination, and interviews with 173 POAG cases and 510 controls. Data analysis comprised descriptive and inferential statistics. Descriptive statistics computed the percentage, mean, and standard deviation (SD); inferential statistics used McNemar's test to measure associations between diseases. POAG affected males more frequently than females. The odds of members of the Gurung ethnic group having POAG were 2.05 times higher than for other ethnic groups. Hypertension and diabetes were strongly associated with POAG. The overall odds of POAG increased 2.72-fold among hypertensive and 3.50-fold among diabetic patients. POAG associates significantly with hypertension and diabetes in Nepal. Thus, periodic glaucoma screening for hypertension and diabetes patients in addition to opportunistic screening at eye clinics may aid in detecting more POAG cases at an early stage and hence in reducing avoidable blindness.

The GesTIO protocol experience: safety of a standardized order set for subcutaneous insulin regimen in elderly hospitalized patients.

PubMed

Franchin, Alessandro; Maran, Alberto; Bruttomesso, Daniela; Corradin, Maria L; Rossi, Francesco; Zanatta, Federica; Barbato, Gian-Maria; Sicolo, Nicola; Manzato, Enzo

2017-12-01

In non-critical hospitalized patients with diabetes mellitus, guidelines suggest subcutaneous insulin therapy with basal-bolus regimen, even in old and vulnerable inpatients. To evaluate safety, efficacy, and benefit on clinical management of the GesTIO protocol, a set of subcutaneous insulin administration rules, in old and vulnerable non-ICU inpatients. Retrospective, observational study. Patients admitted to Geriatric Clinic of Padua were studied. 88 patients matched the inclusion criteria: type 2 diabetes or hospital-related hyperglycemia, ≥65 years, regular measurements of capillary glycemia, and basal-bolus subcutaneous insulin regimen managed by "GesTIO protocol" for five consecutive days. ratio of patients with blood glucose (BG) <3.9 mmol/l; number of BG per patient in target range (5-11.1 mmol/l); daily mean BG; and calls to physicians for adjusting insulin therapy. Mean age was 82 ± 7 years. 9.1% patients experienced mild hypoglycaemia, and no severe hypoglycaemia was reported. The median number of BG per patients in target range increased from 2.0 ± 2 to 3.0 ± 2 (p < 0.001). The daily mean BG decreased from 11.06 ± 3.03 to 9.64 ± 2.58 mmol/l (-12.8%, p < 0.005). The mean number of calls to physicians per patient decreased from 0.83 to 0.45 (p < 0.05). Treatment with GesTIO protocol allows a safe and effective treatment even in very old and vulnerable inpatients with a faster management insulin therapy.

Independent and combined effects of physical activity and body mass index on the development of Type 2 Diabetes - a meta-analysis of 9 prospective cohort studies.

PubMed

Cloostermans, Laura; Wendel-Vos, Wanda; Doornbos, Gerda; Howard, Bethany; Craig, Cora Lynn; Kivimäki, Mika; Tabak, Adam G; Jefferis, Barbara J; Ronkainen, Kimmo; Brown, Wendy J; Picavet, Susan H S J; Ben-Shlomo, Yoav; Laukkanen, Jari Antero; Kauhanen, Jussi; Bemelmans, Wanda J E

2015-12-01

The aim of this harmonized meta-analysis was to examine the independent and combined effects of physical activity and BMI on the incidence of type 2 diabetes. Our systematic literature review in 2011 identified 127 potentially relevant prospective studies of which 9 fulfilled the inclusion criteria (total N = 117,878, 56.2 % female, mean age = 50.0 years, range = 25-65 years). Measures of baseline physical activity (low, intermediate, high), BMI-category [BMI < 18.4 (underweight), 18.5-24.9 (normal weight), 25.0-29.9 (overweight), 30+ (obese)] and incident type 2 diabetes were harmonized across studies. The associations between physical activity, BMI and incident type 2 diabetes were analyzed using Cox regression with a standardized analysis protocol including adjustments for age, gender, educational level, and smoking. Hazard ratios from individual studies were combined in a random-effects meta-analysis. Mean follow-up time was 9.1 years. A total of 11,237 incident type 2 diabetes cases were recorded. In mutually adjusted models, being overweight or obese (compared with normal weight) and having low physical activity (compared with high physical activity) were associated with an increased risk of incident type 2 diabetes (hazard ratios 2.33, 95 % CI 1.95-2.78; 6.10, 95 % CI: 4.63-8.04, and 1.23, 95 % CI: 1.09-1.39, respectively). Individuals who were both obese and had low physical activity had 7.4-fold (95 % CI 3.47-15.89) increased risk of type 2 diabetes compared with normal weight, high physically active participants. This harmonized meta-analysis shows the importance of maintaining a healthy weight and being physically active in diabetes prevention.

Internet protocol television for personalized home-based health information: design-based research on a diabetes education system.

PubMed

Gray, Kathleen Mary; Clarke, Ken; Alzougool, Basil; Hines, Carolyn; Tidhar, Gil; Frukhtman, Feodor

2014-03-10

The use of Internet protocol television (IPTV) as a channel for consumer health information is a relatively under-explored area of medical Internet research. IPTV may afford new opportunities for health care service providers to provide health information and for consumers, patients, and caretakers to access health information. The technologies of Web 2.0 add a new and even less explored dimension to IPTV's potential. Our research explored an application of Web 2.0 integrated with IPTV for personalized home-based health information in diabetes education, particularly for people with diabetes who are not strong computer and Internet users, and thus may miss out on Web-based resources. We wanted to establish whether this system could enable diabetes educators to deliver personalized health information directly to people with diabetes in their homes; and whether this system could encourage people with diabetes who make little use of Web-based health information to build their health literacy via the interface of a home television screen and remote control. This project was undertaken as design-based research in two stages. Stage 1 comprised a feasibility study into the technical work required to integrate an existing Web 2.0 platform with an existing IPTV system, populated with content and implemented for user trials in a laboratory setting. Stage 2 comprised an evaluation of the system by consumers and providers of diabetes information. The project succeeded in developing a Web 2.0 IPTV system for people with diabetes and low literacies and their diabetes educators. The performance of the system in the laboratory setting gave them the confidence to engage seriously in thinking about the actual and potential features and benefits of a more widely-implemented system. In their feedback they pointed out a range of critical usability and usefulness issues related to Web 2.0 affordances and learning fundamentals. They also described their experiences with the system in terms that bode well for its educational potential, and they suggested many constructive improvements to the system. The integration of Web 2.0 and IPTV merits further technical development, business modeling, and health services and health outcomes research, as a solution to extend the reach and scale of home-based health care.

Stem Cell Therapy to Treat Diabetes Mellitus

PubMed Central

Liew, Chee Gee; Andrews, Peter W.

2008-01-01

Transplantation of pancreatic islets offers a direct treatment for type 1 diabetes and in some cases, insulin-dependent type 2 diabetes. However, its widespread use is hampered by a shortage of donor organs. Many extant studies have focused on deriving β-cell progenitors from pancreas and pluripotent stem cells. Efforts to generate β-cells in vitro will help elucidate the mechanisms of β-cell formation and thus provide a versatile in vivo system to evaluate the therapeutic potential of these cells to treat diabetes. Various successful experiments using β-cells in animal models have generated extensive interest in using human embryonic stem cells to restore normoglycemia in diabetic patients. While new techniques are continually unveiled, the success of β-cell generation rests upon successful manipulation of culture conditions and the induction of key regulatory genes implicated in pancreas development. In this review, we compare successfully conducted protocols, highlight essential steps and identify some of the remarkable shortfalls common to these methods. In addition, we discuss recent advancements in the derivation of patient-specific pluripotent stem cells that may facilitate the use of autologous β-cells in stem cell therapy. PMID:19290381

Animal Models of Diabetic Retinopathy: Summary and Comparison

PubMed Central

Lo, Amy C. Y.

2013-01-01

Diabetic retinopathy (DR) is a microvascular complication associated with chronic exposure to hyperglycemia and is a major cause of blindness worldwide. Although clinical assessment and retinal autopsy of diabetic patients provide information on the features and progression of DR, its underlying pathophysiological mechanism cannot be deduced. In order to have a better understanding of the development of DR at the molecular and cellular levels, a variety of animal models have been developed. They include pharmacological induction of hyperglycemia and spontaneous diabetic rodents as well as models of angiogenesis without diabetes (to compensate for the absence of proliferative DR symptoms). In this review, we summarize the existing protocols to induce diabetes using STZ. We also describe and compare the pathological presentations, in both morphological and functional aspects, of the currently available DR animal models. The advantages and disadvantages of using different animals, ranging from zebrafish, rodents to other higher-order mammals, are also discussed. Until now, there is no single model that displays all the clinical features of DR as seen in human. Yet, with the understanding of the pathological findings in these animal models, researchers can select the most suitable models for mechanistic studies or drug screening. PMID:24286086

Diabetes in Kyrgyzstan: changes between 2002 and 2009.

PubMed

Beran, David; Abdraimova, Aida; Akkazieva, Baktygul; McKee, Martin; Balabanova, Dina; Yudkin, John S

2013-01-01

Health system reform in Kyrgyzstan is seen as a relative success story in central Asia. Initially, most attention focused on structural changes, and it is only since 2006 that the delivery of care and the experience of health service users have risen on the agenda. One exception from the earlier period was a rapid appraisal of the management of diabetes, undertaken in 2002. Using that study as a baseline, we describe the findings of a new evaluation of diabetes management, undertaken in 2009, using the Rapid Assessment Protocol for Insulin Access, now implemented in seven countries. Access to care has improved through the creation of the Family Medical Centres and the deployment of endocrinologists to them. Another improvement is the access to insulin and related medicines, although assessment of the procurement system reveals that the government is getting very poor value for money. Looking ahead, there are grounds for optimism that the passage of the law on diabetes may progressively have a greater impact. Although the law is not yet fully implemented, it has enabled the diabetes associations to defend the rights of their members. This increased capacity is credited with some improvements in diabetes care. Copyright © 2012 John Wiley & Sons, Ltd.

Does glimepiride alter the pharmacokinetics of sildenafil citrate in diabetic nephropathy animals: investigating mechanism of interaction by molecular modeling studies.

PubMed

Tripathi, Alok Shiomurti; Timiri, Ajay Kumar; Mazumder, Papiya Mitra; Chandewar, Anil

2015-10-01

The present study evaluates possible drug interactions between glimepiride (GLIM) and sildenafil citrate (SIL) in streptozotocin (STZ)-induced diabetic nephropathic (DN) animals and also postulates the possible mechanism of interaction based on molecular modeling studies. Diabetic nephropathy was induced by single dose of STZ (60 mg kg(-1), i.p.) and was confirmed by assessing blood and urine biochemical parameters 28 days after induction. Selected DN animals were used to explore the drug interaction between GLIM (0.5 mg kg(-1), p.o.) and SIL (2.5 mg kg(-1), p.o.) on the 29th and 70th day of the protocol. Possible drug interaction was assessed by evaluating the plasma drug concentration using HPLC-UV and changes in biochemical parameters in blood and urine were also determined. The mechanism of the interaction was postulated from the results of a molecular modeling study using the Maestro module of Schrodinger software. DN was confirmed as there was significant alteration in blood and urine biochemical parameters in STZ-treated groups. The concentration of SIL increased significantly (P < 0.001) in rat plasma when co-administered with GLIM on the 70th day of the protocol. Molecular modeling revealed important interactions with rat serum albumin and CYP2C9. GLIM has a strong hydrophobic interaction with binding site residues of rat serum albumin compared to SIL, whereas for CYP2C9, GLIM forms a stronger hydrogen bond than SIL with polar contacts and hydrophobic interactions. The present study concludes that bioavailability of SIL increases when co-administered chronically with GLIM in the management of DN animals, and the mechanism is supported by molecular modeling studies.

Diverging effects of diabetes mellitus in patients with peripheral artery disease and abdominal aortic aneurysm and the role of advanced glycation end-products: ARTERY study - protocol for a multicentre cross-sectional study.

PubMed

de Vos, L C; Boersema, J; Hillebrands, J L; Schalkwijk, C G; Meerwaldt, R; Breek, J C; Smit, A J; Zeebregts, C J; Lefrandt, J D

2017-04-11

Diabetes mellitus is a well-defined risk factor for peripheral artery disease (PAD), but protects against the development and growth of abdominal aortic aneurysm (AAA). Diabetes mellitus is associated with arterial stiffening and peripheral arterial media sclerosis. Advanced glycation end-products (AGEs) are increased in diabetes mellitus and cardiovascular disease. AGEs are known to form cross-links between proteins and are associated with arterial stiffness. Whether AGEs contribute to the protective effects of diabetes mellitus in AAA is unknown. Therefore, the ARTERY ( A dvanced glycation end-p R oducts in patients with peripheral ar T ery dis E ase and abdominal ao R tic aneur Y sm) study is designed to evaluate the role of AGEs in the diverging effects of diabetes mellitus on AAA and PAD. This cross-sectional multicentre study will compare the amount, type and location of AGEs in the arterial wall in a total of 120 patients with AAA or PAD with and without diabetes mellitus (n=30 per subgroup). Also, local and systemic vascular parameters, including pulse wave velocity, will be measured to evaluate the association between arterial stiffness and AGEs. Finally, AGEs will be measured in serum, urine, and assessed in skin with skin autofluorescence using the AGE Reader. This study is approved by the Medical Ethics committees of University Medical Center Groningen, Martini Hospital and Medisch Spectrum Twente, the Netherlands. Study results will be disseminated through peer-reviewed journals and scientific events. trialregister.nl NTR 5363. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Fighting discrimination.

PubMed

Wientjens, Wim; Cairns, Douglas

2012-10-01

In the fight against discrimination, the IDF launched the first ever International Charter of Rights and Responsibilities of People with Diabetes in 2011: a balance between rights and duties to optimize health and quality of life, to enable as normal a life as possible and to reduce/eliminate the barriers which deny realization of full potential as members of society. It is extremely frustrating to suffer blanket bans and many examples exist, including insurance, driving licenses, getting a job, keeping a job and family affairs. In this article, an example is given of how pilots with insulin treated diabetes are allowed to fly by taking the responsibility of using special blood glucose monitoring protocols. At this time the systems in the countries allowing flying for pilots with insulin treated diabetes are applauded, particularly the USA for private flying, and Canada for commercial flying. Encouraging developments may be underway in the UK for commercial flying and, if this materializes, could be used as an example for other aviation authorities to help adopt similar protocols. However, new restrictions implemented by the new European Aviation Authority take existing privileges away for National Private Pilot Licence holders with insulin treated diabetes in the UK. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Pancreatic Endoderm-Derived From Diabetic Patient-Specific Induced Pluripotent Stem Cell Generates Glucose-Responsive Insulin-Secreting Cells.

PubMed

Rajaei, Bahareh; Shamsara, Mehdi; Amirabad, Leila Mohammadi; Massumi, Mohammad; Sanati, Mohammad Hossein

2017-10-01

Human-induced pluripotent stem cells (hiPSCs) can potentially serve as an invaluable source for cell replacement therapy and allow the creation of patient- and disease-specific stem cells without the controversial use of embryos and avoids any immunological incompatibility. The generation of insulin-producing pancreatic β-cells from pluripotent stem cells in vitro provides an unprecedented cell source for personal drug discovery and cell transplantation therapy in diabetes. A new five-step protocol was introduced in this study, effectively induced hiPSCs to differentiate into glucose-responsive insulin-producing cells. This process mimics in vivo pancreatic organogenesis by directing cells through stages resembling definitive endoderm, primitive gut-tube endoderm, posterior foregut, pancreatic endoderm, and endocrine precursor. Each stage of differentiation were characterized by stage-specific markers. The produced cells exhibited many properties of functional β-cells, including expression of critical β-cells transcription factors, the potency to secrete C-peptide in response to high levels of glucose and the presence of mature endocrine secretory granules. This high efficient differentiation protocol, established in this study, yielded 79.18% insulin-secreting cells which were responsive to glucose five times higher than the basal level. These hiPSCs-derived glucose-responsive insulin-secreting cells might provide a promising approach for the treatment of type I diabetes mellitus. J. Cell. Physiol. 232: 2616-2625, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Literacy and retention of information after a multimedia diabetes education program and teach-back.

PubMed

Kandula, Namratha R; Malli, Tiffany; Zei, Charles P; Larsen, Emily; Baker, David W

2011-01-01

Few studies have examined the effectiveness of teaching strategies to improve patients' recall and retention of information. As a next step in implementing a literacy-appropriate, multimedia diabetes education program (MDEP), the present study reports the results of two experiments designed to answer (a) how much knowledge is retained 2 weeks after viewing the MDEP, (b) does knowledge retention differ across literacy levels, and (c) does adding a teach-back protocol after the MDEP improve knowledge retention at 2-weeks' follow-up? In Experiment 1, adult primary care patients (n = 113) watched the MDEP and answered knowledge-based questions about diabetes before and after viewing the MDEP. Two weeks later, participants completed the knowledge assessment a third time. Methods and procedures for Experiment 2 (n = 58) were exactly the same, except that if participants answered a question incorrectly after watching the MDEP, they received teach-back, wherein the information was reviewed and the question was asked again, up to two times. Two weeks later, Experiment 2 participants completed the knowledge assessment again. Literacy was measured using the S-TOFHLA. After 2 weeks, all participants, regardless of their literacy levels, forgot approximately half the new information they had learned from the MDEP. In regression models, adding a teach-back protocol did not improve knowledge retention among participants and literacy was not associated with knowledge retention at 2 weeks. Health education interventions must incorporate strategies that can improve retention of health information and actively engage patients in long-term learning.

Exaggerated Liver Injury Induced by Renal Ischemia Reperfusion in Diabetes: Effect of Exenatide

PubMed Central

Vaghasiya, Jitendra D.; Sheth, Navin R.; Bhalodia, Yagnik S.; Jivani, Nurudin P.

2010-01-01

Background/Aim: This study was designed to investigate the possible effect of exenatide (Glucagon like Peptide-1 receptor agonist) on liver injury (distant organ) induced by renal ischemia reperfusion (IR) in diabetic rats. Materials and Methods: In vivo renal IR was performed in both type 2 diabetic and normal rats. Each protocol comprised ischemia for 30 minutes followed by reperfusion for 24 hours and a treatment period of 14 days before induction of ischemia. Results: Lipid peroxidation, xanthine oxidase activity, myeloperoxidase activity and nitric oxide level in liver tissue were significantly increased (P < 0.01, P < 0.001, P < 0.001, P < 0.05, respectively), after IR in diabetic rats compared to normal rats. Antioxidant enzymes like glutathione, superoxide dismutase, catalase and glutathione peroxidase were significantly reduced (P < 0.05, P < 0.05, P < 0.01, P < 0.05, respectively), after IR in diabetic rats compared to normal rats. Exenatide treatment significantly normalized (P < 0.01), these biochemical parameters in treated rats compared to diabetic IR rats. Serum creatinine phosphokinase activity and liver function enzymes were also significantly normalized (P < 0.001, P < 0.001, respectively), after administration of exenatide. Conclusion: Exenatide exerted protective effect on exaggerated remote organ (liver) injury induced by renal IR in diabetes. PMID:20616412

Diabetes in sub-Saharan Africa – from policy to practice to progress: targeting the existing gaps for future care for diabetes

PubMed Central

Pastakia, Sonak D; Pekny, Chelsea R; Manyara, Simon M; Fischer, Lydia

2017-01-01

The global prevalence and impact of diabetes has increased dramatically, particularly in sub-Saharan Africa. This region faces unique challenges in combating the disease including lack of funding for noncommunicable diseases, lack of availability of studies and guidelines specific to the population, lack of availability of medications, differences in urban and rural patients, and inequity between public and private sector health care. Because of these challenges, diabetes has a greater impact on morbidity and mortality related to the disease in sub-Saharan Africa than any other region in the world. In order to address these unacceptably poor trends, contextualized strategies for the prevention, identification, management, and financing of diabetes care within this population must be developed. This narrative review provides insights into the policy landscape, epidemiology, pathophysiology, care protocols, medication availability, and health care systems to give readers a comprehensive summary of many factors in these domains as they pertain to diabetes in sub-Saharan Africa. In addition to providing a review of the current evidence available in these domains, potential solutions to address the major gaps in care will be proposed to reverse the negative trends seen with diabetes in sub-Saharan Africa. PMID:28790858

The Role of Teleophthalmology in the Management of Diabetic Retinopathy.

PubMed

Salongcay, Recivall P; Silva, Paolo S

2018-01-01

The emergence of diabetes as a global epidemic is accompanied by the rise in diabetes‑related retinal complications. Diabetic retinopathy, if left undetected and untreated, can lead to severe visual impairment and affect an individual's productivity and quality of life. Globally, diabetic retinopathy remains one of the leading causes of visual loss in the working‑age population. Teleophthalmology for diabetic retinopathy is an innovative means of retinal evaluation that allows identification of eyes at risk for visual loss, thereby preserving vision and decreasing the overall burden to the health care system. Numerous studies worldwide have found teleophthalmology to be a reliable and cost‑efficient alternative to traditional clinical examinations. It has reduced barriers to access to specialized eye care in both rural and urban communities. In teleophthalmology applications for diabetic retinopathy, it is critical that standardized protocols in image acquisition and evaluation are used to ensure low image ungradable rates and maintain the quality of images taken. Innovative imaging technology such as ultrawide field imaging has the potential to provide significant benefit with integration into teleophthalmology programs. Teleophthalmology programs for diabetic retinopathy rely on a comprehensive and multidisciplinary approach with partnerships across specialties and health care professionals to attain wider acceptability and allow evidence‑based eye care to reach a much broader population. Copyright 2017 Asia-Pacific Academy of Ophthalmology.

[Neonatal Morbidity and Gestational Diabetes: Coincidence or Consequence of the 2011 Protocol].

PubMed

Mimoso, Gabriela; Oliveira, Guiomar

2017-09-29

Gestational diabetes is one of the diseases associated with pregnancy with higher rate of complications. Despite being a transitory condition, short and long term complications related to gestational diabetes have been described. There is scientific evidence to say that good metabolic control decreases perinatal complications. In 2011, new criteria was proposed for its diagnosis, which made possible its diagnosis during the 1st trimester of pregnancy. The aim of this study is to compare neonatal morbidity in two groups of women with gestational diabetes diagnosis before and after the latest Portuguese guidelines for diabetes and pregnancy were published (February 2011). We included all newborns born in Maternidade Bissaya Barreto whose mother, followed at our maternity between 2008 and 2013, had unifetal pregnancy complicated by diabetes. We used a perinatal database and analysed the impact of the new guidelines in perinatal morbidity over two periods of three years. There were 774 women who met the inclusion criteria. We found that gestational diabetes was diagnosed earlier, insulin therapy was more frequent. Neonatal morbidity was increased, and there were more cases of neonatal hypoglycemia and congenital anomalies, and newborns became smaller for gestational age. The increase in neonatal morbidity was associated with early diagnosis and rigorous metabolic control. To analyse national data will be fundamental to understand this unexpected increase in morbidity.

Assessing the Impact of Diabetes Mellitus on Donor Corneal Endothelial Cell Density.

PubMed

Liaboe, Chase A; Aldrich, Benjamin T; Carter, Pamela C; Skeie, Jessica M; Burckart, Kimberlee A; Schmidt, Gregory A; Reed, Cynthia R; Zimmerman, M Bridget; Greiner, Mark A

2017-05-01

To quantify changes in endothelial cell density (ECD) of donor corneal tissue in relation to the presence or absence of a medical history of diabetes mellitus diagnosis, treatment, and complications. A retrospective review was performed for all corneas collected at Iowa Lions Eye Bank between January 2012 and December 2015. For purposes of analysis, donor corneas were divided into 4 groups: nondiabetic, non-insulin-dependent diabetic, insulin-dependent diabetic without medical complications due to diabetes, and insulin-dependent diabetic with medical complications due to diabetes. ECD values (obtained through specular microscopy) and transplant suitability for endothelial transplantation (determined by the standard protocol of the eye bank) were compared among groups using linear mixed model analysis. In total, 4185 corneas from 2112 donors were included for analysis. Insulin-dependent diabetic samples with medical complications due to diabetes (N = 231 from 119 donors) showed lower ECD values compared with nondiabetic samples (-102 cells/mm, P = 0.049) and non-insulin-dependent diabetic samples (-117 cells/mm, P = 0.031). ECD values did not differ significantly among the remaining groups. The likelihood of suitability for endothelial transplantation did not differ among all 4 groups. Corneas from donors with insulin-dependent diabetes mellitus and medical complications resulting from the disease have lower mean ECD values compared with other donors. However, our analysis suggests that these corneas are equally likely to be included in the donor pool for corneal transplantation. Additional studies are needed to determine the mechanism(s) contributing to cell loss in donors with advanced diabetes and to assess associated endothelial cell functional impairment.

Structured nursing follow-up: does it help in diabetes care?

PubMed Central

2014-01-01

Background In 1995 Clalit Health Services introduced a structured follow-up schedule, by primary care nurses, of diabetic patients. This was supplementary care, given in addition to the family physician’s follow-up care. This article aims to describe the performance of diabetes follow-up and diabetes control in patients with additional structured nursing follow-up care, compared to those patients followed only by their family physician. Methods We randomly selected 2,024 type 2 diabetic subjects aged 40–76 years. For each calendar year, from 2005–2007, patients who were “under physician follow-up only” were compared to those who received additional structured nursing follow-up care. Main outcomes Complete diabetes follow-up parameters including: HbA1c, LDL cholesterol, microalbumin, blood pressure measurements and fundus examination. Results The average age of study participants was 60.7 years, 52% were females and 38% were from low socioeconomic status (SES). In 2005, 39.5% of the diabetic patients received structured nursing follow-up, and the comparable figures for 2006 and 2007 were 42.1% 49.6%, respectively. The intervention subjects tended to be older, from lower SES, suffered from more chronic diseases and visited their family physician more frequently than the control patients. Patients in the study group were more likely to perform a complete diabetes follow-up plan: 52.8% vs. 21.5% (2005; p < 0.001) 55.5% vs. 30.3% (2006; p < 0.001), 52.3% vs. 35.7% (2007; p < 0.001). LDL cholesterol levels were lower in the study group only in 2005: 103.7 vs. 110.0 p < 0.001. Conclusion Subjects with supplementary structured nursing follow-up care were more likely to perform complete diabetes follow-up protocol. Our results reinforce the importance of teamwork in diabetic care. Further study is required to identify strategies for channeling the use of the limited resources to the patients who stand to benefit the most. PMID:25180073

The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes.

PubMed

Mahmud, Farid H; De Melo, Emilia N; Noordin, Karima; Assor, Esther; Sahota, Kamaljeet; Davies-Shaw, Jolie; Cutz, Ernest; Somers, Gino; Lawson, Margaret; Mack, David R; Gallego, Patricia; McDonald, Charlotte; Beaton, Melanie D; Bax, Kevin; Saibil, Fred; Gilbert, Jeremy; Kirsch, Susan; Perkins, Bruce A; Cino, Maria; Szentgyorgyi, Eva; Koltin, Dror; Parikh, Amish; Mukerji, Geetha; Advani, Andrew; Lou, Olivia; Marcon, Margaret A

2015-05-11

Coeliac disease (CD) is an autoimmune condition characterised by gluten-induced intestinal inflammation, and observed at a 5-10 fold greater prevalence in type 1 diabetes. While universal screening for CD in patients with diabetes is frequently advocated, objective data is limited as to benefits on diabetes control, bone health or quality of life related to the adoption of a gluten-free diet (GFD) in the large proportion of patients with diabetes with asymptomatic CD. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) study is a multicenter, randomised controlled trial to evaluate the efficacy and safety of a GFD in patients with type 1 diabetes with asymptomatic CD. Children and adults (8-45 years) with type 1 diabetes will be screened for asymptomatic CD. Eligible patients with biopsy-proven CD will be randomly assigned in a 1:1 ratio to treatment with a GFD for 1 year, or continue with a gluten-containing diet. The primary outcome will evaluate the impact of the GFD on change in glycated haemoglobin. Secondary outcomes will evaluate changes in bone mineral density, blood glucose variability and health-related quality of life between GFD-treated and the regular diet group over a 1-year period. The study was initiated in 2012 and has subsequently expanded to multiple paediatric and adult centres in Ontario, Canada. The findings from this study will provide high-quality evidence as to the impact of GFD treatment on glycaemic control and complications in asymptomatic children and adults with CD and type 1 diabetes. NCT01566110. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Evaluation and Referral of Diabetic Eye Disease in the Endocrinology and Primary Care Office Settings.

PubMed

Silva, Fabiana Q; Adhi, Mehreen; Wai, Karen M; Olansky, Leann; Lansang, M Cecilia; Singh, Rishi P

2016-10-01

The purpose of this study was to identify whether endocrinologists and primary care physicians (PCP) adequately screen for ophthalmic symptoms/signs within office visits and provide timely ophthalmology referrals in patients with diabetes. Patients between the ages of 18 years and 80 years with diabetes who underwent an office visit with an endocrinologist or a PCP between January 1, 2014, and December 31, 2014, were identified. Demographics, ophthalmic assessments, and referral information were collected. A total of 1,250 patient records were reviewed. Providers asked about ophthalmic symptoms/signs in 95.5% and 71% of endocrinology and primary care office encounters, respectively (P < .0001). Past and/or future ophthalmology appointments were verified in 86.1% and 49.7% of patients during endocrinology and PCP visits, respectively (P < .0001). Ophthalmic complications from diabetes are not adequately screened, especially within the primary care setting, and further quality improvement measures may improve adherence to recommended screening protocols. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:930-934.]. Copyright 2016, SLACK Incorporated.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial.

PubMed

Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

2013-10-17

Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Primary Dietary Intervention Study to Reduce the Risk of Islet Autoimmunity in Children at Increased Risk for Type 1 Diabetes

PubMed Central

Hummel, Sandra; Pflüger, Maren; Hummel, Michael; Bonifacio, Ezio; Ziegler, Anette-G.

2011-01-01

OBJECTIVE To determine whether delaying the introduction of gluten in infants with a genetic risk of islet autoimmunity is feasible, safe, and may reduce the risk of type 1 diabetes–associated islet autoimmunity. RESEARCH DESIGN AND METHODS A total of 150 infants with a first-degree family history of type 1 diabetes and a risk HLA genotype were randomly assigned to a first gluten exposure at age 6 months (control group) or 12 months (late-exposure group) and were followed 3 monthly until the age of 3 years and yearly thereafter for safety (for growth and autoantibodies to transglutaminase C [TGCAs]), islet autoantibodies to insulin, GAD, insulinoma-associated protein 2, and type 1 diabetes. RESULTS Adherence to the dietary-intervention protocol was reported from 70% of families. During the first 3 years, weight and height were similar in children in the control and late-exposure groups, as was the probability of developing TGCAs (14 vs. 4%; P = 0.1). Eleven children in the control group and 13 children in the late-exposure group developed islet autoantibodies (3-year risk: 12 vs. 13%; P = 0.6). Seven children developed diabetes, including four in the late-exposure group. No significant differences were observed when children were analyzed as per protocol on the basis of the reported first gluten exposure of the children. CONCLUSIONS Delaying gluten exposure until the age of 12 months is safe but does not substantially reduce the risk for islet autoimmunity in genetically at-risk children. PMID:21515839

Cell differentiation: therapeutical challenges in diabetes.

PubMed

Roche, Enrique; Vicente-Salar, Nestor; Arribas, Maribel; Paredes, Beatriz

2012-01-01

Stem cells, derived from either embryonic or adult tissues, are considered to be potential sources of insulin-secreting cells to be transplanted into type 1 and advanced stages of type 2 diabetic patients. Many laboratories have considered this possibility, resulting in a large amount of published protocols, with a wide degree of complexity among them. Our group was the first to report that it was possible to obtain insulin-secreting cells from mouse embryonic stem cells, proving the feasibility of this new challenge. The same observation was immediately reported using human embryonic stem cells. However, the resulting cell product was not properly characterised, affecting the reproducibility of the protocol by other groups. A more elaborated protocol was developed by Lumelsky and co-workers, demonstrating that neuroectodermal cells could be an alternative source for insulin-producing cells. However, the resulting cells of this protocol produced low amounts of the hormone. This aimed other groups to perform key changes in order to improve the insulin content of the resulting cells. Recently, Baetge's group has published a new protocol based on the knowledge accumulated in pancreatic development. In this protocol, human embryonic stem cells were differentiated into islet-like structures through a five step protocol, emulating the key steps during embryonic development of the endocrine pancreas. The final cell product, however, seemed to be in an immature state, thus further improvement is required. Despite this drawback, the protocol represents the culmination of work performed by different groups and offers new research challenges for the investigators in this exciting field. Concerning adult stem cells, the possibility of identifying pancreatic precursors or of reprogramming extrapancreatic derived cells are key possibilities that may circumvent the problems that appear when using embryonic stem cells, such as immune rejection and tumour formation.

Combined exercise for people with type 2 diabetes mellitus: a systematic review.

PubMed

Oliveira, César; Simões, Mário; Carvalho, Joana; Ribeiro, José

2012-11-01

Type 2 diabetes mellitus has emerged as a major non-communicable chronic diseases in many countries. The importance of exercise in the prevention and management of this disease is evident. This paper briefly reviews the effects of combining aerobic and resistance exercises on glycemic control, and details the training and characteristics of various interventions in adults with type 2 diabetes mellitus. Literature searches were performed using electronic databases between the 1st of January 1950 and the 15th of September 2011. Of the 403 articles retrieved, 28 studies met our inclusion criteria. Combined exercise protocols seem to improve glycemic control to a greater extent than isolated forms of exercise. Nevertheless, length, duration, intensity, mode, number of exercises, sets and repetitions varied markedly among studies. Supervised training sessions, recommended structured exercises, and splitting aerobic and resistance training in separate sessions may be relevant for best results. Future studies should analyze the effects of different aerobic and resistance training modes, different training and progression methods, and whether one type of exercise is optimal, as these issues are likely to convey greater knowledge on type 2 diabetes mellitus management through combined exercise. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis.

PubMed

Bukhsh, Allah; Khan, Tahir M; Lee, Shaun W H; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [-0.86, 95% CI -0.983, -0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [-4.94; 95%CI -8.65, -1.23] and triglycerides levels [-0.26, 95%CI -0.51, -0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [-0.57; 95%CI -1.25, -0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes.

The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial)

PubMed Central

Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal

2017-01-01

Background Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. Objective The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to “fit for discharge”, incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. Methods In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann’s solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were “fit for discharge”, which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Results Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. Conclusions VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK) PMID:28630035

A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols.

PubMed

Newton, Robert L; Johnson, William D; Hendrick, Chelsea; Harris, Melissa; Andrews, Emanuel; Johannsen, Neil; Rodarte, Ruben Q; Hsia, Daniel S; Church, Timothy S

2015-07-01

Lack of regular physical activity at prescribed intensity levels is a modifiable risk factor for insulin resistance and the development of diabetes. African American men are at increased risk for developing diabetes and most African American men are not meeting the current recommended levels of physical activity. The primary objective of the Aerobic Plus Resistance Training and Insulin Resistance in African American Men (ARTIIS) study is to determine the effectiveness of an exercise training intervention aimed at reducing diabetes risk factors in African American men at risk for developing diabetes. Insufficiently active 35-70 year old African American men with a family history of diabetes were eligible for the study. The 5-month randomized controlled trial assigns 116 men to an exercise training or healthy living control arm. The exercise training arm combines aerobic and resistance training according to the current national physical activity recommendations and is conducted in community (YMCA) facilities. The healthy living arm receives information promoting healthy lifestyle changes. Insulin response to an oral glucose load is the primary outcome measure, and changes in physiological parameters, cardiorespiratory fitness, strength, body composition, and psychological well-being comprise the secondary outcomes. The ARTIIS study is one of the first adequately powered, rigorously designed studies to investigate the effects of an aerobic plus resistance exercise training program and to assess adherence to exercise training in community facilities, in African American men. Copyright © 2015 Elsevier Inc. All rights reserved.

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. Methods/Design The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. Discussion The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. Trial registration ClinicalTrials.gov: NCT01654341. PMID:24456998

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial.

PubMed

Rodríguez-Mañas, Leocadio; Bayer, Antony J; Kelly, Mark; Zeyfang, Andrej; Izquierdo, Mikel; Laosa, Olga; Hardman, Timothy C; Sinclair, Alan J; Moreira, Severina; Cook, Justin

2014-01-24

Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. ClinicalTrials.gov: NCT01654341.

Comparative occurrence of diabetes in canine, feline, and few wild animals and their association with pancreatic diseases and ketoacidosis with therapeutic approach.

PubMed

Niaz, Kamal; Maqbool, Faheem; Khan, Fazlullah; Hassan, Fatima Ismail; Momtaz, Saeideh; Abdollahi, Mohammad

2018-04-01

Diabetes mellitus (DM) is a chronic metabolic disorder in which blood glucose level raises that can result in severe complications. However, the incidence increased mostly by obesity, pregnancy, persistent corpus luteum, and diestrus phase in humans and animals. This review has focused on addressing the possible understanding and pathogenesis of spontaneous DM in canine, feline, and few wild animals. Furthermore, pancreatic associated disorders, diabetic ketoacidosis, hormonal and drug interaction with diabetes, and herbal remedies associated with DM are elucidated. Bibliographic search for the present review was done using PubMed, Scopus, and Google Scholar for articles on concurrent DM in small and wild animals. Persistent corpus luteal and pseudopregnancy in female dogs generate gestational DM (GDM). GDM can also be caused by extensive use of drugs/hormones such as glucocorticosteroids. Although many similarities are present between diabetic cats and diabetic humans which present islet amyloidosis, there was a progressive loss of β- and α-cells and the normal number of δ-cells. The most prominent similarity is the occurrence of islet amyloidosis in all cases of diabetic cat and over 90% of human non-insulin dependent DM Type-2. Acute pancreatic necrosis (APN) occurs due to predisposing factors such as insulin antagonism, insulin resistance, alteration in glucose tolerance, obesity, hyperadrenocorticism, and persistent usage of glucocorticoids, as these play a vital role in the progression of APN. To manage such conditions, it is important to deal with the etiological agent, risk factors, diagnosis of diabetes, and hormonal and drug interaction along with its termination with suitable therapy (herbal) protocols. It should be noted that the protocols used for the diagnosis and treatment of human DM are not appropriate for animals. Further investigations regarding diabetic conditions of pets and wild animals are required, which will benefit the health status of all animals health worldwide.

Electrophysiological measurements of diabetic peripheral neuropathy: A systematic review.

PubMed

Shabeeb, Dheyauldeen; Najafi, Masoud; Hasanzadeh, Gholamreza; Hadian, Mohammed Reza; Musa, Ahmed Eleojio; Shirazi, Alireza

2018-03-28

Peripheral neuropathy is one of the main complications of diabetes mellitus. One of the features of diabetic nerve damage is abnormality of sensory and motor nerve conduction study. An electrophysiological examination can be reproduced and is also a non-invasive approach in the assessment of peripheral nerve function. Population-based and clinical studies have been conducted to validate the sensitivity of these methods. When the diagnosis was based on clinical electrophysiological examination, abnormalities were observed in all patients. In this research, using a review design, we reviewed the issue of clinical electrophysiological examination of diabetic peripheral neuropathy in articles from 2008 to 2017. For this purpose, PubMed, Scopus and Embase databases of journals were used for searching articles. The researchers indicated that diabetes (both types) is a very disturbing health issue in the modern world and should be given serious attention. Based on conducted studies, it was demonstrated that there are different procedures for prevention and treatment of diabetes-related health problems such as diabetic polyneuropathy (DPN). The first objective quantitative indication of the peripheral neuropathy is abnormality of sensory and motor nerve conduction tests. Electrophysiology is accurate, reliable and sensitive. It can be reproduced and also is a noninvasive approach in the assessment of peripheral nerve function. The methodological review has found that the best method for quantitative indication of the peripheral neuropathy compared with all other methods is clinical electrophysiological examination. For best results, standard protocols such as temperature control and equipment calibration are recommended. Copyright © 2018. Published by Elsevier Ltd.

Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study.

PubMed

Faridi, Zubaida; Liberti, Lauren; Shuval, Kerem; Northrup, Veronika; Ali, Ather; Katz, David L

2008-06-01

Utilizing information technology, such as Internet and cellphones, holds great promise in enhancing diabetic care. Yet few studies have examined the impact of cellphone technology on type 2 diabetics' self-care. The primary aim of the study is to examine the feasibility of utilizing this technology to assist with diabetes self-care in a clinic population as well as its impact on clinical outcomes. Thirty patients with a diagnosis of type 2 diabetes at two Community Health Centers were randomized to intervention or control. Intervention patients participated in a brief intervention and received tailored daily messages via cellphone prompting them to enhance their diabetic self-care behaviour. Patients at the control site continued with their standard diabetes self-management. A mean improvement in HbA1c levels was apparent (-0.1, SD = 0.3%; P = 0.1534) in the intervention group, compared with a mean deterioration in the control (0.3, SD = 1.0%; P = 0.3813), yet without statistical significance. Self-efficacy scores improved significantly in the intervention group (-0.5, SD = 0.6; P = 0.0080) compared with no improvement in the control (0.0, SD = 1.0; P = 0.9060). Participants encountered numerous technological barriers when attempting to adhere to the intervention protocol. The results indicate the intervention had a positive impact on some clinical outcome and self-efficacy. Although the technology appears feasible in a clinical setting technology must be made more user-friendly before a larger phase II trial is conducted.

Effect of irbesartan on nitrotyrosine generation in non-hypertensive diabetic patients.

PubMed

Ceriello, A; Assaloni, R; Da Ros, R; Maier, A; Quagliaro, L; Piconi, L; Esposito, K; Giugliano, D

2004-09-01

Oxidative stress is involved in the pathogenesis of microangiopathic and macroangiopathic diabetic complications. The results of recent trials suggest that type 1 angiotensin II (AT-1) receptor blockers may prevent or delay nephropathy and cardiovascular disease in diabetic patients, independently of their anti-hypertensive action. There is evidence that AT-1 receptor blockers can work as intracellular antioxidants. This study investigated whether the AT-1 receptor blocker irbesartan is able to reduce nitrotyrosine formation in non-hypertensive diabetic patients under fasting conditions and during acute hyperglycaemia. A total of 40 non-hypertensive, non-microalbuminuric Type 2 diabetic patients and 20 healthy, normotensive subjects were recruited for this study. Diabetic patients followed a randomised, double-blind, placebo-controlled, crossover protocol, taking either irbesartan (150 mg orally, twice daily) or placebo for 60 days. Fasting glucose and nitrotyrosine were measured at baseline and at the end of each treatment period. An OGTT was also performed at the same time intervals, during which plasma glucose and nitrotyrosine levels were monitored. Compared with baseline measurements, treatment with irbesartan (0.57+/-0.4 vs 0.35+/-0.3 micromol/l, p<0.01) but not placebo (0.58+/-0.3 vs 0.59+/-0.2 micromol/l) significantly reduced fasting nitrotyrosine levels. Irbesartan also significantly reduced nitrotyrosine formation during the OGTT. . This study demonstrates that irbesartan reduces plasma levels of nitrotyrosine in diabetic patients and is effective in counterbalancing nitrotyrosine formation during acute hyperglycaemia. Our results may help to elucidate how AT-1 receptor blockers exert their beneficial effect independently of their BP-lowering activity.

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Taheri, Shahrad; Chagoury, Odette; Zaghloul, Hadeel; Elhadad, Sara; Ahmed, Salma Hayder; Omar, Omar; Payra, Sherryl; Ahmed, Salma; El Khatib, Neda; Amona, Rasha Abou; El Nahas, Katie; Bolton, Matthew; Chaar, Henem; Suleiman, Noor; Jayyousi, Amin; Zirie, Mahmoud; Janahi, Ibrahim; Elhag, Wahiba; Alnaama, Abdulla; Zainel, Abduljaleel; Hassan, Dahlia; Cable, Tim; Charlson, Mary; Wells, Martin; Al-Hamaq, Abdulla; Al-Abdulla, Samya; Abou-Samra, Abdul Badi

2018-05-21

Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM. The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout. If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM. ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.

Feasibility of a Manualized Occupation-Based Diabetes Management Intervention.

PubMed

Carandang, Kristine M; Pyatak, Elizabeth A

We investigated the feasibility and acceptability of an occupational therapy intervention targeting diabetes management for underserved young adults. Eight participants completed the intervention and a battery of assessments at baseline and after the intervention. At completion, the participants and occupational therapist were interviewed about their experiences with the study. Four categories of assessment questions were used to guide the study: process, resource, management, and scientific. Successes included recruitment; fulfillment of tasks by staff and partnering clinics; adequate space, financial support, and equipment; and meaningfulness of the intervention for participants. Challenges included scheduling participants for the intervention and follow-up focus groups and providing client centeredness and flexibility while reducing burden on the intervener. This feasibility study allowed us to make necessary revisions to our study protocol before implementing a larger pilot study. Copyright © 2018 by the American Occupational Therapy Association, Inc.

Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist—protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol

PubMed Central

Ishøy, Pelle L; Knop, Filip K; Broberg, Brian V; Baandrup, Lone; Fagerlund, Birgitte; Jørgensen, Niklas R; Andersen, Ulrik B; Rostrup, Egill; Glenthøj, Birte Y; Ebdrup, Bjørn H

2014-01-01

Introduction Antipsychotic medication is widely associated with dysmetabolism including obesity and type 2 diabetes, cardiovascular-related diseases and early death. Obesity is considered the single most important risk factor for cardiovascular morbidity and mortality. Interventions against antipsychotic-associated obesity are limited and insufficient. Glucagon-like peptide-1 (GLP-1) receptor agonists are approved for the treatment of type 2 diabetes, but their bodyweight-lowering effects have also been recognised in patients with non-diabetes. The primary endpoint of this trial is weight loss after 3 months of treatment with a GLP-1 receptor agonist (exenatide once weekly) in patients with non-diabetic schizophrenia with antipsychotic-associated obesity. Secondary endpoints include physiological and metabolic measurements, various psychopathological and cognitive measures, and structural and functional brain MRI. Methods and analysis 40 obese patients with schizophrenia or schizoaffective disorder treated with antipsychotic drugs will be randomised to subcutaneous injection of exenatide once weekly (2 mg) or placebo for 3 months, adjunctive to their antipsychotic treatment. Ethics and dissemination The trial has been approved by the Danish Health and Medicines Authority, the National Committee on Health Research Ethics and the Danish Data Protection Agency. Trial participation presupposes theoral and written patient informed consent. An external, independent monitoring committee (Good Clinical Practice Unit at Copenhagen University Hospital) will monitor the study according to the GCP Guidelines. Trial data, including positive, negative and inconclusive results, will be presented at national and international scientific meetings and conferences. Papers will be submitted to peer-reviewed journals. Trial registration ClinicalTrials.gov identifier: NCT01794429; National Committee on Health Research Ethics project number: 36378; EudraCT nr: 2012-005404-17; The Danish Data Protection Agency project number: RHP-2012-027. PMID:24401727

Collaborative depression care among Latino patients in diabetes disease management, Los Angeles, 2011-2013.

PubMed

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen; Wu, Shinyi

2014-08-28

The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes-Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system.

The Belgian Diabetes in Pregnancy Study (BEDIP-N), a multi-centric prospective cohort study on screening for diabetes in pregnancy and gestational diabetes: methodology and design

PubMed Central

2014-01-01

Background The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recommends universal screening with a 75 g oral glucose tolerance test (OGTT) using stricter criteria for gestational diabetes (GDM). This may lead to important increases in the prevalence of GDM and associated costs, whereas the gain in health is unclear. The goal of ‘The Belgian Diabetes in Pregnancy Study’ (BEDIP-N) is to evaluate the best screening strategy for pregestational diabetes in early pregnancy and GDM in an ethnically diverse western European population. The IADPSG screening strategy will be followed, but in addition risk questionnaires and a 50 g glucose challenge test (GCT) will be performed, in order to define the most practical and most cost effective screening strategy in this population. Methods BEDIP-N is a prospective observational cohort study in 6 centers in Belgium. The aim is to enroll 2563 pregnant women in the first trimester with a singleton pregnancy, aged 18–45 years, without known diabetes and without history of bariatric surgery. Women are universally screened for overt diabetes and GDM in the first trimester with a fasting plasma glucose and for GDM between 24–28 weeks using the 50 g GCT and independently of the result of the GCT, all women will receive a 75 g OGTT using the IADPSG criteria. Diabetes and GDM will be treated according to a standardized routine care protocol. Women with GDM, will be reevaluated three months postpartum with a 75 g OGTT. At each visit blood samples are collected, anthropometric measurements are obtained and self-administered questionnaires are completed. Recruitment began in April 2014. Discussion This is the first large, prospective cohort study rigorously assessing the prevalence of diabetes in early pregnancy and comparing the impact of different screening strategies with the IADPSG criteria on the detection of GDM later in pregnancy. Trial registration ClinicalTrials.gov: NCT02036619. Registered 14-1-2014. PMID:25015413

Challenges in Modelling Hypoglycaemia-Associated Autonomic Failure: A Review of Human and Animal Studies

PubMed Central

Zhou, Xin-Fu

2016-01-01

Recurrent insulin-induced hypoglycaemia is a major limitation to insulin treatment in diabetes patients leading to a condition called hypoglycaemia-associated autonomic failure (HAAF). HAAF is characterised by reduced sympathoadrenal response to subsequent hypoglycaemia thereby predisposing the patients to severe hypoglycaemia that can lead to coma or even death. Despite several attempts being made, the mechanism of HAAF is yet to be clearly established. In order for the mechanism of HAAF to be elucidated, establishing a human/animal model of the phenomenon is the foremost requirement. Several research groups have attempted to reproduce the phenomenon in diabetic and nondiabetic humans and rodents and reported variable results. The success of the phenomenon is marked by a significant reduction in plasma adrenaline response to subsequent hypoglycaemic episode relative to that of the antecedent hypoglycaemic episode. A number of factors such as the insulin dosage, route of administration, fasting conditions, blood sampling methods and analyses, depth, duration, and number of antecedent hypoglycaemic episodes can impact the successful reproduction of the phenomenon and thus have to be carefully considered while developing the protocol. In this review, we have outlined the protocols followed by different research groups to reproduce the phenomenon in diabetic and nondiabetic humans and rodents including our own observations in rats and discussed the factors that have to be given careful consideration in reproducing the phenomenon successfully. PMID:27843452

The effects of hyperventilation on axonal excitability parameters in patients with diabetes mellitus and polyneuropathy.

PubMed

Akça, Gökçen; Yerdelen, Deniz; Balcı, Mustafa Kemal; Uysal, Hilmi

2016-08-01

We aimed to explore axonal excitability parameters in patients with diabetes mellitus (DM) and polyneuropathy (PNP) as well as those without PNP. We used the short TROND protocol by QTRAC to measure axonal excitability parameters (strength-duration time constant (SDTC), rheobase, etc.) in 12 healthy subjects and 14 DM patients with PNP and 10 DM patients without PNP. The short TROND protocol was performed before and after 20min of deep hyperventilation in healthy subjects and patients with DM. Also, venous blood pH and partial pressure of O2 and CO2 were recorded before hyperventilation (HPV) and after 20min of HPV. A "hyperventilation score" was evaluated before and after HPV. When the values of DM with PNP group and control group before HPV were compared, SDTC and latency were statistically significant. Comparing the values of the excitability parameters after HPV showed statistically significant changes in the SDTC, rheobase, and refractoriness at 2.5ms in controls and DM patients without PNP. HPV resulted in no changes in SDTC in DM patients with PNP. The results of this study suggest that patients with DM and healthy subjects have different responses to HPV, and pH changes have different effects on diabetic PNP compared with healthy controls and DM patients without PNP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Constructing Benchmark Databases and Protocols for Medical Image Analysis: Diabetic Retinopathy

PubMed Central

Kauppi, Tomi; Kämäräinen, Joni-Kristian; Kalesnykiene, Valentina; Sorri, Iiris; Uusitalo, Hannu; Kälviäinen, Heikki

2013-01-01

We address the performance evaluation practices for developing medical image analysis methods, in particular, how to establish and share databases of medical images with verified ground truth and solid evaluation protocols. Such databases support the development of better algorithms, execution of profound method comparisons, and, consequently, technology transfer from research laboratories to clinical practice. For this purpose, we propose a framework consisting of reusable methods and tools for the laborious task of constructing a benchmark database. We provide a software tool for medical image annotation helping to collect class label, spatial span, and expert's confidence on lesions and a method to appropriately combine the manual segmentations from multiple experts. The tool and all necessary functionality for method evaluation are provided as public software packages. As a case study, we utilized the framework and tools to establish the DiaRetDB1 V2.1 database for benchmarking diabetic retinopathy detection algorithms. The database contains a set of retinal images, ground truth based on information from multiple experts, and a baseline algorithm for the detection of retinopathy lesions. PMID:23956787

Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial.

PubMed

Krul-Poel, Yvonne H M; van Wijland, Hans; Stam, Frank; ten Boekel, Edwin; Lips, Paul; Simsek, Suat

2014-07-17

Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus. In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and six months. Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles. Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire. Advanced glycation end products are measured by an AGE-reader. This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus. The Netherlands trial register: NTR3154.

In vitro antifungal susceptibility of dermatophyte strains causing tinea pedis and onychomycosis in patients with non-insulin-dependent diabetes mellitus: a case-control study.

PubMed

Ozcan, D; Seçkin, D; Demirbilek, M

2010-12-01

The efficacy of antifungal treatment may be reduced and/or delayed in diabetic patients. To date, no study has investigated the in vitro antifungal susceptibility of dermatophytes in this patient group. We aimed to determine the dermatophyte species causing tinea pedis and onychomycosis, and in vitro susceptibility of these dermatophytes to terbinafine, itraconazole, and fluconazole in patients with non-insulin-dependent diabetes mellitus. We compared the findings in diabetic patients with those in non-diabetic individuals. One hundred patients with non-insulin-dependent diabetes mellitus and 100 otherwise healthy controls clinically suspected with tinea pedis and/or onychomycosis were included. Skin scrapings and/or nail clippings were taken and cultured on Sabouraud dextrose agar, mycobiotic agar, and dermatophyte test medium. In vitro antifungal susceptibility tests were carried out according to the Clinical and Laboratory Standards Institute (CLSI) M-38P protocol with some modifications. Fifty-seven samples of 54 diabetics and 50 samples of 50 controls grew dermatophytes. In both groups, Trichophyton rubrum was the most common isolate. Mean MIC values of terbinafine, itraconazole, and fluconazole for all of the isolated dermatophyte strains were similar in two groups (P>0.05). The difference in mean MIC values of three antifungals for T. rubrum and T. mentagrophytes between two groups was not statistically significant (P>0.05). Dermatophyte types causing tinea pedis and onychomycosis, their frequency patterns, and in vitro activity of three antifungals against dermatophytes in diabetics are similar to the non-diabetics. Terbinafine is the most active agent in vitro in both groups. © 2010 The Authors. Journal compilation © 2010 European Academy of Dermatology and Venereology.

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.

PubMed

Akerblom, H K; Krischer, J; Virtanen, S M; Berseth, C; Becker, D; Dupré, J; Ilonen, J; Trucco, M; Savilahti, E; Koski, K; Pajakkala, E; Fransiscus, M; Lough, G; Bradley, B; Koski, M; Knip, M

2011-03-01

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes. The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared. TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017. The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question. ClinicalTrials.gov NCT00179777 The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation).

Is islet transplantation a realistic approach to curing diabetes?

PubMed

Jin, Sang-Man; Kim, Kwang-Won

2017-01-01

Since the report of type 1 diabetes reversal in seven consecutive patients by the Edmonton protocol in 2000, pancreatic islet transplantation has been reappraised based on accumulated clinical evidence. Although initially expected to therapeutically target long-term insulin independence, islet transplantation is now indicated for more specific clinical benefits. With the long-awaited report of the first phase 3 clinical trial in 2016, allogeneic islet transplantation is now transitioning from an experimental to a proven therapy for type 1 diabetes with problematic hypoglycemia. Islet autotransplantation has already been therapeutically proven in chronic pancreatitis with severe abdominal pain refractory to conventional treatments, and it holds promise for preventing diabetes after partial pancreatectomy due to benign pancreatic tumors. Based on current evidence, this review focuses on islet transplantation as a realistic approach to treating diabetes.

Prevalence of diabetic retinopathy and diabetic macular edema in a primary care-based teleophthalmology program for American Indians and Alaskan Natives.

PubMed

Bursell, Sven-Erik; Fonda, Stephanie J; Lewis, Drew G; Horton, Mark B

2018-01-01

Diabetes and its complications are more common in American Indians and Alaska Natives (AI/AN) than other US racial/ethnic populations. Prior reports of diabetic retinopathy (DR) prevalence in AI/AN are dated, and research on diabetic macular edema (DME) is limited. This study characterizes the recent prevalence of DR and DME in AI/AN using primary care-based teleophthalmology surveillance. This is a multi-site, clinic-based, cross-sectional study of DR and DME. The sample is composed of AI /AN patients with diabetes (n = 53,998), served by the nationally distributed Indian Health Service-Joslin Vision Network Teleophthalmology Program (IHS-JVN) in primary care clinics of US Indian Health Service (IHS), Tribal, and Urban Indian health care facilities (I/T/U) from 1 November 2011 to 31 October 2016. Patients were recruited opportunistically for a retinal examination using the IHS-JVN during their regular diabetes care. The IHS-JVN used clinically validated, non-mydriatic, retinal imaging and retinopathy assessment protocols to identify the severity levels of non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), DME, and sight threatening retinopathy (STR; a composite measure). Key social-demographic (age, gender, IHS area), diabetes-related health (diabetes therapy, duration of diabetes, A1c), and imaging technology variables were examined. The analysis calculated frequencies and percentages of severity levels of disease. Prevalence of any NPDR, PDR, DME, and STR among AI/AN patients undergoing DR teleophthalmology surveillance by IHS-JVN was 17.7%, 2.3%, 2.3%, and 4.2%, respectively. Prevalence was lowest in Alaska and highest among patients with A1c >/ = 8%, duration of diabetes > 10 years, or using insulin. Prevalence of DR in this cohort was approximately half that in previous reports for AI/AN, and prevalence of DME was less than that reported in non-AI/AN populations. A similar reduction in diabetes related end-stage renal disease in the same population and time period has been reported by other researchers. Since these two diabetic complications share a common microvasculopathic mechanism, this coincident change in prevalence may also share a common basis, possibly related to improved diabetes management.

Diabetes in pregnancy outcomes: a systematic review and proposed codification of definitions.

PubMed

Feig, Denice S; Corcoy, Rosa; Jensen, Dorte Moller; Kautzky-Willer, Alexandra; Nolan, Christopher J; Oats, Jeremy J N; Sacks, David A; Caimari, Francisca; McIntyre, H David

2015-10-01

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.

Optimization of Protocols for Derivation of Mouse Embryonic Stem Cell Lines from Refractory Strains, Including the Non Obese Diabetic Mouse

PubMed Central

Davies, Timothy J.

2012-01-01

The derivation of pluripotent embryonic stem cells (ESCs) from a variety of genetic backgrounds remains a desirable objective in the generation of mice functionally deficient in genes of interest and the modeling of human disease. Nevertheless, disparity in the ease with which different strains of mice yield ESC lines has long been acknowledged. Indeed, the generation of bona fide ESCs from the non obese diabetic (NOD) mouse, a well-characterized model of human type I diabetes, has historically proved especially difficult to achieve. Here, we report the development of protocols for the derivation of novel ESC lines from C57Bl/6 mice based on the combined use of high concentrations of leukemia inhibitory factor and serum-replacement, which is equally applicable to fresh and cryo-preserved embryos. Further, we demonstrate the success of this approach using Balb/K and CBA/Ca mice, widely considered to be refractory strains. CBA/Ca ESCs contributed to the somatic germ layers of chimeras and displayed a very high competence at germline transmission. Importantly, we were able to use the same protocol for the derivation of ESC lines from nonpermissive NOD mice. These ESCs displayed a normal karyotype that was robustly stable during long-term culture, were capable of forming teratomas in vivo and germline competent chimeras after injection into recipient blastocysts. Further, these novel ESC lines efficiently formed embryoid bodies in vitro and could be directed in their differentiation along the dendritic cell lineage, thus illustrating their potential application to the generation of cell types of relevance to the pathogenesis of type I diabetes. PMID:21933027

Evaluating the evidence for macrophage presence in skeletal muscle and its relation to insulin resistance in obese mice and humans: a systematic review protocol.

PubMed

Bhatt, Meha; Rudrapatna, Srikesh; Banfield, Laura; Bierbrier, Rachel; Wang, Pei-Wen; Wang, Kuan-Wen; Thabane, Lehana; Samaan, M Constantine

2017-08-08

The current global rates of obesity and type 2 diabetes are staggering. In order to implement effective management strategies, it is imperative to understand the mechanisms of obesity-induced insulin resistance and diabetes. Macrophage infiltration and inflammation of the adipose tissue in obesity is a well-established paradigm, yet the role of macrophages in muscle inflammation, insulin resistance and diabetes is not adequately studied. In this systematic review, we will examine the evidence for the presence of macrophages in skeletal muscle of obese humans and mice, and will assess the association between muscle macrophages and insulin resistance. We will identify published studies that address muscle macrophage content and phenotype, and its association with insulin resistance. We will search MEDLINE/PubMed, EMBASE, and Web of Science for eligible studies. Grey literature will be searched in ProQuest. Quality assessment will be conducted using the Systematic Review Centre for Laboratory Animal Experimentation risk of bias Tool for animal studies. The findings of this systematic review will shed light on immune-metabolic crosstalk in obesity, and allow the consideration of targeted therapies to modulate muscle macrophages in the treatment and prevention of diabetes. The review will be published in a peer-reviewed journal and presented at conferences.

High probability of healing without amputation of plantar forefoot ulcers in patients with diabetes.

PubMed

Örneholm, Hedvig; Apelqvist, Jan; Larsson, Jan; Eneroth, Magnus

2015-01-01

Diabetic foot ulcer is an important entity which in many cases is the first serious complication in diabetes. Although a plantar forefoot location is common, there are few studies on larger cohorts and in such studies there is often a combination of various types of ulcer and ulcer locations. The purpose of this study is to discern the outcome of plantar forefoot ulcers and their specific characteristics in a large cohort. All patients (n = 770), presenting with a plantar forefoot ulcer at a multidisciplinary diabetes foot clinic from January 1, 1983 to December 31, 2012 were considered for the study. Seven hundred one patients (median age 67 [22-95]) fulfilled the inclusion criteria and were followed according to a preset protocol until final outcome (healing or death). Severe peripheral vascular disease was present in 26% of the patients and 14% had evidence of deep infection upon arrival at the foot clinic. Fifty-five percent (385/701) of the patients healed without foot surgery, 25% (173/701) healed after major debridement, 9% (60/701) healed after minor or major amputation and 12% (83/701) died unhealed. Median healing time was 17 weeks. An ulcer classified as Wagner grade 1 or 2 at inclusion and independent living were factors associated with a higher healing rate. Seventy-nine percent of 701 patients with diabetes and a plantar forefoot ulcer treated at a multidisciplinary diabetes foot clinic healed without amputation. For one third some form of foot surgery was needed to achieve healing. © 2015 by the Wound Healing Society.

Treatment of Diabetic Ketoacidosis (DKA)/Hyperglycemic Hyperosmolar State (HHS): Novel Advances in the Management of Hyperglycemic Crises (UK Versus USA).

PubMed

Dhatariya, Ketan K; Vellanki, Priyathama

2017-05-01

Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) are diabetic emergencies that cause high morbidity and mortality. Their treatment differs in the UK and USA. This review delineates the differences in diagnosis and treatment between the two countries. Large-scale studies to determine optimal management of DKA and HHS are lacking. The diagnosis of DKA is based on disease severity in the USA, which differs from the UK. The diagnosis of HHS in the USA is based on total rather than effective osmolality. Unlike the USA, the UK has separate guidelines for DKA and HHS. Treatment of DKA and HHS also differs with respect to timing of fluid and insulin initiation. There is considerable overlap but important differences between the UK and USA guidelines for the management of DKA and HHS. Further research needs to be done to delineate a unifying diagnostic and treatment protocol.

ATP sensitive K+ channel subunits (Kir6.1, Kir6.2) are the candidate mediators regulating ameliorating effects of pulsed magnetic field on aortic contractility in diabetic rats.

PubMed

Ocal, Isil; Yilmaz, Mehmet B; Kocaturk-Sel, Sabriye; Tufan, Turan; Erkoc, Mehmet A; Comertpay, Gamze; Oksuz, Hale; Barc, Esma D

2018-05-01

Diabetes mellitus is a metabolic disease that causes increased morbidity and mortality in developed and developing countries. With recent advancements in technology, alternative treatment methods have begun to be investigated in the world. This study aims to evaluate the effect of pulsed magnetic field (PMF) on vascular complications and contractile activities of aortic rings along with Kir6.1 and Kir6.2 subunit expressions of ATP-sensitive potassium channels (K ATP ) in aortas of controlled-diabetic and non-controlled diabetic rats. Controlled-diabetic and non-controlled diabetic adult male Wistar rats were exposed to PMF for a period of 6 weeks according to the PMF application protocol (1 h/day; intensity: 1.5 mT; consecutive frequency: 1, 10, 20, and 40 Hz). After PMF exposure, body weight and blood glucose levels were measured. Then, thoracic aorta tissue was extracted for relaxation-contraction and Kir6.1 and Kir6.2 expression experiments. Blood plasma glucose levels, body weight, and aortic ring contraction percentage decreased in controlled-diabetic rats but increased in non-controlled diabetic rats. PMF therapy repressed Kir6.1 mRNA expression in non-controlled diabetic rats but not in controlled diabetic rats. Conversely, Kir6.2 mRNA expressions were repressed both in controlled diabetic and non-controlled diabetic rats by PMF. Our findings suggest that the positive therapeutic effects of PMF may act through (K ATP ) subunits and may frequently occur in insulin-free conditions. Bioelectromagnetics. 39:299-311, 2018. © 2018 Wiley Periodicals, Inc. © 2018 Wiley Periodicals, Inc.

Reduction in hospital admissions with the addition of prophylactic intramuscular ceftriaxone before transrectal ultrasonography-guided prostate biopsies.

PubMed

Luong, Benjamin; Danforth, Teresa; Visnjevac, Ognjen; Suraf, Margaret; Duff, Michael; Chevli, K Kent

2015-03-01

To evaluate the hospitalization rates in 2 pre-prostate biopsy antibiotic protocols. Two prebiopsy protocols were compared. CiproAlone required ciprofloxacin 500 mg twice daily starting 1 day before biopsy and continuing for 3 days after biopsy (4 days total). Diabetic patients were prescribed ciprofloxacin for 4 days after biopsy. CiproCeft required 1 dose of oral ciprofloxacin 500 mg 1 hour before the biopsy and ceftriaxone 1 g intramuscular at the time of the biopsy. Hospitalization rates between the CiproAlone vs CiproCeft protocols were examined. A total of 4134 biopsies were identified-2093 in the CiproAlone cohort and 2041 in the CiproCeft cohort. The post-prostate biopsy infection hospitalization rate was 0.6% (14 patients) in the CiproAlone group vs 0.0% (0 patients) in the CiproCeft group (P <.0001). Of the patients hospitalized, 12 fit systemic inflammatory response syndrome (SIRS) criteria. Eight of 14 hospitalized patients fit the sepsis (SIRS and source of infection) criteria. Positive cultures (urine and/or blood) resulted from 71% (n = 10) of hospitalized patients. Antibiotic resistance was analyzed. Diabetes mellitus was associated with hospitalization after prostate biopsy (P = .01) in our population, but there was no difference between the 2 groups in the rates of diabetes mellitus (P = .46). Patient age, prostate-specific antigen level, number of biopsy cores obtained, race, and previous antibiotics exposure were not found to be independent predictors of post-transrectal ultrasonography biopsy hospitalization for infection using a multivariate regression analysis. A prophylactic prebiopsy protocol including 2 classes of antibiotics, single-dose ciprofloxacin, and single-dose intramuscular ceftriaxone reduced post-transrectal ultrasonography biopsy rates of hospitalizations compared to oral ciprofloxacin alone. Copyright © 2015 Elsevier Inc. All rights reserved.

Translation, adaptation and validation the contents of the Diabetes Medical Management Plan for the Brazilian context

PubMed Central

Torres, Heloísa de Carvalho; Chaves, Fernanda Figueredo; da Silva, Daniel Dutra Romualdo; Bosco, Adriana Aparecida; Gabriel, Beatriz Diniz; Reis, Ilka Afonso; Rodrigues, Júlia Santos Nunes; Pagano, Adriana Silvina

2016-01-01

ABSTRACT Objective: to translate, adapt and validate the contents of the Diabetes Medical Management Plan for the Brazilian context. This protocol was developed by the American Diabetes Association and guides the procedure of educators for the care of children and adolescents with diabetes in schools. Method: this methodological study was conducted in four stages: initial translation, synthesis of initial translation, back translation and content validation by an expert committee, composed of 94 specialists (29 applied linguists and 65 health professionals), for evaluation of the translated version through an online questionnaire. The concordance level of the judges was calculated based on the Content Validity Index. Data were exported into the R program for statistical analysis: Results: the evaluation of the instrument showed good concordance between the judges of the Health and Applied Linguistics areas, with a mean content validity index of 0.9 and 0.89, respectively, and slight variability of the index between groups (difference of less than 0.01). The items in the translated version, evaluated as unsatisfactory by the judges, were reformulated based on the considerations of the professionals of each group. Conclusion: a Brazilian version of Diabetes Medical Management Plan was constructed, called the Plano de Manejo do Diabetes na Escola. PMID:27508911

Immunotherapy for Type 1 Diabetes: Why Do Current Protocols Not Halt the Underlying Disease Process?

PubMed

Kolb, Hubert; von Herrath, Matthias

2017-02-07

T cell-directed immunosuppression only transiently delays the loss of β cell function in recent-onset type 1 diabetes. We argue here that the underlying disease process is carried by innate immune reactivity. Inducing a non-polarized functional state of local innate immunity will support regulatory T cell development and β cell proliferation. Copyright © 2017 Elsevier Inc. All rights reserved.

Type 2 diabetes management in nurse-led primary healthcare settings in urban and rural Cameroon.

PubMed

Kengne, Andre Pascal; Fezeu, Leopold; Sobngwi, Eugene; Awah, Paschal Kum; Aspray, Terence J; Unwin, Nigel C; Mbanya, Jean-Claude

2009-08-01

To implement a protocol-driven primary nurse-led care for type 2 diabetes in rural and urban Cameroon. We set-up three primary healthcare clinics in Yaounde (Capital city) and two in the Bafut rural health district. Participants were 225 (17% rural) patients with known or newly diagnosed type 2 diabetes, not requiring insulin, referred either from a baseline survey (38 patients, 17%), or secondarily attracted to the clinics. Protocol-driven glucose and blood pressure control were delivered by trained nurses. The main outcomes were trajectories of fasting capillary glucose and blood pressure indices, and differences in the mean levels between baseline and final visits. The total duration of follow-up was 1110 patient-months. During follow-up, there was a significant downward trend in fasting capillary glucose overall (p<0.001) and in most subgroups of participants. Between baseline and final visits, mean fasting capillary glucose dropped by 1.6 mmol/L (95% CI: 0.8-2.3; p< or =0.001). Among those with hypertension, blood pressure also decreased significantly for systolic and marginally for diastolic blood pressure. No major significant change was noticed for body weight. Nurses may be potential alternatives to improve access to diabetes care in settings where physicians are not available.

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial

PubMed Central

Boothby, Clare E; Griffin, Simon J

2018-01-01

Objective To assess the fidelity of general practitioners’ (GPs) adherence to a long-term pragmatic trial protocol. Design Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010. Setting Primary care surgeries in the East of England. Study sample/participants A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40–69 years old with screen-detected diabetes mellitus. Interventions In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. Outcome measures The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1–5 after diabetes diagnosis and the adherence to prescription algorithms. Results The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=−0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up. Conclusions The adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. Trial registration number ISRCTN86769081. PMID:29903781

[Introduction of capillary glycosylated haemoglobin determination in a Primary Care Health Area: Multicentre study of the evolution of patients with type 2 diabetes mellitus].

PubMed

Núñez-Sánchez, M Á; Cervantes-Cuesta, M Á; Brocal-Ibañez, P; Salmeron-Arjona, E; León-Martínez, L P; Cerezo-Sanmartin, M

The aim of this study was to evaluate the efficiency of a joint intervention that included educational components, self-assessment, and information to optimise diabetes control through the introduction of instant capillary glycosylated haemoglobin (HbA1c) determination in Primary Care. A multicentre prospective descriptive study was carried out over 3years in 10Primary Care Centres of the Area VII Murcia East. At the end of the study there were 804 patients with type 2 diabetes (DM2). Patients were divided into 4 groups based on initial values of HbA1c, and if changes in their treatment were needed. HbA1c, body mass index, and blood pressure were monitored. A financial assessment was also performed on the impact of the implementation of a protocol to measure instant capillary RESULTS: A significant reduction was observed in HbA1c values. The initial HbA1c mean value was 7.4±1.4%, which decreased to a final value of 6.9±1.0% (P<.001). At the end of the study, 71.4% of patients included reached diabetic control objectives. In addition, the financial assessment demonstrated that the implementation of this diabetes control system led to a decrease of the 24.7% in spending on glucose strips after the first year of study in Area VII Murcia Health Service. The introduction of capillary HbA1c determination in Primary Care has demonstrated to improve diabetes control and the efficiency of the health personnel. Furthermore, a reduction in the health costs of patients with DM2 was also shown. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial.

PubMed

Ghorob, Amireh; Vivas, Maria Mercedes; De Vore, Diana; Ngo, Victoria; Bodenheimer, Thomas; Chen, Ellen; Thom, David H

2011-04-01

Although self-management support improves diabetes outcomes, it is not consistently provided in health care settings strained for time and resources. One proposed solution to personnel and funding shortages is to utilize peer coaches, patients trained to provide diabetes education and support to other patients. Coaches share similar experiences about living with diabetes and are able to reach patients within and beyond the health care setting. Given the limited body of evidence that demonstrates peer coaching significantly improves chronic disease care, this present study examines the impact of peer coaching delivered in a primary care setting on diabetes outcomes. The aim of this multicenter, randomized control trial is to evaluate the effectiveness of utilizing peer coaches to improve clinical outcomes and self-management skills in low-income patients with poorly controlled diabetes. A total of 400 patients from six primary health centers based in San Francisco that serve primarily low-income populations will be randomized to receive peer coaching (n = 200) or usual care (n = 200) over 6 months. Patients in the peer coach group receive coaching from patients with diabetes who are trained and mentored as peer coaches. The primary outcome is change in HbA1c. Secondary outcomes include change in: systolic blood pressure, body mass index (BMI), LDL cholesterol, diabetes self-care activities, medication adherence, diabetes-related quality of life, diabetes self-efficacy, and depression. Clinical values (HbA1c, LDL cholesterol and blood pressure) and self-reported diabetes self-efficacy and self-care activities are measured at baseline and after 6 months for patients and coaches. Peer coaches are also assessed at 12 months. Patients with diabetes, who are trained as peer health coaches, are uniquely poised to provide diabetes self management support and education to patients. This study is designed to investigate the impact of peer health coaching in patients with poorly controlled diabetes. Additionally, we will assess disease outcomes in patients with well controlled diabetes who are trained and work as peer health coaches. ClinicalTrials.gov identifier: NCT01040806.

Plantar pressures are higher in cases with diabetic foot ulcers compared to controls despite a longer stance phase duration.

PubMed

Fernando, Malindu E; Crowther, Robert G; Lazzarini, Peter A; Sangla, Kunwarjit S; Wearing, Scott; Buttner, Petra; Golledge, Jonathan

2016-09-15

Current international guidelines advocate achieving at least a 30 % reduction in maximum plantar pressure to reduce the risk of foot ulcers in people with diabetes. However, whether plantar pressures differ in cases with foot ulcers to controls without ulcers is not clear. The aim of this study was to assess if plantar pressures were higher in patients with active plantar diabetic foot ulcers (cases) compared to patients with diabetes without a foot ulcer history (diabetes controls) and people without diabetes or a foot ulcer history (healthy controls). Twenty-one cases with diabetic foot ulcers, 69 diabetes controls and 56 healthy controls were recruited for this case-control study. Plantar pressures at ten sites on both feet and stance phase duration were measured using a pre-established protocol. Primary outcomes were mean peak plantar pressure, pressure-time integral and stance phase duration. Non-parametric analyses were used with Holm's correction to correct for multiple testing. Binary logistic regression models were used to adjust outcomes for age, sex and body mass index. Median differences with 95 % confidence intervals and Cohen's d values (standardised mean difference) were reported for all significant outcomes. The majority of ulcers were located on the plantar surface of the hallux and toes. When adjusted for age, sex and body mass index, the mean peak plantar pressure and pressure-time integral of toes and the mid-foot were significantly higher in cases compared to diabetes and healthy controls (p < 0.05). The stance phase duration was also significantly higher in cases compared to both control groups (p < 0.05). The main limitations of the study were the small number of cases studied and the inability to adjust analyses for multiple factors. This study shows that plantar pressures are higher in cases with active diabetic foot ulcers despite having a longer stance phase duration which would be expected to lower plantar pressure. Whether plantar pressure changes can predict ulcer healing should be the focus of future research. These results highlight the importance of offloading feet during active ulceration in addition to before ulceration.

Matching diagnosis and management of diabetes in pregnancy to local priorities and resources: an international approach.

PubMed

McIntyre, H David; Oats, Jeremy J N; Zeck, Willibald; Seshiah, V; Hod, Moshe

2011-11-01

The International Association of the Diabetes and Pregnancy Study Groups' (IADPSG) criteria for the diagnosis and classification of hyperglycemia in pregnancy are described and application of these in differing healthcare contexts on a worldwide basis is reported. Existing local protocols and known epidemiologic and clinical data regarding the detection and management of overt diabetes and gestational diabetes in the context of human pregnancy are considered. Although the IADPSG criteria are uniform, their introduction poses a variety of practical and technical challenges in differing healthcare contexts, both between and within countries. Knowledge of local factors will be vital in the implementation of the new guidelines and will require extensive liaison with local clinical and health policy groups. Resource availability will be critical in determining the type of treatment available in this context. The IADPSG criteria offer an important opportunity for a uniform approach to diabetes in pregnancy. Scaled implementation of these criteria adapted to a variety of local healthcare contexts should improve both research endeavors and patient care. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.. All rights reserved.

Recovery from diabetes in mice by β cell regeneration

PubMed Central

Nir, Tomer; Melton, Douglas A.; Dor, Yuval

2007-01-01

The mechanisms that regulate pancreatic β cell mass are poorly understood. While autoimmune and pharmacological destruction of insulin-producing β cells is often irreversible, adult β cell mass does fluctuate in response to physiological cues including pregnancy and insulin resistance. This plasticity points to the possibility of harnessing the regenerative capacity of the β cell to treat diabetes. We developed a transgenic mouse model to study the dynamics of β cell regeneration from a diabetic state. Following doxycycline administration, transgenic mice expressed diphtheria toxin in β cells, resulting in apoptosis of 70%–80% of β cells, destruction of islet architecture, and diabetes. Withdrawal of doxycycline resulted in a spontaneous normalization of blood glucose levels and islet architecture and a significant regeneration of β cell mass with no apparent toxicity of transient hyperglycemia. Lineage tracing analysis indicated that enhanced proliferation of surviving β cells played the major role in regeneration. Surprisingly, treatment with Sirolimus and Tacrolimus, immunosuppressants used in the Edmonton protocol for human islet transplantation, inhibited β cell regeneration and prevented the normalization of glucose homeostasis. These results suggest that regenerative therapy for type 1 diabetes may be achieved if autoimmunity is halted using regeneration-compatible drugs. PMID:17786244

The assessment of clinical distal symmetric polyneuropathy in type 1 diabetes: a comparison of methodologies from the Pittsburgh Epidemiology of Diabetes Complications Cohort.

PubMed

Pambianco, G; Costacou, T; Strotmeyer, Elsa; Orchard, T J

2011-05-01

Distal symmetrical polyneuropathy (DSP) is the most common type of diabetic neuropathy, but often difficult to diagnose reliably. We evaluated the cross-sectional association between three point-of-care devices, Vibratron II, NC-stat(®), and Neurometer(®), and two clinical protocols, MNSI and monofilament, in identifying those with DSP, and/or amputation/ulcer/neuropathic pain (AUP), the two outcomes of major concern. This report presents data from 195 type 1 diabetic participants of the Epidemiology of Diabetes Complications (EDC) Study attending the 18-year examination (2004-2006). Participants with physician-diagnosed DSP, AUP or who were abnormal on the NC-stat, and the Vibratron II, MNSI, and monofilament were older (p<0.05) and had a longer duration of diabetes (p < 0.05). There was no difference by sex for DSP, AUP, or any testing modality, with the exception of NCstat (motor). The Vibratron II and MNSI showed the highest sensitivity for DSP (>87%) and AUP (>80%), whereas the monofilament had the highest specificity (98% DSP, 94% AUP) and positive predictive value (89% DSP, 47% AUP), but lowest sensitivity (20% DSP, 30% AUP). The MNSI also had the highest negative predictive value (83%) and Youden's Index (37%) and currently presents the single best combination of sensitivity and specificity of DSP in type 1 diabetes. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The assessment of clinical distal symmetric polyneuropathy in type 1 diabetes: A comparison of methodologies from the Pittsburgh Epidemiology of Diabetes Complications Cohort

PubMed Central

Pambianco, G.; Costacou, T.; Strotmeyer, Elsa; Orchard, T.J.

2011-01-01

Distal symmetrical polyneuropathy (DSP) is the most common type of diabetic neuropathy, but often difficult to diagnose reliably. We evaluated the cross-sectional association between three point-of-care devices, Vibratron II, NC-stat®, and Neurometer®, and two clinical protocols, MNSI and monofilament, in identifying those with DSP, and/or amputation/ulcer/neuropathic pain (AUP), the two outcomes of major concern. This report presents data from 195 type 1 diabetic participants of the Epidemiology of Diabetes Complications (EDC) Study attending the 18-year examination (2004–2006). Participants with physician-diagnosed DSP, AUP or who were abnormal on the NC-stat, and the Vibratron II, MNSI, and monofilament were older (p < 0.05) and had a longer duration of diabetes (p < 0.05). There was no difference by sex for DSP, AUP, or any testing modality, with the exception of NCstat (motor). The Vibratron II and MNSI showed the highest sensitivity for DSP (>87%) and AUP (>80%), whereas the monofilament had the highest specificity (98% DSP, 94% AUP) and positive predictive value (89% DSP, 47% AUP), but lowest sensitivity (20% DSP, 30% AUP). The MNSI also had the highest negative predictive value (83%) and Youden's Index (37%) and currently presents the single best combination of sensitivity and specificity of DSP in type 1 diabetes. PMID:21411172

Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp.

PubMed

Ly, Trang T; Breton, Marc D; Keith-Hynes, Patrick; De Salvo, Daniel; Clinton, Paula; Benassi, Kari; Mize, Benton; Chernavvsky, Daniel; Place, Jéróme; Wilson, Darrell M; Kovatchev, Boris P; Buckingham, Bruce A

2014-08-01

To determine the safety and efficacy of an automated unified safety system (USS) in providing overnight closed-loop (OCL) control in children and adolescents with type 1 diabetes attending diabetes summer camps. The Diabetes Assistant (DIAS) USS used the Dexcom G4 Platinum glucose sensor (Dexcom) and t:slim insulin pump (Tandem Diabetes Care). An initial inpatient study was completed for 12 participants to evaluate safety. For the main camp study, 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy (control conditions) per night over the course of a 5- to 6-day diabetes camp. Subjects completed 54 OCL nights and 52 control nights. On an intention-to-treat basis, with glucose data analyzed regardless of system status, the median percent time in range, from 70-150 mg/dL, was 62% (29, 87) for OCL nights versus 55% (25, 80) for sensor-augmented pump therapy (P = 0.233). A per-protocol analysis allowed for assessment of algorithm performance. The median percent time in range, from 70-150 mg/dL, was 73% (50, 89) for OCL nights (n = 41) versus 52% (24, 83) for control conditions (n = 39) (P = 0.037). There was less time spent in the hypoglycemic range <50, <60, and <70 mg/dL during OCL compared with the control period (P = 0.019, P = 0.009, and P = 0.023, respectively). The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Implementation of integrated care for diabetes mellitus type 2 by two Dutch care groups: a case study.

PubMed

Busetto, Loraine; Luijkx, Katrien; Huizing, Anna; Vrijhoef, Bert

2015-08-21

Even though previous research has demonstrated improved outcomes of integrated care initiatives, it is not clear why and when integrated care works. This study aims to contribute to filling this knowledge gap by examining the implementation of integrated care for type 2 diabetes by two Dutch care groups. An embedded single case study was conducted including 26 interviews with management staff, care purchasers and health professionals. The Context + Mechanism = Outcome Model was used to study the relationship between context factors, mechanisms and outcomes. Dutch integrated care involves care groups, bundled payments, patient involvement, health professional cooperation and task substitution, evidence-based care protocols and a shared clinical information system. Community involvement is not (yet) part of Dutch integrated care. Barriers to the implementation of integrated care included insufficient integration between the patient databases, decreased earnings for some health professionals, patients' insufficient medical and policy-making expertise, resistance by general practitioner assistants due to perceived competition, too much care provided by practice nurses instead of general practitioners and the funding system incentivising the provision of care exactly as described in the care protocols. Facilitators included performance monitoring via the care chain information system, increased earnings for some health professionals, increased focus on self-management, innovators in primary and secondary care, diabetes nurses acting as integrators and financial incentives for guideline adherence. Economic and political context and health IT-related barriers were discussed as the most problematic areas of integrated care implementation. The implementation of integrated care led to improved communication and cooperation but also to insufficient and unnecessary care provision and deteriorated preconditions for person-centred care. Dutch integrated diabetes care is still a work in progress, in the academic and the practice setting. This makes it difficult to establish whether overall quality of care has improved. Future efforts should focus on areas that this study found to be problematic or to not have received enough attention yet. Increased efforts are needed to improve the interoperability of the patient databases and to keep the negative consequences of the bundled payment system in check. Moreover, patient and community involvement should be incorporated.

Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

PubMed

Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A; Lee, Verna K M; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P; Ismail, Mastura; Chan, Chun W; Abdul-Rahman, Yong R; Chew, Boon-How; Low, Wilson H H

2014-09-13

Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia. ClinicalTrials.gov NCT01545401.

Effectiveness of community-based peer-led diabetes self-management programmes (COMP-DSMP) for improving clinical outcomes and quality of life of adults with diabetes in primary care settings in low and middle-income countries (LMIC): a systematic review and meta-analysis.

PubMed

Werfalli, Mahmoud; Raubenheimer, Peter; Engel, Mark; Peer, Nasheeta; Kalula, Sebastiana; Kengne, Andre P; Levitt, Naomi S

2015-07-15

Globally, an estimated 380 million people live with diabetes today--80% in low-income and middle-income countries. The Middle East, Western Pacific, Sub-Saharan Africa and South-East Asia remain the most affected regions where economic development has transformed lifestyles, people live longer and there is an increase in the adult population. Although peer support has been used in different conditions with varied results, yet there is limited evidence to date supporting its effectiveness, particularly for individuals with diabetes. In this review, we will focus on community-based peer-led diabetes self-management programmes (COMP-DSMP) and examine the implementation strategies and diabetes-related health outcomes associated with them in LMIC primary healthcare settings. In accordance with reporting equity-focused systematic reviews PRISMA-P (preferred reporting items for systematic review and meta-analysis protocols 2015 checklist) guidelines, a systematic review with meta-analysis of randomised controlled trials (RCTs), non-randomised controlled trials, quasi-randomised controlled trials (CCTs) that involve contact with an individual or group of peers (paid or voluntary). Electronic searches will be performed in The Cochrane Library, MEDLINE, PubMed, SCOUPS, CINAHL and PsycINFO Database for the period January up to July 2000 along with manual searches in the reference lists of relevant papers. The analyses will be performed based on baseline data from RCTs, CCTs and preintervention and postintervention means or proportions will be reported for both intervention and control groups, and the absolute change from baseline will be calculated, together with 95% CIs. For dichotomous outcomes, the relative risk of the outcome will be presented compared to the control group. The risk difference will be calculated, which is the absolute difference in the proportions in each treatment group. Ethics is not required for this study, given that this is a protocol for a systematic review, which utilises published data. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations. PROSPERO (2014:CRD42014007531). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.

PubMed

Sathish, Thirunavukkarasu; Williams, Emily D; Pasricha, Naanki; Absetz, Pilvikki; Lorgelly, Paula; Wolfe, Rory; Mathews, Elezebeth; Aziz, Zahra; Thankappan, Kavumpurathu Raman; Zimmet, Paul; Fisher, Edwin; Tapp, Robyn; Hollingsworth, Bruce; Mahal, Ajay; Shaw, Jonathan; Jolley, Damien; Daivadanam, Meena; Oldenburg, Brian

2013-11-04

India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at 'high risk' of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30-60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

Effectiveness of community-based peer-led diabetes self-management programmes (COMP-DSMP) for improving clinical outcomes and quality of life of adults with diabetes in primary care settings in low and middle-income countries (LMIC): a systematic review and meta-analysis

PubMed Central

Werfalli, Mahmoud; Raubenheimer, Peter; Engel, Mark; Peer, Nasheeta; Kalula, Sebastiana; Kengne, Andre P; Levitt, Naomi S

2015-01-01

Introduction Globally, an estimated 380 million people live with diabetes today—80% in low-income and middle-income countries. The Middle East, Western Pacific, Sub-Saharan Africa and South-East Asia remain the most affected regions where economic development has transformed lifestyles, people live longer and there is an increase in the adult population. Although peer support has been used in different conditions with varied results, yet there is limited evidence to date supporting its effectiveness, particularly for individuals with diabetes. In this review, we will focus on community-based peer-led diabetes self-management programmes (COMP-DSMP) and examine the implementation strategies and diabetes-related health outcomes associated with them in LMIC primary healthcare settings. Methods and analysis In accordance with reporting equity-focused systematic reviews PRISMA-P (preferred reporting items for systematic review and meta-analysis protocols 2015 checklist) guidelines, a systematic review with meta-analysis of randomised controlled trials (RCTs), non-randomised controlled trials, quasi-randomised controlled trials (CCTs) that involve contact with an individual or group of peers (paid or voluntary). Electronic searches will be performed in The Cochrane Library, MEDLINE, PubMed, SCOUPS, CINAHL and PsycINFO Database for the period January up to July 2000 along with manual searches in the reference lists of relevant papers. The analyses will be performed based on baseline data from RCTs, CCTs and preintervention and postintervention means or proportions will be reported for both intervention and control groups, and the absolute change from baseline will be calculated, together with 95% CIs. For dichotomous outcomes, the relative risk of the outcome will be presented compared to the control group. The risk difference will be calculated, which is the absolute difference in the proportions in each treatment group. Ethics and dissemination Ethics is not required for this study, given that this is a protocol for a systematic review, which utilises published data. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations. Trial registration number PROSPERO (2014:CRD42014007531). PMID:26179646

Early feeding and risk of type 1 diabetes: experiences from the Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR).

PubMed

Knip, Mikael; Virtanen, Suvi M; Becker, Dorothy; Dupré, John; Krischer, Jeffrey P; Åkerblom, Hans K

2011-12-01

Short-term breastfeeding and early exposure to complex dietary proteins, such as cow milk proteins and cereals, or to fruit, berries, and roots have been implicated as risk factors for β cell autoimmunity, clinical type 1 diabetes, or both. The Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR) is an international, randomized, double-blind, controlled intervention trial designed to answer the question of whether weaning to an extensively hydrolyzed formula in infancy will decrease the risk of type 1 diabetes later in childhood. In our pilot study, weaning to a highly hydrolyzed formula decreased by ≈ 50% the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y. This finding was confirmed in a recent follow-up analysis to 10 y of age. Currently, the full-scale TRIGR takes place in 77 centers in 15 countries. The TRIGR initially recruited 5606 newborn infants with a family member affected by type 1 diabetes and enrolled 2159 eligible subjects who carried a risk-conferring HLA genotype. All recruited mothers were encouraged to breastfeed. The intervention lasted for 6-8 mo with a minimum study formula exposure time of 2 mo, and hydrolyzed casein and standard cow milk-based weaning formulas were compared. Eighty percent of the participants were exposed to the study formula. The overall retention rate over the first 5 y was 87%, and protocol compliance was 94%. The randomization code will be opened when the last recruited child turns 10 y of age (ie, in 2017).

Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes – A randomized controlled trial

PubMed Central

Heisler, Michele; Mase, Rebecca; Brown, Brianne; Wilson, Shayla; Reeves, Pamela J.

2017-01-01

Background Racial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes. Methods 289 primarily African American adults with poor glycemic control will be recruited from the Detroit Veteran’s Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms will be assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. All participants meet face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant’s personalized health data (iDecide). Over the next six months, Coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. Discussion Tailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management. PMID:28132876

Joint association of coffee consumption and other factors to the risk of type 2 diabetes: a prospective study in Finland.

PubMed

Hu, G; Jousilahti, P; Peltonen, M; Bidel, S; Tuomilehto, J

2006-12-01

To examine joint associations of coffee consumption and other factors (including physical activity, obesity and alcohol consumption) with the risk of type 2 diabetes. Prospective follow-up study. In all, 10 188 Finnish men and 11 197 women aged 35-74 years without a history of stroke, coronary heart disease or diabetes at baseline. A self-administered questionnaire data on coffee, tea, alcohol and other food consumption, physical activity, smoking, socio-economic factors and medical history, together with measured height, weight and blood pressure using standardized protocol. During a mean follow-up of 13.4 years, there were 964 incident cases of type 2 diabetes. Multivariate-adjusted (age, study year, systolic blood pressure, education, smoking, physical activity, body mass index (BMI) and fruit, vegetable, sausage, bread, alcohol and tea consumption) hazard ratio of type 2 diabetes in participants who drank 0-2, 3-6 and > or =7 cups of coffee were 1.00, 0.77 and 0.66 (P=0.022 for trend) in men, 1.00, 0.71 and 0.52 (P=0.001 for trend) in women, and 1.00, 0.75 and 0.61 (P<0.001 for trend) in men and women combined (adjusted also for sex), respectively. This inverse association was consistent in subjects with any joint levels of physical activity and BMI, and in alcohol drinkers and non-drinkers. Among obese and inactive people, coffee drinking of seven cups or more daily reduced the risk of type 2 diabetes to half. Coffee drinking was associated with a reduced risk of type 2 diabetes in both men and women, and this association was observed regardless of the levels of physical activity, BMI and alcohol consumption.

Cerebellar Insulin/IGF-1 signaling in diabetic rats: Effects of exercise training.

PubMed

Borges, Mariana Eiras; Ribeiro, Alessandra Mussi; Pauli, José Rodrigo; Arantes, Luciana Mendonça; Luciano, Eliete; de Moura, Leandro Pereira; de Almeida Leme, José Alexandre Curiacos; Medeiros, Alessandra; Bertolini, Natália Oliveira; Sibuya, Clarice Yoshiko; Gomes, Ricardo José

2017-02-03

The Diabetes Mellitus (DM) is a chronic disease associated with loss of brain regions such as the cerebellum, increasing the risk of developing neurodegenerative diseases such as Parkinson's disease (PD). In the brain of diabetic and PD organisms the insulin/IGF-1 signaling is altered. Exercise training is an effective intervention for the prevention of neurodegerative diseases since it release neurotrophic factors and regulating insulin/IGF-1 signaling in the brain. This study aimed to evaluate the proteins involved in the insulin/IGF-1 pathway in the cerebellum of diabetic rats subjected to exercise training protocol. Wistar rats were distributed in four groups: sedentary control (SC), trained control (TC), sedentary diabetic (SD) and trained diabetic (TD). Diabetes was induced by Alloxan (ALX) (32mg/kgb.w.). The training program consisted in swimming 5days/week, 1h/day, during 6 weeks, supporting an overload corresponding to 90% of the anaerobic threshold. At the end, cerebellum was extracted to determinate the protein expression of GSK-3β, IRβ and IGF-1R and the phosphorylation of β-amyloid, Tau, ERK1+ERK2 by Western Blot analysis. All dependent variables were analyzed by one-way analysis of variance with significance level of 5%. Diabetes causes hyperglycemia in both diabetic groups; however, in TD, there was a reduction in hyperglycemia compared to SD. Diabetes increased Tau and β-amyloid phosphorylation in both SD and TD groups. Furthermore, aerobic exercise increased ERK1+ERK2 expression in TC. The data showed that in cerebellum of diabetic rats induced by alloxan there are some proteins expression like Parkinson cerebellum increased, and the exercise training was not able to modulate the expression of these proteins. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus.

PubMed

Petrak, Frank; Herpertz, Stephan; Albus, Christian; Hermanns, Norbert; Hiemke, Christoph; Hiller, Wolfgang; Kronfeld, Kai; Kruse, Johannes; Kulzer, Bernd; Ruckes, Christian; Müller, Matthias J

2013-08-06

Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. Current controlled trials ISRCTN89333241.

The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol.

PubMed

Barchetta, I; Capoccia, D; Baroni, M G; Buzzetti, R; Cavallo, M G; De Cosmo, S; Leonetti, F; Leotta, S; Morano, S; Morviducci, L; Prudente, S; Pugliese, G; Trischitta, V

2016-02-01

The rate of mortality in diabetic patients, especially of cardiovascular origin, is about twice as much that of nondiabetic individuals. Thus, the pathogenic factors shaping the risk of mortality in such patients must be unraveled in order to target intensive prevention and treatment strategies. The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes" is aimed at identifying new molecular promoters of mortality and major vascular events in patients with type 2 diabetes mellitus (T2DM). The "SUMMER study in diabetes" is an observational, prospective, and collaborative study conducted on at least 5000 consecutive patients with T2DM, recruited from several diabetes clinics of Central-Southern Italy and followed up for a minimum of 5 years. The primary outcome is all-cause mortality; the secondary outcomes are cardiovascular mortality, acute myocardial infarction, stroke, and dialysis. A biobank will be created for genomic, transcriptomic, and metabolomic analysis, in order to unravel new molecular predictors of mortality and vascular morbidity. The "SUMMER study in diabetes" is aimed at identifying new molecular promoters of mortality and major vascular events in patients with T2DM. These novel pathogenic factors will most likely be instrumental in unraveling new pathways underlying such dramatic events. In addition, they will also be used as additional markers to increase the performance of the already existing risk-scoring models for predicting the above-mentioned outcomes in T2DM, as well as for setting up new preventive and treatment strategies, possibly tailored to specific pathogenic backgrounds. ClinicalTrials.gov, NCT02311244; URL https://clinicaltrials.gov/ct2/show/NCT02311244?term=SUMMER&rank=5. Copyright © 2015 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Plantar pressure in diabetic peripheral neuropathy patients with active foot ulceration, previous ulceration and no history of ulceration: a meta-analysis of observational studies.

PubMed

Fernando, Malindu Eranga; Crowther, Robert George; Pappas, Elise; Lazzarini, Peter Anthony; Cunningham, Margaret; Sangla, Kunwarjit Singh; Buttner, Petra; Golledge, Jonathan

2014-01-01

Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers. Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310). Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate. Plantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

Importance of inflammatory markers and IL-6 for diagnosis and follow up of patients with type 2 diabetes mellitus.

PubMed

Malenica, Maja; Šilar, Mira; Dujić, Tanja; Bego, Tamer; Semiz, Sabina; Škrbo, Selma; Prnjavorac, Besim; Čaušević, Adlija

2017-08-01

Aim To analyse the long-term impact of altered metabolism on the level of mediators of inflammatory response in female patients with type 2 diabetes. Methods This study included 97 female patients with type 2 diabetes and 107 female, nondiabetic control subjects, who were recruited at the Clinical Centre University of Sarajevo and the General Hospital Tešanj. The effects of glycaemic control on markers of inflammatory response represented by C-reactive protein (CRP), fibrinogen, leukocytes, sedimentation rate, and cytokine IL-6 were tested. All subjects were free of evidence of infections, surgery, thyroid disease, polycystic ovarian syndrome, active liver and kidney damage. All biochemical analyses were performed according to standard International Federation of Clinical Chemistry (IFCC) protocols. Results A significant increase of fibrinogen (p<0.001), CRP (p=0.001), interleukin-6 (p=0.013), leukocytes (p<0.001) and sedimentation rate (p=0.008) in diabetic female population compared to control subjects was found. A significant correlation between CRP and haemoglobin A1c (p=0.035), interleukin-6 and glucose (p=0.032), IL-6 and body mass index (p=0.007) was found. Conclusion Our data suggest that inflammation plays an important role in the pathogenesis of diabetes in female diabetic population. A more detailed study on a far larger number of subjects is needed if they were to be used effectively as biomarkers in the primary prevention of type 2 diabetes in this population. Copyright© by the Medical Assotiation of Zenica-Doboj Canton.

Collaborative Depression Care Among Latino Patients in Diabetes Disease Management, Los Angeles, 2011–2013

PubMed Central

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen

2014-01-01

Introduction The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes–Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. Methods A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Results Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Conclusion Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system. PMID:25167093

Comprehensive Maturity Onset Diabetes of the Young (MODY) Gene Screening in Pregnant Women with Diabetes in India.

PubMed

Doddabelavangala Mruthyunjaya, Mahesh; Chapla, Aaron; Hesarghatta Shyamasunder, Asha; Varghese, Deny; Varshney, Manika; Paul, Johan; Inbakumari, Mercy; Christina, Flory; Varghese, Ron Thomas; Kuruvilla, Kurien Anil; V Paul, Thomas; Jose, Ruby; Regi, Annie; Lionel, Jessie; Jeyaseelan, L; Mathew, Jiji; Thomas, Nihal

2017-01-01

Pregnant women with diabetes may have underlying beta cell dysfunction due to mutations/rare variants in genes associated with Maturity Onset Diabetes of the Young (MODY). MODY gene screening would reveal those women genetically predisposed and previously unrecognized with a monogenic form of diabetes for further clinical management, family screening and genetic counselling. However, there are minimal data available on MODY gene variants in pregnant women with diabetes from India. In this study, utilizing the Next generation sequencing (NGS) based protocol fifty subjects were screened for variants in a panel of thirteen MODY genes. Of these subjects 18% (9/50) were positive for definite or likely pathogenic or uncertain MODY variants. The majority of these variants was identified in subjects with autosomal dominant family history, of whom five were in women with pre-GDM and four with overt-GDM. The identified variants included one patient with HNF1A Ser3Cys, two PDX1 Glu224Lys, His94Gln, two NEUROD1 Glu59Gln, Phe318Ser, one INS Gly44Arg, one GCK, one ABCC8 Arg620Cys and one BLK Val418Met variants. In addition, three of the seven offspring screened were positive for the identified variant. These identified variants were further confirmed by Sanger sequencing. In conclusion, these findings in pregnant women with diabetes, imply that a proportion of GDM patients with autosomal dominant family history may have MODY. Further NGS based comprehensive studies with larger samples are required to confirm these finding.

Comprehensive Maturity Onset Diabetes of the Young (MODY) Gene Screening in Pregnant Women with Diabetes in India

PubMed Central

Hesarghatta Shyamasunder, Asha; Varghese, Deny; Varshney, Manika; Paul, Johan; Inbakumari, Mercy; Christina, Flory; Varghese, Ron Thomas; Kuruvilla, Kurien Anil; V. Paul, Thomas; Jose, Ruby; Regi, Annie; Lionel, Jessie; Jeyaseelan, L.; Mathew, Jiji; Thomas, Nihal

2017-01-01

Pregnant women with diabetes may have underlying beta cell dysfunction due to mutations/rare variants in genes associated with Maturity Onset Diabetes of the Young (MODY). MODY gene screening would reveal those women genetically predisposed and previously unrecognized with a monogenic form of diabetes for further clinical management, family screening and genetic counselling. However, there are minimal data available on MODY gene variants in pregnant women with diabetes from India. In this study, utilizing the Next generation sequencing (NGS) based protocol fifty subjects were screened for variants in a panel of thirteen MODY genes. Of these subjects 18% (9/50) were positive for definite or likely pathogenic or uncertain MODY variants. The majority of these variants was identified in subjects with autosomal dominant family history, of whom five were in women with pre-GDM and four with overt-GDM. The identified variants included one patient with HNF1A Ser3Cys, two PDX1 Glu224Lys, His94Gln, two NEUROD1 Glu59Gln, Phe318Ser, one INS Gly44Arg, one GCK, one ABCC8 Arg620Cys and one BLK Val418Met variants. In addition, three of the seven offspring screened were positive for the identified variant. These identified variants were further confirmed by Sanger sequencing. In conclusion, these findings in pregnant women with diabetes, imply that a proportion of GDM patients with autosomal dominant family history may have MODY. Further NGS based comprehensive studies with larger samples are required to confirm these finding PMID:28095440

Glycemic control and the outcomes of Hispanic patients with diabetes admitted to the general ward of a community hospital in Puerto Rico.

PubMed

Torres-Torres, Nancy; Maldonado-Rodríguez, Miguel A; Pérez-López, Shirley; Sierra-Martínez, Kassandra; García, Astrid J

2011-06-01

Uncontrolled glucose, present in 40% of diabetic patients admitted to United States hospitals, has been associated with prolonged length of stay and poorer general outcomes in critically ill and surgical patients. However, past studies of general ward patients have shown there to be no consistent benefits of strict glucose control, and the Hispanic population has been underrepresented in such studies. This work evaluated the association between glycemic control and the outcomes of hospitalized Hispanics with diabetes and to describe physicians' interventions in the treatment of diabetes. This is a retrospective chart review of all patients with diabetes admitted over a period of six months in the general ward of a community hospital in Puerto Rico. We evaluated glucose levels during the first 72 hours, length of stay, and reported complications during admission. Outcomes were evaluated with crude odds ratios and multivariate logistic regression. Uncontrolled blood glucose was observed in 59.1% of the 875 patients whose records were revised; of that 59.1%, treatment modification was not prescribed for 43.2%. Patients with poorly controlled glucose were more likely to develop acute coronary syndrome (corrected OR: 11.46; 95% CI = 1.48-88.50) as a complication and less likely to develop hypoglycemia (corrected OR: 0.57; 95% = CI 0.37-0.88). Our results suggest that hospitalized but non-critically ill Hispanic patients with diabetes are prone to poor outcomes secondary to uncontrolled glucose levels; in addition, those results support the creation of standardized protocols for the management of diabetes in this population.

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial.

PubMed

LeBlanc, Annie; Ruud, Kari L; Branda, Megan E; Tiedje, Kristina; Boehmer, Kasey R; Pencille, Laurie J; Van Houten, Holly; Matthews, Marc; Shah, Nilay D; May, Carl R; Yawn, Barbara P; Montori, Victor M

2012-05-28

Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. NCT00388050.

Association of Major Dietary Patterns with General and Abdominal Obesity in Iranian Patients with Type 2 Diabetes Mellitus.

PubMed

Ghane Basiri, Marjan; Sotoudeh, Gity; Djalali, Mahmood; Reza Eshraghian, Mohammad; Noorshahi, Neda; Rafiee, Masoumeh; Nikbazm, Ronak; Karimi, Zeinab; Koohdani, Fariba

2015-01-01

The aim of this study was to identify dietary patterns associated with general and abdominal obesity in type 2 diabetic patients. We included 728 patients (35 - 65 years) with type 2 diabetes mellitus in this cross-sectional study. The usual dietary intake of individuals over 1 year was collected using a validated semi-quantitative food frequency questionnaire. Weight, height, and waist circumference were measured according to standard protocol. The two major dietary patterns identified by factor analysis were healthy and unhealthy dietary patterns. After adjustment for potential confounders, subjects in the highest quintile of the healthy dietary pattern scores had a lower odds ratio for the general obesity when compared to the lowest quintile (OR = 0.45, 95 % CI = 0.26 - 0.79, P for trend = 0.02), while patients in the highest quintile of the unhealthy dietary pattern scores had greater odds for the general obesity (OR = 3.2, 95 % CI = 1.8 - 5.9, P for trend < 0.001). There were no significant associations between major dietary patterns and abdominal obesity, even after adjusting for confounding factors. This study shows that in patients with type 2 diabetes mellitus, a healthy dietary pattern is inversely associated and an unhealthy dietary pattern is directly associated with general obesity.

Comparative effectiveness of vildagliptin in combination with other oral anti-diabetes agents in usual-care conditions: the EDGE-Latin America study.

PubMed

Mendivil, Carlos O; Márquez-Rodríguez, Eduardo; Angel, Iván D; Paz, Gustavo; Rodríguez, Cruz; Almada, Jorge; Szyskowsky, Ofelia

2014-09-01

To assess the proportion of patients on vildagliptin add-on dual therapy who respond to treatment over a 12 month follow-up, relative to comparator oral anti-diabetes dual therapy, in a usual care setting. Participants were patients with type 2 diabetes (T2DM) aged 18 years and older from 311 centers in Argentina, Colombia, Ecuador, Mexico and Venezuela. Patients were taking monotherapy with an oral anti-diabetes drug (OAD), and were prescribed a new add-on OAD based on the judgment of their personal physician. According to this choice, patients were assigned to one of the two cohorts: vildagliptin or comparator OADs. The primary endpoint was the proportion of patients achieving an A1c drop >0.3% without edema, hypoglycemia, weight gain or discontinuation due to gastrointestinal (GI) events. The secondary endpoint was the proportion of patients with baseline A1c ≥7% who reached the goal of an A1c <7% without hypoglycemia or weight gain. The per-protocol population (a subset of the intention-to-treat population that excluded patients with pre-specified protocol deviations) comprised 3773 patients, 3002 in the vildagliptin cohort and 771 in the comparator cohort. The proportion of patients reaching the primary endpoint was higher in the vildagliptin cohort (60.3%) than the comparator cohort (50.7%), OR 1.48 (95% CI: 1.25-1.73). The same was observed for the secondary endpoint (44.8 versus 33.1%) OR 1.64 (95% CI: 1.37-1.98). The incidence of adverse events was low and similar between treatment cohorts. In a usual care setting, patients treated with a vildagliptin combination succeeded in lowering A1c to <7%, without weight gain, hypoglycemia or peripheral edema more often than patients treated with comparator combinations, without increased risk of adverse events. Key limitations are the observational nature of the study and its relatively limited 12 month timeframe.

Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes.

PubMed

Gucciardi, Enza; Demelo, Margaret; Lee, Ruth N; Grace, Sherry L

2007-04-01

To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period. The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence. Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months. Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control.

Short-term dietary salt supplementation blunts telmisartan induced increases in plasma renin activity in hypertensive patients with type 2 diabetes mellitus.

PubMed

Chen, Angela X; Jerums, George; Baqar, Sara; Lambert, Elisabeth; Somarajah, Goji; Thomas, Georgina; O'Callaghan, Christopher; MacIsaac, Richard J; Ekinci, Elif I

2015-09-01

Current guidelines recommend low dietary salt intake (LDS) in patients with diabetes to reduce blood pressure (BP). However, low salt intake has been associated with higher mortality rates in people with diabetes. Our aim is to examine the effect of angiotensin II receptor blocker (ARB), telmisartan, with and without dietary sodium chloride (NaCl) supplementation, on BP [mean arterial pressure (MAP)], plasma renin activity (PRA), serum aldosterone level and estimated glomerular filtration rate (eGFR) in hypertensive patients with type 2 diabetes. In a randomized, double-blind, placebo-controlled study (RCT), 28 patients with type 2 diabetes, treated with telmisartan (40 mg daily), received 2 weeks of placebo or NaCl capsules (100 mmol/24 h). Following a 6-week washout, the protocol was repeated in reverse. Twenty-four-hour urinary sodium excretion (24hUNa), ambulatory BP (ABP) monitoring and blood tests were performed before and after each study phase. The telmisartan-associated increase in PRA was blunted by approximately 50% during salt supplementation compared with placebo; median PRA was 2.3 μg/l/h with placebo compared with 1.7 μg/l/h with salt (P<0.001). A trend towards blunting of ARB induced increases in serum aldosterone was also demonstrated. Salt supplementation significantly reduced the MAP lowering effects of telmisartan (P<0.05). The present study demonstrates that salt supplementation blunts the telmisartan induced increase in PRA in patients with type 2 diabetes. © 2015 Authors; published by Portland Press Limited.

Diagnosis and Management of Diabetes Mellitus in a Bali Mynah (Leucopsar rothschildi).

PubMed

Bartlett, Susan L; Bailey, Ryan; Baitchman, Eric

2016-06-01

An 18-year-old female Bali mynah (Leucopsar rothschildi) was presented for polyphagia, weight loss, and incoordination. Diabetes mellitus was diagnosed based on the history and clinical findings, including persistent hyperglycemia with concurrent hypoinsulinemia and glucosuria. A treatment protocol was developed that led to improvement of clinical signs and management of hyperglycemia over several months. Because of the advanced age of the animal, difficulty in maintaining euglycemia, and the stress of handling and treatment, euthanasia was elected 167 days after initial presentation. At postmortem examination, no pancreatic lesions were detected histologically that would account for the diabetes mellitus. To our knowledge this is the first reported case of diabetes mellitus and clinical management of this condition in a passerine species.

Guidelines for Perioperative Management of the Diabetic Patient

PubMed Central

Surani, Salim R.

2015-01-01

Management of glycemic levels in the perioperative setting is critical, especially in diabetic patients. The effects of surgical stress and anesthesia have unique effects on blood glucose levels, which should be taken into consideration to maintain optimum glycemic control. Each stage of surgery presents unique challenges in keeping glucose levels within target range. Additionally, there are special operative conditions that require distinctive glucose management protocols. Interestingly, the literature still does not report a consensus perioperative glucose management strategy for diabetic patients. We hope to outline the most important factors required in formulating a perioperative diabetic regimen, while still allowing for specific adjustments using prudent clinical judgment. Overall, through careful glycemic management in perioperative patients, we may reduce morbidity and mortality and improve surgical outcomes. PMID:26078998

How to reduce avoidable admissions due to acute diabetes complications?: interrelation between primary and specialized attention in a diabetes unit.

PubMed

García-Talavera Espín, N V; López-Ruiz, A; Nuñez Sánchez, Ma Á; Meoro Avilés, A; Sánchez Cañizares, C; Romero López-Reinoso, H; López Olivar, Ma D; Lapaz Jorge, Ma Á; Guirao Sastre, J Ma; San Eustaquio Tudanca, F; Soriano Palao, J

2012-01-01

Type 2 Diabetes Mellitus is a serious health problem. In the year 2030 it will affect 366 million people around the world. Evaluate the effectiveness of a mixed intervention and reducing the amount and seriousness of acute complications in diabetics from our Health Area. Protocols of action as well as information documents were produced. Diabetes Unit coordinated educational activities in the different support levels of the Area VII of Murcia. Information talks were provided for the people in charge of the Diabetes Unit in every Care Center and Service of the Health Area. Personalized training was provided for patients treated in the different Care levels. The study comprised three stages. Information leaflets were spread and talks offered to the patient regarding in house handling of hypo and hyper glycemia. A reduction of 39% of the emergencies due to acute non complicated diabetes was achieved, as well as a reduction of 47.6% of hospital admissions. There was a reduction of 67.8% of the amount of total hospital stays for the group of patients under 35 years who were admitted into the hospital due to type 1 or 2 diabetes mellitus that didn't show any complications (GRD295). There was a reduction of more than thirty percent in the emergencies due to acute decompensations in the disease and a significant reduction in the avoidable hospital stays in the young adult, thus improving the patients' life quality and reducing the social cost of the diabetic patient.

Adherence To Diabetes Mellitus Treatment Guidelines From Theory To Practice: The Missing Link.

PubMed

Hashmi, Noreen Rahat; Khan, Shahzad Ali

2016-01-01

Diabetes mellitus is a complex multisystem disease that requires high quality care. Clinical practice guidelines help physicians and patients make the best possible health care decisions and improve health care management of diabetic patients. These guidelines provide the norms for clinical management as well as monitoring of diabetes care. They are not simple algorithms but are based on structured evidence based diabetic management protocols developed from randomized controlled trials. Despite the widespread availability of this diabetic guideline, their use is suboptimal at best. There are several factors blamed for contributing to this missing link from available theoretical guideline recommendations to practical applications of these guidelines. We present a brief review based on available literature review for an ongoing interventional study being done by authors in two tertiary care hospital in Lahore Pakistan for improving adherence to diabetes guidelines. We will discuss guideline implementation cycle and also present a framework encompassing various factors involved in adherence to guidelines. Until recently the emphasis to improve the guideline adherence targeted the factors relating to individual health care professionals in reference to their knowledge, attitude practice of the guidelines. However, we will discuss that broader range of health care systems, organizational factors, and factors relating to patients which may also significantly impact the adherence to the guidelines. The framework emphasises that it is important to understand the factors that act as barriers and contribute to the missing link between theory and practice of diabetic guidelines. This will help plan appropriate strategies in the pre-implementation stage for effective and improved diabetes guidelines adherence and management.

The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol].

PubMed

Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

2013-12-20

Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting. The outcomes of the study will have implications not only for diabetes management, but also for the management of other chronic diseases, both in Australia and overseas. Australian New Zealand Clinical Trials Registry (ACTRN12612000363886); World Health Organisation (U1111-1128-0481).

Group clinics for young adults with diabetes in an ethnically diverse, socioeconomically deprived setting (TOGETHER study): protocol for a realist review, co-design and mixed methods, participatory evaluation of a new care model.

PubMed

Papoutsi, Chrysanthi; Hargreaves, Dougal; Colligan, Grainne; Hagell, Ann; Patel, Anita; Campbell-Richards, Desirée; Viner, Russell M; Vijayaraghavan, Shanti; Marshall, Martin; Greenhalgh, Trisha; Finer, Sarah

2017-06-21

Young adults with diabetes often report dissatisfaction with care and have poor diabetes-related health outcomes. As diabetes prevalence continues to rise, group-based care could provide a sustainable alternative to traditional one-to-one consultations, by engaging young people through life stage-, context- and culturally-sensitive approaches. In this study, we will co-design and evaluate a group-based care model for young adults with diabetes and complex health and social needs in socioeconomically deprived areas. This participatory study will include three phases. In phase 1, we will carry out a realist review to synthesise the literature on group-based care for young adults with diabetes. This theory-driven understanding will provide the basis for phase 2, where we will draw on experience-based co-design methodologies to develop a new, group-based care model for young adults (aged <25 years, under the care of adult diabetes services). In phase 3, we will use a researcher-in-residence approach to implement and evaluate the co-designed group clinic model and compare with traditional care. We will employ qualitative (observations in clinics, patient and staff interviews and document analysis) and quantitative methods (eg, biological markers, patient enablement instrument and diabetes distress scale), including a cost analysis. National Health Service ethics approval has been granted (reference 17/NI/0019). The project will directly inform service redesign to better meet the needs of young adults with diabetes in socioeconomically deprived areas and may guide a possible cluster-randomised trial, powered to clinical and cost-effectiveness outcomes. Findings from this study may be transferable to other long-term conditions and/or age groups. Project outputs will include briefing statements, summaries and academic papers, tailored for different audiences, including people living with diabetes, clinicians, policy makers and strategic decision makers. PROSPERO (CRD42017058726). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis

PubMed Central

Bukhsh, Allah; Khan, Tahir M.; Lee, Shaun W. H.; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [−0.86, 95% CI −0.983, −0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [−4.94; 95%CI −8.65, −1.23] and triglycerides levels [−0.26, 95%CI −0.51, −0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [−0.57; 95%CI −1.25, −0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes. PMID:29692730

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

PubMed Central

2013-01-01

Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. Discussion The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505). Trial registration Current controlled trials ISRCTN89333241. PMID:23915015

Sonographic evaluation of the shoulder in asymptomatic elderly subjects with diabetes.

PubMed

Abate, Michele; Schiavone, Cosima; Salini, Vincenzo

2010-12-07

The prevalence of rotator cuff tears increases with age and several studies have shown that diabetes is associated with symptomatic shoulder pathologies. Aim of our research was to evaluate the prevalence of shoulder lesions in a population of asymptomatic elderly subjects, normal and with non insulin - dependent diabetes mellitus. The study was performed on 48 subjects with diabetes and 32 controls (mean age: 71.5 ± 4.8 and 70.7 ± 4.5, respectively), who did not complain shoulder pain or dysfunction. An ultrasound examination was performed on both shoulders according to a standard protocol, utilizing multiplanar scans. Tendons thickness was greater in diabetics than in controls (Supraspinatus Tendon: 6.2 ± 0.09 mm vs 5.2 ± 0.7 mm, p < 0.001; Biceps Tendon: 4 ± 0.8 mm vs 3.2 ± 0.4 mm, p < 0.001). Sonographic appearances of degenerative features in the rotator cuff and biceps were more frequently observed in diabetics (Supraspinatus Tendon: 42.7% vs 20.3%, p < 0.003; Biceps Tendon: 27% vs 7.8%, p < 0.002).Subjects with diabetes exhibited more tears in the Supraspinatus Tendon (Minor tears: 15 (15.8%) vs 2 (3.1%), p < 0.03; Major tears: 15 (15.8%) vs 5 (7.8%), p = ns), but not in the long head of Biceps. More effusions in subacromial bursa were observed in diabetics (23.9% vs 10.9%, p < 0.03) as well as tenosynovitis in biceps tendon (33.3% vs 10.9%, p < 0.001).In both groups, pathological findings were prevalent on the dominant side, but no difference related to duration of diabetes was found. Our results suggest that age - related rotator cuff tendon degenerative changes are more common in diabetics.Ultrasound is an useful tool for discovering in pre - symptomatic stages the subjects that may undergo shoulder symptomatic pathologies.

Sonographic evaluation of the shoulder in asymptomatic elderly subjects with diabetes

PubMed Central

2010-01-01

Background The prevalence of rotator cuff tears increases with age and several studies have shown that diabetes is associated with symptomatic shoulder pathologies. Aim of our research was to evaluate the prevalence of shoulder lesions in a population of asymptomatic elderly subjects, normal and with non insulin - dependent diabetes mellitus. Methods The study was performed on 48 subjects with diabetes and 32 controls (mean age: 71.5 ± 4.8 and 70.7 ± 4.5, respectively), who did not complain shoulder pain or dysfunction. An ultrasound examination was performed on both shoulders according to a standard protocol, utilizing multiplanar scans. Results Tendons thickness was greater in diabetics than in controls (Supraspinatus Tendon: 6.2 ± 0.09 mm vs 5.2 ± 0.7 mm, p < 0.001; Biceps Tendon: 4 ± 0.8 mm vs 3.2 ± 0.4 mm, p < 0.001). Sonographic appearances of degenerative features in the rotator cuff and biceps were more frequently observed in diabetics (Supraspinatus Tendon: 42.7% vs 20.3%, p < 0.003; Biceps Tendon: 27% vs 7.8%, p < 0.002). Subjects with diabetes exhibited more tears in the Supraspinatus Tendon (Minor tears: 15 (15.8%) vs 2 (3.1%), p < 0.03; Major tears: 15 (15.8%) vs 5 (7.8%), p = ns), but not in the long head of Biceps. More effusions in subacromial bursa were observed in diabetics (23.9% vs 10.9%, p < 0.03) as well as tenosynovitis in biceps tendon (33.3% vs 10.9%, p < 0.001). In both groups, pathological findings were prevalent on the dominant side, but no difference related to duration of diabetes was found. Conclusions Our results suggest that age - related rotator cuff tendon degenerative changes are more common in diabetics. Ultrasound is an useful tool for discovering in pre - symptomatic stages the subjects that may undergo shoulder symptomatic pathologies. PMID:21138564

Hyperbaric oxygen therapy for wound healing in diabetic rats: Varying efficacy after a clinically-based protocol

PubMed Central

van Neck, Johan W.; Tuk, Bastiaan; Fijneman, Esther M. G.; Redeker, Jonathan J.; Talahatu, Edwin M.; Tong, Miao

2017-01-01

Hyperbaric oxygen therapy (HBOT) is a clinical treatment in which a patient breathes pure oxygen for a limited period of time at an increased pressure. Although this therapy has been used for decades to assist wound healing, its efficacy for many conditions is unproven and its mechanism of action is not yet fully clarified. This study investigated the effects of HBOT on wound healing using a diabetes-impaired pressure ulcer rat model. Seven weeks after streptozotocin-induced diabetes in rats (n = 55), a pressure ulcer was created on dorsal skin. Subsequently, animals received HBOT during 6 weeks following a standard clinical protocol (HBOT group with varying endpoints up to 42 days post-wounding) versus controls without HBOT. Capillary venous oxygen saturation (SO2) showed a significant increase in the HBOT group on day 24; however, this increase was significant at this time point only. The quantity of hemoglobin in the micro-blood vessels (rHB) showed a significant decrease in the HBOT group on days 21 and 42, and showed a trend to decrease on day 31. Blood flow in the microcirculation showed a significant increase on days 17, 21 and 31 but a significant decrease on days 24 and 28. Inflammation scoring showed significantly decreased CD68 counts in the HBOT group on day 42, but not in the early stages of wound healing. Animals in the HBOT group showed a trend for an increase in mean wound breaking strength on day 42. PMID:28545109

Impact on medication use and adherence of Australian pharmacists' diabetes care services.

PubMed

Krass, Ines; Taylor, Susan J; Smith, Carlene; Armour, Carol L

2005-01-01

To assess the effect of a specialized service implemented in community pharmacies for patients with type 2 diabetes on medication use and medication-related problems. Parallel group, multisite, control versus intervention, repeated measures design, with three different regions in New South Wales, Australia, used as intervention regions, then matched with control regions as much as possible. After initial training, pharmacists followed a clinical protocol for more than 9 months, with patient contact approximately monthly. Each patient received an adherence assessment at the beginning and end of the study, adherence support, and a medication review as part of the intervention. Risk of nonadherence using Brief Medication Questionnaire (BMQ) scores and changes to medication regimen. Compared with 82 control patients, 106 intervention patients with similar demographic and clinical characteristics had significantly improved self-reported nonadherence as reflected in total BMQ scores after 9 months. The mean (+/-SD) number of medications prescribed at follow-up in intervention participants decreased significantly, from 8.2+/-3.0 to 7.7+/-2.7. No reduction was observed among the control patients (7.6+/-2.4 and 7.3+/-2.4). The overall prevalence of changes to the regimen was also significantly higher in the intervention group (51%) compared with controls (40%). Community pharmacists trained in medication review and using protocols in collaboration with providers improved adherence in patients with type 2 diabetes, reduced problems patients had in accessing their medications, and recommended medication regimen changes that improved outcomes.

Isokinetic and Electromyographic Properties of Muscular Endurance in Short and Long-Term Type 2 Diabetes

PubMed Central

Hatef, Boshra; Ghanjal, Ali; Meftahi, Gholam Hossein; Askary-Ashtiani, Ahmadreza

2016-01-01

Background: Patients with type 2 diabetes mellitus (T2DM) are subject to progressive reduction of muscle mass and strength. The aim of this study was to assess muscle forces and electromyography (EMG) indices in short and long-term diabetes during an isokinetic exercise. Methods: The peak torque, work, mean power frequency (MPF) and root mean square (RMS) of knee flexors and extensors during 40 isokinetic knee extension-flexion repetitions with a velocity of 150 degree/s were recorded. 18 patients with less than 10 years with T2DM and 12 patients with equal and more than 10 years of disease were compared with 20 gender, body mass index, physical activity and peripheral circulation matched healthy controls. Results: The fatigue index and slope of line across the peak torque values of the knee flexor indicate that patients with long-term T2DM were significantly more resistant to fatigue in comparison with the two other groups (p<0.009). Whereas the MPF decrease during isokinetic protocol interact with grouping in the medial hamstring (p<0.042), but it was independent to groups in other muscles (p<0.0001). The increase of RMS after fatigue protocol interacted with sex for the medial hamstring and vastus lateralis (p<0.039) and interacted with group for the extensor muscles (p<0.045). Discussion & Conclusion: It seems that long-term T2DM cause some neuromuscular adaptations to maintain knee flexor muscle performance during functional activity especially postural control. PMID:27045412

Second-line bismuth-containing quadruple therapy for Helicobacter pylori eradication and impact of diabetes

PubMed Central

Kim, Sung Eun; Park, Moo In; Park, Seun Ja; Moon, Won; Kim, Jae Hyun; Jung, Kyoungwon; Kim, Hae Koo; Lee, Young Dal

2017-01-01

AIM To investigate Helicobacter pylori (H. pylori) eradication rates using second-line bismuth-containing quadruple therapy and to identify predictors of eradication failure. METHODS This study included 636 patients who failed first-line triple therapy and received 7 d of bismuth-containing quadruple therapy between January 2005 and December 2015. We retrospectively demonstrated H. pylori eradication rates with respect to the year of therapy as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 wk after the completion of bismuth-based quadruple therapy: proton pump inhibitor, metronidazole, bismuth, and tetracycline. RESULTS The overall eradication rates by intention-to-treat analysis and per-protocol analysis were 73.9% (95%CI: 70.1%-77.4%) and 94.5% (95%CI: 92.4%-96.5%), respectively. Annual eradication rates from 2005 to 2015 were 100.0%, 92.9%, 100.0%, 100.0%, 100.0%, 97.4%, 100.0%, 93.8%, 84.4%, 98.9%, and 92.5%, respectively, by per-protocol analysis. A multivariate analysis showed that diabetes mellitus (OR = 3.99, 95%CI: 1.56-10.20, P = 0.004) was associated with H. pylori eradication therapy failure. CONCLUSION The second-line bismuth-containing quadruple therapy for H. pylori infection is still effective in Korea, and diabetes mellitus is suggested to be a risk factor for eradication failure. PMID:28246480

Let’s prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation

PubMed Central

2012-01-01

Background The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care. Design Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention. Methods The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009–2014. Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom. Trial registration Clinicaltrials.gov NCT00677937 PMID:22607160

Screening asymptomatic patients with diabetes for unknown coronary artery disease: does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?).

PubMed

Turrini, Fabrizio; Messora, Roberto; Giovanardi, Paolo; Tondi, Stefano; Magnavacchi, Paolo; Cavani, Rita; Tosoni, Giandomenico; Cappelli, Carlo; Pellegrini, Elisa; Romano, Stefania; Baldini, Augusto; Zennaro, Romeo Giulietto; Bondi, Marco

2009-12-23

Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in a randomized trial. In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease will be screened at two diabetes outpatients services. Those with intermediate or high risk (equal or greater than 10% according to the Italian risk chart) will be asked to participate and enrolled. They will be seen and followed in order to provide the best adherence to medical therapy. Half of the patients will be randomized to undergo an exercise tolerance testing while the other group will continue to be regularly seen at diabetes outpatients services. Best medical/behavioral therapy will be offered to both groups. Those patients with a positive exercise tolerance testing will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery.The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up. The study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world. (ClinicalTrials.gov): NCT00547872.

Screening asymptomatic patients with diabetes for unknown coronary artery disease: Does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?)

PubMed Central

2009-01-01

Background Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in a randomized trial. Methods/Design In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease will be screened at two diabetes outpatients services. Those with intermediate or high risk (equal or greater than 10% according to the Italian risk chart) will be asked to participate and enrolled. They will be seen and followed in order to provide the best adherence to medical therapy. Half of the patients will be randomized to undergo an exercise tolerance testing while the other group will continue to be regularly seen at diabetes outpatients services. Best medical/behavioral therapy will be offered to both groups. Those patients with a positive exercise tolerance testing will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery. The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up. Discussion The study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world. Trial registration (ClinicalTrials.gov): NCT00547872 PMID:20030830

A Digital Framework to Support Providers and Patients in Diabetes Related Behavior Modification.

PubMed

Abidi, Samina; Vallis, Michael; Piccinini-Vallis, Helena; Imran, Syed Ali; Abidi, Syed Sibte Raza

2017-01-01

We present Diabetes Web-Centric Information and Support Environment (D-WISE) that features: (a) Decision support tool to assist family physicians to administer Behavior Modification (BM) strategies to patients; and (b) Patient BM application that offers BM strategies and motivational interventions to engage patients. We take a knowledge management approach, using semantic web technologies, to model the social cognition theory constructs, Canadian diabetes guidelines and BM protocols used locally, in terms of a BM ontology that drives the BM decision support to physicians and BM strategy adherence monitoring and messaging to patients. We present the qualitative analysis of D-WISE usability by both physicians and patients.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

PubMed

Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

2014-11-25

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

Quality of life and sleep quality are similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial.

PubMed

S Delevatti, Rodrigo; Schuch, Felipe Barreto; Kanitz, Ana Carolina; Alberton, Cristine L; Marson, Elisa Corrêa; Lisboa, Salime Chedid; Pinho, Carolina Dertzbocher Feil; Bregagnol, Luciana Peruchena; Becker, Maríndia Teixeira; Kruel, Luiz Fernando M

2018-05-01

To compare the effects of two aerobic training models in water and on dry-land on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Randomized clinical trial. Thirty-five patients with type 2 diabetes were randomly assigned to aquatic aerobic training group (n=17) or dry-land aerobic training group (n=18). Exercise training length was of 12 weeks, performed in three weekly sessions (45min/session), with intensity progressing from 85% to 100% of heart rate of anaerobic threshold during interventions. All outcomes were evaluated at baseline and 12 weeks later. In per protocol analysis, physical and psychological domains of quality of life improved in both groups (p<0.05) without between-group differences. Overall quality of life and sleep quality improved in both groups (p<0.05), without between-group differences in per protocol and intention to treat analysis. No changes on depressive symptoms were observed in both groups at follow-up. Aerobic training in an aquatic environment provides similar effects to aerobic training in a dry-land environment on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Clinical trial reg. no. NCT01956357, clinicaltrials.gov. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Diabetes in rural towns: effectiveness of continuing education and feedback for healthcare providers in altering diabetes outcomes at a population level: protocol for a cluster randomised controlled trial.

PubMed

Paul, Christine L; Piterman, Leon; Shaw, Jonathan; Kirby, Catherine; Sanson-Fisher, Robert W; Carey, Mariko L; Robinson, Jennifer; McElduff, Patrick; Thepwongsa, Isaraporn

2013-03-13

Type 2 diabetes is one of the fastest growing chronic diseases internationally. The health complications associated with type 2 diabetes can be prevented, delayed, or improved via early diagnosis and effective management. This research aims to examine the impact of a primarily web-based educational intervention on the diabetes care provided by general practitioners (GPs) in rural areas, and subsequent patient outcomes. A population-level approach to outcome assessment is used, via whole-town de-identified pathology records. The study uses a cluster randomised controlled trial with rural communities as the unit of analysis. Towns from four Australian states were selected and matched on factors including rurality, population size, proportion of the population who were Indigenous Australians, and socio-economic status. Eleven pairs of towns from two states were suitable for the trial, and one town from each pair was randomised to the experimental group. GPs in the towns allocated to the experimental group are offered an intervention package comprising education on best practice diabetes care via an on-line active learning module, a moderated discussion forum, access to targeted and specialist advice through an on-line request form, and town-based performance feedback on diabetes monitoring and outcomes. The package is offered via repeated direct mail. The benefits of the outcomes of the trial are described along with the challenges and limitations associated with the methodology. Australian New Zealand Clinical Trials Registry: ACTRN12611000553976.

Ethnobotanical survey of medicinal plants used by Bapedi healers to treat diabetes mellitus in the Limpopo Province, South Africa.

PubMed

Semenya, S; Potgieter, M; Erasmus, L

2012-05-07

Bapedi phytomedicine employ a range of plant species to treat diabetes mellitus (DM). Existing literature partially support the use of certain species for this purpose. To report on Bapedi medicinal plants employed to treat DM. A semi-structured questionnaire was employed to conduct a survey on medicinal plants used by Bapedi traditional healers in their DM management protocol. Fifty-two traditional healers from 16 municipalities, covering three districts, were interviewed during the first half of 2011. A total of 24 plant species belonging to 20 families, mostly from the Asteraceae (13%), Cucurbitaceae and Sapotaceae (8%), were used to treat diabetes mellitus. Plant parts mostly preferred were roots and leaves. A decoction of these is most commonly used to make extracts, which are then taken orally for a period of one week. Mimusops zeyheri (29%), Helichrysum caespititium (25%), Plumeria obtusa (21%), Aloe marlothii subsp. marlothii, Hypoxis iridifolia and Moringa oleifera (17% each), were repeatedly mentioned by the traditional healers as most used for the management of diabetes mellitus in the study area. Plumeria obtusa and Momordica balsamina are exclusively used to treat diabetes mellitus, and only in the Sekhukhune District. It is concluded that Bapedi traditional healers do have a basic understanding of the causes and remedial action required in the treatment of diabetes mellitus. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

PubMed

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment. Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .

A Cost Analysis of a Pancreatic Cancer Screening Protocol in High-Risk Populations

PubMed Central

Bruenderman, Elizabeth; Martin, Robert CG

2016-01-01

Background Pancreatic cancer is the 4th leading cause of cancer death in the U.S. A screening protocol is needed to catch early stage, resectable disease. This study suggests a protocol for high-risk individuals and assesses the cost in the context of the Affordable Care Act. Methods Medicare and national average pricing were used for cost analysis of a protocol using MRI/MRCP biannually in high-risk groups. Results: ‘ Costs per year of life added’ based on Medicare and national average costs, respectively, are: $638.62 and $2542.37 for Peutz-Jehgers Syndrome, $945.33 and $3763.44 for Hereditary Pancreatitis, $1141.77 and $4545.45 for Familial Pancreatic Cancer and p16-Leiden mutations, and $356.42 and $1418.92 for new-onset diabetes over age 50 with weight loss or smoking. Conclusion A screening program using MRI/MRCP is affordable in high-risk populations. The U.S. Preventive Services Task Force must reevaluate its pancreatic cancer screening guidelines to make screening more cost-effective for the individual. PMID:26003200

Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: design of a randomised controlled trial.

PubMed

Nobis, Stephanie; Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Heber, Elena; Baumeister, Harald; Becker, Annette; Snoek, Frank; Riper, Heleen

2013-11-15

A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms. A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective. If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes. German Clinical Trial Register (DRKS): DRKS00004748.

Effect of acute exercise on AMPK signaling in skeletal muscle of subjects with type 2 diabetes: a time-course and dose-response study.

PubMed

Sriwijitkamol, Apiradee; Coletta, Dawn K; Wajcberg, Estela; Balbontin, Gabriela B; Reyna, Sara M; Barrientes, John; Eagan, Phyllis A; Jenkinson, Christopher P; Cersosimo, Eugenio; DeFronzo, Ralph A; Sakamoto, Kei; Musi, Nicolas

2007-03-01

Activation of AMP-activated protein kinase (AMPK) by exercise induces several cellular processes in muscle. Exercise activation of AMPK is unaffected in lean (BMI approximately 25 kg/m(2)) subjects with type 2 diabetes. However, most type 2 diabetic subjects are obese (BMI >30 kg/m(2)), and exercise stimulation of AMPK is blunted in obese rodents. We examined whether obese type 2 diabetic subjects have impaired exercise stimulation of AMPK, at different signaling levels, spanning from the upstream kinase, LKB1, to the putative AMPK targets, AS160 and peroxisome proliferator-activated receptor coactivator (PGC)-1alpha, involved in glucose transport regulation and mitochondrial biogenesis, respectively. Twelve type 2 diabetic, eight obese, and eight lean subjects exercised on a cycle ergometer for 40 min. Muscle biopsies were done before, during, and after exercise. Subjects underwent this protocol on two occasions, at low (50% Vo(2max)) and moderate (70% Vo(2max)) intensities, with a 4-6 week interval. Exercise had no effect on LKB1 activity. Exercise had a time- and intensity-dependent effect to increase AMPK activity and AS160 phosphorylation. Obese and type 2 diabetic subjects had attenuated exercise-stimulated AMPK activity and AS160 phosphorylation. Type 2 diabetic subjects had reduced basal PGC-1 gene expression but normal exercise-induced increases in PGC-1 expression. Our findings suggest that obese type 2 diabetic subjects may need to exercise at higher intensity to stimulate the AMPK-AS160 axis to the same level as lean subjects.

Study design of DIACORE (DIAbetes COhoRtE) – a cohort study of patients with diabetes mellitus type 2

PubMed Central

2013-01-01

Background Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE). Methods DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro- and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e.g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness. Discussion DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies. PMID:23409726

The effect of congestive heart failure on sensor accuracy among hospitalized patients with type 2 diabetes.

PubMed

Dungan, Kathleen; Graessle, Kari; Sagrilla, Colleen

2013-10-01

Congestive heart failure (CHF) features disturbances in the interstitial environment that may affect the accuracy of subcutaneous continuous glucose monitoring (CGM). A pooled analysis of two studies of hospitalized patients with type 2 diabetes randomized to intravenous or subcutaneous insulin was conducted. One study enrolled patients with CHF exacerbation, whereas history of CHF was an exclusion criterion in the other. All patients wore a professional CGM device for at least 24 h. Intravenous insulin was administered according to the institution's nursing-run protocol (duration of 12 and 48 h in non-CHF and CHF protocols, respectively). Subcutaneous insulin was delivered similarly in both groups. Subjects with CHF (n=43) had higher admission glucose and hemoglobin A1c compared with non-CHF subjects (n=32), but the sensor glucose values were similar. Overall mean absolute relative difference (MARD) was similar between CHF and non-CHF subjects (0.11 vs. 0.08, respectively; P=0.12). MARD was higher in the 100-149 mg/dL (P=0.003) and >199 mg/dL (P = 0.02) strata among CHF subjects. Static glucose and continuous glucose error grid analyses favored the non-CHF group. In multivariable analyses, only glucose coefficient of variation and log sensor time were independent predictors of elevated overall MARD >0.10. After adjustment for other factors, only increasing log sensor time was a significant predictor of elevated MARD in the 100-149 mg/dL strata. Among hospitalized subjects with type 2 diabetes, CHF exacerbation is not associated with lower sensor accuracy after adjustment for other factors, but this requires confirmation over a wider glucose range.

The Effect of Congestive Heart Failure on Sensor Accuracy Among Hospitalized Patients with Type 2 Diabetes

PubMed Central

Graessle, Kari; Sagrilla, Colleen

2013-01-01

Abstract Background Congestive heart failure (CHF) features disturbances in the interstitial environment that may affect the accuracy of subcutaneous continuous glucose monitoring (CGM). Subjects and Methods A pooled analysis of two studies of hospitalized patients with type 2 diabetes randomized to intravenous or subcutaneous insulin was conducted. One study enrolled patients with CHF exacerbation, whereas history of CHF was an exclusion criterion in the other. All patients wore a professional CGM device for at least 24 h. Intravenous insulin was administered according to the institution's nursing-run protocol (duration of 12 and 48 h in non-CHF and CHF protocols, respectively). Subcutaneous insulin was delivered similarly in both groups. Results Subjects with CHF (n=43) had higher admission glucose and hemoglobin A1c compared with non-CHF subjects (n=32), but the sensor glucose values were similar. Overall mean absolute relative difference (MARD) was similar between CHF and non-CHF subjects (0.11 vs. 0.08, respectively; P=0.12). MARD was higher in the 100–149 mg/dL (P=0.003) and >199 mg/dL (P=0.02) strata among CHF subjects. Static glucose and continuous glucose error grid analyses favored the non-CHF group. In multivariable analyses, only glucose coefficient of variation and log sensor time were independent predictors of elevated overall MARD >0.10. After adjustment for other factors, only increasing log sensor time was a significant predictor of elevated MARD in the 100–149 mg/dL strata. Conclusions Among hospitalized subjects with type 2 diabetes, CHF exacerbation is not associated with lower sensor accuracy after adjustment for other factors, but this requires confirmation over a wider glucose range. PMID:24050738

Community-Based Participatory Research Integrates Behavioral and Biological Research to Achieve Health Equity for Native Hawaiians.

PubMed

Townsend, Claire K M; Dillard, Adrienne; Hosoda, Kelsea K; Maskarinec, Gregory G; Maunakea, Alika K; Yoshimura, Sheryl R; Hughes, Claire; Palakiko, Donna-Marie; Kehauoha, Bridget Puni; Kaholokula, Joseph Keawe'aimoku

2015-12-22

Native Hawaiians bear a disproportionate burden of type-2 diabetes and related complications compared to all other groups in Hawai'i (e.g., Whites, Japanese, Korean). Distrust in these communities is a significant barrier to participation in epigenetic research studies seeking to better understand disease processes. The purpose of this paper is to describe the community-based participatory research (CBPR) approach and research process we employed to integrate behavior and biological sciences with community health priorities. A CBPR approach was used to test a 3-month evidence-based, diabetes self-management intervention (N = 65). To investigate the molecular mechanisms linking inflammation with glucose homeostasis, a subset of participants (n = 16) provided peripheral blood mononuclear cells. Community and academic researchers collaborated on research design, assessment protocols, and participant recruitment, prioritizing participants' convenience and education and strictly limiting the use of the data collected. Preliminary results indicate significant changes in DNA methylation at gene regions associated with inflammation and diabetes signaling pathways and significant improvements in hemoglobin A1c, self-care activities, and diabetes distress and understanding. This study integrates community, behavioral, and epigenomic expertise to better understand the outcomes of a diabetes self-management intervention. Key lessons learned suggest the studies requiring biospecimen collection in indigenous populations require community trust of the researchers, mutual benefits for the community and researchers, and for the researchers to prioritize the community's needs. CBPR may be an important tool in providing communities the voice and protections to participate in studies requiring biospecimens.

A multicentre phase III randomised controlled single-masked clinical trial evaluating the clinical efficacy and safety of light-masks at preventing dark-adaptation in the treatment of early diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial.

PubMed

Sivaprasad, Sobha; Arden, Geoffrey; Prevost, A Toby; Crosby-Nwaobi, Roxanne; Holmes, Helen; Kelly, Joanna; Murphy, Caroline; Rubin, Gary; Vasconcelos, Joanna; Hykin, Philip

2014-11-22

This study will evaluate hypoxia, as a novel concept in the pathogenesis of diabetic macular oedema (DMO). As the oxygen demand of the eye is maximum during dark-adaptation, we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO. The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis. This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography (SD-OCT). Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy. Safety parameters will include sleep disturbance. Adverse events and measures of compliance will be assessed over 24 months. Participants recruited to the mechanistic sub-study will have additional retinal oximetry, multifocal electroretinography (ERG) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months. The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.

Patients with type 2 diabetes demonstrate proprioceptive deficit in the knee

PubMed Central

Ettinger, Lucas Richard; Boucher, Ami; Simonovich, Elisabeth

2018-01-01

AIM To investigate proprioceptive discrepancies in the lower extremity in persons with type 2 diabetes mellitus (T2DM). METHODS In this cross-sectional study, a total of 46 older persons were divided into a T2DM group (n = 23) and a control group who did not have T2DM (n = 23). Participants were given a brief warm up with stretching exercises. Diabetic neuropathy scores were collected prior to proprioceptive testing. For proprioceptive testing, participants performed leg extensions to randomized target positions of 15°, 30°, 45, 60° degrees of elevation in the sagittal plane, each target was repeated a total of four times. Subjects were guided to target positions in the absence of visual feedback via auditory cues from a custom JPS application. When the participant entered the target position, they memorized the location of their limb in space and subsequently attempted to re-locate this position in space. Proprioceptive errors were measured from the target positioned, target remembered, target repositioned protocol. RESULTS Proprioceptive accuracy was lower in the diabetic group at all levels of target angle than the control group (P < 0.05). The diabetic group had 46% greater inaccuracy than the control group at all levels of target position. Diabetics also reported greater neuropathy scores than controls in the past 12 mo P < 0.01. CONCLUSION Deficits in lower limb localization and greater diabetic neuropathy scores were identified in this study. Our findings may be associated with deafferentation as peripheral neuropathy is a common complication with the disease. These findings may help to explain the declining balance function in the older persons with T2DM which is also commonly reported. PMID:29607003

Acquired partial lipodystrophy is associated with increased risk for developing metabolic abnormalities.

PubMed

Akinci, Baris; Koseoglu, Fatos Dilan; Onay, Huseyin; Yavuz, Sevgi; Altay, Canan; Simsir, Ilgin Yildirim; Ozisik, Secil; Demir, Leyla; Korkut, Meltem; Yilmaz, Nusret; Ozen, Samim; Akinci, Gulcin; Atik, Tahir; Calan, Mehmet; Secil, Mustafa; Comlekci, Abdurrahman; Demir, Tevfik

2015-09-01

Acquired partial lipodystrophy (APL) is a rare disorder characterized by progressive selective fat loss. In previous studies, metabolic abnormalities were reported to be relatively rare in APL, whilst they were quite common in other types of lipodystrophy syndromes. In this nationwide cohort study, we evaluated 21 Turkish patients with APL who were enrolled in a prospective follow-up protocol. Subjects were investigated for metabolic abnormalities. Fat distribution was assessed by whole body MRI. Hepatic steatosis was evaluated by ultrasound, MRI and MR spectroscopy. Patients with diabetes underwent a mix meal stimulated C-peptide/insulin test to investigate pancreatic beta cell functions. Leptin and adiponectin levels were measured. Fifteen individuals (71.4%) had at least one metabolic abnormality. Six patients (28.6%) had diabetes, 12 (57.1%) hypertrigylceridemia, 10 (47.6%) low HDL cholesterol, and 11 (52.4%) hepatic steatosis. Steatohepatitis was further confirmed in 2 patients with liver biopsy. Anti-GAD was negative in all APL patients with diabetes. APL patients with diabetes had lower leptin and adiponectin levels compared to patients with type 2 diabetes and healthy controls. However, contrary to what we observed in patients with congenital generalized lipodystrophy (CGL), we did not detect consistently very low leptin levels in APL patients. The mix meal test suggested that APL patients with diabetes had a significant amount of functional pancreatic beta cells, and their diabetes was apparently associated with insulin resistance. Our results show that APL is associated with increased risk for developing metabolic abnormalities. We suggest that close long-term follow-up is required to identify and manage metabolic abnormalities in APL. Copyright © 2015 Elsevier Inc. All rights reserved.

Glycemic Control and the Outcomes of Hispanic Patients with Diabetes Admitted to the General Ward of a Community Hospital in Puerto Rico

PubMed Central

Torres-Torres, Nancy; Maldonado-Rodríguez, Miguel A.; Pérez-López, Shirley; Sierra-Martínez, Kassandra; García, Astrid J.

2017-01-01

Objective Uncontrolled glucose, present in 40% of diabetic patients admitted to United States hospitals, has been associated with prolonged length of stay and poorer general outcomes in critically ill and surgical patients. However, past studies of general ward patients have shown there to be no consistent benefits of strict glucose control, and the Hispanic population has been underrepresented in such studies. This work evaluated the association between glycemic control and the outcomes of hospitalized Hispanics with diabetes and to describe physicians’ interventions in the treatment of diabetes. Methods This is a retrospective chart review of all patients with diabetes admitted over a period of six months in the general ward of a community hospital in Puerto Rico. We evaluated glucose levels during the first 72 hours, length of stay, and reported complications during admission. Outcomes were evaluated with crude odds ratios and multivariate logistic regression. Results Uncontrolled blood glucose was observed in 59.1% of the 875 patients whose records were revised; of that 59.1%, treatment modification was not prescribed for 43.2%. Patients with poorly controlled glucose were more likely to develop acute coronary syndrome (corrected OR: 11.46; 95% CI = 1.48 – 88.50) as a complication and less likely to develop hypoglycemia (corrected OR: 0.57; 95% = CI 0.37 – 0.88). Conclusion Our results suggest that hospitalized but non-critically ill Hispanic patients with diabetes are prone to poor outcomes secondary to uncontrolled glucose levels; in addition, those results support the creation of standardized protocols for the management of diabetes in this population. PMID:21682145

Incidence and Progression of Diabetic Retinopathy in Urban India: Sankara Nethralaya-Diabetic Retinopathy Epidemiology and Molecular Genetics Study (SN-DREAMS II), Report 1.

PubMed

Raman, Rajiv; Ganesan, Suganeswari; Pal, Swakshyar Saumya; Gella, Laxmi; Kulothungan, Vaitheeswaran; Sharma, Tarun

2017-10-01

To evaluate the 4-year incidence and progression of and risk factors for diabetic retinopathy (DR) in an Indian population. From a cross-sectional study of 1425 subjects with diabetes, 911 (63.9%) returned for 4-year follow-up. After excluding 21 with ungradable retinal images, data from 890 subjects were analyzed. Participants underwent examinations based on a standard protocol, which included grading of retinal photographs. The incidences of DR, diabetic macular edema (DME), and sight-threatening diabetic retinopathy (STDR) were 9.2%, 2.6%, and 5.0%, respectively. In subjects with DR at baseline, the incidence of DME and STDR had increased (11.5% and 22.7%, respectively). 1-step and 2-step progressions of DR were seen in 30.2% and 12.6% of participants, respectively, and 1-step and 2-step regressions were seen in 12.0% and 1.8%, respectively. Incident DR, DME, and STDR were associated with higher systolic blood pressure (odds ratio, OR, 1.21, 2.11 and 1.72, respectively, for every 10 mmHg increase). Incident DR and DME were associated with increasing duration of diabetes (OR 2.29 and 4.77, respectively, for every 10-year increase) and presence of anemia (OR 1.96 and 10.14, respectively). Incident DR was also associated with higher hemoglobin A1c (OR 1.16 for every 1% increase). Variables associated with 1-step progression were every 10 mg/dL increase in serum total cholesterol (OR 15.65) as a risk factor, and 10 mg/dL increase in serum triglyceride (OR 0.52) as a protective factor. The incidences of STDR and DME were higher in people with pre-existing DR than in those without DR at baseline.

Self-care coping strategies in people with diabetes: a qualitative exploratory study

PubMed Central

Collins, Margaret M; Bradley, Colin P; O'Sullivan, Tony; Perry, Ivan J

2009-01-01

Background The management of diabetes self-care is largely the responsibility of the patient. With more emphasis on the prevention of complications, adherence to diabetes self-care regimens can be difficult. Diabetes self-care requires the patient to make many dietary and lifestyle changes. This study will explore patient perceptions of diabetes self-care, with particular reference to the burden of self-care and coping strategies among patients. Methods A maximum variation sample of 17 patients was selected from GP practices and diabetes clinics in Ireland to include patients with types 1 and 2 diabetes, various self-care regimens, and a range of diabetes complications. Data were collected by in-depth interviews; which were tape-recorded and transcribed. The transcripts were analysed using open and axial coding procedures to identify main categories, and were reviewed by an independent corroborator. Discussion of the results is made in the theoretical context of the health belief, health value, self-efficacy, and locus of control frameworks. Results Patients' perceptions of their self-care varied on a spectrum, displaying differences in self-care responsibilities such as competence with dietary planning, testing blood sugar and regular exercise. Three patient types could be distinguished, which were labeled: "proactive manager," a patient who independently monitors blood glucose and adjusts his/her self-care regime to maintain metabolic control; "passive follower," a patient who follows his/her prescribed self-care regime, but does not react autonomously to changes in metabolic control; and "nonconformist," a patient who does not follow most of his/her prescribed self-care regimen. Conclusion Patients have different diabetes self-care coping strategies which are influenced by their self-care health value and consequently may affect their diet and exercise choices, frequency of blood glucose monitoring, and compliance with prescribed medication regimens. Particular attention should be paid to the patient's self-care coping strategy, and self-care protocols should be tailored to complement the different patient types. PMID:19232113

The Effect of Using Mobile Technology-Based Methods That Record Food or Nutrient Intake on Diabetes Control and Nutrition Outcomes: A Systematic Review.

PubMed

Porter, Judi; Huggins, Catherine E; Truby, Helen; Collins, Jorja

2016-12-17

(1) Background: Mobile technologies may be utilised for dietary intake assessment for people with diabetes. The published literature was systematically reviewed to determine the effect of using mobile electronic devices to record food or nutrient intake on diabetes control and nutrition outcomes; (2) Methods: The review protocol was registered with PROSPERO: registration number CRD42016050079, and followed PRISMA guidelines. Original research of mobile electronic devices where food or nutrient intake was recorded in people with diabetes with any treatment regimen, and where this intervention was compared with usual care or alternative treatment models, was considered. Quality was assessed using the Quality Criteria Checklist for Primary Research; (3) Results: Nine papers formed the final library with a range of interventions and control practices investigated. The food/nutrient intake recording component of the intervention and patient engagement with the technology was not well described. When assessed for quality, three studies rated positive, five were neutral and one negative. There was significantly greater improvement in HbA1c in the intervention group compared to the control group in four of the nine studies; (4) Conclusion: Based on the available evidence there are no clear recommendations for using technology to record dietary data in this population.

The Effect of Using Mobile Technology-Based Methods That Record Food or Nutrient Intake on Diabetes Control and Nutrition Outcomes: A Systematic Review

PubMed Central

Porter, Judi; Huggins, Catherine E.; Truby, Helen; Collins, Jorja

2016-01-01

(1) Background: Mobile technologies may be utilised for dietary intake assessment for people with diabetes. The published literature was systematically reviewed to determine the effect of using mobile electronic devices to record food or nutrient intake on diabetes control and nutrition outcomes; (2) Methods: The review protocol was registered with PROSPERO: registration number CRD42016050079, and followed PRISMA guidelines. Original research of mobile electronic devices where food or nutrient intake was recorded in people with diabetes with any treatment regimen, and where this intervention was compared with usual care or alternative treatment models, was considered. Quality was assessed using the Quality Criteria Checklist for Primary Research; (3) Results: Nine papers formed the final library with a range of interventions and control practices investigated. The food/nutrient intake recording component of the intervention and patient engagement with the technology was not well described. When assessed for quality, three studies rated positive, five were neutral and one negative. There was significantly greater improvement in HbA1c in the intervention group compared to the control group in four of the nine studies; (4) Conclusion: Based on the available evidence there are no clear recommendations for using technology to record dietary data in this population. PMID:27999302

Diabetes Mellitus Following Renal Transplantation: Clinical and Pharmacological Considerations for the Elderly Patient.

PubMed

Langsford, David; Steinberg, Adam; Dwyer, Karen M

2017-08-01

Post-transplant diabetes mellitus occurs in 30-50% of cases during the first year post-renal transplantation. It is associated with increased morbidity, mortality and healthcare costs. Risk factors include age and specific immunosuppression regimens. At the same time, renal transplantation is increasingly indicated in elderly (aged >65 years) patients as this proportion of older patients in the prevalent dialysis population has increased. The immune system and β cells undergo senescence and this impacts on the risk for developing post-transplant diabetes and our ability to prevent such development. It may, however, be possible to identify patients at risk of developing post-transplant diabetes, enabling treatment protocols that prevent or reduce the impact of post-transplant diabetes. Much work remains to be completed in this area and is facilitated by the growing base of knowledge regarding the pathophysiology of post-transplant diabetes. Should post-transplant diabetes develop, there are a range of treatment options available. There is increasing interest in using newer agents, although their safety and efficacy in transplant recipients remains to be conclusively established.

Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States.

PubMed

Brennan, D C; Kopetskie, H A; Sayre, P H; Alejandro, R; Cagliero, E; Shapiro, A M J; Goldstein, J S; DesMarais, M R; Booher, S; Bianchine, P J

2016-02-01

We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

The impact of brief high-intensity exercise on blood glucose levels.

PubMed

Adams, O Peter

2013-01-01

Moderate-intensity exercise improves blood glucose (BG), but most people fail to achieve the required exercise volume. High-intensity exercise (HIE) protocols vary. Maximal cycle ergometer sprint interval training typically requires only 2.5 minutes of HIE and a total training time commitment (including rest and warm up) of 25 minutes per session. The effect of brief high-intensity exercise on blood glucose levels of people with and without diabetes is reviewed. HIE (≥80% maximal oxygen uptake, VO2max) studies with ≤15 minutes HIE per session were reviewed. Six studies of nondiabetics (51 males, 14 females) requiring 7.5 to 20 minutes/week of HIE are reviewed. Two weeks of sprint interval training increased insulin sensitivity up to 3 days postintervention. Twelve weeks near maximal interval running (total exercise time 40 minutes/week) improved BG to a similar extent as running at 65% VO2max for 150 minutes/week. Eight studies of diabetics (41 type 1 and 22 type 2 subjects) were reviewed. Six were of a single exercise session with 44 seconds to 13 minutes of HIE, and the others were 2 and 7 weeks duration with 20 and 2 minutes/week HIE, respectively. With type 1 and 2 diabetes, BG was generally higher during and up to 2 hours after HIE compared to controls. With type 1 diabetics, BG decreased from midnight to 6 AM following HIE the previous morning. With type 2 diabetes, a single session improved postprandial BG for 24 hours, while a 2-week program reduced the average BG by 13% at 48 to 72 hours after exercise and also increased GLUT4 by 369%. Very brief HIE improves BG 1 to 3 days postexercise in both diabetics and non-diabetics. HIE is unlikely to cause hypoglycemia during and immediately after exercise. Larger and longer randomized studies are needed to determine the safety, acceptability, long-term efficacy, and optimal exercise intensity and duration.

Plantar pressures are elevated in people with longstanding diabetes-related foot ulcers during follow-up

PubMed Central

Fernando, Malindu E.; Crowther, Robert G.; Lazzarini, Peter A.; Yogakanthi, Saiumaeswar; Sangla, Kunwarjit S.; Buttner, Petra; Jones, Rhondda; Golledge, Jonathan

2017-01-01

Objective High plantar pressures are implicated in the development of diabetes-related foot ulcers. Whether plantar pressures remain high in patients with chronic diabetes-related foot ulcers over time is uncertain. The primary aim of this study was to compare plantar pressures at baseline and three and six months later in participants with chronic diabetes-related foot ulcers (cases) to participants without foot ulcers (controls). Methods Standardised protocols were used to measure mean peak plantar pressure and pressure-time integral at 10 plantar foot sites (the hallux, toes, metatarsals 1 to 5, mid-foot, medial heel and lateral heel) during barefoot walking. Measurements were performed at three study visits: baseline, three and six months. Linear mixed effects random-intercept models were utilised to assess whether plantar pressures differed between cases and controls after adjusting for age, sex, body mass index, neuropathy status and follow-up time. Standardised mean differences (Cohen’s d) were used to measure effect size. Results Twenty-one cases and 69 controls started the study and 16 cases and 63 controls completed the study. Cases had a higher mean peak plantar pressure at several foot sites including the toes (p = 0.005, Cohen’s d = 0.36) and mid-foot (p = 0.01, d = 0.36) and a higher pressure-time integral at the hallux (p<0.001, d = 0.42), metatarsal 1 (p = 0.02, d = 0.33) and mid-foot (p = 0.04, d = 0.64) compared to controls throughout follow-up. A reduction in pressure-time integral at multiple plantar sites over time was detected in all participants (p<0.05, respectively). Conclusions Plantar pressures assessed during gait are higher in diabetes patients with chronic foot ulcers than controls at several plantar sites throughout prolonged follow-up. Long term offloading is needed in diabetes patients with diabetes-related foot ulcers to facilitate ulcer healing. PMID:28859075

Flash glucose monitoring system may benefit children and adolescents with type 1 diabetes during fasting at Ramadan.

PubMed

Al-Agha, Abdulmoein E; Kafi, Shahd E; Zain Aldeen, Abdullah M; Khadwardi, Raghdah H

2017-04-01

To assess the benefit of using the flash glucose monitoring system (FGMS) in children and adolescents with type 1 diabetes mellitus (T1DM) during Ramadan fasting. Methods: A prospective pilot study of 51 participants visited the pediatric diabetes clinic at King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia from between June until and July 2016. The FreeStyle® Libre™ FGMS (Abbott Diabetes Care, Alameda, CA, USA) was used. Hypoglycemia was defined as glucose values of less than 70 mg/dL, while hyperglycemia as glucose values of more than 150 mg/dL for all participants based on our institute's protocol. Results: Participants were able to fast for 67.0% of the total days eligible for fasting, whereas they did not fast on 33% of the days due to either hypoglycemia (15.4%) or non-diabetes-related reasons (17.6 %). None of the participants developed severe hypoglycemia. The mean number of hyperglycemic episodes during fasting hours was 1.29, per day, which was higher than that of hypoglycemic episodes (0.7). None of the participants developed diabetic ketoacidosis (DKA). Glycemic control with mean of estimated hemoglobin A1C reading during Ramadan (8.16 ± 1.64% [pre study]) to 8.2 ± 1.63% [post study] p=0.932. Conclusions: Children and adolescents with T1DM who use the FGMS could fast without the risk of life-threatening episodes of severe hypoglycemia (namely seizure, coma), or DKA during Ramadan. Adequate education and good glycemic control prior to Ramadan are important strategies in combination with the use of an FGMS to achieve better outcome.

Inter-arm blood pressure difference in type 2 diabetes: a barrier to effective management?

PubMed Central

Clark, Christopher E; Greaves, Colin J; Evans, Philip H; Dickens, Andy; Campbell, John L

2009-01-01

Background Previous studies have identified a substantial prevalence of a blood pressure difference between arms in various populations, but not patients with type 2 diabetes. Recognition of such a difference would be important as a potential cause of underestimation of blood pressure. Aim To measure prevalence of an inter-arm blood pressure difference in patients with type 2 diabetes, and to estimate how frequently blood pressure measurements could be erroneously underestimated if an inter-arm difference is unrecognised. Design of study Cross-sectional study. Setting Five surgeries covered by three general practices, Devon, England. Method Patients with type 2 diabetes underwent bilateral simultaneous blood pressure measurements using a validated protocol. Mean blood pressures were calculated for each arm to derive mean systolic and diastolic differences, and to estimate point prevalence of predefined magnitudes of difference. Results A total of 101 participants were recruited. Mean age was 66 years (standard deviation [SD] = 13.9 years); 59% were male, and mean blood pressure was 138/79 mmHg (SD = 15/10 mmHg). Ten participants (10%; 95% confidence interval [CI] = 4 to 16) had a systolic inter-arm difference ≥10 mmHg; 29 (29%; 95% CI = 20 to 38) had a diastolic difference ≥5 mmHg; and three (3%; 95% CI = 0 to 6) a diastolic difference ≥10 mmHg. No confounding variable was observed to account for the magnitude of an inter-arm difference. Conclusion A systolic inter-arm difference ≥10 mmHg was observed in 10% of patients with diabetes. Failure to recognise this would misclassify half of these as normotensive rather than hypertensive using the lower-reading arm. New patients with type 2 diabetes should be screened for an inter-arm blood pressure difference. PMID:19520026

Higher levels of self-reported sitting time is associated with higher risk of type 2 diabetes independent of physical activity in Chile.

PubMed

Díaz-Martínez, Ximena; Steell, Lewis; Martinez, María Adela; Leiva, Ana María; Salas-Bravo, Carlos; Labraña, Ana María; Duran, Eliana; Cristi-Montero, Carlos; Livingstone, Katherine M; Garrido-Méndez, Alex; Alvarez, Cristian; Poblete-Valderrama, Felipe; Luisa Zagalaz, María; Valdivia-Moral, Pedro; Cuadra, Liliana; Ulloa, Natalia; Willis, Naomi D; Celis-Morales, Carlos A

2017-07-28

Sitting behaviours have increased markedly during the last two decades in Chile. However, their associations with health outcomes such as diabetes have not been reported. Therefore, the aim of this study was to investigate the independent association of self-reported sitting time with diabetes-related markers and diabetes prevalence in Chile. This cross-sectional study included participants (aged ≥18 years) from the Chilean National Health Survey 2009-10 (n = 4457). Fasting glucose and haemoglobin A1c (HbA1c) were measured by standardized protocols. The prevalence of type 2 diabetes (T2D) was determined using WHO criteria. Physical activity (PA) and time spent sitting were determined using the Global Physical Activity Questionnaire (GPAQ). The odds ratio for T2D was 1.10 [95% CI: 1.04-1.16, P = 0.002] and 1.08 [1.02-1.14, P = 0.002] per 1 h increase in sitting time in men and women, respectively, independent of age, education, smoking, BMI and total PA. Overall, prevalence of T2D was 10.2 and 17.2% in individuals classified in the lowest and highest categories of sitting time, respectively. No significant associations were found between sitting time and glucose or HbA1c. Sitting time is positively associated with diabetes risk, independent of socio-demographic, obesity and PA levels, in the Chilean population. © The Author 2017. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Safety and specificity of the growth hormone suppression test in patients with diabetes.

PubMed

Rosario, Pedro Weslley; Calsolari, Maria Regina

2015-02-01

The purpose of this study was to evaluate the safety of the oral glucose tolerance test (OGTT) and its capacity to suppress growth hormone (GH) in diabetic patients without acromegaly. A total of 135 diabetic patients submitted to the OGTT for GH suppression were studied. The following selection criteria were applied: age between 20 and 70 years; body mass index≥18.5 and ≤27 kg/m2; absence of kidney, liver, or thyroid disease; no use of estrogens, androgens, corticosteroids, or levothyroxine. Adequate suppression of GH was defined as a nadir below the cut-off established for a sample of 200 normoglycemic subjects (<0.25 µg/L for men, <0.74 µg/L for premenopausal women, and <0.5 µg/L for postmenopausal women). Acromegaly was diagnosed in five patients. Among the 130 diabetic patients without known pituitary disease or a clinical suspicion of acromegaly, 95.5% of men, 94% of premenopausal women, and 96.6% of postmenopausal women presented adequate GH suppression (vs 97.5% of normoglycemic controls). In all patients without acromegaly, the lowest GH levels (nadir) were achieved after the administration of glucose and not during baseline measurement. None of the patients had acute complications [ketoacidosis, hyperosmolar state, and symptomatic marked hyperglycemia (>300 mg/dL)] on the day of the test and up to 3 days thereafter. We demonstrated the safety of the OGTT and its capacity to suppress GH in diabetic patients without acromegaly. In addition, we suggest the adoption of a protocol to prevent possible risks of the OGTT in patients with diabetes.

Rapid identification of illegal synthetic adulterants in herbal anti-diabetic medicines using near infrared spectroscopy

NASA Astrophysics Data System (ADS)

Feng, Yanchun; Lei, Deqing; Hu, Changqin

We created a rapid detection procedure for identifying herbal medicines illegally adulterated with synthetic drugs using near infrared spectroscopy. This procedure includes a reverse correlation coefficient method (RCCM) and comparison of characteristic peaks. Moreover, we made improvements to the RCCM based on new strategies for threshold settings. Any tested herbal medicine must meet two criteria to be identified with our procedure as adulterated. First, the correlation coefficient between the tested sample and the reference must be greater than the RCCM threshold. Next, the NIR spectrum of the tested sample must contain the same characteristic peaks as the reference. In this study, four pure synthetic anti-diabetic drugs (i.e., metformin, gliclazide, glibenclamide and glimepiride), 174 batches of laboratory samples and 127 batches of herbal anti-diabetic medicines were used to construct and validate the procedure. The accuracy of this procedure was greater than 80%. Our data suggest that this protocol is a rapid screening tool to identify synthetic drug adulterants in herbal medicines on the market.

Air pollution and respiratory health among diabetic and non-diabetic subjects in Pune, India-results from the Wellcome Trust Genetic Study.

PubMed

Khafaie, Morteza Abdullatif; Salvi, Sundeep Santosh; Yajnik, Chittaranjan Sakerlal; Ojha, Ajay; Khafaie, Behzad; Gore, Sharad Damodar

2017-06-01

Diabetics may be more vulnerable to the harmful effects of ambient air pollutants than healthy individuals. But, the risk factors that lead to susceptibility to air pollution in diabetics have not yet been identified. We examined the effect of exposure to ambient PM 10 on chronic symptoms and the pulmonary function tests (PFT) in diabetic and non-diabetic subjects. Also, to investigate possible determinants of susceptibility, we recruited 400 type 2 diabetic and 465 healthy subjects who were investigated for chronic respiratory symptoms (CRSs) and then underwent measurement of forced vital capacity (FVC) and forced expiratory volume 1 (FEV1) according to standard protocol. Percent predicted FEV1 and FVC (FEV1% and FVC%, respectively) for each subject were calculated. Particulate matter (PM 10 ) concentrations at residence place of subjects were estimated using AERMOD dispersion model. The association between PM 10 and CRSs was explored using logistic regression. We also used linear regression models controlling for potential confounders to study the association between chronic exposure to PM 10 and FEV1% and FVC%. Prevalence of current wheezing, allergy symptom, chest tightness, FEV1/FVC <70%, and physician-diagnosed asthma and COPD was significantly higher among diabetic subjects than non-diabetics. There was no significant difference between percent predicted value of PFT among diabetic and non-diabetic subjects (P < 0.05). We estimated that 1 SD increase in PM 10 concentration was associated with a greater risk of having dyspnea by 1.50-fold (95% CI, 1.12-2.01). Higher exposure to PM 10 concentration was also significantly associated with lower FVC%. The size of effect for 1 SD μg/m 3 (=98.38) increase in PM 10 concentration was 3.71% (95% CI, 0.48-4.99) decrease in FVC%. In addition, we indicated that strength of these associations was higher in overweight, smoker, and aged persons. We demonstrated a possible contribution of air pollution to reduced lung function independent of diabetes status. This study suggests that decline in exposure may significantly reduce disease manifestation as dyspnea and impaired lung function. We conduct that higher BMI, smoking, and older age were associated with higher levels of air pollution effects.

A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine.

PubMed

Mancini, Alessio; Esposto, Giampaolo; Manfrini, Silvana; Rilli, Silvia; Tinti, Gessica; Carta, Giuseppe; Petrolati, Laura; Vidali, Matteo; Barocci, Simone

2018-05-01

The aim of this retrospective study is to evaluate the reliability and robustness of six glucose meters for point-of-care testing in our wards using a brand-new protocol. During a 30-days study period a total of 50 diabetes patients were subjected to venous blood sampling and glucose meter blood analysis. The results of six glucose meters were compared with our laboratory reference assay. GlucoMen Plus (Menarini) with the 82% of acceptable results was the most robust glucose meter. Even if the Passing-Bablok analysis demonstrates the presence of constant systematic errors and the Bland-Altman test highlighted a possible overestimation, the surveillance error grid analysis showed that this glucose meter can be used safely. We proved that portable glucose meters are not always reliable in routinely clinical settings.

Study Protocol – Diabetes and related conditions in urban Indigenous people in the Darwin, Australia region: aims, methods and participation in the DRUID Study

PubMed Central

Cunningham, Joan; O'Dea, Kerin; Dunbar, Terry; Weeramanthri, Tarun; Zimmet, Paul; Shaw, Jonathan

2006-01-01

Background Diabetes mellitus is a serious and increasing health problem in Australia and is a designated national health priority. Diabetes and related conditions represent an even greater health burden among Indigenous Australians (Aborigines and Torres Strait Islanders), but there are critical gaps in knowledge relating to the incidence and prevalence, aetiology, and prevention of diabetes in this group, including a lack of information on the burden of disease among Indigenous people in urban areas. The DRUID Study (Diabetes and Related conditions in Urban Indigenous people in the Darwin region) was designed to address this knowledge gap. Methods/design The study was conducted in a specified geographic area in and around Darwin, Australia. Eligible participants underwent a health examination, including collection of blood and urine samples, clinical and anthropometric measurements, and administration of questionnaires, with an additional assessment for people with diabetes. The study was designed to incorporate local Indigenous leadership, facilitate community engagement, and provide employment and training opportunities for local Indigenous people. A variety of recruitment methods were used. A total of 1,004 eligible people gave consent and provided at least one measurement. When compared with census data for the Indigenous population living in the study area, there was a marked under-representation of males, but no substantial differences in age, place of residence, Indigenous group, or household income. Early participants were more likely than later participants to have previously diagnosed diabetes. Discussion Despite lower than anticipated recruitment, this is, to our knowledge, the largest study ever conducted on the health of Indigenous Australians living in urban areas, a group which comprises the majority of Australia's Indigenous population but about whose health and wellbeing relatively little is known. The study is well-placed to provide new information that can be used by policy makers and service providers to improve the delivery of services and programs that affect the health of Indigenous people. It also represents a valuable opportunity to establish an urban Indigenous cohort study, provided participants can be followed successfully over time. PMID:16417641

The impact of financial incentives on the implementation of asthma or diabetes self-management: A systematic review.

PubMed

Jackson, Tracy; Shields, Michael D; Heaney, Liam G; Kendall, Marilyn; Pearce, Christina J; Hui, Chi Yan; Pinnock, Hilary

2017-01-01

Financial incentives are utilised in healthcare systems in a number of countries to improve quality of care delivered to patients by rewarding practices or practitioners for achieving set targets. To systematically review the evidence investigating the impact of financial incentives for implementation of supported self-management on quality of care including: organisational process outcomes, individual behavioural outcomes, and health outcomes for individuals with asthma or diabetes; both conditions with an extensive evidence base for self-management. We followed Cochrane methodology, using a PICOS search strategy to search eight databases in November 2015 (updated May 2017) including a broad range of implementation methodologies. Studies were weighted by robustness of methodology, number of participants and the quality score. We used narrative synthesis due to heterogeneity of studies. We identified 2,541 articles; 12 met our inclusion criteria. The articles were from the US (n = 7), UK (n = 4) and Canada (n = 1). Measured outcomes were HbA1c tests undertaken and/or the level achieved (n = 10), written action plans for asthma (n = 1) and hospital/emergency department visits (n = 1). Three of the studies were part of a larger incentive scheme including many conditions; one focused on asthma; eight focussed on diabetes. In asthma, the proportion receiving 'perfect care' (including providing a written action plan) increased from 4% to 88% in one study, and there were fewer hospitalisations/emergency department visits in another study. Across the diabetes studies, quality-of-care/GP performance scores improved in three, were unchanged in six and deteriorated in one. Results for the impact of financial incentives for the implementation of self-management were mixed. The evidence in diabetes suggests no consistent impact on diabetic control. There was evidence from a single study of improved process and health outcomes in asthma. Further research is needed to confirm these findings and understand the process by which financial incentives may impact (or not) on care. Protocol registration number: CRD42016027411.

Randomized controlled trial for assessment of Internet of Things system to guide intensive glucose control in diabetes outpatients: Nagoya Health Navigator Study protocol.

PubMed

Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi

2017-08-01

The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost.

Usability testing of Avoiding Diabetes Thru Action Plan Targeting (ADAPT) decision support for integrating care-based counseling of pre-diabetes in an electronic health record

PubMed Central

Chrimes, Dillon; Kushniruk, Andre; Kitos, Nicole R.

2014-01-01

Purpose Usability testing can be used to evaluate human computer interaction (HCI) and communication in shared decision making (SDM) for patient-provider behavioral change and behavioral contracting. Traditional evaluations of usability using scripted or mock patient scenarios with think-aloud protocol analysis provide a to identify HCI issues. In this paper we describe the application of these methods in the evaluation of the Avoiding Diabetes Thru Action Plan Targeting (ADAPT) tool, and test the usability of the tool to support the ADAPT framework for integrated care counseling of pre-diabetes. The think-aloud protocol analysis typically does not provide an assessment of how patient-provider interactions are effected in “live” clinical workflow or whether a tool is successful. Therefore, “Near-live” clinical simulations involving applied simulation methods were used to compliment the think-aloud results. This complementary usability technique was used to test the end-user HCI and tool performance by more closely mimicking the clinical workflow and capturing interaction sequences along with assessing the functionality of computer module prototypes on clinician workflow. We expected this method to further complement and provide different usability findings as compared to think-aloud analysis. Together, this mixed method evaluation provided comprehensive and realistic feedback for iterative refinement of the ADAPT system prior to implementation. Methods The study employed two phases of testing of a new interactive ADAPT tool that embedded an evidence-based shared goal setting component into primary care workflow for dealing with pre-diabetes counseling within a commercial physician office electronic health record (EHR). Phase I applied usability testing that involved “think-aloud” protocol analysis of 8 primary care providers interacting with several scripted clinical scenarios. Phase II used “near-live” clinical simulations of 5 providers interacting with standardized trained patient actors enacting the clinical scenario of counseling for pre-diabetes, each of whom had a pedometer that recorded the number of steps taken over a week. In both phases, all sessions were audio-taped and motion screen-capture software was activated for onscreen recordings. Transcripts were coded using iterative qualitative content analysis methods. Results In Phase I, the impact of the components and layout of ADAPT on user’s Navigation, Understandability, and Workflow were associated with the largest volume of negative comments (i.e. approximately 80% of end-user commentary), while Usability and Content of ADAPT were representative of more positive than negative user commentary. The heuristic category of Usability had a positive-to-negative comment ratio of 2.1, reflecting positive perception of the usability of the tool, its functionality, and overall co-productive utilization of ADAPT. However, there were mixed perceptions about content (i.e., how the information was displayed, organized and described in the tool). In Phase II, the duration of patient encounters was approximately 10 minutes with all of the Patient Instructions (prescriptions) and behavioral contracting being activated at the end of each visit. Upon activation, providers accepted the pathway prescribed by the tool 100% of the time and completed all the fields in the tool in the simulation cases. Only 14% of encounter time was spent using the functionality of the ADAPT tool in terms of keystrokes and entering relevant data. The rest of the time was spent on communication and dialogue to populate the patient instructions. In all cases, the interaction sequence of reviewing and discussing exercise and diet of the patient was linked to the functionality of the ADAPT tool in terms of monitoring, response-efficacy, self-efficacy, and negotiation in the patient-provider dialogue. There was a change from one-way dialogue to two-way dialogue and negotiation that ended in a behavioral contract. This change demonstrated the tool’s sequence, which supported recording current exercise and diet followed by a diet and exercise goal setting procedure to reduce the risk of diabetes onset. Conclusions This study demonstrated that “think-aloud” protocol analysis with “near-live” clinical simulations provided a successful usability evaluation of a new primary care pre-diabetes shared goal setting tool. Each phase of the study provided complementary observations on problems with the new onscreen tool and was used to show the influence of the ADAPT framework on the usability, workflow integration, and communication between the patient and provider. The think-aloud tests with the provider showed the tool can be used according to the ADAPT framework (exercise-to-diet behavior change and tool utilization), while the clinical simulations revealed the ADAPT framework to realistically support patient-provider communication to obtain behavioral change contract. SDM interactions and mechanisms affecting protocol-based care can be more completely captured by combining “near-live” clinical simulations with traditional “think-aloud analysis” which augments clinician utilization. More analysis is required to verify if the rich communication actions found in Phase II compliment clinical workflows. PMID:24981988

Usability testing of Avoiding Diabetes Thru Action Plan Targeting (ADAPT) decision support for integrating care-based counseling of pre-diabetes in an electronic health record.

PubMed

Chrimes, Dillon; Kitos, Nicole R; Kushniruk, Andre; Mann, Devin M

2014-09-01

Usability testing can be used to evaluate human-computer interaction (HCI) and communication in shared decision making (SDM) for patient-provider behavioral change and behavioral contracting. Traditional evaluations of usability using scripted or mock patient scenarios with think-aloud protocol analysis provide a way to identify HCI issues. In this paper we describe the application of these methods in the evaluation of the Avoiding Diabetes Thru Action Plan Targeting (ADAPT) tool, and test the usability of the tool to support the ADAPT framework for integrated care counseling of pre-diabetes. The think-aloud protocol analysis typically does not provide an assessment of how patient-provider interactions are effected in "live" clinical workflow or whether a tool is successful. Therefore, "Near-live" clinical simulations involving applied simulation methods were used to compliment the think-aloud results. This complementary usability technique was used to test the end-user HCI and tool performance by more closely mimicking the clinical workflow and capturing interaction sequences along with assessing the functionality of computer module prototypes on clinician workflow. We expected this method to further complement and provide different usability findings as compared to think-aloud analysis. Together, this mixed method evaluation provided comprehensive and realistic feedback for iterative refinement of the ADAPT system prior to implementation. The study employed two phases of testing of a new interactive ADAPT tool that embedded an evidence-based shared goal setting component into primary care workflow for dealing with pre-diabetes counseling within a commercial physician office electronic health record (EHR). Phase I applied usability testing that involved "think-aloud" protocol analysis of eight primary care providers interacting with several scripted clinical scenarios. Phase II used "near-live" clinical simulations of five providers interacting with standardized trained patient actors enacting the clinical scenario of counseling for pre-diabetes, each of whom had a pedometer that recorded the number of steps taken over a week. In both phases, all sessions were audio-taped and motion screen-capture software was activated for onscreen recordings. Transcripts were coded using iterative qualitative content analysis methods. In Phase I, the impact of the components and layout of ADAPT on user's Navigation, Understandability, and Workflow were associated with the largest volume of negative comments (i.e. approximately 80% of end-user commentary), while Usability and Content of ADAPT were representative of more positive than negative user commentary. The heuristic category of Usability had a positive-to-negative comment ratio of 2.1, reflecting positive perception of the usability of the tool, its functionality, and overall co-productive utilization of ADAPT. However, there were mixed perceptions about content (i.e., how the information was displayed, organized and described in the tool). In Phase II, the duration of patient encounters was approximately 10 min with all of the Patient Instructions (prescriptions) and behavioral contracting being activated at the end of each visit. Upon activation, providers accepted the pathway prescribed by the tool 100% of the time and completed all the fields in the tool in the simulation cases. Only 14% of encounter time was spent using the functionality of the ADAPT tool in terms of keystrokes and entering relevant data. The rest of the time was spent on communication and dialog to populate the patient instructions. In all cases, the interaction sequence of reviewing and discussing exercise and diet of the patient was linked to the functionality of the ADAPT tool in terms of monitoring, response-efficacy, self-efficacy, and negotiation in the patient-provider dialog. There was a change from one-way dialog to two-way dialog and negotiation that ended in a behavioral contract. This change demonstrated the tool's sequence, which supported recording current exercise and diet followed by a diet and exercise goal setting procedure to reduce the risk of diabetes onset. This study demonstrated that "think-aloud" protocol analysis with "near-live" clinical simulations provided a successful usability evaluation of a new primary care pre-diabetes shared goal setting tool. Each phase of the study provided complementary observations on problems with the new onscreen tool and was used to show the influence of the ADAPT framework on the usability, workflow integration, and communication between the patient and provider. The think-aloud tests with the provider showed the tool can be used according to the ADAPT framework (exercise-to-diet behavior change and tool utilization), while the clinical simulations revealed the ADAPT framework to realistically support patient-provider communication to obtain behavioral change contract. SDM interactions and mechanisms affecting protocol-based care can be more completely captured by combining "near-live" clinical simulations with traditional "think-aloud analysis" which augments clinician utilization. More analysis is required to verify if the rich communication actions found in Phase II compliment clinical workflows. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Retrospective Evaluation of a Teleretinal Screening Program in Detecting Multiple Nondiabetic Eye Diseases.

PubMed

Maa, April Y; Patel, Shivangi; Chasan, Joel E; Delaune, William; Lynch, Mary G

2017-01-01

Diabetic teleretinal screening programs have been utilized successfully across the world to detect diabetic retinopathy (DR) and are well validated. Less information, however, exists on the ability of teleretinal imaging to detect nondiabetic ocular pathology. This study performed a retrospective evaluation to assess the ability of a community-based diabetic teleretinal screening program to detect common ocular disease other than DR. A retrospective chart review of 1,774 patients who underwent diabetic teleretinal screening was performed. Eye clinic notes from the Veterans Health Administration's electronic medical record, Computerized Patient Record System, were searched for each of the patients screened through teleretinal imaging. When a face-to-face examination note was present, the physical findings were compared to those obtained through teleretinal imaging. Sensitivity, specificity, and positive and negative predictive values were calculated for suspicious nerve, cataract, and age-related macular degeneration. A total of 903 patients underwent a clinical examination. The positive predictive value was highest for cataract (100%), suspicious nerve (93%), and macular degeneration (90%). The negative predictive value and the percent agreement between teleretinal imaging and a clinical examination were over 90% for each disease category. A teleretinal imaging protocol may be used to screen for other common ocular diseases. It may be feasible to use diabetic teleretinal photographs to screen patients for other potential eye diseases. Additional elements of the eye workup may be added to enhance accuracy of disease detection. Further study is necessary to confirm this initial retrospective review.

Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial.

PubMed

Mayfield, Karla; Siskind, Dan; Winckel, Karl; Hollingworth, Samantha; Kisely, Steve; Russell, Anthony W

2015-06-01

Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists. This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks. To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters. This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation. A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Effectiveness of motivational interviewing for improving physical activity self-management for adults with type 2 diabetes: A review.

PubMed

Soderlund, Patricia Davern

2018-03-01

Objectives This review examines the effectiveness of motivational interviewing for physical activity self-management for adults diagnosed with diabetes mellitus type 2. Motivational interviewing is a patient centered individually tailored counseling intervention that aims to elicit a patient's own motivation for health behavior change. Review questions include (a) How have motivational interviewing methods been applied to physical activity interventions for adults with diabetes mellitus type 2? (b) What motivational interviewing approaches are associated with successful physical activity outcomes with diabetes mellitus 2? Methods Database searches used PubMed, CINAHL, and PsycINFO for the years 2000 to 2016. Criteria for inclusion was motivational interviewing used as the principal intervention in the tradition of Miller and Rollnick, measurement of physical activity, statistical significance reported for physical activity outcomes, quantitative research, and articles written in English. Results A total of nine studies met review criteria and four included motivational interviewing interventions associated with significant physical activity outcomes. Discussion Findings suggest motivational interviewing sessions should target a minimal number of self-management behaviors, be delivered by counselors proficient in motivational interviewing, and use motivational interviewing protocols with an emphasis placed either on duration or frequency of sessions.

Cognitive performance, symptoms and counter-regulation during hypoglycaemia in patients with type 1 diabetes and high or low renin-angiotensin system activity.

PubMed

Høi-Hansen, Thomas; Pedersen-Bjergaard, Ulrik; Andersen, Rikke Due; Kristensen, Peter Lommer; Thomsen, Carsten; Kjaer, Troels; Høgenhaven, Hans; Smed, Annelise; Holst, Jens Juul; Dela, Flemming; Boomsma, Frans; Thorsteinsson, Birger

2009-12-01

High basal renin-angiotensin system (RAS) activity is associated with increased risk of severe hypoglycaemia in type 1 diabetes. We tested whether this might be explained by more pronounced cognitive dysfunction during hypoglycaemia in patients with high RAS activity than in patients with low RAS activity. Nine patients with type 1 diabetes and high and nine with low RAS activity were subjected to hypoglycaemia and euglycaemia in a cross-over study using an intravenous insulin infusion protocol. Cognitive function, electroencephalography, auditory evoked potentials and hypoglycaemic symptoms were recorded. At a hypoglycaemic nadir of 2.2 (SD 0.3) mmol/L the high RAS group displayed significant deterioration in cognitive performance during hypoglycaemia in the three most complex reaction time tasks. In the low RAS group, hypoglycaemia led to cognitive dysfunction in only one reaction time task. The high RAS group reported lower symptom scores during hypoglycaemia than the low RAS group, suggesting poorer hypoglycaemia awareness. High RAS activity is associated with increased cognitive dysfunction and blunted symptoms during mild hypoglycaemia compared to low RAS activity. This may explain why high RAS activity is a risk factor for severe hypoglycaemia in type 1 diabetes.

Steroid-induced diabetes: a clinical and molecular approach to understanding and treatment

PubMed Central

Hwang, Jessica L.; Weiss, Roy E.

2014-01-01

Summary Since the advent of glucocorticoid therapy for autoimmune disease in the 1940s, their widespread application has led to the concurrent therapy-limiting discovery of many adverse metabolic side effects. Unanticipated hyperglycemia associated with the initiation of glucocorticoids often leads to preventable hospital admissions, prolonged hospital stays, increased risks for infection and reduced graft function in solid organ transplant recipients. Challenges in managing steroid-induced diabetes stem from wide fluctuations in post-prandial hyperglycemia and the lack of clearly defined treatment protocols. The mainstay of treatment is insulin therapy coincident with meals. This article aims to review the pathogenesis, risk factors, diagnosis and treatment principles unique to steroid-induced diabetes. PMID:24123849

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program

PubMed Central

2013-01-01

Background India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at ‘high risk’ of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. Methods/design A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30–60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. Trial registration Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909. PMID:24180316

Evaluation of the correlation between type 1 diabetes and cognitive function in children and adolescents, and comparison of this correlation with structural changes in the central nervous system: a study protocol.

PubMed

Pourabbasi, Ata; Tehrani-Doost, Mehdi; Ebrahimi Qavam, Soqra; Larijani, Bagher

2016-04-28

Diabetes mellitus type 1 (T1DM) affects nearly 15 million children worldwide and failure to achieve and maintain good glycaemic control in this group can lead to diabetes-related complications. Children with T1DM can experience impairment in cognitive function such as memory, attention and executive function. This study is designed to evaluate the correlation between diabetes and cognitive dysfunction as well as to clarify whether this correlation can be linked to neurological structural changes in 6-11-year-old children with diabetes. 310 eligible children with diabetes will be divided into two groups based on glycaemic control according to their HbA1c index. The control group will include 150 children aged 6-11 without diabetes. The following parameters will be measured and investigated: duration of the disease since diagnosis, required daily insulin dose, frequency of insulin administration, hospital admissions due to diabetes, hypoglycaemic episodes during the last year, and episodes of diabetic ketoacidosis. The following components of cognitive function will be evaluated: memory, attention, executive function, decision-making and academic performance. Cognitive function and subsequent subtests will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) tools. Brain structural indices such as intracranial vault (ICV), as well as cerebrospinal fluid (CSF), ventricle, hippocampus, total intracranial, total brain, grey matter and white matter volume will be measured using MRI. ANOVA, correlational tests (Spearman) and regression models will be used to evaluate the hypothesis. This study is approved by the ethics committee of the Endocrinology and Metabolism Research Institute (EMRI) of Tehran University of Medical Sciences (TUMS) under reference number 00300. Our findings are to be published in a peer-reviewed journal and disseminated both electronically and in print. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Prevalence of blindness and diabetic retinopathy in northern Jordan.

PubMed

Rabiu, Mansur M; Al Bdour, Muawyah D; Abu Ameerh, Mohammed A; Jadoon, Muhammed Z

2015-01-01

To estimate the prevalence of blindness, visual impairment, diabetes, and diabetic retinopathy in north Jordan (Irbid) using the rapid assessment of avoidable blindness and diabetic retinopathy methodology. A multistage cluster random sampling technique was used to select participants for this survey. A total of 108 clusters were selected using probability proportional to size method while subjects within the clusters were selected using compact segment method. Survey teams moved from house to house in selected segments examining residents 50 years and older until 35 participants were recruited. All eligible people underwent a standardized examination protocol, which included ophthalmic examination and random blood sugar test using digital glucometers (Accu-Chek) in their homes. Diabetic retinopathy among diabetic patients was assessed through dilated fundus examination. A total of 3638 out of the 3780 eligible participants were examined. Age- and sex-adjusted prevalence of blindness, severe visual impairment, and visual impairment with available correction were 1.33% (95% confidence interval [CI] 0.87-1.73), 1.82% (95% CI 1.35-2.25), and 9.49% (95% CI 8.26-10.74), respectively, all higher in women. Untreated cataract and diabetic retinopathy were the major causes of blindness, accounting for 46.7% and 33.2% of total blindness cases, respectively. Glaucoma was the third major cause, accounting for 8.9% of cases. The prevalence of diabetes mellitus was 28.6% (95% CI 26.9-30.3) among the study population and higher in women. The prevalence of any retinopathy among diabetic patients was 48.4%. Cataract and diabetic retinopathy are the 2 major causes of blindness and visual impairment in northern Jordan. For both conditions, women are primarily affected, suggesting possible limitations to access to services. A diabetic retinopathy screening program needs to proactively create sex-sensitive awareness and provide easily accessible screening services with prompt treatment.

Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol.

PubMed

Gómez-Marcos, Manuel A; Recio-Rodríguez, José I; Rodríguez-Sánchez, Emiliano; Castaño-Sánchez, Yolanda; de Cabo-Laso, Angela; Sánchez-Salgado, Benigna; Rodríguez-Martín, Carmela; Castaño-Sánchez, Carmen; Gómez-Sánchez, Leticia; García-Ortiz, Luis

2010-03-18

Diabetic patients show an increased prevalence of non-dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk.The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus or metabolic syndrome. This is an observational prospective study with 5 years duration, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up. The study will be carried out in the urban primary care setting. Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included. Patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. Height, weight, heart rate and abdominal circumference. Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity C-reactive protein. Clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. Common carotid artery ultrasound for the determination of mean carotid intima-media thickness. Electrocardiogram for assessing left ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together with antiplatelet drugs. The results of this study will help to know and quantify the prognostic value of central arterial pressure and pulse wave velocity in relation to the evolution of the subclinical target organ damage markers and the possible incidence of cardiovascular events in patients with type 2 diabetes mellitus.

The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

PubMed Central

2013-01-01

Background Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. Methods/Design The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month’s duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. Discussion This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting. The outcomes of the study will have implications not only for diabetes management, but also for the management of other chronic diseases, both in Australia and overseas. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12612000363886); World Health Organisation (U1111-1128-0481). PMID:24359432

The Challenges and Recommendations for Gestational Diabetes Mellitus Care in India: A Review

PubMed Central

Morampudi, Suman; Balasubramanian, Gayathri; Gowda, Arun; Zomorodi, Behsad; Patil, Anand Shanthanagowd

2017-01-01

Gestational diabetes mellitus (GDM) is a primary concern in India affecting approximately five million women each year. Existing literature indicate that prediabetes and diabetes affect approximately six million births in India alone, of which 90% are due to GDM. Studies reveal that there is no consensus among physicians and health-care providers in India regarding management of GDM prepartum and postpartum despite available guidelines. Also, there is no consensus among physicians as to when a woman should undergo oral glucose tolerance test after delivery. This clearly shows that management of GDM is challenging and controversial in India due to conflicting guidelines and treatment protocols, despite availability of straightforward protocols for screening and management. Also, a collaborative approach remains a key for GDM management, as patient compliance and proper educational interventions promote better pregnancy outcomes. Management of GDM plays a pivotal role, as women with GDM have an increased chance of developing diabetes mellitus 5–10 years after pregnancy. Also, children born in GDM pregnancies face an increased risk for obesity and type 2 diabetes. The cornerstone for the management of GDM is glycemic control and quality nutritional intake. GDM management is complex in India, and existing challenges are multifactorial. However, there are little published data outlining these challenges. This review gives an account of some of the key challenges from self-management and health-care provider perspective. The recommendations in this review provide insights for building a more structured model for GDM care in India. This research has several practical applications. First, it points out to reaching a consensus on approaches for screening, diagnosis, and treatment of care across clinical practices in the nation that can aid in overcoming certain challenges observed. Second, it highlights the importance to build capacities and capabilities, especially in resource-limited settings. Health education among pregnant women remains a priority to resolve issues related to self-management. More broadly, further research, specifically qualitative is vital to determine forthcoming challenges with respect to patients, caregivers, providers, and policy makers and to provide solutions fitted to practice setting and demographic background. PMID:28392778

Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.

PubMed

Jha, Dilip; Gupta, Priti; Ajay, Vamadevan S; Jindal, Devraj; Perel, Pablo; Prieto-Merino, David; Jacob, Pramod; Nyong, Jonathan; Venugopal, Vidya; Singh, Kavita; Goenka, Shifalika; Roy, Ambuj; Tandon, Nikhil; Patel, Vikram; Prabhakaran, Dorairaj

2017-08-11

Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system. METHODS AND ANALYSIS: mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness. The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms. mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Hospital Guidelines for Diabetes Management and the Joint Commission-American Diabetes Association Inpatient Diabetes Certification.

PubMed

Arnold, Pamela; Scheurer, Danielle; Dake, Andrew W; Hedgpeth, Angela; Hutto, Amy; Colquitt, Caroline; Hermayer, Kathie L

2016-04-01

The Joint Commission Advanced Inpatient Diabetes Certification Program is founded on the American Diabetes Association's Clinical Practice Recommendations and is linked to the Joint Commission Standards. Diabetes currently affects 29.1 million people in the USA and another 86 million Americans are estimated to have pre-diabetes. On a daily basis at the Medical University of South Carolina (MUSC) Medical Center, there are approximately 130-150 inpatients with a diagnosis of diabetes. The program encompasses all service lines at MUSC. Some important features of the program include: a program champion or champion team, written blood glucose monitoring protocols, staff education in diabetes management, medical record identification of diabetes, a plan coordinating insulin and meal delivery, plans for treatment of hypoglycemia and hyperglycemia, data collection for incidence of hypoglycemia, and patient education on self-management of diabetes. The major clinical components to develop, implement, and evaluate an inpatient diabetes care program are: I. Program management, II. Delivering or facilitating clinical care, III. Supporting self-management, IV. Clinical information management and V. performance measurement. The standards receive guidance from a Disease-Specific Care Certification Advisory Committee, and the Standards and Survey Procedures Committee of the Joint Commission Board of Commissioners. The Joint Commission-ADA Advanced Inpatient Diabetes Certification represents a clinical program of excellence, improved processes of care, means to enhance contract negotiations with providers, ability to create an environment of teamwork, and heightened communication within the organization. Published by Elsevier Inc.

The ADDITION-Cambridge trial protocol: a cluster -- randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients.

PubMed

Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Williams, Kate M; Barling, Roslyn S; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

2009-05-12

The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, the benefits of such a strategy remain uncertain. The ADDITION-Cambridge study aims to evaluate the effectiveness and cost-effectiveness of (i) a stepwise screening strategy for type 2 diabetes; and (ii) intensive multifactorial treatment for people with screen-detected diabetes in primary care. 63 practices in the East Anglia region participated. Three undertook the pilot study, 33 were allocated to three groups: no screening (control), screening followed by intensive treatment (IT) and screening plus routine care (RC) in an unbalanced (1:3:3) randomisation. The remaining 27 practices were randomly allocated to IT and RC. A risk score incorporating routine practice data was used to identify people aged 40-69 years at high-risk of undiagnosed diabetes. In the screening practices, high-risk individuals were invited to take part in a stepwise screening programme. In the IT group, diabetes treatment is optimised through guidelines, target-led multifactorial treatment, audit, feedback, and academic detailing for practice teams, alongside provision of educational materials for newly diagnosed participants. Primary endpoints are modelled cardiovascular risk at one year, and cardiovascular mortality and morbidity at five years after diagnosis of diabetes. Secondary endpoints include all-cause mortality, development of renal and visual impairment, peripheral neuropathy, health service costs, self-reported quality of life, functional status and health utility. Impact of the screening programme at the population level is also assessed through measures of mortality, cardiovascular morbidity, health status and health service use among high-risk individuals. ADDITION-Cambridge is conducted in a defined high-risk group accessible through primary care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Current Controlled trials ISRCTN86769081.

The ADDITION-Cambridge trial protocol: a cluster – randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

PubMed Central

Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Williams, Kate M; Barling, Roslyn S; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

2009-01-01

Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, the benefits of such a strategy remain uncertain. Methods and design The ADDITION-Cambridge study aims to evaluate the effectiveness and cost-effectiveness of (i) a stepwise screening strategy for type 2 diabetes; and (ii) intensive multifactorial treatment for people with screen-detected diabetes in primary care. 63 practices in the East Anglia region participated. Three undertook the pilot study, 33 were allocated to three groups: no screening (control), screening followed by intensive treatment (IT) and screening plus routine care (RC) in an unbalanced (1:3:3) randomisation. The remaining 27 practices were randomly allocated to IT and RC. A risk score incorporating routine practice data was used to identify people aged 40–69 years at high-risk of undiagnosed diabetes. In the screening practices, high-risk individuals were invited to take part in a stepwise screening programme. In the IT group, diabetes treatment is optimised through guidelines, target-led multifactorial treatment, audit, feedback, and academic detailing for practice teams, alongside provision of educational materials for newly diagnosed participants. Primary endpoints are modelled cardiovascular risk at one year, and cardiovascular mortality and morbidity at five years after diagnosis of diabetes. Secondary endpoints include all-cause mortality, development of renal and visual impairment, peripheral neuropathy, health service costs, self-reported quality of life, functional status and health utility. Impact of the screening programme at the population level is also assessed through measures of mortality, cardiovascular morbidity, health status and health service use among high-risk individuals. Discussion ADDITION-Cambridge is conducted in a defined high-risk group accessible through primary care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration Current Controlled trials ISRCTN86769081 PMID:19435491

A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol.

PubMed

Bukhsh, Allah; Nawaz, Muhammad Sarfraz; Ahmed, Hafiz Sajjad; Khan, Tahir Mehmood

2018-03-01

Diabetes self-care activities, like, healthy diet, regular exercise, self-monitoring of blood glucose, and rational use of medicines are considered to play a vital role in establishing euglycemia. Health literacy among type 2 diabetes mellitus (T2DM) patients in Pakistan is very low, which is the most likely cause for poor clinical outcomes. This study is designed to investigate the impact of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among T2DM patients in Pakistan. In this randomized controlled trail, effectiveness of a 6-month pharmacist-led educational intervention will be examined on glycemic control, diabetes self-care activities and disease knowledge of 80 adult T2DM patients (age >30 years) with poorly controlled T2DM (HbA1c> 7%), after randomizing them into intervention and control groups, at diabetes care clinic of Capital Hospital Islamabad, Pakistan. The primary outcome is change in patients' HbA1c, whereas, changes in self-care activities and patients' disease knowledge are the secondary outcomes. After baseline assessment of their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively, interventional group patients will be supplemented with a face-to-face pharmacist-led educational intervention, whereas, the control group will receive usual care. Intervention arm patients will be educated successively at their first follow-up visit (12th week) and telephonically after every 4 weeks. All assessments will be made at baseline and end of trail for both intervention and control groups. Multivariate general linear model will be applied to analyze the effects of the intervention. Glycemic control in T2DM patients requires optimum self-care activities. This study is an attempt to improve self-care behaviors among poorly controlled T2DM patients who are at higher risk of diabetes-associated late complications.

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

PubMed

Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

2016-04-27

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers. Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual. ClinicalTrials.gov: NCT01714986.

Advances in generation of functional β-cells from induced pluripotent stem cells as a cure for diabetes mellitus.

PubMed

Kalra, Kunal; Chandrabose, Srijaya Thekkeparambil; Ramasamy, Thamil Selvee; Kasim, Noor Hayaty Binti Abu

2018-06-04

Diabetes mellitus is one of the leading cause for death worldwide. Loss and functional failure of pancreatic β-cells, the parenchyma cells in the islets of Langerhans onsets and progresses diabetes mellitus. The increasing incidence of this metabolic disorder necessitates efficient strategies to produce functional β-cells for treating diabetes mellitus. Human induced pluripotent stem cells (hiPSC), holds potential for treating diabetes owning to their self-renewal capacity and ability to differentiate into β-cells. iPSC technology also provides unlimited starting material to generate differentiated cells for regenerative applications. Progress has also been made in establishing in-vitro culture protocols to yield definitive endoderm, pancreatic endoderm progenitor cells and β-cells via different reprogramming strategies and growth factor supplementation. However, these generated β-cells are still immature, lack functional characteristics and exhibit lower capability in reversing the diseases conditions. Current methods employed to generate mature and functional β-cells include; use of small and large molecules to enhance the reprogramming and differentiation efficiency, 3D culture systems to improve the functional properties and heterogeneity of differentiated cells. This review details recent advancements in the generation of mature β-cells by reprogramming stem cells into iPSCs that is further programmed to β-cells. It also provides deeper insight of current reprogramming protocols and their efficacy, focusing on the underlying mechanism of chemical based approach to generate iPSCs. Furthermore, we have highlighted the recent differentiation strategies both in-vitro and in-vivo to date and the future prospects in generation of mature β-cells. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Persistence of Diabetes and Hypertension After Multimodal Treatment of Acromegaly.

PubMed

González, Baldomero; Vargas, Guadalupe; de Los Monteros, Ana Laura Espinosa; Mendoza, Victoria; Mercado, Moisés

2018-06-01

Diabetes and hypertension are frequent comorbidities of acromegaly. To analyze the course of diabetes and hypertension at diagnosis and after multimodal therapy in a large cohort of patients with acromegaly. Retrospective study at a tertiary care center. A total of 522 patients with acromegaly treated according to a preestablished protocol. Prevalence of diabetes and hypertension and its relationship with biochemical indices of acromegalic control. The cohort was stratified according to disease activity upon last visit to clinic: (1) surgical remission (n = 122), (2) pharmacologically controlled (n = 92), (3) active disease (n = 148), (4) insulinlike growth factor (IGF)-1 discordance (n = 64), and (5) growth hormone (GH) discordance (n = 96). The prevalence of diabetes and hypertension at diagnosis was 30% and 37%, respectively, and did not change upon the last visit (30.6% and 38%). Both comorbidities were more prevalent at diagnosis and on the last visit than in the general population. Diabetes was less prevalent on the last visit in patients who achieved surgical remission than in those who persisted with active disease (25% vs 40%, P = 0.01). Upon multivariate analysis, diabetes was associated with an IGF-1 at diagnosis >2× upper limit of normal, with the persistence of active acromegaly, the presence of hypertension upon the last visit, with the presence of a macroadenoma, and with female sex. Our findings underscore the importance of an integral approach when managing these patients, focusing not only on the control of GH and IGF-1 levels but also on the timely diagnosis and the specific treatment of each comorbidity.

Randomised, prospective, medico-economic nationwide French study of islet transplantation in patients with severely unstable type 1 diabetes: the STABILOT study protocol.

PubMed

Lablanche, Sandrine; David-Tchouda, Sandra; Margier, Jennifer; Schir, Edith; Wojtusciszyn, Anne; Borot, Sophie; Kessler, Laurence; Morelon, Emmanuel; Thivolet, Charles; Pattou, François; Vantyghem, Marie Christine; Berney, Thierry; Benhamou, Pierre-Yves

2017-02-20

Islet transplantation may be an appropriate treatment option for patients with severely unstable type 1 diabetes experiencing major glucose variability with severe hypoglycaemia despite intensive insulin therapy. Few data are available on the costs associated with islet transplantation in relation to its benefits. The STABILOT study proposes to assess the economic impact of islet transplantation in comparison with the current best medical treatment defined as sensor-augmented pump (SAP) therapy. The trial will adopt an open-label, randomised, multicentred design. The study will include 30 patients with severely unstable type 1 diabetes. Eligible participants will be 18-65 years old, with type 1 diabetes duration >5 years, a negative basal or stimulated C-peptide, and severe instability defined by persistent, recurrent and disabling severe hypoglycaemia, despite optimised medical treatment. Participants will be randomised into two groups: one group with immediate registration for islet transplantation, and one group with delayed registration for 1 year while patients receive SAP therapy. The primary endpoint will be the incremental cost-utility ratio at 1 year between islet transplantation and SAP therapy. Perspectives of both the French Health Insurance System and the hospitals will be retained. Ethical approval has been obtained at all sites. The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02854696). All participants will sign a free and informed consent form before randomisation. Results of the study will be communicated during national and international meetings in the field of diabetes and transplantation. A publication will be sought in journals usually read by physicians involved in diabetes care, transplantation and internal medicine. NCT02854696; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A fermented soy permeate improves the skeletal muscle glucose level without restoring the glycogen content in streptozotocin-induced diabetic rats.

PubMed

Malardé, Ludivine; Vincent, Sophie; Lefeuvre-Orfila, Luz; Efstathiou, Théo; Groussard, Carole; Gratas-Delamarche, Arlette

2013-02-01

Exercise is essential into the therapeutic management of diabetic patients, but their level of exercise tolerance is lowered due to alterations of glucose metabolism. As soy isoflavones have been shown to improve glucose metabolism, this study aimed to assess the effects of a dietary supplement containing soy isoflavones and alpha-galactooligosaccharides on muscular glucose, glycogen synthase (GSase), and glycogen content in a type 1 diabetic animal model. The dietary supplement tested was a patented compound, Fermented Soy Permeate (FSP), developed by the French Company Sojasun Technologies. Forty male Wistar rats were randomly assigned to control or diabetic groups (streptozotocin, 45 mg/kg). Each group was then divided into placebo or FSP-supplemented groups. Both groups received by oral gavage, respectively, water or diluted FSP (0.1 g/day), daily for a period of 3 weeks. At the end of the protocol, glycemia was noticed after a 24-h fasting period. Glucose, total GSase, and the glycogen content were determined in the skeletal muscle (gastrocnemius). Diabetic animals showed a higher blood glucose concentration, but a lower glucose and glycogen muscle content than controls. Three weeks of FSP consumption allowed to restore the muscle glucose concentration, but failed to reduce glycemia and to normalize the glycogen content in diabetic rats. Furthermore, the glycogen content was increased in FSP-supplemented controls compared to placebo controls. Our results demonstrated that diabetic rats exhibited a depleted muscle glycogen content (-25%). FSP-supplementation normalized the muscle glucose level without restoring the glycogen content in diabetic rats. However, it succeeded to increase it in the control group (+20%).

A study of red blood cell deformability in diabetic retinopathy using optical tweezers

NASA Astrophysics Data System (ADS)

Smart, Thomas J.; Richards, Christopher J.; Bhatnagar, Rhythm; Pavesio, Carlos; Agrawal, Rupesh; Jones, Philip H.

2015-08-01

Diabetic retinopathy (DR) is a microvascular complication of diabetes mellitus (DM) in which high blood sugar levels cause swelling, leaking and occlusions in the blood vessels of the retina, often resulting in a loss of sight. The microvascular system requires red blood cells (RBCs) to undergo significant cellular deformation in order to pass through vessels whose diameters are significantly smaller than their own. There is evidence to suggest that DM impairs the deformability of RBCs, and this loss of deformability has been associated with diabetic kidney disease (or nephropathy) - another microvascular complication of DM. However, it remains unclear whether reduced deformability of RBCs correlates with the presence of DR. Here we present an investigation into the deformability of RBCs in patients with diabetic retinopathy using optical tweezers. To extract a value for the deformability of RBCs we use a dual-trap optical tweezers set-up to stretch individual RBCs. RBCs are trapped directly (i.e. without micro-bead handles), so rotate to assume a `side-on' orientation. Video microscopy is used to record the deformation events, and shape analysis software is used to determine parameters such as initial and maximum RBC length, allowing us to calculate the deformability for each RBC. A small decrease in deformability of diabetes cells subject to this stretching protocol is observed when compared to control cells. We also report on initial results on three dimensional imaging of individual RBCs using defocussing microscopy.

Alleviation of streptozotocin-induced diabetes in nude mice by stem cells derived from human first trimester umbilical cord.

PubMed

Cao, M; Zhang, J B; Dong, D D; Mou, Y; Li, K; Fang, J; Wang, Z Y; Chen, C; Zhao, J; Yie, S M

2015-10-16

Cells isolated from human first trimester umbilical cord perivascular layer (hFTM-PV) tissues display the pluripotent characteristics of stem cells. In this study, we examined whether hFTM-PV cells can differentiate into islet-like clusters (ILCs) in vitro, and whether transplantation of the hFTM-PV cells with and without differentiation in vitro can alleviate diabetes in nude mice. The hFTM-PV cells were differentiated into ILCs in vitro through a simple stepwise culture protocol. To examine the in vivo effects of the cells, the hFTM-PV cells with and without differentiation in vitro were transplanted into the abdominal cavity of nude mice with streptozotocin (STZ)-induced diabetes. Blood glucose levels, body weight, and the survival probability of the diabetic nude mice were then statistically analyzed. The hFTM-PV cells were successfully induced into ILCs that could release insulin in response to elevated concentrations of glucose in vitro. In transplantation experiments, we observed that mice transplanted with the undifferentiated hFTM-PV cells, embryonic body-like cell aggregations, or ILCs all demonstrated normalized hyperglycemia and showed improved survival rate compared with those without cell transplantation. The hFTM-PV cells have the ability to differentiate into ILCs in vitro and transplantations of undifferentiated and differentiated cells can alleviate STZ-induced diabetes in nude mice. This may offer a potential cell source for stem cell-based therapy for treating diabetes in the future.

Rates and drivers of progression to pre-diabetes and diabetes mellitus among HIV-infected adults on antiretroviral therapy: a global systematic review and meta-analysis protocol.

PubMed

Nansseu, Jobert Richie N; Bigna, Jean Joel R; Kaze, Arnaud D; Noubiap, Jean Jacques N

2016-09-15

With the new 'test and treat' policy of the WHO, it is obvious that the number of HIV-infected patients taking antiretroviral therapy (ART) will grow exponentially, with consequential increase in the burden of diabetes mellitus (DM). Our aim is to summarise existing data on the incidence of pre-diabetes and DM, and associated risk factors among HIV-infected adults. This systematic review will include cohort studies reporting the incidence of pre-diabetes and/or DM, and associated risk factors among HIV-infected adults on ART, with these patients being free of any impaired glucose metabolism at study baseline. We will perform electronic searches in PubMed, Excerpta Medica Database (EMBASE), Web of Science and WHO Global Health Library, supplemented with manual searches. Articles published from 1 January 2000 to 31 July 2016, in English or French languages, and without any geographical restriction will be eligible for inclusion. 3 authors will independently screen, select studies, extract data and assess the risk of bias with discrepancies resolved by consensus. We will assess clinical heterogeneity by examining the study design and setting, criteria and cut-offs used to define pre-diabetes or DM, process of calculation of incidence and outcomes in each study. We will also assess statistical heterogeneity using the χ(2) test of homogeneity and quantify it using the I(2) statistic. A random effects meta-analysis will be used to estimate the overall cumulative incidence of pre-diabetes/DM and risk factors. This systematic review will use data from published studies and does not require ethics approval. Its results are expected to help putting in place action plans and preventive measures to curb the growing burden of DM in the HIV population on ART. Findings will be published in a peer-reviewed journal and presented at scientific conferences. CRD42016039651. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Conventional insulin vs insulin infusion therapy in acute coronary syndrome diabetic patients

PubMed Central

Arvia, Caterina; Siciliano, Valeria; Chatzianagnostou, Kyriazoula; Laws, Gillian; Quinones Galvan, Alfredo; Mammini, Chiara; Berti, Sergio; Molinaro, Sabrina; Iervasi, Giorgio

2014-01-01

AIM: To evaluate the impact on glucose variability (GLUCV) of an nurse-implemented insulin infusion protocol when compared with a conventional insulin treatment during the day-to-day clinical activity. METHODS: We enrolled 44 type 2 diabetic patients (n = 32 males; n = 12 females) with acute coronary syndrome (ACS) and randomy assigned to standard a subcutaneous insulin treatment (n = 23) or a nurse-implemented continuous intravenous insulin infusion protocol (n = 21). We utilized some parameters of GLUCV representing well-known surrogate markers of prognosis, i.e., glucose standard deviation (SD), the mean daily δ glucose (mean of daily difference between maximum and minimum glucose), and the coefficient of variation (CV) of glucose, expressed as percent glucose (SD)/glucose (mean). RESULTS: At the admission, first fasting blood glucose, pharmacological treatments (insulin and/or anti-diabetic drugs) prior to entering the study and basal glycated hemoglobin (HbA1c) were observed in the two groups treated with subcutaneous or intravenous insulin infusion, respectively. When compared with patients submitted to standard therapy, insulin-infused patients showed both increased first 24-h (median 6.9 mmol/L vs 5.7 mmol/L P < 0.045) and overall hospitalization δ glucose (median 10.9 mmol/L vs 9.3 mmol/L, P < 0.028), with a tendency to a significant increase in first 24-h glycaemic CV (23.1% vs 19.6%, P < 0.053). Severe hypoglycaemia was rare (14.3%), and it was observed only in 3 patients receiving insulin infusion therapy. HbA1c values measured during hospitalization and 3 mo after discharge did not differ in the two groups of treatment. CONCLUSION: Our pilot data suggest that no real benefit in terms of GLUCV is observed when routinely managing blood glucose by insulin infusion therapy in type 2 diabetic ACS hospitalized patients in respect to conventional insulin treatment PMID:25126402

DIAGNOSING AND MONITORING ENDOCRINE DYSFUNCTION, DIABETES, AND OBESITY IN A COHORT OF ADULT SURVIVORS OF CHILDHOOD CANCER.

PubMed

Hudspeth, Victoria Rollins; Gold, Stuart Harrison; Clemmons, David Robert

2017-12-01

The 5-year survival rate for childhood cancer has increased to 80%, resulting in a growing population of adult survivors of childhood cancer (ASOCC). Long-term endocrine dysfunction is as high as 63% when screened in research protocols. The purpose of this study was to evaluate the prevalence of endocrine testing, endocrine dysfunction, diabetes, obesity, and endocrinologist visits outside of a research screening protocol. A retrospective chart review was performed for 176 ASOCC who were diagnosed with cancer before age 18, followed at least 10 years, were now at least 18, and had survived to the time of chart review. After a mean follow-up of 15.2 years (range 10-21 years), 33.5% of ASOCC had endocrine dysfunction, excluding obesity and diabetes. These outcomes were more common in those with any radiation (64.8%, P<.0001) or cranial radiation (73.1%, P<.0001). Many subjects had never had certain endocrine tests. Over half (54.6%) of subjects were either overweight or obese. Glycated hemoglobin A1C (A1C) testing was rare, but when performed, 38.1% were abnormal. 71% of subjects had never seen an endocrinologist. Even among subjects with cranial radiation, 65.4% had either never seen an endocrinologist or had not seen one in the past 5 years. This cohort of ASOCC showed high rates of endocrine dysfunction, overweight or obesity, and diabetes in those who had been tested, combined with low rates of testing and endocrinology evaluation. Endocrinologists need to be aware of the endocrine risks in ASOCC, the need for long-term monitoring, and increase their collaboration with oncology. A1C = glycated hemoglobin A1C ASOCC = adult survivors of childhood cancer BMI = body mass index COG = Children's Oncology Group EMR = electronic medical record FSH = follicle-stimulating hormone IGF-1 = insulin-like growth factor 1 LH = luteinizing hormone TSH = thyroid-stimulating hormone.

Effectiveness of resistance exercise compared to aerobic exercise without insulin therapy in patients with type 2 diabetes mellitus: a meta-analysis.

PubMed

Nery, Cybelle; Moraes, Silvia Regina Arruda De; Novaes, Karyne Albino; Bezerra, Márcio Almeida; Silveira, Patrícia Verçoza De Castro; Lemos, Andrea

Physical exercise has been used to mitigate the metabolic effects of diabetes mellitus. To evaluate the effect of resistance exercise when compared to aerobic exercise without insulin therapy on metabolic and clinical outcomes in patients with type 2 diabetes mellitus. Papers were searched on the databases MEDLINE/PubMed, CINAHL, SPORTDiscus, LILACS, and SCIELO, without language or date of publication limits. Clinical trials that compared resistance exercise to aerobic exercise in adults with type 2 diabetes mellitus who did not use insulin therapy were included. The quality of evidence and risk of bias were assessed using the GRADE system and the Cochrane Risk of Bias tool, respectively. Meta-analysis was also used, whenever possible. Two reviewers extracted the data independently. Eight eligible articles were included in this study, with a total of 336 individuals, with a mean age of 48-58 years. The protocols of aerobic and resistance exercise varied in duration from eight to 22 weeks, 30-60min/day, three to five times/week. Overall the available evidence came from a very low quality of evidence and there was an increase in Maximal oxygen consumption (mean difference: -2.86; 95% CI: -3.90 to -1.81; random effect) for the resistance exercise and no difference was found in Glycated hemoglobin, Body mass index, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, triglycerides, and total cholesterol. Resistance exercise appears to be more effective in promoting an increase in Maximal oxygen consumption in protocols longer than 12 weeks and there is no difference in the control of glycemic and lipid levels between the two types of exercise. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Management of diabetes in Morocco: results of the International Diabetes Management Practices Study (IDMPS) – wave 5

PubMed Central

Chadli, Asmae; El Aziz, Siham; El Ansari, Nawal; Ajdi, Farida; Seqat, Mehdi; Latrech, Hanane; Belmejdoub, Ghizlaine

2016-01-01

Objectives: The International Diabetes Mellitus Practice Study (IDMPS) is a 5-year survey documenting changes in diabetes treatment practices in developing countries. The primary objective of this survey was to assess the therapeutic management of type 2 diabetes mellitus (T2DM) in real-life medical practice. The secondary objectives were to evaluate the clinical management of type 1 diabetes mellitus (T1DM) and to assess the proportion of all diabetic patients failing to reach the glycated haemoglobin (HbA1c) <7% target. Methods: Data were analysed for 738 patients (240 with T1DM and 498 with T2DM) included in wave 5 of the IDMPS in Morocco in 2011. Results: Nearly two-thirds (61%) of T2DM patients were treated with oral glucose-lowering drugs (OGLDs) alone, 13.1% were treated with insulin alone and 23.3% were treated with OGLDs plus insulin. Insulin use was less frequent, was initiated later and involved a greater use of premixes versus basal/prandial schedules compared to other populations evaluated in the IDMPS. The majority (92.5%) of T1DM patients were treated with insulin alone and the remainder received insulin plus an OGLD. Insulin protocols included basal + prandial dosing (37.5%) and premix preparations (41.3%). The recommended target of HbA1c <7% was achieved by only 22.2% of T1DM patients and 26.8% of T2DM patients. More macrovascular but fewer microvascular complications were reported in T2DM compared to T1DM patients. Late complications increased with disease duration so that 20 years after diagnosis, 75.7% of T2DM patients were found to have at least one late complication. Conclusions: The clinical burden of diabetes is high in Morocco and the majority of patients do not achieve the recommended glycaemia target, suggesting that there is a huge gap between evidence-based diabetic management and real-life practice. Better education of patients and improved compliance with international recommendations are necessary to deliver a better quality of diabetic care. PMID:27293539

Web-Based Remote Monitoring Systems for Self-Managing Type 2 Diabetes: A Systematic Review.

PubMed

Mushcab, Hayat; Kernohan, W George; Wallace, Jonathan; Martin, Suzanne

2015-07-01

This systematic review aims to evaluate evidence for viability and impact of Web-based telemonitoring for managing type 2 diabetes mellitus. A review protocol included searching Medline, EMBASE, CINAHL, AMED, the Cochrane Library, and PubMed using the following terms: telemonitoring, type 2 diabetes mellitus, self-management, and web-based Internet solutions. The technology used, trial design, quality of life measures, and the glycated hemoglobin (HbA1c) levels were extracted. This review identified 426 publications; of these, 19 met preset inclusion criteria. Ten quasi-experimental research designs were found, of which seven were pre-posttest studies, two were cohort studies, and one was an interrupted time-series study; in addition, there were nine randomized controlled trials. Web-based remote monitoring from home to hospital is a viable approach for healthcare delivery and enhances patients' quality of life. Six of these studies were conducted in South Korea, five in the United States, three in the United Kingdom, two in Taiwan, and one each in Spain, Poland, and India. The duration of the studies varied from 4 weeks to 18 months, and the participants were all adults. Fifteen studies showed positive improvement in HbA1c levels. One study showed high acceptance of the technology among participants. It remains challenging to identify clear evidence of effectiveness in the rapidly changing area of remote monitoring in diabetes care. Both the technology and its implementations are complex. The optimal design of a telemedicine system is still uncertain, and the value of the real-time blood glucose transmissions is still controversial.

C-peptide does not affect ocular blood flow in patients with type 1 diabetes.

PubMed

Polska, Elzbieta; Kolodjaschna, Julia; Berisha, Fatmire; Malec, Maria M; Simader, Christian; Bayerle-Eder, Michaela; Roden, Michael; Schmetterer, Leopold

2006-09-01

The aim of the present study was to investigate the effect of intravenous C-peptide infusion on ocular blood flow in patients with type 1 diabetes under euglycemic conditions. The study was performed in a randomized, placebo-controlled, double-masked, two-way, crossover design in 10 type 1 diabetic patients. C-peptide was intravenously administered at two different dosages (dosage 1: 25 pmol . kg(-1) . min(-1) bolus followed by 5 pmol . kg(-1) . min(-1) continuous infusion; dosage 2: six times higher than dosage 1), each for 60 min. Physiologic saline solution was used as a control for C-peptide on a different study day. On both study days, euglycemic clamps were performed. To assess retinal blood flow, laser Doppler velocimetry (blood flow velocities) and retinal vessel analyzer (vessels diameters) measurements were performed. Laser interferometric measurements of fundus pulsation were used to assess pulsatile choroidal blood flow. Blood velocities in the ophthalmic artery were measured using color Doppler imaging. Eight patients (two female and six male) completed the study according to the protocol and without adverse events. One patient developed an anaphylactic reaction to C-peptide, which resolved without sequelae. The following results originate from the remaining eight subjects. Systemic hemodynamic parameters remained stable during both study days. Infusion of C-peptide did not affect any ocular hemodynamic parameter. The data of the present study indicate that exogenous C-peptide exerts no effect on ocular hemodynamic parameters in type 1 diabetic patients under euglycemic conditions. The maximum detectable change in these parameters was <25%.

Does co-morbid depression impact diabetes related costs? Evidence from a cross-sectional survey in a low-income country.

PubMed

Chereches, Răzvan M; Litan, Cristian M; Zlati, Alina M; Bloom, Joan R

2012-09-01

The economic implications of co-morbid depression in patients with chronic medical disorders have been studied mainly in high-income countries. However, the applicability of such findings in developing countries cannot be assumed. In the present study we estimate diabetes related costs and explore the link between depression and diabetes related costs in Romania. In this former communist country, the general perception of practitioners and policy-makers is that psychological issues are far less important than medical concerns for patients with diabetes, a perception that may lead to the misallocation of already scarce resources. Data related to costs of diabetes care and to co-morbid depression were collected from a sample of 1,171 diabetes patients at the Nutrition and Diabetes Center in Cluj-Napoca, Romania, using the Diabetes Costs Questionnaire (DCQ) and the Patient Health Questionnaire 9 (PHQ9). The gathered data were subjected to a bivariate analysis of the depression-cost relationship, as well as a regression analysis in order to isolate the effect of depression on diabetes related costs from the effect of covariates. Direct and indirect diabetes related costs equally contributed to the total costs. The repartition of the cost burden between the public system and private agents is nearly equal as well. The bivariate analysis of the depression-cost relationship reveals statistically significant larger diabetes related costs for patients with major depression than for patients with minor depression, and the latter have larger diabetes related costs than patients free of depression symptoms. When the pure effect of depression on diabetes related costs was isolated by means of regression techniques, the provisional diagnosis of major depression was found to significantly increase diabetes related costs. The equal distribution of diabetes related costs between direct and indirect measures, as well as the cost burden equally split between the public system and private agents can be explained by the costs of medication and the costs associated with time lost by the non-compensated caregivers. Consistent with Romanian cultural traditions, most of the patients rely on their relatives in an informal diabetes caregiving market for assistance. Alongside depression, the multivariate analysis revealed that factors such as Hungarian ethnicity, income, and number of years since diagnosis also significantly contribute to diabetes related costs. Findings that depression increases diabetes related costs bear potential implications for health policies and health care provision (i.e., the effect of depression on costs can be minimized by adequate recognition and treatment). As such, screening and treatment of co-occurring depression in diabetes patients should become part of the diabetes treatment protocol, not only in Romania but in other Central and Eastern European countries as well.

Serum bilirubin levels are negatively associated with diabetic retinopathy in patients with type 1 diabetes and normal renal function.

PubMed

Bulum, Tomislav; Tomić, Martina; Duvnjak, Lea

2018-06-01

Previous studies suggested that total serum bilirubin levels are negatively associated with diabetic retinopathy (DR) and nephropathy in patients with diabetes mellitus. The objective of this study was to explore the relationship between serum total bilirubin levels and prevalence of DR in patients with type 1 diabetes (T1DM) and normal renal function. Study included 163 T1DM with normal renal function (urinary albumin excretion rate <30 mg/24 h, estimated glomerular filtration rate (eGFR) >60 ml min -1 1.73 m -2 ). Photo-documented retinopathy status was made according to the EURODIAB protocol. Patients with DR were older (49 vs 42 years, p = 0.001), had higher systolic blood pressure (130 vs 120 mmHg, p = 0.001), triglycerides (0.89 vs 0.77 mmol/L, p = 0.01), and lower serum total bilirubin (12 vs 15 U/L, p = 0.02) and eGFR (100 vs 106 ml min -1 1.73 m -2 , p = 0.03). In multivariate logistic regression analysis, only total serum bilirubin was significantly associated with risk of DR in our subjects (OR 0.88, CI 0.81-0.96, p = 0.006). These data suggest that serum total bilirubin levels are independently negatively associated with DR in T1DM with normal renal function. Prospective studies are needed to confirm whether lower serum total bilirubin has predictive value for the development of DR in T1DM with normal renal function.

Efficacy and effectiveness of screen and treat policies in prevention of type 2 diabetes: systematic review and meta-analysis of screening tests and interventions.

PubMed

Barry, Eleanor; Roberts, Samantha; Oke, Jason; Vijayaraghavan, Shanti; Normansell, Rebecca; Greenhalgh, Trisha

2017-01-04

 To assess diagnostic accuracy of screening tests for pre-diabetes and efficacy of interventions (lifestyle or metformin) in preventing onset of type 2 diabetes in people with pre-diabetes.  Systematic review and meta-analysis.  Medline, PreMedline, and Embase. Study protocols and seminal papers were citation-tracked in Google Scholar to identify definitive trials and additional publications. Data on study design, methods, and findings were extracted onto Excel spreadsheets; a 20% sample was checked by a second researcher. Data extracted for screening tests included diagnostic accuracy and population prevalence. Two meta-analyses were performed, one summarising accuracy of screening tests (with the oral glucose tolerance test as the standard) for identification of pre-diabetes, and the other assessing relative risk of progression to type 2 diabetes after either lifestyle intervention or treatment with metformin.  Empirical studies evaluating accuracy of tests for identification of pre-diabetes. Interventions (randomised trials and interventional studies) with a control group in people identified through screening. No language restrictions.  2874 titles were scanned and 148 papers (covering 138 studies) reviewed in full. The final analysis included 49 studies of screening tests (five of which were prevalence studies) and 50 intervention trials. HbA 1c had a mean sensitivity of 0.49 (95% confidence interval 0.40 to 0.58) and specificity of 0.79 (0.73 to 0.84), for identification of pre-diabetes, though different studies used different cut-off values. Fasting plasma glucose had a mean sensitivity of 0.25 (0.19 to 0.32) and specificity of 0.94 (0.92 to 0.96). Different measures of glycaemic abnormality identified different subpopulations (for example, 47% : of people with abnormal HbA 1c had no other glycaemic abnormality). Lifestyle interventions were associated with a 36% (28% to 43%) reduction in relative risk of type 2 diabetes over six months to six years, attenuating to 20% (8% to 31%) at follow-up in the period after the trails.  HbA 1c is neither sensitive nor specific for detecting pre-diabetes; fasting glucose is specific but not sensitive. Interventions in people classified through screening as having pre-diabetes have some efficacy in preventing or delaying onset of type 2 diabetes in trial populations. As screening is inaccurate, many people will receives an incorrect diagnosis and be referred on for interventions while others will be falsely reassured and not offered the intervention. These findings suggest that "screen and treat" policies alone are unlikely to have substantial impact on the worsening epidemic of type 2 diabetes.  PROSPERO (No CRD42016042920). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol.

PubMed

Gimbel, Ronald; Shi, Lu; Williams, Joel E; Dye, Cheryl J; Chen, Liwei; Crawford, Paul; Shry, Eric A; Griffin, Sarah F; Jones, Karyn O; Sherrill, Windsor W; Truong, Khoa; Little, Jeanette R; Edwards, Karen W; Hing, Marie; Moss, Jennie B

2017-03-06

The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei). ©Ronald Gimbel, Lu Shi, Joel E Williams, Cheryl J Dye, Liwei Chen, Paul Crawford, Eric A Shry, Sarah F Griffin, Karyn O Jones, Windsor W Sherrill, Khoa Truong, Jeanette R Little, Karen W Edwards, Marie Hing, Jennie B Moss. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2017.

Enhancing the effectiveness of diabetes self-management education: the diabetes literacy project.

PubMed

Van den Broucke, S; Van der Zanden, G; Chang, P; Doyle, G; Levin, D; Pelikan, J; Schillinger, D; Schwarz, P; Sørensen, K; Yardley, L; Riemenschneider, H

2014-12-01

Patient empowerment through self-management education is central to improving the quality of diabetes care and preventing Type 2 Diabetes. Although national programs exist, there is no EU-wide strategy for diabetes self-management education, and patients with limited literacy face barriers to effective self-management. The Diabetes Literacy project, initiated with the support of the European Commission, aims to fill this gap. The project investigates the effectiveness of diabetes self-management education, targeting people with or at risk of Type 2 Diabetes in the 28 EU Member States, as part of a comprehensive EU-wide diabetes strategy. National diabetes strategies in the EU, US, Taiwan, and Israel are compared, and diabetes self-management programs inventorized. The costs of the diabetes care pathway are assessed on a per person basis at national level. A comparison is made of the (cost)-effectiveness of different methods for diabetes self-management support, and the moderating role of health literacy, organization of the health services, and implementation fidelity of education programs are considered. Web-based materials are developed and evaluated by randomized trials to evaluate if interactive internet delivery can enhance self-management support for people with lower levels of health literacy. The 3-year project started in December 2012. Several literature reviews have been produced and protocol development and research design are in the final stages. Primary and secondary data collection and analysis take place in 2014. The results will inform policy decisions on improving the prevention, treatment, and care for persons with diabetes across literacy levels. © Georg Thieme Verlag KG Stuttgart · New York.

Blood glucose self-monitoring patterns in Mexican Americans: further lessons from the Starr County Border Health Initiative.

PubMed

Cuevas, Heather E; Brown, Sharon A; García, Alexandra A; Winter, Mary; Brown, Adama; Hanis, Craig L

2015-02-01

The purpose was to describe patterns of home self-monitoring of blood glucose (SMBG) in Mexican Americans with type 2 diabetes mellitus enrolled in a diabetes self-management education protocol. Research questions were as follows: (1) What were the patterns and rates of home glucose self-monitoring over the 6-month course of the study? (2) What were the differences in monitoring rates between experimental and control groups? (3) What were the relationships between rates of monitoring and glycosylated hemoglobin (A1C), gender, and years with diabetes? We used a randomized (by group) repeated-measures pretest/posttest control group design. Glucometer data from an experimental group (diabetes self-management education plus nurse case management) and a comparison group (diabetes self-management education only) were analyzed. Data were collected at baseline and at 3 and 6 months. Overall average SMBG rates were low. Experimental and control group monitoring levels were not significantly different. More females than males never monitored glucose values, but more females than males checked at least one time per week. Those participants who checked their glucose levels more than once per week had diabetes for a longer period of time. Rates of monitoring were not strongly associated with A1C levels at 3 and 6 months, but at 6 months A1C levels were statistically significantly different based on whether or not individuals monitored their glucose levels (P=0.03, n=71). SMBG rates were low in this study despite SMBG education and access to free glucometers and test strips. The lower rates of SMBG may reflect the effects of unexpected environmental challenges, but exact causes remain unclear. Reasons for low rates of SMBG need to be explored further, especially in underserved communities.

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Palacios, Talia; Vitetta, Luis; Coulson, Samantha; Madigan, Claire D; Denyer, Gareth S; Caterson, Ian D

2017-01-09

Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus. Sixty adults with a body mass index ≥25 kg/m 2 with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment. Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications. Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013.

Inter-arm blood pressure difference in type 2 diabetes: a barrier to effective management?

PubMed

Clark, Christopher E; Greaves, Colin J; Evans, Philip H; Dickens, Andy; Campbell, John L

2009-06-01

Previous studies have identified a substantial prevalence of a blood pressure difference between arms in various populations, but not patients with type 2 diabetes. Recognition of such a difference would be important as a potential cause of underestimation of blood pressure. To measure prevalence of an inter-arm blood pressure difference in patients with type 2 diabetes, and to estimate how frequently blood pressure measurements could be erroneously underestimated if an inter-arm difference is unrecognised. Cross-sectional study. Five surgeries covered by three general practices, Devon, England. Patients with type 2 diabetes underwent bilateral simultaneous blood pressure measurements using a validated protocol. Mean blood pressures were calculated for each arm to derive mean systolic and diastolic differences, and to estimate point prevalence of predefined magnitudes of difference. A total of 101 participants were recruited. Mean age was 66 years (standard deviation [SD] = 13.9 years); 59% were male, and mean blood pressure was 138/79 mmHg (SD = 15/10 mmHg). Ten participants (10%; 95% confidence interval [CI] = 4 to 16) had a systolic inter-arm difference > or =10 mmHg; 29 (29%; 95% CI = 20 to 38) had a diastolic difference >/=5 mmHg; and three (3%; 95% CI = 0 to 6) a diastolic difference > or =10 mmHg. No confounding variable was observed to account for the magnitude of an inter-arm difference. A systolic inter-arm difference > or =10 mmHg was observed in 10% of patients with diabetes. Failure to recognise this would misclassify half of these as normotensive rather than hypertensive using the lower-reading arm. New patients with type 2 diabetes should be screened for an inter-arm blood pressure difference.

An observational 7-year study of continuous subcutaneous insulin infusion for the treatment of type 1 diabetes mellitus.

PubMed

Papargyri, Panagiota; Ojeda Rodríguez, Sylvie; Corrales Hernández, Juan José; Mories Álvarez, María Teresa; Recio Córdova, José María; Delgado Gómez, Manuel; Sánchez Marcos, Ana Isabel; Iglesias López, Rosa Ana; Herrero Ruiz, Ana; Beaulieu Oriol, Myriam; Miralles García, José Manuel

2014-03-01

This work reports the experience with use of continuous subcutaneous insulin infusion (CSII) in 112 type 1 diabetic patients followed up for 7 years and previously treated with multiple daily insulin injections (MDII). A retrospective, observational study in 112 patients with diabetes mellitus treated with CSII from 2005 to 2012, previously treated with MDII and receiving individualized diabetic education with a specific protocol. Variables analyzed included: prevalence of the different indications of pump treatment; mean annual HbA1c and fructosamine values before and after CSII treatment; and hypoglycemia frequency and symptoms. The most common reason for pump treatment was brittle diabetes (74.1%), followed by frequent or severe hypoglycemia or hypoglycemia unawareness (44.6%). Other indications were irregular food intake times for professional reasons (20.2%), dawn phenomenon (15.7%), pregnancy (12.3%), requirement of very low insulin doses (8.9%), and gestational diabetes (0.9%). HbA1c decreased by between 0.6% and 0.9%, and fructosamine by between 5.1% and 12.26%. Nine percent of patients experienced hypoglycemia weekly, 24% every two weeks, and 48% monthly. No hypoglycemia occurred in 19% of patients. Only 10% had neuroglycopenic symptoms. Hypoglycemia unawareness was found in 21%. Hypoglycemia was more common at treatment start, and its frequency rapidly decreased thereafter. CSII therapy provides a better glycemic control than MDII treatment. Specific patient training and fine adjustment of insulin infusion doses are required to prevent hypoglycemic episodes, which are the most common complications, mainly at the start of treatment. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

Is there a role for HbA1c in predicting mortality and morbidity outcomes after coronary artery bypass graft surgery?

PubMed Central

Tennyson, Charlene; Lee, Rebecca; Attia, Rizwan

2013-01-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was is there a role for HbA1c in predicting morbidity and mortality outcomes after coronary artery bypass surgery? Eleven studies presented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The studies presented analyse the relationship between preoperative HbA1c levels and postoperative outcomes following coronary artery bypass graft (CABG) in diabetic, non-diabetic or mixed patient groups. Four studies found significant increases in early and late mortality at higher HbA1c levels, regardless of a preoperative diagnosis of diabetes. One study demonstrated that 30-day survival outcomes were significantly worse in patients with previously undiagnosed diabetes and elevated HbA1c compared with those with good control [HbA1c >6%; odds ratio 1.53, confidence interval (CI) (1.24–1.91); P = 0.0005]. However, four studies of early mortality outcomes in diabetic patients only showed no significant differences between patients with normal and those with deranged HbA1c levels (P = 0.99). There were mixed reports on morbidity outcomes. Three studies identified a significant increase in infectious complications in patients with poorly controlled HbA1c, two of which were irrespective of previous diabetic status [deep sternal wound infection (P = 0.014); superficial sternal wound infection (P = 0.007) and minor infections (P = 0.006) in poorly controlled diabetics only]. Four studies presented outcomes for total length of stay (LOS). Three of these papers looked specifically at diabetic patients, of which two found no significant differences in length of stay between good and poor preoperative glycaemic control [LOS: P = 0.59 and 0.86 vs P < 0.001]. However, elevated HbA1c vs normal HbA1c was associated with prolonged stay in hospital and in intensive care unit (ICU) in patients irrespective of previous diabetic status [total LOS (P < 0.001)]. Elevated HbA1c levels were also a significant predictor of reduced intraoperative insulin sensitivity in diabetic patients (R = −0.527; P < 0.001). Furthermore, higher HbA1c levels were associated with a reduced incidence of postoperative atrial fibrillation (P = 0.001). We conclude that elevated HbA1c is a strong predictor of mortality and morbidity irrespective of previous diabetic status. In particular, the mortality risk for CABG is quadrupled at HbA1c levels >8.6%. Some studies have called into question the predictive value of HbA1c on short-term outcomes in well-controlled diabetics; however, long-term outcomes in this population have not been reported. PMID:24021615

Early alteration of kidney function in nonuremic type 1 diabetic islet transplant recipients under tacrolimus-mycophenolate therapy.

PubMed

Gillard, Pieter; Rustandi, Maria; Efendi, Achmad; Lee, Da Hae; Ling, Zhidong; Hilbrands, Robert; Kuypers, Dirk; Mathieu, Chantal; Jacobs-Tulleneers-Thevissen, Daniel; Gorus, Frans; Pipeleers, Daniel; Keymeulen, Bart

2014-08-27

Transplant patients on tacrolimus therapy exhibit a reduced glomerular filtration rate (GFR). The type of graft and immune treatment protocol may influence the extent and reversibility of this side effect. The present single-center study is conducted in 48 nonuremic type 1 diabetic recipients of an intraportal islet-cell graft under maintenance immunosuppression (IS) with tacrolimus and mycophenolate mofetil. Estimated GFR (eGFR) and albuminuria were followed up to 5 years posttransplantation. Mean eGFR values decreased by 19 mL/min/1.73 m after 1 to 2 weeks of IS (P<0.0001) and then remained stable throughout the complete treatment period. The decrease was related to predose trough tacrolimus concentrations or doses and disappeared upon its discontinuation; it was also associated with the presence of albuminuria at the time of transplantation. Tacrolimus treatment resulted in a reduction of albuminuria; its discontinuation restored albuminuria to the initial levels. The use of tacrolimus in our islet-cell transplant protocol caused an initial 20% reduction in eGFR, which was reversible following its discontinuation, at least within the 5-year follow-up period. The associated reduction in albuminuria was also reversible, compatible with a tacrolimus-induced preglomerular vasoconstriction. These observations support further use of our tacrolimus regimen in this patient population.

Generation of insulin-producing cells from human bone marrow-derived mesenchymal stem cells: comparison of three differentiation protocols.

PubMed

Gabr, Mahmoud M; Zakaria, Mahmoud M; Refaie, Ayman F; Khater, Sherry M; Ashamallah, Sylvia A; Ismail, Amani M; El-Badri, Nagwa; Ghoneim, Mohamed A

2014-01-01

Many protocols were utilized for directed differentiation of mesenchymal stem cells (MSCs) to form insulin-producing cells (IPCs). We compared the relative efficiency of three differentiation protocols. Human bone marrow-derived MSCs (HBM-MSCs) were obtained from three insulin-dependent type 2 diabetic patients. Differentiation into IPCs was carried out by three protocols: conophylline-based (one-step protocol), trichostatin-A-based (two-step protocol), and β -mercaptoethanol-based (three-step protocol). At the end of differentiation, cells were evaluated by immunolabeling for insulin production, expression of pancreatic endocrine genes, and release of insulin and c-peptide in response to increasing glucose concentrations. By immunolabeling, the proportion of generated IPCs was modest ( ≃ 3%) in all the three protocols. All relevant pancreatic endocrine genes, insulin, glucagon, and somatostatin, were expressed. There was a stepwise increase in insulin and c-peptide release in response to glucose challenge, but the released amounts were low when compared with those of pancreatic islets. The yield of functional IPCs following directed differentiation of HBM-MSCs was modest and was comparable among the three tested protocols. Protocols for directed differentiation of MSCs need further optimization in order to be clinically meaningful. To this end, addition of an extracellular matrix and/or a suitable template should be attempted.

Effect of low-level light therapy on diabetic foot ulcers: a near-infrared spectroscopy study

NASA Astrophysics Data System (ADS)

Salvi, Massimo; Rimini, Daniele; Molinari, Filippo; Bestente, Gianni; Bruno, Alberto

2017-03-01

Diabetic foot ulcer (DFU) is a diabetic complication due to peripheral vasculopathy and neuropathy. A promising technology for wound healing in DFU is low-level light therapy (LLLT). Despite several studies showing positive effects of LLLT on DFU, LLLT's physiological effects have not yet been studied. The objective of this study was to investigate vascular and nervous systems modification in DFU after LLLT. Two samples of 45 DFU patients and 11 healthy controls (HCs) were recruited. The total hemoglobin (totHb) concentration change was monitored before and after LLLT by near-infrared spectroscopy and analyzed in time and frequency domains. The spectral power of the totHb changes in the very-low frequency (VLF, 20 to 60 mHz) and low frequency (LF, 60 to 140 mHz) bandwidths was calculated. Data analysis revealed a mean increase of totHb concentration after LLLT in DFU patients, but not in HC. VLF/LF ratio decreased significantly after the LLLT period in DFU patients (indicating an increased activity of the autonomic nervous system), but not in HC. Eventually, different treatment intensities in LLLT therapy showed a different response in DFU. Overall, our results demonstrate that LLLT improves blood flow and autonomic nervous system regulation in DFU and the importance of light intensity in therapeutic protocols.

Effect of low-level light therapy on diabetic foot ulcers: a near-infrared spectroscopy study.

PubMed

Salvi, Massimo; Rimini, Daniele; Molinari, Filippo; Bestente, Gianni; Bruno, Alberto

2017-03-01

Diabetic foot ulcer (DFU) is a diabetic complication due to peripheral vasculopathy and neuropathy. A promising technology for wound healing in DFU is low-level light therapy (LLLT). Despite several studies showing positive effects of LLLT on DFU, LLLT’s physiological effects have not yet been studied. The objective of this study was to investigate vascular and nervous systems modification in DFU after LLLT. Two samples of 45 DFU patients and 11 healthy controls (HCs) were recruited. The total hemoglobin (totHb) concentration change was monitored before and after LLLT by near-infrared spectroscopy and analyzed in time and frequency domains. The spectral power of the totHb changes in the very-low frequency (VLF, 20 to 60 mHz) and low frequency (LF, 60 to 140 mHz) bandwidths was calculated. Data analysis revealed a mean increase of totHb concentration after LLLT in DFU patients, but not in HC. VLF/LF ratio decreased significantly after the LLLT period in DFU patients (indicating an increased activity of the autonomic nervous system), but not in HC. Eventually, different treatment intensities in LLLT therapy showed a different response in DFU. Overall, our results demonstrate that LLLT improves blood flow and autonomic nervous system regulation in DFU and the importance of light intensity in therapeutic protocols.

Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient.

PubMed

Evert, Alison; Trence, Dace; Catton, Sarah; Huynh, Peter

2009-01-01

The purpose of this article is to describe the development and implementation of an educational program for the initiation of real-time continuous glucose monitoring (CGM) technology for personal use, not 3-day CGMS diagnostic studies. The education program was designed to meet the needs of patients managing their diabetes with either diabetes medications or insulin pump therapy in an outpatient diabetes education center using a team-based approach. Observational research, complemented by literature review, was used to develop an educational program model and teaching strategies. Diabetes educators, endocrinologists, CGM manufacturer clinical specialists, and patients with diabetes were also interviewed for their clinical observations and experience. The program follows a progressive educational model. First, patients learn in-depth about real-time CGM technology by attending a group presensor class that provides detailed information about CGM. This presensor class facilitates self-selection among patients concerning their readiness to use real-time CGM. If the patient decides to proceed with real-time CGM use, CGM initiation is scheduled, using a clinic-centered protocol for both start-up and follow-up. Successful use of real-time CGM involves more than just patient enthusiasm or interest in a new technology. Channeling patient interest into a structured educational setting that includes the benefits and limitations of real-time CGM helps to manage patient expectations.

Insulin Delivery Into the Peripheral Circulation: A Key Contributor to Hypoglycemia in Type 1 Diabetes

PubMed Central

Kraft, Guillaume; Scott, Melanie F.; Neal, Doss W.; Farmer, Ben; Smith, Marta S.; Hastings, Jon R.; Allen, Eric J.; Donahue, E. Patrick; Rivera, Noelia; Winnick, Jason J.; Edgerton, Dale S.; Nishimura, Erica; Fledelius, Christian; Brand, Christian L.; Cherrington, Alan D.

2015-01-01

Hypoglycemia limits optimal glycemic control in type 1 diabetes mellitus (T1DM), making novel strategies to mitigate it desirable. We hypothesized that portal (Po) vein insulin delivery would lessen hypoglycemia. In the conscious dog, insulin was infused into the hepatic Po vein or a peripheral (Pe) vein at a rate four times of basal. In protocol 1, a full counterregulatory response was allowed, whereas in protocol 2, glucagon was fixed at basal, mimicking the diminished α-cell response to hypoglycemia seen in T1DM. In protocol 1, glucose fell faster with Pe insulin than with Po insulin, reaching 56 ± 3 vs. 70 ± 6 mg/dL (P = 0.04) at 60 min. The change in area under the curve (ΔAUC) for glucagon was similar between Pe and Po, but the peak occurred earlier in Pe. The ΔAUC for epinephrine was greater with Pe than with Po (67 ± 17 vs. 36 ± 14 ng/mL/180 min). In protocol 2, glucose also fell more rapidly than in protocol 1 and fell faster in Pe than in Po, reaching 41 ± 3 vs. 67 ± 2 mg/dL (P < 0.01) by 60 min. Without a rise in glucagon, the epinephrine responses were much larger (ΔAUC of 204 ± 22 for Pe vs. 96 ± 29 ng/mL/180 min for Po). In summary, Pe insulin delivery exacerbates hypoglycemia, particularly in the presence of a diminished glucagon response. Po vein insulin delivery, or strategies that mimic it (i.e., liver-preferential insulin analogs), should therefore lessen hypoglycemia. PMID:26085570

Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

PubMed Central

Wilhelm, Kay; Robins, Lisa; Proudfoot, Judy

2017-01-01

Background Diabetes mellitus is Australia’s fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. Objective The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes. Methods A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners’ offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups. Results This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken. Conclusions This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes. Trial Registration Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538) PMID:28292741

Organization of wound healing services: The impact on lowering the diabetes foot amputation rate in a ten-year review and the importance of early debridement.

PubMed

Hsu, Cherng-Ru; Chang, Chang-Cheng; Chen, Yu-Tsung; Lin, Wei-Nung; Chen, Mei-Yen

2015-07-01

Diabetes foot ulceration (DFU) has a negative impact on the quality of life and leads to disabling morbidity, such as lower extremity amputation (LEA). This study aimed to evaluate the LEA trend before and after the establishment of the diabetes foot team, an on-time debridement, on-site screening, and multidisciplinary integration with standardizing care, in Chang Gung Memorial Hospital, Chia Yi, Taiwan, starting in 2010. The study retrospectively investigated the non-traumatic LEA rate in diabetes foot (identified by using ICD-9-Clinical Modification (CM) codes, 250.70-250.83) and whole patients with diabetes (ICD-9 250.XX) yearly from 2004 to 2013. Patients were enrolled from hospitalization, emergency room (ER), or outpatient departments, respectively. Despite the overall incidence of diabetes foot in patients with diabetes remaining constant, from 3.47% in 2004 to 3.58% in 2013, the incidence of hospitalized diabetes foot from diabetes reduced, from 2.83% in 2004 to 1.51% in 2013. Introduction of integrated wound care also led to a reduction of the average LEA rate in hospitalized patients, from 15.27% (2004-2009) to 6.08% (2010-2013) (P<0.001). A similar decline of the LEA rate was observed for patients from hospitalization, ER and outpatient departments together with an average LEA rate from 7.99% (2004-2009) down to 3.02% (2010-2013) (P<0.001). In trend analysis, the curve estimation revealed a quadratic trend in the relationship between LEA rate and time (R-square=0.869, P=0.001) for hospitalized patients as well as a linear (R-square=0.819, P<0.001) and quadratic (R-square=0.845, P=0.001) trend in the relationship between LEA rate and time for hospitalization, ER, and outpatient departments together. The LEA rate for DM patients declined from 372.72/100,000 in 2004 to 61.74/100,000 in 2013. With establishment of an organizing, standardized wound care protocol and integrated multidisciplinary team, we demonstrated a significant decline in the LEA rate both in diabetes foot patients and all patients with diabetes. These improvements can be attributed to introducing an efficient pathway with on-time debridement and early intervention of diabetes foot ulcers. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

PubMed

Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

2018-06-18

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

Implementation and evaluation of Australian pharmacists' diabetes care services.

PubMed

Armour, Carol L; Taylor, Susan J; Hourihan, Fleur; Smith, Carlene; Krass, Ines

2004-01-01

To implement and evaluate a specialized service for type 2 diabetes mellitus in the community pharmacy. Parallel group, multisite, control versus intervention, repeated measures design, with three different regions in New South Wales, Australia, used as intervention regions, then matched with control regions as much as possible. Following training, pharmacists followed a clinical protocol over 9 months, with approximately monthly intervention site visits during which blood glucose readings were downloaded and discussed with the patient, interventions were documented, and goals set with each patient. Quality of life, well-being, risk of nonadherence, and glycosylated hemoglobin (A1C) values at the beginning and end of the study. Blood glucose levels were measured in intervention patients only. A total of 106 intervention and 82 control patients completed the study. Patient groups were similar at baseline. Pharmacists delivered 1,459 interventions and blood glucose levels were significantly reduced in all intervention regions. The proportion of patients with A1C values greater than 7% was similar in control sites at baseline (54%) and after 9 months (61%). In intervention sites this proportion was significantly reduced, from 72% at baseline to 53% after 9 months. Well-being and the risk of nonadherence were significantly improved in intervention patients. Implementation of a specialized service for diabetes in community pharmacy resulted in better diabetes control and health care outcomes for the patient.

mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

PubMed

Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

2018-02-15

Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5). ©Sheridan Miyamoto, Madan Dharmar, Sarina Fazio, Yajarayma Tang-Feldman, Heather M Young. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.02.2018.

A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

PubMed

Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

2014-02-01

Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study.

PubMed

Vitale, M; Masulli, M; Rivellese, A A; Bonora, E; Cappellini, F; Nicolucci, A; Squatrito, S; Antenucci, D; Barrea, A; Bianchi, C; Bianchini, F; Fontana, L; Fornengo, P; Giorgino, F; Gnasso, A; Mannucci, E; Mazzotti, A; Nappo, R; Palena, A P; Pata, P; Perriello, G; Potenziani, S; Radin, R; Ricci, L; Romeo, F; Santini, C; Scarponi, M; Serra, R; Timi, A; Turco, A A; Vedovato, M; Zavaroni, D; Grioni, S; Riccardi, G; Vaccaro, O

2018-03-01

Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes.

Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: design of a randomised controlled trial

PubMed Central

2013-01-01

Background A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms. Methods/Design A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants’ satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective. Discussion If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes. Trial registration German Clinical Trial Register (DRKS): DRKS00004748. PMID:24238346

Technology for the manufacture of Diabetic Rosogolla.

PubMed

Chavan, R S; Prajapati, P S; Chavan, S R; Jana, A

2014-01-01

Diabetic Rosogolla was manufactured by using low-fat cow milk. Six different combinations viz. type of chhana and two different concentrations (40° and 50° Brix) of cooking medium. All of the experimental samples and control were analyzed for physico-chemical, textural, and sensory properties. A 40° Brix concentration of cooking medium was preferred to give a highly acceptable Diabetic Rosogolla. The average composition of Diabetic Rosogolla is moisture-52.20%, fat-4.46%, protein-12.78%, sorbitol-29.66%, and ash-0.89%. Similarly, the rheological properties were hardness-7.85 N, cohesiveness-0.54, springiness-6.06 mm, gumminess-3.8 N, chewiness-26.07 Nmm, fracture force-4.1 N, adhesiveness-0.0272 Nmm, and stiffness-2.17 N/mm. This protocol can be adopted at commercial level and be used to serve the customers who desire fewer calories but cannot resist having the sweets after their meal.

Quality of the parent-child interaction in young children with type 1 diabetes mellitus: study protocol.

PubMed

Nieuwesteeg, Anke M; Pouwer, Frans; van Bakel, Hedwig Ja; Emons, Wilco Hm; Aanstoot, Henk-Jan; Odink, Roelof; Hartman, Esther E

2011-04-14

In young children with type 1 diabetes mellitus (T1DM) parents have full responsibility for the diabetes-management of their child (e.g. blood glucose monitoring, and administering insulin). Behavioral tasks in childhood, such as developing autonomy, and oppositional behavior (e.g. refusing food) may interfere with the diabetes-management to achieve an optimal blood glucose control. Furthermore, higher blood glucose levels are related to more behavioral problems. So parents might need to negotiate with their child on the diabetes-management to avoid this direct negative effect. This interference, the negotiations, and the parent's responsibility for diabetes may negatively affect the quality of parent-child interaction. Nevertheless, there is little knowledge about the quality of interaction between parents and young children with T1DM, and the possible impact this may have on glycemic control and psychosocial functioning of the child. While widely used global parent-child interaction observational methods are available, there is a need for an observational tool specifically tailored to the interaction patterns of parents and children with T1DM. The main aim of this study is to construct a disease-specific observational method to assess diabetes-specific parent-child interaction. Additional aim is to explore whether the quality of parent-child interactions is associated with the glycemic control, and psychosocial functioning (resilience, behavioral problems, and quality of life). First, we will examine which situations are most suitable for observing diabetes-specific interactions. Then, these situations will be video-taped in a pilot study (N = 15). Observed behaviors are described into rating scales, with each scale describing characteristics of parent-child interactional behaviors. Next, we apply the observational tool on a larger scale for further evaluation of the instrument (N = 120). The parents are asked twice (with two years in between) to fill out questionnaires about psychosocial functioning of their child with T1DM. Furthermore, glycemic control (HbA1c) will be obtained from their medical records. A disease-specific observational tool will enable the detailed assessment of the quality of diabetes-specific parent-child interactions. The availability of such a tool will facilitate future (intervention) studies that will yield more knowledge about impact of parent-child interactions on psychosocial functioning, and glycemic control of children with T1DM.

Quality of the parent-child interaction in young children with type 1 diabetes mellitus: study protocol

PubMed Central

2011-01-01

Background In young children with type 1 diabetes mellitus (T1DM) parents have full responsibility for the diabetes-management of their child (e.g. blood glucose monitoring, and administering insulin). Behavioral tasks in childhood, such as developing autonomy, and oppositional behavior (e.g. refusing food) may interfere with the diabetes-management to achieve an optimal blood glucose control. Furthermore, higher blood glucose levels are related to more behavioral problems. So parents might need to negotiate with their child on the diabetes-management to avoid this direct negative effect. This interference, the negotiations, and the parent's responsibility for diabetes may negatively affect the quality of parent-child interaction. Nevertheless, there is little knowledge about the quality of interaction between parents and young children with T1DM, and the possible impact this may have on glycemic control and psychosocial functioning of the child. While widely used global parent-child interaction observational methods are available, there is a need for an observational tool specifically tailored to the interaction patterns of parents and children with T1DM. The main aim of this study is to construct a disease-specific observational method to assess diabetes-specific parent-child interaction. Additional aim is to explore whether the quality of parent-child interactions is associated with the glycemic control, and psychosocial functioning (resilience, behavioral problems, and quality of life). Methods/Design First, we will examine which situations are most suitable for observing diabetes-specific interactions. Then, these situations will be video-taped in a pilot study (N = 15). Observed behaviors are described into rating scales, with each scale describing characteristics of parent-child interactional behaviors. Next, we apply the observational tool on a larger scale for further evaluation of the instrument (N = 120). The parents are asked twice (with two years in between) to fill out questionnaires about psychosocial functioning of their child with T1DM. Furthermore, glycemic control (HbA1c) will be obtained from their medical records. Discussion A disease-specific observational tool will enable the detailed assessment of the quality of diabetes-specific parent-child interactions. The availability of such a tool will facilitate future (intervention) studies that will yield more knowledge about impact of parent-child interactions on psychosocial functioning, and glycemic control of children with T1DM. PMID:21492413

Health benefits of Quran memorization for older men

PubMed Central

Saquib, Nazmus; Saquib, Juliann; Alhadlag, Abdulrahman; Albakour, Mohamad Anas; Aljumah, Bader; Sughayyir, Mohammed; Alhomidan, Ziad; Alminderej, Omar; Aljaser, Mohamed; Al-Dhlawiy, Ahmed Mohammed; Al-Mazrou, Abdulrahman

2017-01-01

Objective: To examine the association between Quran memorization and health among older men. Methods: This cross-sectional study included older Saudi men (age ≥ 55 years) from Buraidah, Al-Qassim. The neighborhoods were selected randomly (20 out of 96); eligible men from the mosques were recruited. Demographics, lifestyle, and depression were assessed with standardized questionnaires; height, weight, blood pressure, and random blood glucose (glucometer) were measured with standard protocol. Results: The mean and standard deviation for age, body mass index, and Quran memorization were 63 years (7.5), 28.9 kg/m2 (4.8), and 4.3 sections (6.9). Prevalence of hypertension, diabetes, and depression were 71%, 29%, and 22%, respectively. Those who memorized at least 10 sections of Quran were 64%, 71%, and 81% less likely to have hypertension, diabetes, and depression compared to those who memorized less than 0.5 sections, after controlling for covariates. Conclusion: There was a strong linear association between Quran memorization and hypertension, diabetes, and depression indicating that those who had memorized a larger portion of the Quran were less likely to have one of these chronic diseases. Future studies should explore the potential health benefits of Quran memorization and the underlying mechanisms. PMID:29163949

Health benefits of Quran memorization for older men.

PubMed

Saquib, Nazmus; Saquib, Juliann; Alhadlag, Abdulrahman; Albakour, Mohamad Anas; Aljumah, Bader; Sughayyir, Mohammed; Alhomidan, Ziad; Alminderej, Omar; Aljaser, Mohamed; Al-Dhlawiy, Ahmed Mohammed; Al-Mazrou, Abdulrahman

2017-01-01

To examine the association between Quran memorization and health among older men. This cross-sectional study included older Saudi men (age ≥ 55 years) from Buraidah, Al-Qassim. The neighborhoods were selected randomly (20 out of 96); eligible men from the mosques were recruited. Demographics, lifestyle, and depression were assessed with standardized questionnaires; height, weight, blood pressure, and random blood glucose (glucometer) were measured with standard protocol. The mean and standard deviation for age, body mass index, and Quran memorization were 63 years (7.5), 28.9 kg/m 2 (4.8), and 4.3 sections (6.9). Prevalence of hypertension, diabetes, and depression were 71%, 29%, and 22%, respectively. Those who memorized at least 10 sections of Quran were 64%, 71%, and 81% less likely to have hypertension, diabetes, and depression compared to those who memorized less than 0.5 sections, after controlling for covariates. There was a strong linear association between Quran memorization and hypertension, diabetes, and depression indicating that those who had memorized a larger portion of the Quran were less likely to have one of these chronic diseases. Future studies should explore the potential health benefits of Quran memorization and the underlying mechanisms.

Peritoneal Dialysis in Diabetics: There Is Room for More

PubMed Central

Cotovio, P.; Rocha, A.; Rodrigues, A.

2011-01-01

End stage renal disease diabetic patients suffer from worse clinical outcomes under dialysis-independently of modality. Peritoneal dialysis offers them the advantages of home therapy while sparing their frail vascular capital and preserving residual renal function. Other benefits and potential risks deserve discussion. Predialysis intervention with early nephrology referral, patient education, and multidisciplinary support are recommended. Skilled and updated peritoneal dialysis protocols must be prescribed to assure better survival. Optimized volume control, glucose-sparing peritoneal dialysis regimens, and elective use of icodextrin are key therapy strategies. Nutritional evaluation and support, preferential use of low-glucose degradation products solutions, and prescription of renin-angiotensin-aldosterone system acting drugs should also be part of the panel to improve diabetic care under peritoneal dialysis. PMID:22013524

Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.

PubMed

Avery, Leah; Sniehotta, Falko F; Denton, Sarah J; Steen, Nick; McColl, Elaine; Taylor, Roy; Trenell, Michael I

2014-02-03

Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012.

Towards Standardized Stem Cell Therapy in Type 2 Diabetes Mellitus: A Systematic Review.

PubMed

Pawitan, Jeanne Adiwinata; Yang, Zheng; Wu, Ying Nan; Leed, Eng Hin

2018-05-02

To compile and analyze the published studies on cell therapy for type 2 diabetes mellitus (T2DM) to obtain a better insight into management of T2DM that involved stem cell therapy. We searched all published studies in Pubmed/Medline, and Cochrane library, using keywords: 'stem cell' AND 'therapy' AND 'diabetes type 2'. original articles on the use of stem cells in humans with T2DM. articles in the non-English literature, studies on T2DM complications that did not assess both adverse events and any of the common diabetes study outcomes. type of study, number of cases, and all data that were related to outcome and adverse events. Data were analyzed descriptively to conclude the possible cause of adverse reactions, and which protocols gave a satisfactory outcome. We collected 26 original articles, out of which 17 studies did not have controls and were classified as case reports, while there were 8 studies that were controlled clinical trials. Most studies used autologous bone marrow mononuclear cells (BM-MNCs) or autologous or allogeneic mesenchymal stem cells (MSCs) from various sources. Adverse events were mild and mostly intervention related. Efficacy of autologous BM-MNCs that were given via interventional route was comparable to Wharton jelly or umbilical cord MSCs that were given via intravenous (IV), Intra muscular (IM), or subcutaneous (SC) route. Further controlled studies that compare BM-MNCs to BM-MSCs or WJ-MSCs or UCSCs are recommended to prove their comparable efficacy. In addition, studies that compare various routes of administration (IV, IM or SC) versus the more invasive interventional routes are needed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Importance of Considering the Middle Capillary Plexus on OCT Angiography in Diabetic Retinopathy.

PubMed

Onishi, Alex C; Nesper, Peter L; Roberts, Philipp K; Moharram, Ganna A; Chai, Haitao; Liu, Lei; Jampol, Lee M; Fawzi, Amani A

2018-04-01

To quantify microvasculature changes in the superficial (SCP), middle (MCP), and deep capillary plexuses (DCP) in diabetic retinopathy (DR). Retrospective cross-sectional study at a tertiary academic referral center, in which 26 controls (44 eyes), 27 diabetic subjects without retinopathy (44 eyes), 32 subjects with nonproliferative retinopathy (52 eyes), and 27 subjects with proliferative retinopathy (40 eyes) were imaged with optical coherence tomography angiography (OCTA). Outcome measures included parafoveal vessel density (VD), percentage area of nonperfusion (PAN), and adjusted flow index (AFI) at the different plexuses. MCP VD and MCP AFI decreased with worsening DR, while PAN increased, mirroring changes within the DCP. The fitted regression line for MCP and DCP AFI were significantly different than the SCP, while DCP PAN differed from SCP PAN with disease progression. Higher SCP AFI and PAN were different in eyes with diabetes without retinopathy compared with controls. Unexpectedly, sex was found to independently influence MCP VD and AFI with worsening disease. OCTA parameters in the MCP and DCP displayed parallel changes with DR progression, different from the SCP, emphasizing the importance of physiologic considerations in the retinal capillaries. Thus, segmentation protocols that include the MCP within the SCP may be confounded. A difference in DCP PAN with worsening DR was unmasked relative to a prior study that included the MCP with SCP. We confirm that SCP AFI and PAN may serve as early indicators of microvascular changes in DR and identify an interaction between sex and the MCP deserving further study.

The effect of community groups and mobile phone messages on the prevention and control of diabetes in rural Bangladesh: study protocol for a three-arm cluster randomised controlled trial.

PubMed

Fottrell, Edward; Jennings, Hannah; Kuddus, Abdul; Ahmed, Naveed; Morrison, Joanna; Akter, Kohenour; Shaha, Sanjit Kumar; Nahar, Badrun; Nahar, Tasmin; Haghparast-Bidgoli, Hassan; Khan, A K Azad; Costello, Anthony; Azad, Kishwar

2016-12-19

Increasing rates of type 2 diabetes mellitus place a substantial burden on health care services, communities, families and individuals living with the disease or at risk of developing it. Estimates of the combined prevalence of intermediate hyperglycaemia and diabetes in Bangladesh vary, and can be as high as 30% of the adult population. Despite such high prevalence, awareness and control of diabetes and its risk factors are limited. Prevention and control of diabetes and its complications demand increased awareness and action of individuals and communities, with positive influences on behaviours and lifestyle choices. In this study, we will test the effect of two different interventions on diabetes occurrence and its risk factors in rural Bangladesh. A three-arm cluster randomised controlled trial of mobile health (mHealth) and participatory community group interventions will be conducted in four rural upazillas in Faridpur District, Bangladesh. Ninety-six clusters (villages) will be randomised to receive either the mHealth intervention or the participatory community group intervention, or be assigned to the control arm. In the mHealth arm, enrolled individuals will receive twice-weekly voice messages sent to their mobile phone about prevention and control of diabetes. In the participatory community group arm, facilitators will initiate a series of monthly group meetings for men and women, progressing through a Participatory Learning and Action cycle whereby group members and communities identify, prioritise and tackle problems associated with diabetes and the risk of developing diabetes. Both interventions will run for 18 months. The primary outcomes of the combined prevalence of intermediate hyperglycaemia and diabetes and the cumulative 2-year incidence of diabetes among individuals identified as having intermediate hyperglycaemia at baseline will be evaluated through baseline and endline sample surveys of permanent residents aged 30 years or older in each of the study clusters. Data on blood glucose level, blood pressure, body mass index and hip-to-waist ratio will be gathered through physical measurements by trained fieldworkers. Demographic and socioeconomic data, as well as data on knowledge of diabetes, chronic disease risk factor prevalence and quality of life, will be gathered through interviews with sampled respondents. This study will increase our understanding of diabetes and other non-communicable disease burdens and risk factors in rural Bangladesh. By documenting and evaluating the delivery, impact and cost-effectiveness of participatory community groups and mobile phone voice messaging, study findings will provide evidence on how population-level strategies of community mobilisation and mHealth can be implemented to prevent and control noncommunicable diseases and risk factors in this population. ISRCTN41083256 . Registered on 30 Mar 2016 (Retrospectively Registered). D-Magic: Diabetes Mellitus - Action through Groups or mobile Information for better Control.

The effects of Low Level LASER Therapy (LLLT) on blood glucose levels in patients with Diabetes Mellitus type I : a case report

NASA Astrophysics Data System (ADS)

Longo, Leonardo; Postiglione, Marco; Buccioni, Tommaso; Longo, Diego

2009-06-01

Diabetes Mellitus (DM) is a widespread disease and a serious public health problem. Low Level LASER Therapy (LLLT) has been found to reduce glycaemia on DM type 1 patients, an observation requiring further research especially as regards characteristics of treatment protocol. The purpose of this work is to continue the line of research and propose a specific protocol for LLLT use. In spring 2008 a 48 year old man, DM type 1 insulin dependent patient has been submitted to 810 nm wavelength LLLT treatment in specific body areas daily for 3 weeks and then once a week for 4 weeks until normalization of glycaemia. Medical supervision was present before, during and after application. Insulin was reduced progressively and then stopped. A gradual reduction of glycaemia was noted during the course of treatment. In successive follow-ups a reduction in HbA1c was noted. Results confirm previous observations and need for further research on large cohorts. The indication that LASER may become a valuable addition to DM type 1 treatment is confirmed and the proposed protocol appears to be effective. The case presented merits review since it reports a therapeutic challenge, contributes to advance in medical science and spawns research.

Medication Adherence With Diabetes Medication: A Systematic Review of the Literature.

PubMed

Capoccia, Kam; Odegard, Peggy S; Letassy, Nancy

2016-02-01

The primary purpose of this systematic review is to synthesize the evidence regarding risk factors associated with nonadherence to prescribed glucose-lowering agents, the impact of nonadherence on glycemic control and the economics of diabetes care, and the interventions designed to improve adherence. Medline, EMBASE, the Cochrane Collaborative, BIOSIS, and the Health and Psychosocial Instruments databases were searched for studies of medication adherence for the period from May 2007 to December 2014. Inclusion criteria were study design and primary outcome measuring or characterizing adherence. Published evidence was graded according to the American Association of Clinical Endocrinologists protocol for standardized production of clinical practice guidelines. One hundred ninety-six published articles were reviewed; 98 met inclusion criteria. Factors including age, race, health beliefs, medication cost, co-pays, Medicare Part D coverage gap, insulin use, health literacy, primary nonadherence, and early nonpersistence significantly affect adherence. Higher adherence was associated with improved glycemic control, fewer emergency department visits, decreased hospitalizations, and lower medical costs. Adherence was lower when medications were not tolerated or were taken more than twice daily, with concomitant depression, and with skepticism about the importance of medication. Intervention trials show the use of phone interventions, integrative health coaching, case managers, pharmacists, education, and point-of-care testing improve adherence. Medication adherence remains an important consideration in diabetes care. Health professionals working with individuals with diabetes (eg, diabetes educators) are in a key position to assess risks for nonadherence, to develop strategies to facilitate medication taking, and to provide ongoing support and assessment of adherence at each visit. © 2015 The Author(s).

Home-based treadmill training improved seminal quality in adults with type 2 diabetes.

PubMed

Rosety-Rodriguez, M; Rosety, J M; Fornieles, G; Rosety, M A; Diaz, A J; Rosety, I; Rodríguez-Pareja, A; Rosety, M; Ordonez, F J; Elosegui, S

2014-11-01

This was the first study conducted to determine the influence of home-based treadmill training on seminal quality in adults with type 2 diabetes. Sixty sedentary adults with type 2 diabetes volunteered for the current study. Thirty were randomly allocated to the intervention group and performed a a 14-week, home-based, treadmill training program, 3 sessions per week, consisting of a warm-up (10-15min), 40min treadmill exercise at a work intensity of 55-70% of peak heart rate (increasing by 2.5% each two weeks) measured during a maximal treadmill test, and cooling-down (5-10min). The control group included 30, age and BMI matched adults with type 2 diabetes who did not take part in any training program. Seminal quality analysis included semen volume, sperm concentration, motility and normal morphologic features. Furthermore, total antioxidant status (TAS) as well as glutathione peroxidase (GPX) activity were assessed in seminal plasma. This protocol was approved by an Institutional Ethics Committee. The home-based treadmill training significantly increased sperm concentration as well as percentages of total sperm motility and normal spermatozoa. Furthermore, TAS and GPX activity were increased after the completion of the training program. No significant changes in any of the measured variables were found in the control group. Home-based treadmill training improved seminal quality in adults with type 2 diabetes. A secondary finding was that seminal antioxidant defense system was significantly increased after being exercised. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

Impact of different dietary approaches on glycemic control and cardiovascular risk factors in patients with type 2 diabetes: a protocol for a systematic review and network meta-analysis.

PubMed

Schwingshackl, Lukas; Chaimani, Anna; Hoffmann, Georg; Schwedhelm, Carolina; Boeing, Heiner

2017-03-20

Dietary advice is one of the cornerstones in the management of type 2 diabetes mellitus. The American Diabetes Association recommended a hypocaloric diet for overweight or obese adults with type 2 diabetes in order to induce weight loss. However, there is limited evidence on the optimal approaches to control hyperglycemia in type 2 diabetes patients. The aim of the present study is to assess the comparative efficacy of different dietary approaches on glycemic control and blood lipids in patients with type 2 diabetes mellitus in a systematic review including a standard pairwise and network meta-analysis of randomized trials. We will conduct searches in Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, PubMed (from 1966), and Google Scholar. Citations, abstracts, and relevant papers will be screened for eligibility by two reviewers independently. Randomized controlled trials (with a control group or randomized trials with at least two intervention groups) will be included if they meet the following criteria: (1) include type 2 diabetes mellitus, (2) include patients aged ≥18 years, (3) include dietary intervention (different type of diets: e.g., Mediterranean dietary pattern, low-carbohydrate diet, low-fat diet, vegetarian diet, high protein diet); either hypo, iso-caloric, or ad libitum diets, (4) minimum intervention period of 12 weeks. For each outcome measure of interest, random effects pairwise and network meta-analyses will be performed in order to determine the pooled relative effect of each intervention relative to every other intervention in terms of the post-intervention values (or mean differences between the changes from baseline value scores). Subgroup analyses are planned for study length, sample size, age, and sex. This systematic review will synthesize the available evidence on the comparative efficacy of different dietary approaches in the management of glycosylated hemoglobin (primary outcome), fasting glucose, and cardiovascular risk factors in type 2 diabetes mellitus patients. The results of the present network meta-analysis will influence evidence-based treatment decisions since it will be fundamental for based recommendations in the management of type 2 diabetes. PROSPERO 42016047464.

A novel 5HT3 antagonist 4i (N-(3-chloro-2-methylphenyl)quinoxalin-2-carboxamide) prevents diabetes-induced depressive phenotypes in mice: Modulation of serotonergic system.

PubMed

Gupta, Deepali; Thangaraj, Devadoss; Radhakrishnan, Mahesh

2016-01-15

Despite the presence of a multitudinous pharmacotherapy, diabetes-induced depressive disorder remains undertreated. Evidence suggests that brain serotonergic deficits are associated with depressive-like behavior in diabetes and that 5HT3 receptor (5HT3R) antagonists have serotonergic facilitatory effects. This study examined the effects of a novel 5HT3R antagonist, 4i (N-(3-chloro-2-methylphenyl)quinoxalin-2-carboxamide), in diabetes-induced depressive phenotypes. Experimentally, (1) to evaluate the effects of 4i, mice with 8-weeks of diabetes (induced by streptozotocin, 200mg/kg, i.p.) were treated with vehicle, 4i (0.5 and 1mg/kg/day, i.p.), fluoxetine (10mg/kg/day, i.p.) for 4-weeks and subjected to neurobehavioral assays, followed by biochemical estimation of serotonin levels in midbrain, prefrontal-cortex and cerebellum. (2) To evaluate the role of 5HT3R in the postulated effect of 4i, diabetic mice were given 4i (1mg/kg/day, i.p.) after 1h of 1-(m-chlorophenyl)-biguanide (mCPBG, a 5HT3R agonist, 10mg/kg/day, i.p.) treatment and subjected to the same protocol. The results showed that diabetic mice exhibited a significant behavioral deficit, including depression-like behavior in forced swim test, anxiety-like in open field test and sociability deficits in social interaction test, along with a significant decrease in serotonin level in these brain regions. 4i (1mg/kg), similar to fluoxetine, prevented these behavioral abnormalities and normalized brain serotonin levels. 4i (0.5mg/kg) ameliorated only diabetes-induced depressive-like behavior and serotonin deficits, but not anxiety-like effects. mCPBG blunted 4i-mediated behavioral response and increase in brain serotonin levels. Altogether, this study suggests that 4i prevents diabetes-induced depressive phenotypes in mice, which may involve antagonism of 5HT3Rs and increase in serotonin levels in discrete brain regions. Copyright © 2015 Elsevier B.V. All rights reserved.

Incentives in Diabetic Eye Assessment by Screening (IDEAS): study protocol of a three-arm randomized controlled trial using financial incentives to increase screening uptake in London.

PubMed

Judah, Gaby; Vlaev, Ivo; Gunn, Laura; King, Dominic; King, Derek; Valabhji, Jonathan; Darzi, Ara; Bicknell, Colin

2016-03-18

Diabetes is an increasing public health problem in the UK and globally. Diabetic retinopathy is a microvascular complication of diabetes, and is one of the leading causes of blindness in the UK working age population. The diabetic eye screening programme in England aims to invite all people with diabetes aged 12 or over for retinal photography to screen for the presence of diabetic retinopathy. However, attendance rates are only 81 %, leaving many people at risk of preventable sight loss. This is a three arm randomized controlled trial to investigate the impact of different types of financial incentives (based on principles from behavioral economics) on increasing attendance at diabetic eye screening appointments in London. Eligible participants will be aged 16 or over, and are those who have been invited to screening appointments annually, but who have not attended, or telephoned to rearrange an appointment, within the last 24 months. Eligible participants will be randomized to one of three conditions: 1. Control condition (usual invitation letter) 2. Fixed incentive condition (usual invitation letter, including a voucher for £10 if they attend their appointment) 3. Probabilistic incentive condition (invitation letter, including a voucher for a 1 in 100 chance of winning £1000 if they attend their appointment). Participants will be sent invitation letters, and the primary outcome will be whether or not they attend their appointment. One thousand participants will be included in total, randomized with a ratio of 1.4:1:1. In order to test whether the incentive scheme has a differential impact on patients from different demographic or socio-economic groups, information will be recorded on age, gender, distance from screening center, socio-economic status and length of time since they were last screened. A cost-effectiveness analysis will also be performed. This study will be the first trial of financial incentives for improving uptake of diabetic eye screening. If effective, the intervention may suggest a cost-effective way to increase screening rates, thus reducing unnecessary blindness. ISRCTN14896403, 25 February 2016.

Association between type 2 diabetes mellitus and anthropometric measurements - a case control study in South India.

PubMed

Awasthi, A; Rao, C R; Hegde, D S; Rao N, K

2017-03-01

Obesity is a major risk factor for type 2 diabetes mellitus (T2DM). Clinical evidence indicates a stronger association of diabetes with central obesity than general obesity. The present study aimed to compare the association between type 2 diabetes mellitus and different anthropometric measurements and evaluate the usefulness of these measurements in clinical practice. A case-control study was done among 102 individuals; of whom 51 cases included diagnosed T2DM (≥ 20 years age) patients attending the Medicine out-patient consultation of a tertiary care hospital and 51 controls who were screen negative for T2DM and recruited from the local community. Various anthropometric measurements were used according to standard World Health Organization (WHO) protocols. Data was entered and analyzed using Statistical Package for Social Sciences (SPSS) version 15. The proportion of cases with Body Mass Index (BMI) ≥ 25 kg/m 2 was 55% as compared to 22% of controls and this association was statistically significant (p < 0.05). The proportion of cases with high waist circumference cut-offs (WC) was 74.5% as compared to 45.1% healthy individuals and this association was also statistically significant (p < 0.05, OR = 3.56). A Receiver Operating Characteristic (ROC) curve for both gender revealed highest area under the curve for body mass index (area = 0.787). Body mass index had the best discriminatory power. Waist to hip ratio was not a sensitive marker especially for females. A strong association between obesity indices and diabetes was identified. BMI and WC could be used in clinical practice for suggesting life style modifications.

Surgical Models of Roux-en-Y Gastric Bypass Surgery and Sleeve Gastrectomy in Rats and Mice

PubMed Central

Bruinsma, Bote G.; Uygun, Korkut; Yarmush, Martin L.; Saeidi, Nima

2015-01-01

Bariatric surgery is the only definitive solution currently available for the present obesity pandemic. These operations typically involve reconfiguration of gastrointestinal tract anatomy and impose profound metabolic and physiological benefits, such as substantially reducing body weight and ameliorating type II diabetes. Therefore, animal models of these surgeries offer unique and exciting opportunities to delineate the underlying mechanisms that contribute to the resolution of obesity and diabetes. Here we describe a standardized procedure for mouse and rat models of Roux-en-Y gastric bypass (80–90 minutes operative time) and sleeve gastrectomy (30–45 minutes operative time), which, to a high degree resemble operations in human. We also provide detailed protocols for both pre- and post-operative techniques that ensure a high success rate in the operations. These protocols provide the opportunity to mechanistically investigate the systemic effects of the surgical interventions, such as regulation of body weight, glucose homeostasis, and gut microbiome. PMID:25719268

Assessing the Potential Use of Eye-Tracking Triangulation for Evaluating the Usability of an Online Diabetes Exercise System.

PubMed

Schaarup, Clara; Hartvigsen, Gunnar; Larsen, Lars Bo; Tan, Zheng-Hua; Årsand, Eirik; Hejlesen, Ole Kristian

2015-01-01

The Online Diabetes Exercise System was developed to motivate people with Type 2 diabetes to do a 25 minutes low-volume high-intensity interval training program. In a previous multi-method evaluation of the system, several usability issues were identified and corrected. Despite the thorough testing, it was unclear whether all usability problems had been identified using the multi-method evaluation. Our hypothesis was that adding the eye-tracking triangulation to the multi-method evaluation would increase the accuracy and completeness when testing the usability of the system. The study design was an Eye-tracking Triangulation; conventional eye-tracking with predefined tasks followed by The Post-Experience Eye-Tracked Protocol (PEEP). Six Areas of Interests were the basis for the PEEP-session. The eye-tracking triangulation gave objective and subjective results, which are believed to be highly relevant for designing, implementing, evaluating and optimizing systems in the field of health informatics. Future work should include testing the method on a larger and more representative group of users and apply the method on different system types.

Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.

PubMed

Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A; Gilman, Robert H; Malaga, German; Armstrong, David G; Miranda, J Jaime

2016-04-19

Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability. This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .

Noninvasive measurement of plasma glucose from exhaled breath in healthy and type 1 diabetic subjects

PubMed Central

Oliver, Stacy R.; Ngo, Jerry; Flores, Rebecca; Midyett, Jason; Meinardi, Simone; Carlson, Matthew K.; Rowland, F. Sherwood; Blake, Donald R.; Galassetti, Pietro R.

2011-01-01

Effective management of diabetes mellitus, affecting tens of millions of patients, requires frequent assessment of plasma glucose. Patient compliance for sufficient testing is often reduced by the unpleasantness of current methodologies, which require blood samples and often cause pain and skin callusing. We propose that the analysis of volatile organic compounds (VOCs) in exhaled breath can be used as a novel, alternative, noninvasive means to monitor glycemia in these patients. Seventeen healthy (9 females and 8 males, 28.0 ± 1.0 yr) and eight type 1 diabetic (T1DM) volunteers (5 females and 3 males, 25.8 ± 1.7 yr) were enrolled in a 240-min triphasic intravenous dextrose infusion protocol (baseline, hyperglycemia, euglycemia-hyperinsulinemia). In T1DM patients, insulin was also administered (using differing protocols on 2 repeated visits to separate the effects of insulinemia on breath composition). Exhaled breath and room air samples were collected at 12 time points, and concentrations of ∼100 VOCs were determined by gas chromatography and matched with direct plasma glucose measurements. Standard least squares regression was used on several subsets of exhaled gases to generate multilinear models to predict plasma glucose for each subject. Plasma glucose estimates based on two groups of four gases each (cluster A: acetone, methyl nitrate, ethanol, and ethyl benzene; cluster B: 2-pentyl nitrate, propane, methanol, and acetone) displayed very strong correlations with glucose concentrations (0.883 and 0.869 for clusters A and B, respectively) across nearly 300 measurements. Our study demonstrates the feasibility to accurately predict glycemia through exhaled breath analysis over a broad range of clinically relevant concentrations in both healthy and T1DM subjects. PMID:21467303

Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

PubMed Central

Côté, José

2016-01-01

Background Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes. Objective This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes. Methods A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period. Results The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites. Conclusions By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical activity promotion in adult populations with type 2 diabetes. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r) PMID:26869015

Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care.

PubMed

Ricci-Cabello, Ignacio; Olry de Labry-Lima, Antonio; Bolívar-Muñoz, Julia; Pastor-Moreno, Guadalupe; Bermudez-Tamayo, Clara; Ruiz-Pérez, Isabel; Quesada-Jiménez, Fermín; Moratalla-López, Enrique; Domínguez-Martín, Susana; de los Ríos-Álvarez, Ana M; Cruz-Vela, Pilar; Prados-Quel, Miguel A; López-De Hierro, José A

2013-10-23

In the last decades the presence of social inequalities in diabetes care has been observed in multiple countries, including Spain. These inequalities have been at least partially attributed to differences in diabetes self-management behaviours. Communication problems during medical consultations occur more frequently to patients with a lower educational level. The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention. We report the design and implementation of this on-going study. The study is being conducted in a General Practice located in a deprived neighbourhood of Granada, Spain. Diabetic patients 18 years old or older with a low educational level and inadequate glycaemic control (HbA1c > 7%) were recruited. General Practitioners (GPs) were randomised to three groups: intervention A, intervention B and control group. GPs allocated to intervention groups A and B received training in communication skills and are providing graphic feedback about glycosylated haemoglobin levels. Patients whose GPs were allocated to group B are additionally receiving telephone reinforcement whereas patients from the control group are receiving usual care. The described interventions are being conducted during 7 consecutive medical visits which are scheduled every three months. The main outcome measure will be HbA1c; blood pressure, lipidemia, body mass index and waist circumference will be considered as secondary outcome measures. Statistical analysis to evaluate the effectiveness of the interventions will include multilevel regression analysis with three hierarchical levels: medical visit level, patient level and GP level. The results of this study will provide new knowledge about possible strategies to promote a better diabetes self-management in a particularly vulnerable group. If effective, this low cost intervention will have the potential to be easily incorporated into routine clinical practice, contributing to decrease health inequalities in diabetic patients. Clinical Trials U.S. National Institutes of Health, NCT01849731.

Parenteral vitamin D supplementation is superior to oral in vitamin D insufficient patients with type 2 diabetes mellitus.

PubMed

Dwivedi, Awanindra; Gupta, Balram; Tiwari, Shalbha; Pratyush, Daliparthy D; Singh, Saurabh; Singh, Surya Kumar

2017-11-01

Oral vitamin D supplementation is better than parenteral in improving vitamin D deficiency in individuals with no systemic illness. Our aim was to compare the efficacy of oral and parenteral routes of vitamin D supplementation on circulating serum 25(OH) vitamin D level in patients with type 2 diabetes mellitus. Total 85 cases of with type 2 diabetes mellitus were screened for vitamin D status of which 71 patients were vitamin D insufficient/deficient. They were randomized into two intent to treat groups with different vitamin D supplementation protocols (a) Oral-60000 IU per day for 5days (group I; n=40) and (b) injectable-300000 IU intramuscularly once (group II; n=31). Baseline and one month post supplementation 25(OH) vitamin D levels were measured in both the groups. Baseline clinical characteristics and 25(OH) vitamin D levels were comparable in both the groups. Post treatment 25(OH) vitamin D level in group I was 26.06±9.06ng/ml and in group II was 49.69±18.92ng/ml. After one month of vitamin D supplementation, increment in 25(OH) vitamin D level from baseline was significantly higher in group II than group I (p<0.001). Injectable method of supplementation was better than oral route in improving serum 25 (OH) vitamin D status in patients with type 2 diabetes. The study suggested impaired absorption of vitamin D from the gastrointestinal tract in patients with type 2 diabetes mellitus and a need for parenteral route of vitamin D supplementation in deficient patients with type 2 diabetes mellitus. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Apigenin ameliorates streptozotocin-induced diabetic nephropathy in rats via MAPK-NF-κB-TNF-α and TGF-β1-MAPK-fibronectin pathways.

PubMed

Malik, Salma; Suchal, Kapil; Khan, Sana Irfan; Bhatia, Jagriti; Kishore, Kamal; Dinda, Amit Kumar; Arya, Dharamvir Singh

2017-08-01

Diabetic nephropathy (DN), a microvascular complication of diabetes, has emerged as an important health problem worldwide. There is strong evidence to suggest that oxidative stress, inflammation, and fibrosis play a pivotal role in the progression of DN. Apigenin has been shown to possess antioxidant, anti-inflammatory, antiapoptotic, antifibrotic, as well as antidiabetic properties. Hence, we evaluated whether apigenin halts the development and progression of DN in streptozotocin (STZ)-induced diabetic rats. Male albino Wistar rats were divided into control, diabetic control, and apigenin treatment groups (5-20 mg/kg po, respectively), apigenin per se (20 mg/kg po), and ramipril treatment group (2 mg/kg po). A single injection of STZ (55 mg/kg ip) was administered to all of the groups except control and per se groups to induce type 1 diabetes mellitus. Rats with fasting blood glucose >250 mg/dl were included in the study and randomized to different groups. Thereafter, the protocol was continued for 8 mo in all of the groups. Apigenin (20 mg/kg) treatment attenuated renal dysfunction, oxidative stress, and fibrosis (decreased transforming growth factor-β1, fibronectin, and type IV collagen) in the diabetic rats. It also significantly prevented MAPK activation, which inhibited inflammation (reduced TNF-α, IL-6, and NF-κB expression) and apoptosis (increased expression of Bcl-2 and decreased Bax and caspase-3). Furthermore, histopathological examination demonstrated reduced inflammation, collagen deposition, and glomerulosclerosis in the renal tissue. In addition, all of these changes were comparable with those produced by ramipril. Hence, apigenin ameliorated renal damage due to DN by suppressing oxidative stress and fibrosis and by inhibiting MAPK pathway. Copyright © 2017 the American Physiological Society.

Development of a Protocol for Automated Glucose Measurement Transmission Used in Clinical Decision Support Systems Based on the Continua Design Guidelines.

PubMed

Meyer, Markus; Donsa, Klaus; Truskaller, Thomas; Frohner, Matthias; Pohn, Birgit; Felfernig, Alexander; Sinner, Frank; Pieber, Thomas

2018-01-01

A fast and accurate data transmission from glucose meter to clinical decision support systems (CDSSs) is crucial for the management of type 2 diabetes mellitus since almost all therapeutic interventions are derived from glucose measurements. Aim was to develop a prototype of an automated glucose measurement transmission protocol based on the Continua Design Guidelines and to embed the protocol into a CDSS used by healthcare professionals. A literature and market research was performed to analyze the state-of-the-art and thereupon develop, integrate and validate an automated glucose measurement transmission protocol in an iterative process. Findings from literature and market research guided towards the development of a standardized glucose measurement transmission protocol using a middleware. The interface description to communicate with the glucose meter was illustrated and embedded into a CDSS. A prototype of an interoperable transmission of glucose measurements was developed and implemented in a CDSS presenting a promising way to reduce medication errors and improve user satisfaction.

Impact of streptozotocin on altering normal glucose homeostasis during insulin testing in diabetic rats compared to normoglycemic rats

PubMed Central

Qinna, Nidal A; Badwan, Adnan A

2015-01-01

Streptozotocin (STZ) is currently the most used diabetogenic agent in testing insulin and new antidiabetic drugs in animals. Due to the toxic and disruptive nature of STZ on organs, apart from pancreas, involved in preserving the body’s normal glucose homeostasis, this study aims to reassess the action of STZ in inducing different glucose response states in diabetic rats while testing insulin. Diabetic Sprague-Dawley rats induced with STZ were classified according to their initial blood glucose levels into stages. The effect of randomizing rats in such a manner was investigated for the severity of interrupting normal liver, pancreas, and kidney functions. Pharmacokinetic and pharmacodynamic actions of subcutaneously injected insulin in diabetic and nondiabetic rats were compared. Interruption of glucose homeostasis by STZ was challenged by single and repeated administrations of injected insulin and oral glucose to diabetic rats. In diabetic rats with high glucose (451–750 mg/dL), noticeable changes were seen in the liver and kidney functions compared to rats with lower basal glucose levels. Increased serum levels of recombinant human insulin were clearly indicated by a significant increase in the calculated maximum serum concentration and area under the concentration–time curve. Reversion of serum glucose levels to normal levels pre- and postinsulin and oral glucose administrations to STZ diabetic rats were found to be variable. In conclusion, diabetic animals were more responsive to insulin than nondiabetic animals. STZ was capable of inducing different levels of normal glucose homeostasis disruption in rats. Both pharmacokinetic and pharmacodynamic actions of insulin were altered when different initial blood glucose levels of STZ diabetic rats were selected for testing. Such findings emphasize the importance of selecting predefined and unified glucose levels when using STZ as a diabetogenic agent in experimental protocols evaluating new antidiabetic agents and insulin delivery systems. PMID:26005328

Increased levels of N(ε)- Carboxy methyl lysine (N(ε)-CML) are associated with topographic alterations in retinal pigment epithelium: A preliminary study.

PubMed

Mishra, Nibha; Saxena, Sandeep; Ruia, Surabhi; Prasad, Senthamizh; Singh, Vinita; Khanna, Vinay; Staffa, Robert; Gaspar, Ludovit; Kruzliak, Peter

2016-07-01

To evaluate the association of serum levels of N(ε)- Carboxy methyl lysine (N(ε)-CML), an advanced glycation end product with topographic alterations in retinal pigment epithelium (RPE) in diabetic retinopathy on spectral domain optical coherence tomography (SD-OCT). Consecutive cases of type 2 diabetes mellitus with no retinopathy (n=20); non-proliferative diabetic retinopathy (n=20); proliferative diabetic retinopathy (n=20) and healthy controls (n=20) between the ages of 40 and 65years were included. RPE alterations were graded on segmentation map of SD-OCT: grade 0, No RPE alterations; grade 1, RPE alterations in up to two quadrants and grade 2, RPE alterations in more than two quadrants. Serum level of N(ε)-CML and glycated hemoglobin (HbA1c) was analyzed using the standard protocol. Statistical analysis was done. Significant increase in N(ε)-CML was observed with increased severity of diabetic retinopathy (F=34.1; p<0.0001). Fisher exact test revealed significant increase in grades of RPE alterations with increased severity of diabetic retinopathy (p<0.001). Univariate ordinal regression analysis was done to calculate the risk of progression in grades of RPE alteration with individual changes in variables like duration of diabetes (odds ratio=1.37; p=0.001), HbA1c (odds ratio=1.37; p=0.002) and Nε-CML (odds ratio=1.37; p<0.0001). Multivariate ordinal regression analysis for predicting progression in grades of RPE alteration revealed Nε-CML to be an independent predictor of increase in grades of RPE alteration (adjusted odds ratio=1.07; p<0.01) when duration of diabetes and HbA1c were held constant. Increase in serum levels of N(ε)- Carboxy methyl lysine is significantly associated with topographic alterations in RPE. Grades of RPE alteration increase significantly with increased severity of diabetic retinopathy. Copyright © 2016 Elsevier Inc. All rights reserved.

A pilot study of an HbA1c chairside screening protocol for diabetes in patients with chronic periodontitis: the dental hygienist's role.

PubMed

Bossart, M; Calley, K H; Gurenlian, J R; Mason, B; Ferguson, R E; Peterson, T

2016-05-01

To assess effectiveness, convenience and cost of point-of-care diabetes screenings performed by a dental hygienist for patients with periodontitis, using a diabetes risk questionnaire, periodontal findings and a glycosylated haemoglobin (HbA1c) analyser. A purposive sample of 50 participants with periodontitis, never diagnosed with diabetes, reporting ≥one diabetes risk factor, were administered an HbA1c test. Spearman's correlation measured relationships between HbA1c and diabetes risk test scores, numbers of missing teeth, percentage of deep pockets ≥5 mm and percentage of bleeding sites (BOP). Cost and time were assessed. Analyses used 0.05 alpha levels. Thirty-two per cent (n = 16) of participants presented HbA1c values indicating prediabetes; one HbA1c value indicated type 2 diabetes, totalling 34% (N = 17). No relationships existed between HbA1c values and diabetes risk scores (rs = 0.153; P = 0.144), numbers of missing teeth (r = 0.190; P = 0.093), percentage of deep pockets (rs = -0.048; P = 0.370) or percentage of BOP sites (rs = 0.066, P = 0.324). Direct cost for each HbA1c was $9US, excluding follow-up medical diagnosis. Mean screening time including patient education was 14 min (SD = 6.2). Fifty-three per cent (n = 9 of 17) of participants with elevated HbA1c values contacted their primary healthcare provider within 2 weeks as recommended. Point-of-care HbA1c screenings by dental hygienists were effective and convenient for identifying undiagnosed prediabetes and provide opportunity for interprofessional patient care; cost or lack of dental insurance may inhibit implementation. Identification of patients at risk for diabetes requires further evaluation. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Acute management and outcomes of patients with diabetes mellitus presenting to Canadian emergency departments with hypoglycemia.

PubMed

Rowe, Brian H; Singh, Mira; Villa-Roel, Cristina; Leiter, Lawrence A; Hramiak, Irene; Edmonds, Marcia L; Lang, Eddy; Sivilotti, Marco; Scheuermeyer, Frank; Worster, Andrew; Riley, Jennifer; Afilalo, Marc; Stiell, Ian; Yale, Jean-Francois; Woo, Vincent C; Campbell, Samuel

2015-02-01

This retrospective chart audit examined the demographics, investigations, management and outcomes of adult patients with diabetes mellitus presenting to Canadian emergency departments (EDs). All sites conducted a search of their electronic medical records using International Classification of Diseases, Tenth Revision, codes to identify ED visits for hypoglycemia between 2008 and 2010. Patient characteristics, demographics, ED management, ED resources and outcome are reported. A total of 1039 patients over the age of 17 years were included in the study; 347 (33.4%) were classified as type 1 diabetes and 692 (66.6%) were classified as type 2 diabetes. Type 2 diabetes patients were significantly older (73 vs. 49 years; p<0.0001) and had more chronic conditions recorded on their chart (all p<0.001). Most subjects arrived by ambulance, and triage scores revealed severe presentations in 39% of cases. Treatments for hypoglycemia were common (75.7%) during prehospital transport; 38.5% received intravenous glucose and 40.1% received glucagon. Hypoglycemia treatments in the ED included oral (76.8%), intravenous (29.6%) and continuous infusion (27.7%) of glucose. Diagnostic testing (81.9%) commonly included electrocardiograms (51.9%), chest radiography (37.5%) and head computed tomography scans (14.5%). Most patients (73.5%) were discharged; however, more subjects with type 2 diabetes required admission (30.3 vs. 8.8%). Discharge instructions were documented in only 55.5% of patients, and referral to diabetes services occurred in fewer than 20% of cases. Considerable variation existed in the management of hypoglycemia across EDs. Patients with diabetes presenting to an ED with hypoglycemia consume considerable healthcare resources, and practice variation exists. Emergency departments should develop protocols for the management of hypoglycemia, with attention to discharge planning to reduce recurrence. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Protocol-based care: the standardisation of decision-making?

PubMed

Rycroft-Malone, Jo; Fontenla, Marina; Seers, Kate; Bick, Debra

2009-05-01

To explore how protocol-based care affects clinical decision-making. In the context of evidence-based practice, protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalising the information with which to make judgements and ultimately decisions. However, whether protocol-based care does, in the reality of practice, standardise decision-making is unknown. This paper reports on a study that explored the impact of protocol-based care on nurses' decision-making. Theoretically informed by realistic evaluation and the promoting action on research implementation in health services framework, a case study design using ethnographic methods was used. Two sites were purposively sampled; a diabetic and endocrine unit and a cardiac medical unit. Within each site, data collection included observation, postobservation semi-structured interviews with staff and patients, field notes, feedback sessions and document review. Data were inductively and thematically analysed. Decisions made by nurses in both sites were varied according to many different and interacting factors. While several standardised care approaches were available for use, in reality, a variety of information sources informed decision-making. The primary approach to knowledge exchange and acquisition was person-to-person; decision-making was a social activity. Rarely were standardised care approaches obviously referred to; nurses described following a mental flowchart, not necessarily linked to a particular guideline or protocol. When standardised care approaches were used, it was reported that they were used flexibly and particularised. While the logic of protocol-based care is algorithmic, in the reality of clinical practice, other sources of information supported nurses' decision-making process. This has significant implications for the political goal of standardisation. The successful implementation and judicious use of tools such as protocols and guidelines will likely be dependant on approaches that facilitate the development of nurses' decision-making processes in parallel to paying attention to the influence of context.

Factors Associated with Prosthetic Looseness in Lower Limb Amputees.

PubMed

Phonghanyudh, Thong; Sutpasanon, Taweesak; Hathaiareerug, Chanasak; Devakula, M L Buddhibongsa; Kumnerddee, Wipoo

2015-12-01

To determine the factors associated with prosthetic looseness in lower limb amputees in Sisaket province. The present was a cross-sectional descriptive study. Subjects were lower limb amputees who previously obtained prostheses and required prosthetic replacements at the mobile prosthetic laboratory unit under the Prostheses Foundation of H.R.H. the Princess Mother at Khun Han Hospital, Sisaket province, in February 2013. Data including participant characteristics, prosthetic looseness data, and various variables were collected by direct semi-structured interview. Energy expenditures in physical activities were measured using the Thai version of the short format international physical activity questionnaire. Data between participants with and without prosthetic looseness were compared to determine prosthetic loosening associated factors. Among 101 participants enrolled, 33 (32.7%) had prosthetic looseness with average onset of 1.76 ± 1.67 years. Diabetes mellitus was the only significant factor associated with prosthetic looseness from both univariate and multivariate analyses (HR = 7.05, p = 0.002 and HR = 5.93, p = 0.007 respectively). Among the lower limb amputees in Sisaket province, diabetes mellitus was the only factor associated with prosthetic looseness. Therefore, diabetic screening should be supplemented in lower limb amputee assessment protocol. In addition, we recommend that amputees with diabetes mellitus should receive prosthesis check out at approximately

A lifestyle intervention supported by mobile health technologies to improve the cardiometabolic risk profile of individuals at risk for cardiovascular disease and type 2 diabetes: study rationale and protocol.

PubMed

Stuckey, Melanie I; Shapiro, Sheree; Gill, Dawn P; Petrella, Robert J

2013-11-07

Metabolic syndrome is a cluster of cardiovascular risk factors that greatly increase the risk of developing cardiovascular disease and type 2 diabetes. Regular exercise improves the risk profile, but most people do not successfully change their exercise habits to beneficially reduce risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce cardiometabolic risk, but optimal implementation practices remain unknown. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities is not well understood. This study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve metabolic syndrome and related cardiometabolic risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes. Adults (n = 149) with at least two metabolic syndrome risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription. All participants reported to the research centre at baseline, and at 12-, 24- and 52-week follow-up visits for measurement of anthropometrics and blood pressure and for a blood draw to test blood-borne markers of cardiometabolic health. Vascular and autonomic function were examined. Fitness was assessed and exercise prescribed according to the Step Test and Exercise Prescription protocol. This study tested the effects of a prescriptive exercise intervention alone, versus one supported by mobile health technology on cardiometabolic risk factors. The intervention was designed to be translated into clinical or community-based programming. Results will contribute to the current literature by investigating the utility of mobile health technology support for exercise prescription interventions to improve cardiometabolic risk status and maintain improvements over time; particularly in rural communities. NCT01944124.

Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol

PubMed Central

2010-01-01

Background Diabetic patients show an increased prevalence of non-dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk. The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus or metabolic syndrome. Methods/Design Design: This is an observational prospective study with 5 years duration, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up. Setting: The study will be carried out in the urban primary care setting. Study population: Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included. Measurements: Patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. Height, weight, heart rate and abdominal circumference. Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity C-reactive protein. Clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. Common carotid artery ultrasound for the determination of mean carotid intima-media thickness. Electrocardiogram for assessing left ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together with antiplatelet drugs. Discussion The results of this study will help to know and quantify the prognostic value of central arterial pressure and pulse wave velocity in relation to the evolution of the subclinical target organ damage markers and the possible incidence of cardiovascular events in patients with type 2 diabetes mellitus. Trial Registration ClinicalTrials.gov Identifier: NCT01065155 PMID:20298558

The impact of financial incentives on the implementation of asthma or diabetes self-management: A systematic review

PubMed Central

Shields, Michael D.; Heaney, Liam G.; Kendall, Marilyn; Pearce, Christina J.; Hui, Chi Yan; Pinnock, Hilary

2017-01-01

Introduction Financial incentives are utilised in healthcare systems in a number of countries to improve quality of care delivered to patients by rewarding practices or practitioners for achieving set targets. Objectives To systematically review the evidence investigating the impact of financial incentives for implementation of supported self-management on quality of care including: organisational process outcomes, individual behavioural outcomes, and health outcomes for individuals with asthma or diabetes; both conditions with an extensive evidence base for self-management. Methods We followed Cochrane methodology, using a PICOS search strategy to search eight databases in November 2015 (updated May 2017) including a broad range of implementation methodologies. Studies were weighted by robustness of methodology, number of participants and the quality score. We used narrative synthesis due to heterogeneity of studies. Results We identified 2,541 articles; 12 met our inclusion criteria. The articles were from the US (n = 7), UK (n = 4) and Canada (n = 1). Measured outcomes were HbA1c tests undertaken and/or the level achieved (n = 10), written action plans for asthma (n = 1) and hospital/emergency department visits (n = 1). Three of the studies were part of a larger incentive scheme including many conditions; one focused on asthma; eight focussed on diabetes. In asthma, the proportion receiving ‘perfect care’ (including providing a written action plan) increased from 4% to 88% in one study, and there were fewer hospitalisations/emergency department visits in another study. Across the diabetes studies, quality-of-care/GP performance scores improved in three, were unchanged in six and deteriorated in one. Conclusions Results for the impact of financial incentives for the implementation of self-management were mixed. The evidence in diabetes suggests no consistent impact on diabetic control. There was evidence from a single study of improved process and health outcomes in asthma. Further research is needed to confirm these findings and understand the process by which financial incentives may impact (or not) on care. Trial registration Protocol registration number: CRD42016027411 PMID:29107955

Quantification of oxygen-induced retinopathy in the mouse: a model of vessel loss, vessel regrowth and pathological angiogenesis

PubMed Central

Connor, Kip M; Krah, Nathan M; Dennison, Roberta J; Aderman, Christopher M; Chen, Jing; Guerin, Karen I; Sapieha, Przemyslaw; Stahl, Andreas; Willett, Keirnan L; Smith, Lois E H

2013-01-01

The mouse model of oxygen-induced retinopathy (OIR) has been widely used in studies related to retinopathy of prematurity, proliferative diabetic retinopathy and in studies evaluating the efficacy of antiangiogenic compounds. In this model, 7-d-old (P7) mouse pups with nursing mothers are subjected to hyperoxia (75% oxygen) for 5 d, which inhibits retinal vessel growth and causes significant vessel loss. on P12, mice are returned to room air and the hypoxic avascular retina triggers both normal vessel regrowth and retinal neovascularization (NV), which is maximal at P17. neovascularization spontaneously regresses between P17 and P25. although the OIR model has been the cornerstone of studies investigating proliferative retinopathies, there is currently no harmonized protocol to assess aspects of angiogenesis and treatment outcome. In this protocol we describe standards for mouse size, sample size, retinal preparation, quantification of vascular loss, vascular regrowth, NV and neovascular regression. PMID:19816419

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

PubMed

Cortez, Daniel Nogueira; Macedo, Maísa Mara Lopes; Souza, Débora Aparecida Silva; Dos Santos, Jéssica Caroline; Afonso, Gesana Sousa; Reis, Ilka Afonso; Torres, Heloísa de Carvalho

2017-01-06

The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition. In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively. There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and -5.13, respectively (p < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group. The empowerment program improved metabolic control of type 2 diabetes in Brazilian users. NCT02132338 - April 22, 2014.

Glycemia and peak incremental indices of six popular fruits in Taiwan: healthy and Type 2 diabetes subjects compared

PubMed Central

Chen, Ya-Yen; Wu, Pin-Ching; Weng, Shuen-Fu; Liu, Jen-Fang

2011-01-01

The aim of this study was to evaluate the glycemic index and peak incremental indices of six popular fruits in Taiwan, comparing healthy subjects (n = 20) and patients with Type 2 diabetes (n = 17). The six kinds of fruits tested were grapes, Asian pears, guavas, golden kiwifruit, lychees and bananas. Glycemic index values were tested according to the standard glycemic index testing protocol. The glycemic index and peak incremental indices were calculated according to published formulas. In Type 2 diabetes subjects, the glycemic index values of grapes, Asian pears, guavas, golden kiwifruit, lychees and bananas were 49.0 ± 4.5, 25.9 ± 2.9, 32.8 ± 5.2, 47.0 ± 6.5, 60.0 ± 8.0 and 41.3 ± 3.5. In healthy subjects, the glycemic index values were 49.1 ± 7.3, 18.0 ± 5.4, 31.1 ± 5.1, 47.3 ± 12.1, 47.9 ± 6.8 and 35.1 ± 5.6. There was no significant difference in glycemic index values between healthy and Type 2 diabetes subjects. There was also no significant difference in PII when comparing healthy subjects and subjects with Type 2 diabetes. In conclusion, glycemic index and peak incremental indices in healthy subjects can be approximately the same for Type 2 diabetes. PMID:22128219

β-MSCs: successful fusion of MSCs with β-cells results in a β-cell like phenotype.

PubMed

Azizi, Zahra; Lange, Claudia; Paroni, Federico; Ardestani, Amin; Meyer, Anke; Wu, Yonghua; Zander, Axel R; Westenfelder, Christof; Maedler, Kathrin

2016-08-02

Bone marrow mesenchymal stromal cells (MSC) have anti-inflammatory, anti-apoptotic and immunosuppressive properties and are a potent source for cell therapy. Cell fusion has been proposed for rapid generation of functional new reprogrammed cells. In this study, we aimed to establish a fusion protocol of bone marrow-derived human MSCs with the rat beta-cell line (INS-1E) as well as human isolated pancreatic islets in order to generate insulin producing beta-MSCs as a cell-based treatment for diabetes.Human eGFP+ puromycin+ MSCs were co-cultured with either stably mCherry-expressing rat INS-1E cells or human dispersed islet cells and treated with phytohemagglutinin (PHA-P) and polyethylene glycol (PEG) to induce fusion. MSCs and fused cells were selected by puromycin treatment.With an improved fusion protocol, 29.8 ± 2.9% of all MSCs were β-MSC heterokaryons based on double positivity for mCherry and eGFP.After fusion and puromycin selection, human NKX6.1 and insulin as well as rat Neurod1, Nkx2.2, MafA, Pdx1 and Ins1 mRNA were highly elevated in fused human MSC/INS-1E cells, compared to the mixed control population. Such induction of beta-cell markers was confirmed in fused human MSC/human dispersed islet cells, which showed elevated NEUROD1, NKX2.2, MAFA, PDX1 and insulin mRNA compared to the mixed control. Fused cells had higher insulin content and improved insulin secretion compared to the mixed control and insulin positive beta-MSCs also expressed nuclear PDX1. We established a protocol for fusion of human MSCs and beta cells, which resulted in a beta cell like phenotype. This could be a novel tool for cell-based therapies of diabetes.

Vancomycin Powder Regimen for Prevention of Surgical Site Infection in Complex Spine Surgeries.

PubMed

Van Hal, Michael; Lee, Joon; Laudermilch, Dann; Nwasike, Chinedu; Kang, James

2017-10-01

In total, 496 patients of a single surgeon cohort examining the surgical-site infection (SSI) rates with the addition of vancomycin powder in both diabetic and revision spine surgery cases. A historical control group of 652 patients were compared from the same surgeon over an earlier time period before the inception of using vancomycin powder prophylaxis. The objective of this study was to describe and compare the rates of infection in high-risk patient populations while using vancomycin powder. Vancomycin powder may not decrease an already low rate of infection. Therefore, use of vancomycin powder in high-risk patients with a higher rate of infection would potentially show benefit of vancomycin powder. In total, 496 patient charts were collected from a database of cases. Patients were included in the cohort if they had revision spinal operation or if they were diabetic. Patients in the time period July 2010 to August 2013 were included in the vancomycin protocol where 1 g of vancomycin powder was added to the wound before wound closure. Cases were considered positive if there was a positive culture or if there was sufficient clinical suspicion to treat. As a control to this cohort, 692 charts were reviewed from a earlier time period of the same surgeon and institution. In total, 28 patients of 496 (5.6%) patients in the cohort returned to the operating room for seroma, hematoma, draining wound, or infection. Sixteen of these patients (16/496, 3.2%) had a culture positive infection or were treated as an infection. This rate was significantly lower than the historical rate before the protocol. Although vancomycin does seem to be useful in decreasing SSIs, it is not a panacea. SSIs in high-risk patients were not completely eliminated by the vancomycin protocol.

The relationship between insulin resistance/β-cell dysfunction and diabetic retinopathy in Chinese patients with type 2 diabetes mellitus: the Desheng Diabetic Eye Study.

PubMed

Li, Yun-Yun; Yang, Xiu-Fen; Gu, Hong; Snellingen, Torkel; Liu, Xi-Pu; Liu, Ning-Pu

2018-01-01

To investigate the relationship between insulin resistance (IR)/β-cell dysfunction and diabetic retinopathy (DR) in Chinese patients with type 2 diabetes mellitus (T2DM), and to explore further whether there were differences in the relationship among diabetic patients with higher and lower body mass index (BMI). Cross-sectional study. A total of 1466 subjects with T2DM were recruited in a local Desheng Community of urban Beijing from November 2009 to June 2012 for the cohort of Beijing Desheng Diabetic Eye Study. Standardized evaluation was carried out for each participant, including questionnaire, ocular and anthropometric examinations, and laboratory tests. Seven fields 30° color fundus photographs were used for DR grading according to the Early Treatment Diabetic Retinopathy Study protocols. Homeostatis Model Assessment (HOMA) method was employed for IR and β-cell function assessment. After excluding those participants who were treated with insulin ( n =352) or had missing data of fasting insulin ( n =96), and further excluding those with poor quality of retinal photographs ( n =10), a total of 1008 subjects were included for the final analysis, 406 (40.3%) were men and 602 (59.7%) were women, age ranging from 34 to 86 (64.87±8.28)y. Any DR (levels 14 and above) was present in 278 (27.6%) subjects. After adjusting for possible covariates, the presence of any DR did not correlate with HOMA IR [odds ratio (OR) 1.51, 95% confidence interval (CI) 0.87-2.61, P =0.14] or HOMA β-cell (OR 0.71, 95%CI 0.40-1.26, P =0.25). After stratification by BMI, the presence of any DR was associated positively with HOMA IR (OR 2.46, 95%CI: 1.18-5.12, P =0.016), and negatively with HOMA β-cell (OR 0.40, 95%CI: 0.19-0.87, P =0.021) in the group of patients with higher BMI (≥25 kg/m 2 ). In the group of patients with lower BMI (<25 kg/m 2 ), the presence of any DR was not associated with HOMA IR (OR 1.00, 95%CI: 0.43-2.33, P =1.00) or HOMA β-cell (OR 1.41, 95%CI: 0.60-3.32, P =0.43). The data suggest that higher IR and lower β-cell function are associated with the presence of DR in the subgroup of diabetic patients with higher BMI. However, this association is not statistically significant in diabetic patients with lower BMI.

Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial.

PubMed

Huhn, E A; Fischer, T; Göbl, C S; Todesco Bernasconi, M; Kreft, M; Kunze, M; Schoetzau, A; Dölzlmüller, E; Eppel, W; Husslein, P; Ochsenbein-Koelble, N; Zimmermann, R; Bäz, E; Prömpeler, H; Bruder, E; Hahn, S; Hoesli, I

2016-10-12

As the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an 'early' oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort. In a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany. Women are screened for pre-existing diabetes mellitus and GDM by an 'early' OGTT 75 g and/or the new biomarker, glyFn, at 12-15 weeks of gestation. Different screening strategies are compared to evaluate the impact on detection of GDM by an OGTT 75 g at 24-28 weeks of gestation as recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). A new screening algorithm is created by using multivariable risk estimation based on 'early' OGTT 75 g and/or glyFn results, incorporating maternal risk factors. Recruitment began in May 2014. This study received ethical approval from the ethics committees in Basel, Zurich, Vienna, Salzburg and Freiburg. It was registered under http://www.ClinicalTrials.gov (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals. NCT02035059. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Remote monitoring technologies for the prevention of metabolic syndrome: the Diabetes and Technology for Increased Activity (DaTA) study.

PubMed

Stuckey, Melanie; Fulkerson, Robyn; Read, Emily; Russell-Minda, Elizabeth; Munoz, Claudio; Kleinstiver, Peter; Petrella, Robert

2011-07-01

Remote monitoring technologies are ideally suited for rural communities with limited access to health care. In an 8-week pilot study, we examined the feasibility of implementing and conducting a technology-intensive intervention in an underserviced rural setting. Our goal was to test the utility of self-monitoring technologies, physical activity, and education as tools to manage health indicators for the development of the cardiovascular complications (CVCs) of type 2 diabetes. The Diabetes and Technology for Increased Activity study was an open single-center study conducted in a community-based research setting. All 24 participants were provided with a Blackberry™ Smartphone, blood pressure monitor, glucometer, and pedometer. Smartphones transmitted measurements and survey results to the database, interfaced participants with the clinical team, and allowed for self-monitoring. Outcomes were improved body composition, improved markers of CVC risk factors, increased daily exercise, and interest in or awareness of lifestyle changes that impact health outcomes. Participants had excellent compliance for measurements, as self-monitoring provided a sense of security that improved from week 4 to week 8. Our team gained substantial insight into the operational requirements of technology-facilitated health care, including redefined hours of service; data reporting, management, and access protocols; and the utility of real-time clinical measures by remote monitoring. We developed an understanding of knowledge translation strategies as well as successful motivational and educational tools. Importantly, remote monitoring technology was found to be feasible and accepted in a rural setting. © 2011 Diabetes Technology Society.

Detection of hepatic and pancreatic fat infiltration in type II diabetes mellitus patients with IDEAL-Quant using 3.0T MR: comparison with single-voxel proton spectroscopy.

PubMed

Ma, Jing; Song, Zhiqiang; Yan, Fuhua

2014-01-01

Type II diabetes mellitus usually related to visceral and other organ (ectopic) fat. The purpose of this study was to detect hepatic and pancreatic fat infiltration in type II diabetes mellitus patients using 3.0T magnetic resonance (MR) and to compare the performance of iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL-Quant) with single-voxel proton spectroscopy (H(1)-MRS). The study protocol was approved by our Institutional Review Board. Written informed consent was obtained from each subject in this study. We prospectively performed IDEAL-Quant and single-voxel proton spectroscopy with an echo time of 35 ms on 24 type II diabetes patients and 10 healthy volunteers. The hepatic proton density fat fraction (HPDFF) and pancreatic proton density fat fraction (PPDFF) were calculated, compared, and analyzed by t-tests and Spearman's correlation. The HPDFF and PPDFF measured with IDEAL-Quant were significantly different between the healthy volunteers and type II diabetes patients (th = 9.377, P = 0.000; tp = 2.813, P = 0.008). The HPDFF and PPDFF measured with MRS were also significantly different between the healthy volunteers and type II diabetes patients (th = 5.342, P = 0.000; tp = 2.63, P = 0.013). The HPDFF and PPDFF measured by the two methods were in good agreement (rh = 0.854, P = 0.000; rp = 0.774, P = 0.000). The HPDFF and PPDFF were not significantly correlated with each other (rMRS = 0.203, p = 0.248; rIDEAL-Quant = 0.301, P = 0.084). The PPDFF measured with IDEAL-Quant was associated with body mass index (r = 0.377, P = 0.028). IDEAL-Quant is a nice method for hepatic and pancreatic fat detection, and it can be applied in clinical practice.

The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial.

PubMed

Game, Frances; Jeffcoate, William; Tarnow, Lise; Day, Florence; Fitzsimmons, Deborah; Jacobsen, Judith

2017-10-10

Diabetic foot ulcers are a common and severe complication of diabetes mellitus. Standard treatment includes debridement, offloading, management of infection and revascularisation where appropriate, although healing times may be long. The LeucoPatch® device is used to generate an autologous platelet-rich fibrin and leucocyte wound dressing produced from the patient's own venous blood by centrifugation, but without the addition of any reagents. The final product comprises a thin, circular patch composed predominantly of fibrin together with living platelets and leucocytes. Promising results have been obtained in non-controlled studies this system, but this now needs to be tested in a randomised controlled trial (RCT). If confirmed, the LeucoPatch® may become an important new tool in the armamentarium in the management of diabetic foot ulcers which are hard-to-heal. People with diabetes and hard-to-heal ulcers of the foot will receive either pre-specified good standard care or good standard care supplemented by the application of the LeucoPatch® device. The primary outcome will be the percentage of ulcers healed within 20 weeks. Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group. Ulcers of the foot are a major source of morbidity to patients with diabetes and costs to health care economies. The study population is designed to be as inclusive as possible with the aim of maximising the external validity of any findings. The primary outcome measure is healing within 20 weeks of randomisation and the trial also includes a number of secondary outcome measures. Among these are rate of change in ulcer area as a predictor of the likelihood of eventual healing, minor and major amputation of the target limb, the incidence of infection and quality of life. International Standard Randomised Controlled Trial, ISRCTN27665670 . Registered on 5 July 2013.

Cognitive-Behavioral Group Therapy for Latino youth with Type 1 Diabetes and depression: A case study.

PubMed

Cumba-Avilés, Eduardo

2017-02-01

This group case study describes the course of a 14-session Cognitive Behavioral Therapy (CBT) for Latino adolescents with Type 1 Diabetes Mellitus (T1DM) and depressive symptoms. The intervention, known as CBT-DM, is an adaptation of an efficacious group intervention for adolescent depression. The treatment rationale and cultural adaption model are described as well as procedures used to achieve sensitivity to the characteristics of the T1DM culture as experienced by Latino youth from Puerto Rico. Session-by-session protocol is reviewed and treatment gains on the group as a whole and on its individual members are presented, providing quantitative and qualitative data. Treatment feasibility, clients' acceptance and satisfaction with treatment, and follow-up data up to 6 months post-treatment are also examined, considering cognitive, behavioral, emotional, relational, medical, and functional outcomes. Complicating factors, barriers to care, and treatment implications are discussed in the context of treating clients with comorbid chronic physical illness and emotional problems also embedded in a Latino culture. Translation of evidence-based treatments for depression into primary care settings and adapting protocols to youth populations with other medical illnesses is proposed. Recommendations for clinicians are provided, emphasizing the establishment of collaborative relationships with clients, assessing their stage in the process of accepting their chronic illness, as well as understanding their overall context to avoid unnecessary attributions of pathology to their thoughts, behaviors, and feelings.

Cognitive-Behavioral Group Therapy for Latino youth with Type 1 Diabetes and depression: A case study

PubMed Central

Cumba-Avilés, Eduardo

2018-01-01

This group case study describes the course of a 14-session Cognitive Behavioral Therapy (CBT) for Latino adolescents with Type 1 Diabetes Mellitus (T1DM) and depressive symptoms. The intervention, known as CBT-DM, is an adaptation of an efficacious group intervention for adolescent depression. The treatment rationale and cultural adaption model are described as well as procedures used to achieve sensitivity to the characteristics of the T1DM culture as experienced by Latino youth from Puerto Rico. Session-by-session protocol is reviewed and treatment gains on the group as a whole and on its individual members are presented, providing quantitative and qualitative data. Treatment feasibility, clients’ acceptance and satisfaction with treatment, and follow-up data up to 6 months post-treatment are also examined, considering cognitive, behavioral, emotional, relational, medical, and functional outcomes. Complicating factors, barriers to care, and treatment implications are discussed in the context of treating clients with comorbid chronic physical illness and emotional problems also embedded in a Latino culture. Translation of evidence-based treatments for depression into primary care settings and adapting protocols to youth populations with other medical illnesses is proposed. Recommendations for clinicians are provided, emphasizing the establishment of collaborative relationships with clients, assessing their stage in the process of accepting their chronic illness, as well as understanding their overall context to avoid unnecessary attributions of pathology to their thoughts, behaviors, and feelings. PMID:29568241

Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial.

PubMed

Xu, Wang Hong; Rothman, Russell L; Li, Rui; Chen, Yingyao; Xia, Qinghua; Fang, Hong; Gao, Junling; Yan, Yujie; Zhou, Peng; Jiang, Yu; Liu, Yinan; Zhou, Fangjia; Wang, Wei; Chen, Minling; Liu, Xiao Yu; Liu, Xiao Na

2014-12-20

Diabetes self-management often involves the interpretation and application of oral, written, or quantitative information. Numerous diabetes patients in China have limited health literacy, which likely leads to poorer clinical outcomes. This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients. This is a cluster randomized controlled trial (RCT) conducted in 20 community healthcare sites in Shanghai, China. Overall, 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c (HbA1c) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale. During the 1-year period of intervention, while the control group will receive usual care, the intervention group will be supplemented with a comprehensive health literacy strategy which includes i) training healthcare providers in effective health communication skills that address issues related to low literacy, and ii) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors. Assessments will be conducted at both patient and healthcare provider levels, and will take place upon admission and after 3, 6, 12, and 24 months of intervention. The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients. Secondary outcomes at the patient level will include improvement in i) clinical outcomes (blood pressure, fasting lipids, body mass index, weight, smoking status), ii) patient reported self-management behaviors, and iii) patient-reported self-efficacy. Outcomes at the provider level will include: i) provider satisfaction and ii) intensity and type of care provided. The effects of the intervention will be examined in multivariable general linear models. Both cost-effectiveness and cost-utility analyses will be performed. The main strengths of this study are its large sample size and RCT design, involvement of both patients and healthcare providers, and the long term follow-up (24-months). This project will help to demonstrate the value of addressing health literacy and health communication to improve self-management and clinical outcomes among Chinese diabetes patients. ISRCTN76130594, Registration date: Sept 22, 2014.

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol

PubMed Central

Karlsen, Bjørg; Oftedal, Bjørg; Stangeland Lie, Silje; Rokne, Berit; Peyrot, Mark; Zoffmann, Vibeke; Graue, Marit

2016-01-01

Introduction Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c). Methods and analysis A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention. Ethics and dissemination The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences. Trial registration number: NCT02575599. PMID:27965253

Maturation of Human Embryonic Stem Cell–Derived Pancreatic Progenitors Into Functional Islets Capable of Treating Pre-existing Diabetes in Mice

PubMed Central

Rezania, Alireza; Bruin, Jennifer E.; Riedel, Michael J.; Mojibian, Majid; Asadi, Ali; Xu, Jean; Gauvin, Rebecca; Narayan, Kavitha; Karanu, Francis; O’Neil, John J.; Ao, Ziliang; Warnock, Garth L.

2012-01-01

Diabetes is a chronic debilitating disease that results from insufficient production of insulin from pancreatic β-cells. Islet cell replacement can effectively treat diabetes but is currently severely limited by the reliance upon cadaveric donor tissue. We have developed a protocol to efficiently differentiate commercially available human embryonic stem cells (hESCs) in vitro into a highly enriched PDX1+ pancreatic progenitor cell population that further develops in vivo to mature pancreatic endocrine cells. Immature pancreatic precursor cells were transplanted into immunodeficient mice with streptozotocin-induced diabetes, and glycemia was initially controlled with exogenous insulin. As graft-derived insulin levels increased over time, diabetic mice were weaned from exogenous insulin and human C-peptide secretion was eventually regulated by meal and glucose challenges. Similar differentiation of pancreatic precursor cells was observed after transplant in immunodeficient rats. Throughout the in vivo maturation period hESC-derived endocrine cells exhibited gene and protein expression profiles that were remarkably similar to the developing human fetal pancreas. Our findings support the feasibility of using differentiated hESCs as an alternative to cadaveric islets for treating patients with diabetes. PMID:22740171

Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research

PubMed Central

Singh, Sonal

2013-01-01

Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences. PMID:24555077

Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research.

PubMed

Maruthur, Nisa M; Joy, Susan; Dolan, James; Segal, Jodi B; Shihab, Hasan M; Singh, Sonal

2013-01-01

Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial.

PubMed

Calvo-Marín, Javier; Torrealba-Acosta, Gabriel; Campbell, Matthew; Gaboury, Jesse; Ali, Ajmol; Chen-Ku, Chih Hao

2017-07-20

Despite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking. We designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing. Inclusion criteria comprise: age older than 18 years, more than 2 years since T1D diagnosis, low C-peptide level, a stable insulin regimen, HbA1c less than 9.0% and regular participation in soccer activities. Our primary outcome evaluates safety regarding hypoglycemia events in patients using dietary and therapeutic adjustments, compared with the performance under the implementation of current American Diabetes Association (ADA) usual recommendations for nutritional and pharmacological adjustments for exercise. Additionally, we will evaluate as secondary outcomes: soccer performance, indexed by performance in well-established soccer skill tests, cognitive functions (indexed by Stroop, digital vigilance test (DVT), Corsi block-tapping task (CBP), and rapid visual information processing (RVIP) tests), and glycemic control measured with a continuous glucose monitor (CGM). Dietary and insulin adjustments standardized under a 4-step method strategy have never been tested in a clinical trial setting with intermittent forms of exercise, such as soccer. We hypothesize that through this strategy we will observe better performance by persons with T1D in soccer and cognitive evaluations, and more stable control of glycemic parameters before, during and after exercise execution, indexed by CGM measurements. ISRCTN, ISRCTN17447843. Registered on 5 January 2017.

Collection and processing of whole blood for transformation of peripheral blood mononuclear cells and extraction of DNA: the Type 1 Diabetes Genetics Consortium

PubMed Central

Rosinger, Silke; Nutland, Sarah; Mickelson, Eric; Varney, Michael D; Boehm, Bernard O; Olsem, Gary J; Hansen, John A; Nicholson, Ian; Hilner, Joan E; Perdue, Letitia H; Pierce, June J; Akolkar, Beena; Nierras, Concepcion; Steffes, Michael W

2010-01-01

Background and Purpose To yield large amounts of DNA for many genotype analyses and to provide a renewable source of DNA, the Type 1 Diabetes Genetics Consortium (T1DGC) harvested DNA and peripheral blood mononuclear cells (PBMCs) from individuals with type 1 diabetes and their family members in several regions of the world. Methods DNA repositories were established in Asia-Pacific, Europe, North America, and the United Kingdom. To address region-specific needs, different methods and sample processing techniques were used among the laboratories to extract and to quantify DNA and to establish Epstein-Barr virus transformed cell lines. Results More than 98% of the samples of PBMCs were successfully transformed. Approximately 20–25 µg of DNA were extracted per mL of whole blood. Extraction of DNA from the cell pack ranged from 92 to 165 µg per cell pack. In addition, the extracted DNA from whole blood or transformed cells was successfully utilized in each regional human leukocyte antigen genotyping laboratory and by several additional laboratories performing consortium-wide genotyping projects. Limitations Although the isolation of PBMCs was consistent among sites, the measurement of DNA was difficult to harmonize. Conclusions DNA repositories can be established in different regions of the world and produce similar amounts of high-quality DNA for a variety of high-throughput genotyping techniques. Furthermore, even with the distances and time necessary for transportation, highly efficient transformation of PBMCs is possible. For future studies/trials involving several laboratories in different locations, the T1DGC experience includes examples of protocols that may be applicable. In summary, T1DGC has developed protocols that would be of interest to any scientific organization attempting to overcome the logistical problems associated with studies/trials spanning multiple research facilities, located in different regions of the world. PMID:20595244

A comprehensive review of adherence to diabetes and cardiovascular medications in Iran; implications for practice and research

PubMed Central

2013-01-01

Treatment of diseases such as diabetes mellitus and cardiovascular disorders are highly dependent on medications and particularly adherence to medications to achieve optimal pharmacotherapy outcomes. Several factors can affect a patient’s adherence including: knowledge and beliefs about their illness and medications, concomitant psychological disorders, type of therapeutic regimen, and lack of access to medicines. In Iran, a middle income country, essential medicines are highly available and affordable. However, adherence to medications has not been emphasized especially for patients with diabetes and cardiovascular diseases. In the present study, we reviewed the available literature on adherence to medications used to treat diabetes and cardiovascular disorders in Iran. We systematically searched Scopus, Web of Science, PubMed, CINAHL, Google Scholar, Scientific Information Database, and IranMedex using a highly sensitive protocol on July 2012. We retrieved 1003 citations; and two independent researchers screened them for relevant publications. Studies were included if they reported rate or determinants of adherence to diabetes mellitus and cardiovascular medications. Trials on improving interventions were also included. The quality of studies was assessed using appropriate guidelines. Fourteen studies were eligible for data extraction and review. The definition of adherence and the measurement tools used were unclear among studies. Methodological caveats including inappropriate sample size, sampling methods, inclusion/exclusion criteria, and high rate of loss to follow-up were also observed. Nevertheless, adherence rate was reported to be 62.8-86.3% for oral hypoglycemic medications and 38.8-60.0% for cardiovascular medicines. Forgetfulness, lack of knowledge about medical condition and prescribed medications, and concerns about medications efficacy and side effects were consistently reported as barriers to adherence. Patient education plus telephone or short message service follow-ups were reported to improve adherence to oral hypo-glycemic medications. We did not find any high quality trials on adherence to cardiovascular medicines. In conclusion, adherence to cardiovascular and diabetes medications is not assured in Iranian patients. Based on the available literature, patient education and reinforcement interventions are required to address this issue. Future studies should employ careful designs and standard tools for assessment of adherence to medications. PMID:24360356

Advancement of the Artificial Pancreas through the Development of Interoperability Standards

PubMed Central

Picton, Peter E.; Yeung, Melanie; Hamming, Nathaniel; Desborough, Lane; Dassau, Eyal; Cafazzo, Joseph A.

2013-01-01

Despite advancements in the development of the artificial pancreas, barriers in the form of proprietary data and communication protocols of diabetes devices have made the integration of these components challenging. The Artificial Pancreas Standards and Technical Platform Project is an initiative funded by the JDRF Canadian Clinical Trial Network with the goal of developing device communication standards for the interoperability of diabetes devices. Stakeholders from academia, industry, regulatory agencies, and medical and patient communities have been engaged in advancing this effort. In this article, we describe this initiative along with the process involved in working with the standards organizations and stakeholders that are key to ensuring effective standards are developed and adopted. Discussion from a special session of the 12th Annual Diabetes Technology Meeting is also provided. PMID:23911190

Mining the Human Phenome using Semantic Web Technologies: A Case Study for Type 2 Diabetes

PubMed Central

Pathak, Jyotishman; Kiefer, Richard C.; Bielinski, Suzette J.; Chute, Christopher G.

2012-01-01

The ability to conduct genome-wide association studies (GWAS) has enabled new exploration of how genetic variations contribute to health and disease etiology. However, historically GWAS have been limited by inadequate sample size due to associated costs for genotyping and phenotyping of study subjects. This has prompted several academic medical centers to form “biobanks” where biospecimens linked to personal health information, typically in electronic health records (EHRs), are collected and stored on large number of subjects. This provides tremendous opportunities to discover novel genotype-phenotype associations and foster hypothesis generation. In this work, we study how emerging Semantic Web technologies can be applied in conjunction with clinical and genotype data stored at the Mayo Clinic Biobank to mine the phenotype data for genetic associations. In particular, we demonstrate the role of using Resource Description Framework (RDF) for representing EHR diagnoses and procedure data, and enable federated querying via standardized Web protocols to identify subjects genotyped with Type 2 Diabetes for discovering gene-disease associations. Our study highlights the potential of Web-scale data federation techniques to execute complex queries. PMID:23304343

Mining the human phenome using semantic web technologies: a case study for Type 2 Diabetes.

PubMed

Pathak, Jyotishman; Kiefer, Richard C; Bielinski, Suzette J; Chute, Christopher G

2012-01-01

The ability to conduct genome-wide association studies (GWAS) has enabled new exploration of how genetic variations contribute to health and disease etiology. However, historically GWAS have been limited by inadequate sample size due to associated costs for genotyping and phenotyping of study subjects. This has prompted several academic medical centers to form "biobanks" where biospecimens linked to personal health information, typically in electronic health records (EHRs), are collected and stored on large number of subjects. This provides tremendous opportunities to discover novel genotype-phenotype associations and foster hypothesis generation. In this work, we study how emerging Semantic Web technologies can be applied in conjunction with clinical and genotype data stored at the Mayo Clinic Biobank to mine the phenotype data for genetic associations. In particular, we demonstrate the role of using Resource Description Framework (RDF) for representing EHR diagnoses and procedure data, and enable federated querying via standardized Web protocols to identify subjects genotyped with Type 2 Diabetes for discovering gene-disease associations. Our study highlights the potential of Web-scale data federation techniques to execute complex queries.

Patterns of glycemic control using glycosylated hemoglobin in diabetics.

PubMed

Kahlon, Arunpreet Singh; Pathak, Rambha

2011-07-01

Till now estimation of blood glucose is the highly effective method for diagnosing diabetes mellitus but it provides a short-term picture of control. More evidence is required to prove that plasma glucose and glycosylated hemoglobin levels together gives a better estimate of glycemic control and compliance with treatment. Indian diabetes risk score (IDRS) is a simplified screening tool for identifying undiagnosed diabetic subjects, requires minimum time, and effort and can help to considerably reduce the costs of screening. To study patterns of glycemic control using glycosylated hemoglobin in diabetic patients. To find out correlation between levels of plasma glucose and glycosylated hemoglobin in diabetics and to calculate IDRS of the study population. A cross sectional study was conducted among 300 known diabetic patients attending outpatient department of a rural medical college in Haryana, India. Following standard procedures and protocols FPG and glycosylated hemoglobin were measured to find out a pattern of glycemic control in them after taking their written and informed consent. A correlation between the levels of glycosylated hemoglobin and fasting blood glucose was also calculated. These patients were made to fill a performa and their demographic and clinical risk factors were noted and based on this, their IDRS was calculated. This was done to validate the IDRS in Indian rural population. Fifty-two percent of the population had fasting plasma glucose level between 125-150 mg/dl, 21% had this level between 151-175 mg/dl. Thirteen percent of the study subjects had HbA1C between 6.5-7.5, more than half (57.3%) had this value between 7.5-8.5, 12% and 18% had values between 8.5-9.5 and 9.5-10.5, respectively. Twelve percent of the participants had HbA1C level higher than 10.5. Correlation of fasting plasma glucose level and HbA1C was also studied and found that correlation coefficient came out to be .311. This correlation was found to be statistically significant (P = .007). Sixty-five percent of the case had IDRS higher than 60. Glycaemic control in diabetics can be better assessed with glycosylated hemoglobin and FPG together. A positive correlation between FPG and HbA1c allows for the use of HbA1c along with FPG in diagnosing type 2 DM but the two should not be used interchangeably. IDRS can be used as a screening tool for diabetes.

Effect of aerobic exercise and low carbohydrate diet on pre-diabetic non-alcoholic fatty liver disease in postmenopausal women and middle aged men--the role of gut microbiota composition: study protocol for the AELC randomized controlled trial.

PubMed

Liu, Wu Yi; Lu, Da Jiang; Du, Xia Ming; Sun, Jian Qin; Ge, Jun; Wang, Ren Wei; Wang, Ru; Zou, Jun; Xu, Chang; Ren, Jie; Wen, Xin Fei; Liu, Yang; Cheng, Shu Mei; Tan, Xiao; Pekkala, Satu; Munukka, Eveliina; Wiklund, Petri; Chen, Yan Qiu; Gu, Qing; Xia, Zheng Chang; Liu, Jun Jun; Liu, Wen Bin; Chen, Xue Bo; Zhang, Yi Min; Li, Rui; Borra, Ronald J H; Yao, Jia Xin; Chen, Pei Jie; Cheng, Sulin

2014-01-17

Pre-diabetes and non-alcoholic fatty liver disease (NAFLD) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system. In this study, we aim to explore whether individualized aerobic exercise (AEx) and low carbohydrate diet (LCh) intervention affect hepatic fat content (HFC) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects. A 6-month randomized intervention with 6-month follow-up is conducted from January 2013 to December 2015. The target sample size for intervention is 200 postmenopausal women and middle-aged men aged 50-65 year-old with pre-diabetes and NAFLD. The qualified subjects are randomized into 4 groups with 50 subjects in each group: 1 = AEx, 2 = LCh, 3 = AEx + LCh, and 4 = control. In addition, two age-matched reference groups (5 = pre-diabetes without NAFLD (n = 50) and 6 = Healthy without pre-diabetes or NAFLD (n = 50)) are included. The exercise program consists of progressive and variable aerobic exercise (intensity of 60 to 75% of initial fitness level, 3-5 times/week and 30-60 min/time). The diet program includes dietary consultation plus supplementation with a special lunch meal (40% of total energy intake/day) which aims to reduce the amount of carbohydrate consumption (30%). The control and reference groups are advised to maintain their habitual habits during the intervention. The primary outcome measures are HFC, serum metabolomics and gut microbiota composition. The secondary outcome measures include body composition and cytokines. In addition, socio-psychological aspects, social support, physical activity and diet will be performed by means of questionnaire and interview. Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition. Besides, the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders. If our program is shown to be effective, it will open new strategies to combat these chronic diseases. Current Controlled Trials: ISRCTN42622771.

Eye Disease in Patients with Diabetes Screened with Telemedicine.

PubMed

Park, Dong-Wouk; Mansberger, Steven L

2017-02-01

Telemedicine with nonmydriatic cameras can detect not only diabetic retinopathy but also other eye disease. To determine the prevalence of eye diseases detected by telemedicine in a population with a high prevalence of minority and American Indian/Alaskan Native (AI/AN) ethnicities. We recruited diabetic patients 18 years and older and used telemedicine with nonmydriatic cameras to detect eye disease. Two trained readers graded the images for diabetic retinopathy, age-related macular degeneration (ARMD), glaucomatous features, macular edema, and other eye disease using a standard protocol. We included both eyes for analysis and excluded images that were too poor to grade. We included 820 eyes from 424 patients with 72.3% nonwhite ethnicity and 50.3% AI/AN heritage. While 283/424 (66.7%) patients had normal eye images, 120/424 (28.3%) had one disease identified; 15/424 (3.5%) had two diseases; and 6/424 (1.4%) had three diseases in one or both eyes. After diabetic retinopathy (104/424, 24.5%), the most common eye diseases were glaucomatous features (44/424, 10.4%) and dry ARMD (24/424, 5.7%). Seventeen percent (72/424, 17.0%) showed eye disease other than diabetic retinopathy. Telemedicine with nonmydriatic cameras detected diabetic retinopathy, as well as other visually significant eye disease. This suggests that a diabetic retinopathy screening program needs to detect and report other eye disease, including glaucoma and macular disease.

Specific endothelin ET(A) receptor antagonism does not modulate insulin-induced hemodynamic effects in the human kidney, eye, or forearm.

PubMed

Rab, Anna; Dallinger, Susanne; Polak, Kaija; Pleiner, Johannes; Polska, Elzbieta; Wolzt, Michael; Schmetterer, Leopold

2004-05-01

There is evidence that hyperinsulinemia may stimulate endothelin-1 (ET-1) generation or release, which may affect diabetic vascular complications. BQ-123, a specific ET(A) receptor antagonist, was used to investigate if insulin-induced vascular effects are influenced by an acute ET-1 release. Two randomized, placebo-controlled, double-blind, cross-over studies were performed. In protocol 1, 12 healthy subjects received, on separate study days, infusions of BQ-123 (60 microg/min for 30 min) during placebo clamp conditions, BQ-123 during euglycemic hyperinsulinemia (3 mU/kg/min for 390 min), or placebo during euglycemic hyperinsulinemia. Fundus pulsation amplitude (FPA) was measured to assess pulsatile choroidal blood flow, and mean flow velocity (MFV) of the ophtalmic artery was measured by color Doppler imaging. In protocol 2, eight healthy subjects received, on separate study days, intra-arterial infusions of BQ-123 (32 microg/min for 120 min) during placebo or insulin clamp. Forearm blood flow was measured with bilateral plethysmography, expressing the ratio of responses in the intervention arm and in the control arm. Insulin alone increased FPA (+10%, p < 0.001) and forearm blood flow (+19%). BQ-123 increased FPA, MFV, and forearm blood flow ratio in the absence and presence of exogenous insulin, but this effect was not different between normo- and hyperinsulinemic conditions. ET-1 plasma concentrations were not affected by insulin. In conclusion, these data do not support the concept that hyperinsulinemia increases ET-1 generation in healthy subjects. Our results, however, cannot necessarily be extrapolated to diabetic and obese subjects.

Pharmacist and physician perspectives on diabetes service delivery within community pharmacies in Indonesia: a qualitative study.

PubMed

Wibowo, Yosi; Sunderland, Bruce; Hughes, Jeffery

2016-05-01

To explore perspectives of physicians and pharmacists on diabetes service delivery within community pharmacies in Indonesia. In depth interviews were conducted with 10 physicians and 10 community pharmacists in Surabaya, Indonesia, using a semi-structured interview guide. Nvivo version 9 was used to facilitate thematic content analysis to identify barriers/facilitators for community pharmacists to provide diabetes services. The identified themes indicating barriers/facilitators for diabetes service delivery within Indonesian community pharmacies included: (1) pharmacist factors - i.e. positive views (facilitator) and perceived lack of competence (barrier); (2) pharmacist-physician relationships - i.e. physicians' lack of support and accessibility (barriers); (3) pharmacist-patient relationships - i.e. perceived patients' lack of support and accessibility (barriers); (4) pharmacy environment - i.e. business orientation (barrier), lack of staff and poor pharmacist availability (barriers), and availability of supporting resources, such as counselling areas/rooms, procedures/protocols and IT systems for labelling and patient records (facilitators); and (5) external environment - i.e. a health system to support pharmacist roles, remuneration, marketing and professional assistance (facilitators). Issues related to the pharmacist-physician-patient relationships, pharmacy environment and external environment need to be addressed before Indonesian community pharmacists can provide additional pharmacy services for type 2 diabetes patients. Collaboration between the Government, Ikatan Apoteker Indonesia (Indonesian Pharmacists Association) and Ikatan Dokter Indonesia (Indonesian Medical Association) is required to improve the pharmacy professional environment and facilities. © 2015 Royal Pharmaceutical Society.

Cardiac stress test as a risk-stratification tool for posttransplant cardiac outcomes in diabetic kidney transplant recipients.

PubMed

Singh, Neeraj; Parikh, Samir; Bhatt, Udayan; Vonvisger, Jon; Nori, Uday; Hasan, Ayesha; Samavedi, Srinivas; Andreoni, Kenneth; Henry, Mitchell; Pelletier, Ronald; Rajab, Amer; Elkhammas, Elmahdi; Pesavento, Todd

2012-12-27

The utility of cardiac stress testing as a risk-stratification tool before kidney transplantation remains debatable owing to discordance with coronary angiography and outcome yields at different centers. We conducted a retrospective study of 273 diabetic kidney transplant recipients from 2006 to 2010. By protocol, all diabetic patients underwent pharmacological radionucleotide stress test or dobutamine stress echocardiography before transplant. We compared the 1-year cardiac outcomes between those with negative stress test results and those with positive stress test results. Patients with a positive stress test result (n=67) underwent coronary angiogram, and significant coronary artery disease (≥70% coronary stenosis) was found in 35 (52.2%) patients. Of the latter, 32 (91.4%) underwent cardiac revascularization (24 underwent cardiac stenting and 8 underwent coronary artery bypass grafting). The rest (n=35) were treated medically. Within 1 year after transplant, the group with positive stress test results experienced more cardiac events (34.3% vs. 3.9%, P<0.001) including acute myocardial infarction (22.4% vs. 3.4%, P<0.001) and ventricular arrhythmias (8.9% vs. 0.05%, P=0.001), higher all-cause mortality (19.4% vs. 4.8%, P<0.001), and cardiac mortality (17.9% vs. 0.9%, P<0.001) compared with the group with negative stress test results. In this diabetic population, stress testing showed positive and negative predictive values of 34.3% and 96.1%, respectively. Pharmacological cardiac stress testing provided excellent risk stratification in diabetic kidney transplant recipients.

Health Insurance Portability and Accountability Act-Compliant Ocular Telehealth Network for the Remote Diagnosis and Management of Diabetic Retinopathy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, Yaquin; Karnowski, Thomas Paul; Tobin Jr, Kenneth William

2011-01-01

In this article, we present the design and implementation of a regional ocular telehealth network for remote assessment and management of diabetic retinopathy (DR), including the design requirements, network topology, protocol design, system work flow, graphics user interfaces, and performance evaluation. The Telemedical Retinal Image Analysis and Diagnosis Network is a computer-aided, image analysis telehealth paradigm for the diagnosis of DR and other retinal diseases using fundus images acquired from primary care end users delivering care to underserved patient populations in the mid-South and southeastern United States.

A health insurance portability and accountability act-compliant ocular telehealth network for the remote diagnosis and management of diabetic retinopathy.

PubMed

Li, Yaqin; Karnowski, Thomas P; Tobin, Kenneth W; Giancardo, Luca; Morris, Scott; Sparrow, Sylvia E; Garg, Seema; Fox, Karen; Chaum, Edward

2011-10-01

In this article, we present the design and implementation of a regional ocular telehealth network for remote assessment and management of diabetic retinopathy (DR), including the design requirements, network topology, protocol design, system work flow, graphics user interfaces, and performance evaluation. The Telemedical Retinal Image Analysis and Diagnosis Network is a computer-aided, image analysis telehealth paradigm for the diagnosis of DR and other retinal diseases using fundus images acquired from primary care end users delivering care to underserved patient populations in the mid-South and southeastern United States.

Reducing severe hypoglycaemia in hospitalised patients with diabetes: Early outcomes of standardised reporting and management.

PubMed

Araque, Katherine A; Kadayakkara, Deepak K; Gigauri, Nino; Sheehan, Diane; Majumdar, Sachin; Buller, Gregory; Flannery, Clare A

2018-01-01

Severe hypoglycaemic events (HGEs) in hospitalised patients are associated with poor outcomes and prolonged hospitalization. Systematic, coordinated care is required for acute management and prevention of HGEs; however, studies evaluating quality control efforts are scarce. To investigate the effectiveness of system-based interventions to improve management response to HGEs. System-based interventions were designed and implemented following a root cause analysis of HGE in adult patients with diabetes from two general medical wards with the highest incidence of HGE. Interventions included electronic medical record programming for a standardised order set for basal-bolus insulin regimen and hypoglycemia protocol, automated dextrose order, automated MD notification, and recommendation for endocrine consultation after two critical HGEs. The Pyxis MedStation was programmed to alert nurses to recheck blood glucose 15 min after the treatment. A card with the HGE management protocol was attached to each provider's ID badge and educational seminars were given to all providers. Primary outcomes were to evaluate median time from HGE (glucose <50 mg/dL) to euglycemia (>100 mg/dL), and time from HGE to follow-up finger-stick (FS) testing preintervention and postintervention. Secondary outcomes were cumulative incidence of HGEs, recurrent hypoglycemia, rate of physician notification and use of standardised treatments among adults with diabetes on the two general medical wards. Among hospitalised adults with diabetes and HGE, median time from HGE to euglycemia declined from 225±46 min preintervention to 87±26 min postintervention (p=0.03). Median time from HGE to next FS testing also declined (76±14 min to 28±10 min, p<0.001). Standardised treatment administration for HGE improved significantly from 34% (12/35) to 97% (36/37); physician notification rate improved significantly from 51% (18/35) to 78% (29/37).Among hospitalised adults with diabetes, incidence of HGE decreased from 12% (35/295) over 3 months (preintervention period) to 6% (37/610) over 6 months (postintervention period) (p<0.001), while recurrent HGE did not show significant differences (37% (13/35) to 24% (9/37), p=0.09). System-based interventions had a clinically important impact on decreasing time from HGE to euglycemia and to next FS testing. This hypoglycemia bundle of care may be applied and tested in other community hospitals to improve patient safety.

"DAK", a traditional decoction in Palau, as adjuvant for patients with insufficient control of diabetes mellitus type II.

PubMed

Kitalong, Christopher; Nogueira, Renata Campos; Benichou, Jeanne; Yano, Victor; Espangel, Vanessa; Houriet, Joëlle; Rudigier, Carla; Graz, Bertrand

2017-06-09

Can a medicinal plant be useful when standard modern treatment is insufficient? After a population survey in the Republic of Palau (retrospective treatment-outcome study, following the reverse pharmacology approach) on local treatments and associated outcomes for diabetes, a traditional drink made with Phaleria nisidai Kaneh and several other plants called "Delal A Kar", (meaning "mother of medicine") appeared as a promising therapy. This is the first clinical study on a standardized version of "Delal A Kar" called DAK. This is a study of the effect of DAK as adjuvant therapy when diabetes control is insufficient. In this randomized, double blind, crossover study conducted in Koror, Palau, DAK or placebo was assigned to 68 patients with type II diabetes treated with oral hypoglycemic agents and with insufficient glycaemic control. All patients received instructions on how to improve their diet and a home glucometer for blood glucose follow-up. Fifty-five patients completed the study and significant improvements were observed in both groups over the 12 weeks follow-up period: weight decreased an average of 2 to -4.5 pounds (p<0,001) and HbA1C also decreased from 9.7% to 7.8% (p<0,001), with a consistent trend toward better outcomes after DAK, as compared to placebo. The average effect of Ongael was 0.5% (SD 2.5) decrease of HbA1C. Furthermore, seventy-five percent (41/55) of the patients reduced their HbA1C by at least 0.7% at 12 weeks. The observed trends in this trial suggest that poorly controlled diabetic patients improved their control of diabetes within 12 weeks when drinking DAK for at least 6 weeks. The drink DAK, in addition to the usual prevention activities of special diet and physical exercise, was followed by improvement of diabetes control (HbA1C) and decrease of blood pressure and weight. The study protocol was approved by the Institutional Ethical Committee and registered by international Australia and New Zealand trial registry (Request Number: 369395) FUNDING: Pacific Academic Institute for Research office fund, Belau Medical Clinic, The Environment, Inc, Antenna Foundation, Grandjean and Michèle Berset funds and the Weil Foundation. Copyright © 2017. Published by Elsevier B.V.

Comparison of Film and Digital Fundus Photographs in Eyes of Individuals with Diabetes Mellitus

PubMed Central

Gangaputra, Sapna; Glassman, Adam R.; Aiello, Lloyd Paul; Bressler, Neil; Bressler, Susan B.; Danis, Ronald P.; Davis, Matthew D.

2011-01-01

Purpose. To compare grading of diabetic retinopathy (DR) and diabetic macular edema (DME) from stereoscopic film versus stereoscopic digital photographs obtained from a subset of Diabetic Retinopathy Clinical Research Network (DRCR.net) participants. Methods. In this photographic media comparison study, digital and film images were obtained at a single study visit from some of the subjects enrolled in active DRCR.net clinical study protocols. Digital camera systems and digital and film photographers were certified to obtain images according to standard procedures. Images were graded for DR severity and DME in a masked fashion by Fundus Photograph Reading Center (Madison, WI) graders. Agreement between gradings was assessed by calculating the percentage of agreement and κ statistics. Results. Images obtained with both film and digital media were submitted for 155 eyes of 96 study participants. On a nine-step Early Treatment Diabetic Retinopathy study DR severity scale, grading agreed exactly in 74%, and was within one step of agreement in 93%, with a weighted κ statistic of 0.82 (95% confidence interval [CI], 0.71–0.92). On a nine-step DME severity scale and three-step clinically significant macular edema (CSME) scale, grading agreed exactly in 39% and 88%, respectively, and within one step in 70% and 92% (weighted κ statistic, 0.44 [95% Cl, 0.34–0.54] and 0.72 [95% Cl, 0.55–0.90], respectively). Conclusions. Among clinical sites participating in the DRCR.net, agreement between film and digital images was substantial to almost perfect for DR severity level and moderate to substantial for DME and CSME severity levels, respectively. Replacement of film fundus images with digital images for DR severity level should not adversely affect clinical trial quality. (ClinicalTrials.gov numbers, NCT00367133, NCT00369486, NCT00444600, NCT00445003, NCT00709319.) PMID:21571677

Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol.

PubMed

de Burgos-Lunar, Carmen; Gómez-Campelo, Paloma; Cárdenas-Valladolid, Juan; Fuentes-Rodríguez, Carmen Y; Granados-Menéndez, María I; López-López, Francisco; Salinero-Fort, Miguel A

2012-07-30

Type 2 diabetes mellitus and depression are highly prevalent diseases that are associated with an increased risk of cardiovascular disease and mortality. There is evidence about a bidirectional association between depressive symptoms and type 2 diabetes mellitus. However, prognostic implications of the joint effects of these two diseases on cardiovascular morbidity and mortality are not well-known. A three-year, observational, prospective, cohort study, carried out in Primary Health Care Centres in Madrid (Spain). The project aims to analyze the effect of depression on cardiovascular events, all-cause and cardiovascular mortality in patients with type 2 diabetes mellitus, and to estimate a clinical predictive model of depression in these patients.The number of patients required is 3255, all them with type 2 diabetes mellitus, older than 18 years, who regularly visit their Primary Health Care Centres and agree to participate. They are chosen by simple random sampling from the list of patients with type 2 diabetes mellitus of each general practitioner.The main outcome measures are all-cause and cardiovascular mortality and cardiovascular morbidity; and exposure variable is the major depressive disorder.There will be a comparison between depressed and not depressed patients in all-cause mortality, cardiovascular mortality, coronary artery disease and stroke using the Chi-squared test. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors that might alter the effect recorded will be taken into account in this analysis. To assess the effect of depression on the mortality, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of a Cox regression model. Our study's main contribution is to evaluate the increase in the risk of cardiovascular morbidity and mortality, in depressed Spanish adults with type 2 diabetes mellitus attended in Primary Health Care Setting. It would also be useful to identify subgroups of patients for which the interventions could be more beneficial.

Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol

PubMed Central

Salinero-Fort, Miguel Ángel; de Burgos-Lunar, Carmen; Mostaza Prieto, José; Lahoz Rallo, Carlos; Abánades-Herranz, Juan Carlos; Gómez-Campelo, Paloma; Laguna Cuesta, Fernando; Estirado De Cabo, Eva; García Iglesias, Francisca; González Alegre, Teresa; Fernández Puntero, Belén; Montesano Sánchez, Luis; Vicent López, David; Cornejo Del Río, Víctor; Fernández García, Pedro J; Sabín Rodríguez, Concesa; López López, Silvia; Patrón Barandío, Pedro

2015-01-01

Introduction The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide. When diagnosed, many patients already have organ damage or advance subclinical atherosclerosis. An early diagnosis could allow the implementation of lifestyle changes and treatment options aimed at delaying the progression of the disease and to avoid cardiovascular complications. Different scores for identifying undiagnosed diabetes have been reported, however, their performance in populations of southern Europe has not been sufficiently evaluated. The main objectives of our study are: to evaluate the screening performance and cut-off points of the main scores that identify the risk of undiagnosed T2DM and prediabetes in a Spanish population, and to develop and validate our own predictive models of undiagnosed T2DM (screening model), and future T2DM (prediction risk model) after 5-year follow-up. As a secondary objective, we will evaluate the atherosclerotic burden of the population with undiagnosed T2DM. Methods and analysis Population-based prospective cohort study with baseline screening, to evaluate the performance of the FINDRISC, DANISH, DESIR, ARIC and QDScore, against the gold standard tests: Fasting plasma glucose, oral glucose tolerance and/or HbA1c. The sample size will include 1352 participants between the ages of 45 and 74 years. Analysis: sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio positive, likelihood ratio negative and receiver operating characteristic curves and area under curve. Binary logistic regression for the first 700 individuals (derivation) and last 652 (validation) will be performed. All analyses will be calculated with their 95% CI; statistical significance will be p<0.05. Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of the Carlos III Hospital (Madrid). The score performance and predictive model will be presented in medical conferences, workshops, seminars and round table discussions. Furthermore, the predictive model will be published in a peer-reviewed medical journal to further increase the exposure of the scores. PMID:26220868

Micropulsed diode laser therapy: evolution and clinical applications.

PubMed

Sivaprasad, Sobha; Elagouz, Mohammed; McHugh, Dominic; Shona, Olajumoke; Dorin, Giorgio

2010-01-01

Many clinical trials have demonstrated the clinical efficacy of laser photocoagulation in the treatment of retinal vascular diseases, including diabetic retinopathy. There is, however, collateral iatrogenic retinal damage and functional loss after conventional laser treatment. Such side effects may occur even when the treatment is appropriately performed because of morphological damage caused by the visible endpoint, typically a whitening burn. The development of the diode laser with micropulsed emission has allowed subthreshold therapy without a visible burn endpoint. This greatly reduces the risk of structural and functional retinal damage, while retaining the therapeutic efficacy of conventional laser treatment. Studies using subthreshold micropulse laser protocols have reported successful outcomes for diabetic macular edema, central serous chorioretinopathy, macular edema secondary to retinal vein occlusion, and primary open angle glaucoma. The report includes the rationale and basic principles underlying micropulse diode laser therapy, together with a review of its current clinical applications. Copyright © 2010 Elsevier Inc. All rights reserved.

Design of a randomized, non-inferiority trial to evaluate the reliability of videoconferencing for remote consultation of diabetes.

PubMed

Fatehi, Farhad; Martin-Khan, Melinda; Gray, Leonard C; Russell, Anthony W

2014-02-14

An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030. Management of this disease and its complications is a challenge for many countries. Optimal glycaemic control is necessary to minimize complications, but less than 70% of diabetic patients achieve target levels of blood glucose, partly due to poor access to qualified health care providers. Telemedicine has the potential to improve access to health care, especially for rural and remote residents. Video teleconsultation, a real-time (or synchronous) mode of telemedicine, is gaining more popularity around the world through recent improvements in digital telecommunications. If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management, then it is important to demonstrate that this can be achieved without loss of clinical fidelity. This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes. A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group. Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference. The primary outcome measure will be a change in the patient's medication. Secondary outcome measures will be findings in physical examination, detecting complications, and patient satisfaction. A difference of less than 20% in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care (face-to-face). Despite rapid growth in application of telemedicine in a variety of medical specialties, little is known about the reliability of videoconferencing for remote consultation of people with diabetes. Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes. Australian New Zealand Clinical Trials Registry ACTRN12612000315819.

Relation of four nontraditional lipid profiles to diabetes in rural Chinese H-type hypertension population.

PubMed

Wang, Haoyu; Guo, Xiaofan; Chen, Yintao; Li, Zhao; Xu, Jiaqi; Sun, Yingxian

2017-10-11

Mounting evidence suggested that nontraditional lipid profiles have been recognized as a reliable indicator for unfavorable cardiovascular events. The purpose of this study was to explore the role of nontraditional lipid profiles as potential clinical indices for the assessment of prevalent diabetes in rural Chinese H-type hypertension population. During 2012 to 2013, we conducted a large cross-sectional study of 2944 H-type hypertension participants (≥35 years of age) from rural areas in northeast China. Subjects underwent accurate assessment of lipid profiles, fasting plasma glucose (FPG), homocysteine (Hcy) according to standard protocols. The proportion of diabetes showed a graded and linear increase across the quartiles for all four nontraditional lipid parameters. Nontraditional lipid variables were independent determinants of FPG, and its correlation for TG/HDL-C was strongest, whether potential confounders were adjusted or not. Multivariable logistic regression analysis established that the highest triglycerides (TG)/ high-density lipoprotein cholesterol (HDL-C) quartile manifested the largest ORs of prevalent diabetes (OR: 3.275, 95%CI: 2.109-5.087) compared with the lowest quartile. The fully adjusted ORs (95%CI) were 2.753 (1.783-4.252), 2.178 (1.415-2.351), 1.648 (1.097-2.478) for the top quartile of total cholesterol (TC)/HDL-C, low-density lipoprotein cholesterol (LDL-C)/HDL-C, and non-high-density lipoprotein cholesterol (non-HDL-C), respectively. On the basis of the area under receiver-operating characteristic curve (AUC), TG/HDL-C showed the optimal discriminating power for diabetes (AUC: 0.684, 95% CI: 0.650-0.718). Nontraditional lipid profiles (TG/HDL-C, TC/HDL-C, LDL-C/HDL-C and non-HDL-C) were all consistently and independently correlated with prevalent diabetes among the H-type hypertension population in rural China. TG/HDL-C was prone to be more profitable in assessing the risk of prevalent diabetes and should be encouraged as an effective clinical tool for monitoring and targeted intervention of diabetes in H-type hypertension adults.

Design of a randomized, non-inferiority trial to evaluate the reliability of videoconferencing for remote consultation of diabetes

PubMed Central

2014-01-01

Background An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030. Management of this disease and its complications is a challenge for many countries. Optimal glycaemic control is necessary to minimize complications, but less than 70% of diabetic patients achieve target levels of blood glucose, partly due to poor access to qualified health care providers. Telemedicine has the potential to improve access to health care, especially for rural and remote residents. Video teleconsultation, a real-time (or synchronous) mode of telemedicine, is gaining more popularity around the world through recent improvements in digital telecommunications. If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management, then it is important to demonstrate that this can be achieved without loss of clinical fidelity. This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes. Methods/Design A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group. Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference. The primary outcome measure will be a change in the patient’s medication. Secondary outcome measures will be findings in physical examination, detecting complications, and patient satisfaction. A difference of less than 20% in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care (face-to-face). Discussion Despite rapid growth in application of telemedicine in a variety of medical specialities, little is known about the reliability of videoconferencing for remote consultation of people with diabetes. Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12612000315819. PMID:24528569

An evaluation of the telehealth facilitation of diabetes and cardiovascular care in remote Australian Indigenous communities: - protocol for the telehealth eye and associated medical services network [TEAMSnet] project, a pre-post study design.

PubMed

Brazionis, Laima; Jenkins, Alicia; Keech, Anthony; Ryan, Chris; Bursell, Sven-Erik

2017-01-05

Despite substantial investment in detection, early intervention and evidence-based treatments, current management strategies for diabetes-associated retinopathy and cardiovascular disease are largely based on real-time and face-to-face approaches. There are limited data re telehealth facilitation in type 2 diabetes management. Therefore, we aim to investigate efficacy of telehealth facilitation of diabetes and cardiovascular disease care in high-risk vulnerable Aboriginal and Torres Strait Islanders in remote/very remote Australia. Using a pre-post intervention design, 600 Indigenous Australians with type 2 diabetes will be recruited from three primary-care health-services in the Northern Territory. Diabetes status will be based on clinical records. There will be four technological interventions: 1. Baseline retinal imaging [as a real-time patient education/engagement tool and telehealth screening strategy]. 2. A lifestyle survey tool administered at ≈ 6-months. 3. At ≈ 6- and 18-months, an electronic cardiovascular disease and diabetes decision-support tool based on current guidelines in the Standard Treatment Manual of the Central Australian Rural Practitioner's Association to generate clinical recommendations. 4. Mobile tablet technology developed to enhance participant engagement in self-management. Data will include: Pre-intervention clinical and encounter-history data, baseline retinopathy status, decision-support and survey data/opportunistic mobile tablet encounter data. The primary outcome is increased participant adherence to clinical appointments, a marker of engagement and self-management. A cost-benefit analysis will be performed. Remoteness is a major barrier to provision and uptake of best-practice chronic disease management. Telehealth, beyond videoconferencing of consultations, could facilitate evidence-based management of diabetes and cardiovascular disease in Indigenous Australians and serve as a model for other conditions. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN 12616000370404 was retrospectively registered on 22/03/2016.

Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial.

PubMed

da Silva, José Roberto; Borges, Paulo Sérgio; Agra, Karine F; Pontes, Isabelle Albuquerque; Alves, João Guilherme Bezerra

2013-11-19

Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes. However, there are no randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes. An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira (IMIP), Brazil. A total of 72 pregnant women will be studied; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool, 3 times per week over 2 months. The primary endpoint will be glucose level control and use of insulin; secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, pre-eclampsia diagnosis, intrauterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. Endpoints between intervention and control group will analyzed by t test for unpaired data and χ² test, and the level of significance will set at <0.05. The physical proprieties of water make aquatic exercises ideal for pregnant women. An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance. It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control. ClinicalTrial.gov, NCT01940003.

Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus

PubMed Central

2014-01-01

Background Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in cystic fibrosis, cystic fibrosis related diabetes will be diagnosed more frequently in the future. Up to date, no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy. Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment. Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy. Based on an initiative of the German Mukoviszidosis-Foundation, the present study tries to answer the question, whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus. Methods/Design In all cystic fibrosis patients with an age of 10 years or older, an oral glucose tolerance test is recommended. The result of this test is classified according to the WHO cut off values. It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus. This study is a multi-national, multicentre, open labelled, randomized and prospective controlled parallel group’s trial, with 24 months treatment. The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment. The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes. Patients are randomised by central fax randomisation. Primary endpoint is mean HbA1c after 24 months of treatment. Secondary endpoints are change in FEV1% predicted and change in BMI-Z-score. Discussion There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia. The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide. HbA1c and lung function (FEV1%pred) were unchanged for either group. The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group. Therefore a direct comparison of the effect of repaglinide versus insulin on BMI, HbA1c and FEV1%pred was not presented. According to our protocol, we will directly compare treatment effects (HbA1c, BMI, FEV1%pred) in between both groups. The actual Cochrane report regarding “Insulin and oral agents for managing CFRD” stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents. We expect that the results of our study will help to address this clinical need. Trial registration ClinicalTrials.gov Identifier: NCT00662714 PMID:24620855

Impact of Common Diabetes Risk Variant in MTNR1B on Sleep, Circadian, and Melatonin Physiology.

PubMed

Lane, Jacqueline M; Chang, Anne-Marie; Bjonnes, Andrew C; Aeschbach, Daniel; Anderson, Clare; Cade, Brian E; Cain, Sean W; Czeisler, Charles A; Gharib, Sina A; Gooley, Joshua J; Gottlieb, Daniel J; Grant, Struan F A; Klerman, Elizabeth B; Lauderdale, Diane S; Lockley, Steven W; Munch, Miriam; Patel, Sanjay; Punjabi, Naresh M; Rajaratnam, Shanthakumar M W; Rueger, Melanie; St Hilaire, Melissa A; Santhi, Nayantara; Scheuermaier, Karin; Van Reen, Eliza; Zee, Phyllis C; Shea, Steven A; Duffy, Jeanne F; Buxton, Orfeu M; Redline, Susan; Scheer, Frank A J L; Saxena, Richa

2016-06-01

The risk of type 2 diabetes (T2D) is increased by abnormalities in sleep quantity and quality, circadian alignment, and melatonin regulation. A common genetic variant in a receptor for the circadian-regulated hormone melatonin (MTNR1B) is associated with increased fasting blood glucose and risk of T2D, but whether sleep or circadian disruption mediates this risk is unknown. We aimed to test if MTNR1B diabetes risk variant rs10830963 associates with measures of sleep or circadian physiology in intensive in-laboratory protocols (n = 58-96) or cross-sectional studies with sleep quantity and quality and timing measures from self-report (n = 4,307-10,332), actigraphy (n = 1,513), or polysomnography (n = 3,021). In the in-laboratory studies, we found a significant association with a substantially longer duration of elevated melatonin levels (41 min) and delayed circadian phase of dim-light melatonin offset (1.37 h), partially mediated through delayed offset of melatonin synthesis. Furthermore, increased T2D risk in MTNR1B risk allele carriers was more pronounced in early risers versus late risers as determined by 7 days of actigraphy. Our results provide the surprising insight that the MTNR1B risk allele influences dynamics of melatonin secretion, generating a novel hypothesis that the MTNR1B risk allele may extend the duration of endogenous melatonin production later into the morning and that early waking may magnify the diabetes risk conferred by the risk allele. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Differences in diabetes prevalence and inequalities in disease management and glycaemic control by immigrant status: a population-based study (Italy).

PubMed

Ballotari, Paola; Caroli, Stefania; Ferrari, Francesca; Romani, Gabriele; Marina, Greci; Chiarenza, Antonio; Manicardi, Valeria; Giorgi Rossi, Paolo

2015-02-06

The diabetes prevalence increases at an alarming rate around the world and understanding disparities in occurrence, care management, and health outcomes may be a starting point towards achieving more effective strategies to prevent and manage it. The aims of this study are to compare immigrants and Italians in terms of the differences in diabetes prevalence and to evaluate inequalities in disease management and glycaemic control by using information included in Reggio Emilia diabetes register. We retrieved from the diabetes register subjects aged 20-74 on December 31(st), 2009. Using citizenship, we created three main groups: Italy, High Developed Countries (HDC), and High Migration Pressure Countries (HMPC). These were split into sub-regions of origin. We calculated age-adjusted prevalence by gender and sub-region. Using logistic regression model, we analyzed the association between area of origin and following indicators: 1) not being in care of diabetes clinics; 2) not having glycated haemoglobin (HbA1c) test in 2010; 3) among those tested, having a HbA1c value > = 9% (75 mmol/mol). We found 15,889 Italian and 1,295 HMPC citizens with diabetes. HMPC citizens had higher age-adjusted prevalence of diabetes than Italians (females 5.0% vs 3.6%; males 6.5% vs 5.5%). The excess was mostly due to a strong excess in immigrants from Southern Asia (females 9.7%, males 10.2%) and Northern Africa (females 9.3%, males 5.9%). HMPC citizens were cared for by diabetes clinics in a similar proportion than Italians (OR: 1.08; 95% CI: 0.93-1.25), but had a greater odds of not being tested for HbA1c (OR: 1.51; 95% CI: 1.34-1.71), as well as of having HbA1c values equal to or over 9% (OR: 2.06; 95% CI: 1.80-3.14). The outcomes were poorer in HMPC females for the first two outcomes, while there was no difference for the HbA1c values (Wald test for heterogeneity p = 0.0850; p = 0.0156; p = 0.6635, respectively). Our findings highlight the need for gender-oriented actions for prevention and early diagnosis of the diabetes to contrast the higher risk in Northern Africans and Southern Asians. Further studies are required to determine whether the protocols in use are adequate for different immigrant groups.

Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care

PubMed Central

2014-01-01

Background Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. Methods This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. Discussion Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. Trial registration Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012. PMID:24491134

Spinal epidural abscess: Report on 27 cases

PubMed Central

Khursheed, Nayil; Dar, Sultan; Ramzan, Altaf; Fomda, Bashir; Humam, Nisar; Abrar, Wani; Singh, Sarbjit; Sajad, Arif; Mahek, Masood; Yawar, Shoaib

2017-01-01

Background: Spinal epidural abscess, although an uncommon disease, often correlates with a high morbidity owing to significant delay in diagnosis. Methods: In a prospective 5-year study, the clinical and magnetic resonance (MR) findings, treatment protocols, microbiology, and neurological outcomes were analyzed for 27 patients with spinal epidural abscess. Results: Patients were typically middle-aged with underlying diabetes and presented with lumbar abscesses. Those undergoing surgical intervention >36 h after the onset of symptoms had poor neurological outcomes. Conclusion: Early recognition and timely evacuation of spinal abscesses minimized neurological morbidity and potential mortality. PMID:29026676

Spinal epidural abscess: Report on 27 cases.

PubMed

Khursheed, Nayil; Dar, Sultan; Ramzan, Altaf; Fomda, Bashir; Humam, Nisar; Abrar, Wani; Singh, Sarbjit; Sajad, Arif; Mahek, Masood; Yawar, Shoaib

2017-01-01

Spinal epidural abscess, although an uncommon disease, often correlates with a high morbidity owing to significant delay in diagnosis. In a prospective 5-year study, the clinical and magnetic resonance (MR) findings, treatment protocols, microbiology, and neurological outcomes were analyzed for 27 patients with spinal epidural abscess. Patients were typically middle-aged with underlying diabetes and presented with lumbar abscesses. Those undergoing surgical intervention >36 h after the onset of symptoms had poor neurological outcomes. Early recognition and timely evacuation of spinal abscesses minimized neurological morbidity and potential mortality.

Acute cellular insulin resistance and hyperglycemia associated with hypophosphatemia after cardiac surgery.

PubMed

Garazi, Esther; Bridge, Suzanne; Caffarelli, Anthony; Ruoss, Stephen; Van der Starre, Pieter

2015-01-15

Successful glycemic control reduces morbidity and mortality in cardiac surgery patients. Protocols that include insulin infusions are commonly followed to achieve target blood glucose levels. Insulin resistance has been reported and linked to low serum phosphate levels in animal models and studies in diabetic outpatients, but not in postoperative patients. The following case series is a retrospective observational review of 8 cardiac surgery patients who developed insulin resistance early after surgery; this resistance was reversed by correcting serum hypophosphatemia. We discuss the multiple underlying mechanisms causing hypophosphatemia.

The Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: study protocol for a randomized controlled trial.

PubMed

O'Brien, Casey L; Ski, Chantal F; Thompson, David R; Moore, Gaye; Mancuso, Serafino; Jenkins, Alicia; Ward, Glenn; MacIsaac, Richard J; Loh, Margaret; Knowles, Simon R; Rossell, Susan L; Castle, David J

2016-09-09

After a diagnosis of diabetes mellitus, people not only have to cope with the physical aspects and common complications that require daily self-management, they are also faced with ongoing psychosocial challenges. Subsequently they find themselves having to navigate the health system to engage multidisciplinary supports; the combination of these factors often resulting in reduced health-related quality of life. To maintain optimal diabetes control, interventions need to incorporate psychosocial supports and a skill base for disease management. Therefore, our aim was to evaluate an 'Optimal Health Program' that adopts a person-centred approach and engages collaborative therapy to educate and support the psychosocial health of people diagnosed with type I or II diabetes. This prospective randomised controlled trial will include 166 people diagnosed with diabetes: 83 in the intervention (Optimal Health Program) and 83 in the control (usual care) group. Participants with type diabetes mellitus will be recruited through hospital outpatient clinics and diabetes community organisations. Participants in the intervention group will receive nine (8 + 1 booster session) sequential sessions, based on a structured treatment manual emphasising educational and psychosocial support self-efficacy and skills building. The primary outcome measures will be generalised self-efficacy (GSE) and health-related quality of life (AQoL-6D and EQ-5D). Secondary measures will be anxiety and depression (HADS), social and workplace functioning (WSAS), diabetes-related quality of life (DQoL), diabetes-related distress (PAID), and type of coping strategies (Brief COPE). In addition, a health economic cost analysis and process evaluations will be performed to assess the economic cost and efficacy of the program's operations, implementation and service delivery. We envisage that the Optimal Health Program's emphasis on self-efficacy and self-management will provide participants with the skills and knowledge to achieve increased empowerment and independence in aspects of health, which in turn, will help participants deal more effectively with the physical and psychosocial complexities of diabetes. ACTRN12614001085662 . Registered on 10 October 2014.

Using computer-aided drug design and medicinal chemistry strategies in the fight against diabetes.

PubMed

Semighini, Evandro P; Resende, Jonathan A; de Andrade, Peterson; Morais, Pedro A B; Carvalho, Ivone; Taft, Carlton A; Silva, Carlos H T P

2011-04-01

The aim of this work is to present a simple, practical and efficient protocol for drug design, in particular Diabetes, which includes selection of the illness, good choice of a target as well as a bioactive ligand and then usage of various computer aided drug design and medicinal chemistry tools to design novel potential drug candidates in different diseases. We have selected the validated target dipeptidyl peptidase IV (DPP-IV), whose inhibition contributes to reduce glucose levels in type 2 diabetes patients. The most active inhibitor with complex X-ray structure reported was initially extracted from the BindingDB database. By using molecular modification strategies widely used in medicinal chemistry, besides current state-of-the-art tools in drug design (including flexible docking, virtual screening, molecular interaction fields, molecular dynamics, ADME and toxicity predictions), we have proposed 4 novel potential DPP-IV inhibitors with drug properties for Diabetes control, which have been supported and validated by all the computational tools used herewith.

Extracellular Matrix Scaffold Technology for Bioartificial Pancreas Engineering: State of the Art and Future Challenges.

PubMed

Salvatori, Marcus; Katari, Ravi; Patel, Timil; Peloso, Andrea; Mugweru, Jon; Owusu, Kofi; Orlando, Giuseppe

2014-01-01

Emergent technologies in regenerative medicine may soon overcome the limitations of conventional diabetes therapies. Collaborative efforts across the subfields of stem cell technology, islet encapsulation, and biomaterial carriers seek to produce a bioengineered pancreas capable of restoring endocrine function in patients with insulin-dependent diabetes. These technologies rely on a robust understanding of the extracellular matrix (ECM), the supportive 3-dimensional network of proteins necessary for cellular attachment, proliferation, and differentiation. Although these functions can be partially approximated by biosynthetic carriers, novel decellularization protocols have allowed researchers to discover the advantages afforded by the native pancreatic ECM. The native ECM has proven to be an optimal platform for recellularization and whole-organ pancreas bioengineering, an exciting new field with the potential to resolve the dire shortage of transplantable organs. This review seeks to contextualize recent findings, discuss current research goals, and identify future challenges of regenerative medicine as it applies to diabetes management. © 2014 Diabetes Technology Society.

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

PubMed Central

Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-01

Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). PMID:25608692

The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol.

PubMed

Helou, Nancy; Talhouedec, Dominique; Shaha, Maya; Zanchi, Anne

2016-07-19

Diabetic kidney disease, a global health issue, remains associated with high morbidity and mortality. Previous research has shown that multidisciplinary management of chronic disease can improve patient outcomes. The effect of multidisciplinary self-care management on quality of life and renal function of patients with diabetic kidney disease has not yet been well established. The aim of this study is to evaluate the impact of a multidisciplinary self-care management program on quality of life, self-care behavior, adherence to anti-hypertensive treatment, glycemic control, and renal function of adults with diabetic kidney disease. A uniform balanced cross-over design is used, with the objective to recruit 40 adult participants with diabetic kidney disease, from public and private out-patient settings in French speaking Switzerland. Participants are randomized in equal number into four study arms. Each participant receives usual care alternating with the multidisciplinary self- care management program. Each treatment period lasts three months and is repeated twice at different time intervals over 12 months depending on the cross-over arm. The multidisciplinary self-care management program is led by an advanced practice nurse and adds nursing and dietary consultations and follow-ups, to the habitual management provided by the general practitioner, the nephrologist and the diabetologist. Data is collected every three months for 12 months. Quality of life is measured using the Audit of Diabetes-Dependent Quality of Life scale, patient self-care behavior is assessed using the Revised Summary of Diabetes Self-Care Activities, and adherence to anti-hypertensive therapy is evaluated using the Medication Events Monitoring System. Blood glucose control is measured by the glycated hemoglobin levels and renal function by serum creatinine, estimated glomerular filtration rate and urinary albumin/creatinine ratio. Data will be analyzed using STATA version 14. The cross-over design will elucidate the responses of individual participant to each treatment, and will allow us to better evaluate the use of such a design in clinical settings and behavioral studies. This study also explores the impact of a theory-based nursing practice and its implementation into a multidisciplinary context. ClinicalTrials.gov identifier: NCT01967901 , registered on the 18th of October 2013.

Comparison of two individualized treatment regimens with ranibizumab for diabetic macular edema.

PubMed

Ebneter, Andreas; Waldmeier, Dominik; Zysset-Burri, Denise C; Wolf, Sebastian; Zinkernagel, Martin Sebastian

2017-03-01

To compare outcomes between an as-needed and a treat-and-extend regimen in managing diabetic macular edema with intravitreal ranibizumab. This was a retrospective, single-centre, comparative case series on 46 treatment naive patients with diabetic macular edema. Twenty-two patients were treated following an optical coherence tomography guided treat-and-extend protocol (OCTER), and 24 patients were treated according to a visual acuity guided pro re nata regimen (VAPRN) at a tertiarry referral centre. The main outcome measures were best-corrected visual acuity, central retinal thickness, and the number of ranibizumab injections, as well as visits after 12 months of treatment. After 12 months, the mean gain in best-corrected visual acuity (± standard deviation) was 8.3 ± 6.7 versus 9.3 ± 8.9 letters in the VAPRN and OCTER group, respectively (p = 0.3). The mean decrease in central retinal thickness was 68.1 ± 88.0 μm in the VAPRN group and 117.6 ± 114.4 μm in the OCTER group (p = 0.2). The mean number of ranibizumab injections was significantly different between the VAPRN (5.9 ± 1.8) and the OCTER protocol (8.9 ± 2.0) (p < 0.001). The visual acuity driven retreatment regimen resulted in a similar visual acuity outcome like optical coherence tomography guided retreatment for diabetic macular edema. Although the number of visits was similar in both groups, patients in the VAPRN group received significantly fewer intravitreal injections than patients in the OCTER group.

Continuous subcutaneous insulin infusion allows tolerance induction and diabetes treatment in a type 1 diabetic child with insulin allergy.

PubMed

Hasselmann, C; Pecquet, C; Bismuth, E; Raverdy, C; Sola-Gazagnes, A; Lobut, J-B; Carel, J-C; Tubiana-Rufi, N

2013-04-01

Insulin allergy is a rare but serious and challenging condition in patients with type 1 diabetes (T1D). This is a case report of an 8-year-old boy with T1D and an allergy to insulin. Three months after being diagnosed with T1D, the patient developed progressive skin reactions to insulin, characterized by small 1.5-cm pruritic wheals at injection sites that persisted for several days. Seven months after diagnosis, he experienced two episodes of generalized urticaria with systemic symptoms that were seen within a few seconds of insulin injection. Examination revealed lipoatrophy of the thighs. Intradermal skin tests were positive for protamine, glargine and lispro. The patient was started on a continuous subcutaneous insulin infusion (CSII) tolerance induction protocol, consisting of a very low basal rate that was progressively increased, with the first bolus given under medical supervision, and was well tolerated for 4 months. After this period of time, the skin wheals reappeared, localized to the infusion sites, but without urticaria or any other generalized reactions. Intradermal skin tests were repeated and were again positive. Serum insulin-specific IgE measured 30 months after the first allergic reactions were positive. After 3 years, pump therapy is ongoing and blood glucose control has remained relatively good (HbA1c 7.6%). In T1D children with insulin allergy, CSII can successfully be used to both induce insulin tolerance and allow diabetes insulin therapy, although insulin desensitization cannot always be fully achieved. The induction protocol was easily manageable partly due to the "honeymoon" period that the patient was still in, but it should nonetheless be used even when the patient has higher insulin requirements. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial.

PubMed

McTavish, Lindsay; Wiltshire, Esko

2011-06-01

To determine the most effective of four oral treatments for hypoglycemia in children with type 1 diabetes using a weight-based protocol during diabetes camp. During diabetes camp treatment of hypoglycemia was randomized to one of the four treatments, randomly assigned for each episode using a sealed envelope: glucose tablets, jellybeans, orange juice, and sugar mints (Mentos dragees®). An equivalent carbohydrate dose was calculated for each patient for each treatment (0.3 g carbohydrate/kg) and provided to camp leaders. Glucose was measured at 0, 2, 5, 10, and 15 min and symptoms recorded. A total of 191 episodes of hypoglycemia were recorded in 39 children (1-12 episodes per child), with 2 episodes excluded because of protocol violations. Fifty-two episodes were treated with glucose tablets, 45 with jellybeans, 44 with juice, and 48 with sugar mints. Change in glucose at 10 (p = 0.034) and 15 min (p = 0.005) and glucose at 15 min (p = 0.026) were significantly different between treatment groups - jellybeans produced the lowest and slowest response. Glucose tablets did not differ significantly from juice or Mentos dragees. There was a trend for repeat treatment to be required more often with a single treatment 'dose' of jellybeans (p = 0.058). Symptoms occurred in 112 episodes, with a median time to symptom resolution of 12 min (interquartile range (IQR) 8-15 min). Jellybeans are less effective treatment for hypoglycemia than the other three treatments. Glucose tablets, Mentos dragees® and orange juice are of similar efficacy. Treatment with 0.3 g/kg of carbohydrate (excluding jellybeans) effectively resolved hypoglycemia in most children, with 15 min often required to normalize blood glucose. © 2011 John Wiley & Sons A/S.

[Virtual environment: assistance in nursing care for the deaf based on the protocol of primary care].

PubMed

Rodrigues, Silvia Cristina Martini; Damião, Gardênia Costa

2014-08-01

Presenting a Virtual Environment (VE) based on the Protocol of Treatment of Hypertension and Diabetes Mellitus type 2, used in Primary Care for evaluation of dietary habits in nursing consultations. An experimental study applied by two nurses and a nurse manager, in a sample of 30 deaf patients aged between 30 and 60 years. The environment was built in Visual Basic NET and offered eight screens about feeding containing food pictures, videos in Libras (Brazilian sign language) and audio. The analysis of the VE was done through questionnaires applied to patients and professionals by the Poisson statistical test. The VE shows the possible diagnostics in red, yellow, green and blue colors, depending on the degree of patients' need. The environment obtained excellent acceptance by patients and nurses, allowing great interaction between them, even without an interpreter. The time in consultation was reduced to 15 minutes, with the preservation of patient privacy.

What is the relationship between type 2 diabetes mellitus status and the neuroradiological correlates of cerebral small vessel disease in adults? Protocol for a systematic review.

PubMed

Funnell, Clark; Doyle-Waters, Mary M; Yip, Samuel; Field, Thalia

2017-01-17

Cerebral small vessel disease (CSVD) is a common cause of stroke, dementia, and functional decline. In recent years, neuroradiologic correlates of CSVD have been identified. These imaging findings, best characterized on magnetic resonance imaging (MRI), include some combination of white matter hyperintensities, lacunes, cerebral microbleeds, enlarged perivascular spaces, and cerebral atrophy. Though some cohorts have reported that participants with type 2 diabetes mellitus (T2DM), an important risk factor for CSVD, may have a distinct neuroradiologic phenotype, this relationship is not well-characterized. Adults with diabetes mellitus have a two- to threefold higher incidence of ischemic stroke compared to controls and are an increasingly important population given global trends of increasing diabetes prevalence. This study aims to determine if adults with CSVD and T2DM have a distinct neuroradiologic phenotype. A systematic search of the literature will be conducted to find articles that report the MRI features of CSVD in a cohort of participants including those with and without type 2 diabetes mellitus (T2DM). A number of databases will be searched including MEDLINE, Embase, CINAHL, and Web of Science. Proceedings and abstracts from key conferences will also be reviewed and relevant journals hand searched for additional papers. The references from selected papers will be scanned. Screening of potential articles, data extraction, and quality appraisal will be performed in duplicate by independent reviewers. Odds ratios and 95% confidence intervals for the presence versus absence of each neuroradiologic correlate of interest from each included study will be calculated. If sufficient homogeneity exists among studies, a meta-analysis will be performed for each neuroradiologic correlate of CSVD. If heterogeneity of studies precludes data pooling, results will be presented in narrative form. Determining whether a distinct neuroradiologic phenotype of CSVD exists in adults with T2DM will provide insight into the underlying mechanisms of CSVD and guide future research on therapeutic targets. PROSPERO CRD42016046669.

Development of the IMB Model and an Evidence-Based Diabetes Self-management Mobile Application.

PubMed

Jeon, Eunjoo; Park, Hyeoun-Ae

2018-04-01

This study developed a diabetes self-management mobile application based on the information-motivation-behavioral skills (IMB) model, evidence extracted from clinical practice guidelines, and requirements identified through focus group interviews (FGIs) with diabetes patients. We developed a diabetes self-management (DSM) app in accordance with the following four stages of the system development life cycle. The functional and knowledge requirements of the users were extracted through FGIs with 19 diabetes patients. A system diagram, data models, a database, an algorithm, screens, and menus were designed. An Android app and server with an SSL protocol were developed. The DSM app algorithm and heuristics, as well as the usability of the DSM app were evaluated, and then the DSM app was modified based on heuristics and usability evaluation. A total of 11 requirement themes were identified through the FGIs. Sixteen functions and 49 knowledge rules were extracted. The system diagram consisted of a client part and server part, 78 data models, a database with 10 tables, an algorithm, and a menu structure with 6 main menus, and 40 user screens were developed. The DSM app was Android version 4.4 or higher for Bluetooth connectivity. The proficiency and efficiency scores of the algorithm were 90.96% and 92.39%, respectively. Fifteen issues were revealed through the heuristic evaluation, and the app was modified to address three of these issues. It was also modified to address five comments received by the researchers through the usability evaluation. The DSM app was developed based on behavioral change theory through IMB models. It was designed to be evidence-based, user-centered, and effective. It remains necessary to fully evaluate the effect of the DSM app on the DSM behavior changes of diabetes patients.

High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner–the Diabetes Research in Children Network (DirecNet) experience

PubMed Central

Barnea-Goraly, Naama; Weinzimer, Stuart A.; Mauras, Nelly; Beck, Roy W.; Marzelli, Matt J.; Mazaika, Paul K.; Aye, Tandy; White, Neil H.; Tsalikian, Eva; Fox, Larry; Kollman, Craig; Cheng, Peiyao; Reiss, Allan L.

2013-01-01

Background The ability to lie still in an MRI scanner is essential for obtaining usable image data. To reduce motion, young children are often sedated, adding significant cost and risk. Objective We assessed the feasibility of using a simple and affordable behavioral desensitization program to yield high-quality brain MRI scans in sedation-free children. Materials and methods 222 children (4–9.9 years), 147 with type 1 diabetes and 75 age-matched non-diabetic controls, participated in a multi-site study focused on effects of type 1 diabetes on the developing brain. T1-weighted and diffusion-weighted imaging (DWI) MRI scans were performed. All children underwent behavioral training and practice MRI sessions using either a commercial MRI simulator or an inexpensive mock scanner consisting of a toy tunnel, vibrating mat, and video player to simulate the sounds and feel of the MRI scanner. Results 205 children (92.3%), mean age 7±1.7 years had high-quality T1-W scans and 174 (78.4%) had high-quality diffusion-weighted scans after the first scan session. With a second scan session, success rates were 100% and 92.5% for T1-and diffusion-weighted scans, respectively. Success rates did not differ between children with type 1 diabetes and children without diabetes, or between centers using a commercial MRI scan simulator and those using the inexpensive mock scanner. Conclusion Behavioral training can lead to a high success rate for obtaining high-quality T1-and diffusion-weighted brain images from a young population without sedation. PMID:24096802

Development of the IMB Model and an Evidence-Based Diabetes Self-management Mobile Application

PubMed Central

Jeon, Eunjoo

2018-01-01

Objectives This study developed a diabetes self-management mobile application based on the information-motivation-behavioral skills (IMB) model, evidence extracted from clinical practice guidelines, and requirements identified through focus group interviews (FGIs) with diabetes patients. Methods We developed a diabetes self-management (DSM) app in accordance with the following four stages of the system development life cycle. The functional and knowledge requirements of the users were extracted through FGIs with 19 diabetes patients. A system diagram, data models, a database, an algorithm, screens, and menus were designed. An Android app and server with an SSL protocol were developed. The DSM app algorithm and heuristics, as well as the usability of the DSM app were evaluated, and then the DSM app was modified based on heuristics and usability evaluation. Results A total of 11 requirement themes were identified through the FGIs. Sixteen functions and 49 knowledge rules were extracted. The system diagram consisted of a client part and server part, 78 data models, a database with 10 tables, an algorithm, and a menu structure with 6 main menus, and 40 user screens were developed. The DSM app was Android version 4.4 or higher for Bluetooth connectivity. The proficiency and efficiency scores of the algorithm were 90.96% and 92.39%, respectively. Fifteen issues were revealed through the heuristic evaluation, and the app was modified to address three of these issues. It was also modified to address five comments received by the researchers through the usability evaluation. Conclusions The DSM app was developed based on behavioral change theory through IMB models. It was designed to be evidence-based, user-centered, and effective. It remains necessary to fully evaluate the effect of the DSM app on the DSM behavior changes of diabetes patients. PMID:29770246

Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview.

PubMed

Medina, Wilson L; Wilson, David; de Salvo, Vera; Vannucchi, Bruna; de Souza, Érika Leonardo; Lucena, Leandro; Sarto, Héctor Morillo; Modrego-Alarcón, Marta; Garcia-Campayo, Javier; Demarzo, Marcelo

2017-01-01

Diabetes mellitus (DM) is an emerging global healthcare problem and its prevalence is increasing at an alarming rate. Despite improvements in both medical and pharmacological therapies, a complex medical condition may demand a diversified approach, such as: drug therapy, healthy diet and exercises, diabetes education programs, adherence to medical treatment and active participation of the patients in their lifestyle changes, such as stress management. The concept of mindfulness is here defined as the awareness that unfolds from the intention to attentively observe the current experience in a non-judgmental and non-evaluative way. This state of awareness can be enhanced through the use of mindfulness-based interventions (MBIs), which have been associated to many physical and psychological health indicators. The aim of this overview is to offer the rationale and potential benefits of mindfulness in the control of DM and its complications. a narrative review of the current and updated literature available on online database and which came up using the terms "mindfulness" and "diabetes mellitus". Mindfulness-based Interventions (MBIs) can be seen as preventive and complementary interventions in DM, particularly for the relief of symptoms related to depression and anxiety in diabetic patients and also in the management of other factors, including mindful eating, physical exercises and treatment adherence. Although many studies only present research protocols, mindfulness seems to have beneficial effects on all aspects of diabetes, including incidence, control and complications. Furthermore, longer term and more carefully controlled trials are necessary in order to draw consistent conclusions on the beneficial role of MBIs on DM. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial

PubMed Central

Lewey, Jennifer; Wei, Wenhui; Makanji, Sagar; Chant, Alan; DiGeronimo, Jeff; Nanchanatt, Gina; Jan, Saira; Choudhry, Niteesh K

2017-01-01

Introduction Adherence to and persistence of medications for chronic diseases remains poor and many interventions to improve medication use have only been modestly effective. Targeting interventions to patients who are most likely to benefit should improve their efficiency and clinical impact. This study aims to test the impact of three cost-equivalent pharmacist-led interventions on insulin persistence and glycaemic control among patients with diabetes. Methods and analysis TARGIT-Diabetes (Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes) is a randomised controlled trial that will evaluate three different multifaceted pharmacist-outreach strategies for improving long-term insulin use among individuals with diabetes. We will randomise 6000 patients in a large insurer to one of three arms. The arms are designed to deliver an increasingly intensive intervention to a progressively targeted population, identified using predictive analytics. The central component of the intervention in all arms is a tailored telephone consultation with a pharmacist which varies across arms based on the: (A) proportion of patients offered the intervention and (B) intervention intensity, including follow-up frequency and cointerventions such as text reminders and interactions with patients’ providers. The primary outcome is insulin persistence, assessed using pharmacy claims data, and the secondary outcomes are glycaemic control as measured by glycosylated haemoglobin values, healthcare utilisation and healthcare spending. Ethics and dissemination This protocol has been approved by the Institutional Review Board of Brigham and Women’s Hospital and the Privacy Board of Horizon Blue Cross Blue Shield of New Jersey. We plan to present the results of this trial at national meetings and in manuscripts submitted to peer-reviewed journals. Trial registration number NCT 02846779. PMID:29084790

Physical exercise enhances protein kinase C delta activity and insulin receptor tyrosine phosphorylation in diabetes-prone psammomys obesus.

PubMed

Heled, Yuval; Shapiro, Yair; Shani, Yoav; Moran, Dani S; Langzam, Leah; Braiman, Liora; Sampson, Sanford R; Meyerovitch, Joseph

2003-08-01

We recently reported that physical exercise prevents the progression of type 2 diabetes mellitus in Psammomys obesus, an animal model of nutritionally induced type 2 diabetes mellitus. In the present study we characterized the effect of physical exercise on protein kinase C delta (PKC delta) activity, as a mediator of the insulin-signaling cascade in vivo. Three groups of Psammomys obesus were exposed to a 4-week protocol: high-energy diet (HE/C), high-energy diet and exercise (HE/EX), or low-energy diet (LE/C). None of the animals in the HE/EX group became diabetic, whereas all the animals in the HE/C group became diabetic. After overnight fast, intraperitoneal (IP) insulin (1U) caused a greater reduction in blood glucose levels in the HE/EX and LE/C groups compared to the HE/C group. Tyrosine phosphorylation of insulin receptor (IR), insulin receptor substrate-1 (IRS-1), and phosphatidylinositol 3 kinase (PI3 kinase) was significantly higher in the HE/EX and LE/C groups compared with the HE/C group. Finally, IR-associated PKC delta was higher in the HE/EX and LE/C groups compared to the HE/C group. Coprecipitation of PKC delta with IR was higher in the HE/EX and LE/C groups compared to the HE/C group. Thus, we suggest that 4 weeks of physical exercise results in improved insulin-signaling response in Psammomys obesus accompanied by a direct connection between PKC delta and IR. We conclude that this mechanism may be involved in the preventive effect of exercise on type 2 diabetes mellitus in Psammomys obesus.

Perioperative management of diabetes in elective patients: a region-wide audit.

PubMed

Jackson, M J; Patvardhan, C; Wallace, F; Martin, A; Yusuff, H; Briggs, G; Malik, R A

2016-04-01

Ten percent of elective surgical patients have diabetes. These patients demonstrate excess perioperative morbidity and mortality. National guidance on the management of adults with diabetes undergoing surgery was published in 2011. We present a region-wide audit of adherence to this guidance across the North Western Deanery. Local teams prospectively collected data according to a locally approved protocol. Pregnant, paediatric and non-elective patients were excluded from this audit. Patient characteristics, type of surgery and aspects of perioperative management were collated and centrally analysed against audit criteria based upon national recommendations. 247 patients with diabetes were identified. HbA1c was recorded in 71% of patients preoperatively; 9% of patients with an abnormal HbA1c were not known by, or referred to, the diabetes team. 17% of patients were admitted the evening preceding surgery. The mean fasting time was 12:20(4) h. Variable rate i.v. insulin infusions (VRIII) were not used when indicated in 11%. Only 8% of patients received the recommended substrate fluid, along with the VRIII (5% glucose in 0.45% saline). Intra-operative capillary blood glucose (CBG) was measured hourly in 56% of patients. Intra-operative CBG was within the acceptable range (4-12 mmol.L(-1)) in 85% of patients. 73% of patients had a CBG measurement performed in recovery. The WHO checklist was used in 95% of patients. National perioperative guidelines were not adhered to in a substantial proportion of patients with diabetes undergoing elective surgery. This study represents a template for future trainee networks. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Successful reversal of streptozotocin-induced diabetes with stable allogeneic islet function in a preclinical model of type 1 diabetes.

PubMed

Thomas, J M; Contreras, J L; Smyth, C A; Lobashevsky, A; Jenkins, S; Hubbard, W J; Eckhoff, D E; Stavrou, S; Neville, D M; Thomas, F T

2001-06-01

The recent focus on islet transplantation as primary therapy for type 1 diabetes has heightened interest in the reversal of type 1 diabetes in preclinical models using minimal immunosuppression. Here, we demonstrated in a preclinical rhesus model a consistent reversal of all measured glycemic patterns of streptozotocin-induced type 1 diabetes. The model used single-donor islet transplantation with induction of operational tolerance. The term "operational tolerance" is used to indicate durable survival of single-donor major histocompatibility complex (MHC)-mismatched islet allografts without maintenance immunosuppressive therapy and without rejection or loss of functional islet mass or insulin secretory reserve. In this operational tolerance model, all immunosuppression was discontinued after day 14 posttransplant, and recipients recovered with excellent health. The operational tolerance induction protocol combined peritransplant anti-CD3 immunotoxin to deplete T-cells and 15-deoxyspergualin to arrest proinflammatory cytokine production and maturation of dendritic cells. T-cell deficiency was specific but temporary, in that T-cell-dependent responses in long-term survivors recovered to normal, and there was no evidence of increased susceptibility to infection. Anti-donor mixed lymphocyte reaction responses were positive in the long-term survivors, but all showed clear evidence of systemic T-helper 2 deviation, suggesting that an immunoregulatory rather than a deletional process underlies this operational tolerance model. This study provides the first evidence that operational tolerance can protect MHC nonhuman primate islets from rejection as well as loss of functional islet mass. Such an approach has potential to optimize individual recipient recovery from diabetes as well as permitting more widespread islet transplantation with the limited supply of donor islets.

Geography does not limit optimal diabetes care: use of a tertiary centre model of care in an outreach service for type 1 diabetes mellitus.

PubMed

Simm, Peter J; Wong, Nicole; Fraser, Lynne; Kearney, John; Fenton, Judy; Jachno, Kim; Cameron, Fergus J

2014-06-01

Young people with type 1 diabetes mellitus living in rural and regional Australia have previously been shown to have limited access to specialised diabetes services. The Royal Children's Hospital Melbourne has been running diabetes outreach clinics to Western Victoria, Australia, for over 13 years. We aim to evaluate this service by comparing the outcomes of three outreach clinics with our urban diabetes clinic at the Royal Children's Hospital Melbourne. We examine our tertiary, multidisciplinary team-based model of care, where visiting specialist medical staff work alongside local allied health teams. The local teams provide interim care between clinics utilising the same protocols and treatment practices as the tertiary centre. Longitudinal data encapsulating the years 2005-2010, as a cohort study with a control group, are reviewed. A total of 69 rural patients were compared with 1387 metropolitan patients. Metabolic control was comparable, with no difference in mean HbA1c (8.3%/67 mmol/mol for both groups). Treatment options varied slightly at diagnosis, while insulin pump usage was comparable between treatment settings (20.3% rural compared with 27.6% urban, P = 0.19). Of note was that the number of visits per year was higher in the rural group (3.3 per year rural compared with 2.7 urban, P < 0.001). We conclude that the outreach service is able to provide a comparable level of care when the urban model is translated to a rural setting. This model may be further able to be extrapolated to other geographic areas and also other chronic health conditions of childhood. © 2014 The Authors. Journal of Paediatrics and Child Health © 2014 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Depressive symptom deterioration among predominantly Hispanic diabetes patients in safety net care.

PubMed

Ell, Kathleen; Katon, Wayne; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffrey; Xie, Bin; Chou, Chih-Ping

2012-01-01

This study examines clinical predictors of symptom deterioration (relapse/recurrence) at the completion of a clinical intervention trial of depressed, low-income, predominantly Hispanic diabetes patients who were randomized to socio-culturally adapted collaborative depression treatment or usual care and who no longer met clinically significant depression criteria at 12 months post-trial baseline. A sub-cohort of 193 diabetes patients with major depression symptoms at baseline, who were randomized to a 12-month collaborative care intervention (INT) (problem-solving therapy and/or pharmacotherapy, telephone symptom monitoring/relapse prevention, behavioral activation and patient navigation support) or enhanced usual care (EUC), and who did not meet major depression criteria at 12 months were subsequently observed over 18 to 24 months. Post-trial depression symptom deterioration was similar between INT (35.2%) and EUC (35.3%) groups. Among the combined groups, significant predictors of symptom deterioration were baseline history of previous depression and/or dysthymia (odds ratio [OR] = 2.66), 12-month PHQ-9 score (OR = 1.22), antidepressant treatment receipt during the initial 12-months (OR = 2.38), 12-month diabetes symptoms (OR = 2.27), and new ICD-9 medical diagnoses in the initial 12 months (OR = 1.11) (R2 = 27%; max-rescaled R2 = 37%; likelihood ratio test, χ2 = 59.79, df = 5, P < 0.0001). Among predominantly Hispanic diabetes patients in community safety net primary care clinics whose depression had improved over 1 year, more than one-third experienced symptom deterioration over the following year. A primary care management depression care protocol that includes ongoing depression symptom monitoring, antidepressant adherence, and diabetes and co-morbid illness monitoring plus depression medication adjustment and behavioral activation may reduce and/or effectively treat depression symptom deterioration. Copyright © 2012 The Academy of Psychosomatic Medicine. All rights reserved.

The outcome of manipulation under general anesthesia for the management of frozen shoulder in patients with diabetes mellitus.

PubMed

Jenkins, Emily F; Thomas, William J C; Corcoran, John P; Kirubanandan, Ravisankar; Beynon, Celia R; Sayers, Adrian E; Woods, David A

2012-11-01

Frozen shoulder has a greater incidence, more severe course, and resistance to treatment in patients with diabetes mellitus compared with the general population. We hypothesized that diabetic patients with frozen shoulder undergoing treatment with manipulation under general anaesthesia (MUA) would have the same outcome as patients without diabetes. We retrospectively analyzed data collected during a 10-year period of referrals for frozen shoulder. In all cases, a standardized MUA protocol was followed once the diagnosis of frozen shoulder in the frozen phase was made; this included an early repeat MUA in individuals with recurrence. We compared outcomes for patients documented as having diabetes with a nondiabetic control group and assessed the effect of insulin dependence and frozen shoulder etiology within the diabetic group. Of a consecutive series of 315 frozen shoulders, 36 patients (39 shoulders) were included in the diabetic group, with 256 patients (274 shoulders) as controls. There was a significant improvement in range of movement and Oxford Shoulder Score (P all <.001), with no difference between diabetic and control groups at early or late follow-up (mean, 41 months). A repeat procedure was required in 36% of diabetic patients compared with 15% of control patients. Recurrence in the diabetic group was influenced by etiology (47% of primary vs 0% of secondary frozen shoulders) and insulin requirement (39% insulin-dependent vs. 31% non-insulin-dependent). We provide a strategy for the management of diabetic frozen shoulders using MUA and estimates of success and recurrence rates that may be useful when informing consent. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.