HBA1C CONTROL AND COST-EFFECTIVENESS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INITIATED ON CANAGLIFLOZIN OR A GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONIST IN A REAL-WORLD SETTING.

PubMed

Wysham, Carol H; Pilon, Dominic; Ingham, Mike; Lafeuille, Marie-Hélène; Emond, Bruno; Kamstra, Rhiannon; Pfeifer, Michael; Lefebvre, Patrick

2018-03-01

To compare glycated hemoglobin (HbA1c) control and medication costs between patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin 300 mg (CANA) or a glucagon-like peptide 1 receptor agonist (GLP-1 RA) in a real-world setting. Adults with T2DM newly initiated on CANA or a GLP-1 RA (index date) were identified from IQVIA ™ Real-World Data Electronic Medical Records U.S. database (March 29, 2012-April 30, 2016). Inverse probability of treatment weighting accounted for differences in baseline characteristics. HbA1c levels at 3-month intervals were compared using generalized estimating equations. Medication costs used wholesale acquisition costs. For both cohorts (CANA: n = 11,435; GLP-1 RA: n = 11,582), HbA1c levels decreased at 3 months postindex and remained lower through 30 months. Absolute changes in mean HbA1c from index to 3 months postindex for CANA and GLP-1 RA were -1.16% and -1.21% (patients with baseline HbA1c ≥7% [53 mmol/mol]); -1.54% and -1.51% (patients with baseline HbA1c ≥8% [64 mmol/mol]); and -2.13% and -1.99% (patients with baseline HbA1c ≥9% [75 mmol/mol]), respectively. Postindex, CANA patients with baseline HbA1c ≥7% had similar HbA1c levels at each interval versus GLP-1 RA patients, except 9 months (mean HbA1c, 7.75% [61 mmol/mol] vs. 7.86% [62 mmol/mol]; P = .0305). CANA patients with baseline HbA1c ≥8% and ≥9% had consistently lower HbA1c numerically versus GLP-1 RA patients and statistically lower HbA1c at 9 (baseline HbA1c ≥8% or ≥9%), 27, and 30 months (baseline HbA1c ≥9%). Continuous 12-month medication cost $3,326 less for CANA versus GLP-1 RA. This retrospective study demonstrated a similar evolution of HbA1c levels among CANA and GLP-1 RA patients in a real-world setting. Lower medication costs suggest CANA is economically dominant over GLP-1 RA (similar effectiveness, lower cost). AHA = antihyperglycemic agent BMI = body mass index CANA = canagliflozin 300 mg DCSI = diabetes complications severity index eGFR = estimated glomerular filtration rate EMR = electronic medical record GLP-1 RA = glucagon-like peptide 1 receptor agonist HbA1c = glycated hemoglobin ICD-9-CM = International Classification of Diseases-Ninth Revision-Clinical Modification ICD-10-CM = International Classification of Diseases-Tenth Revision-Clinical Modification IPTW = inverse probability of treatment weighting ITT = intent-to-treat MPR = medication possession ratio PDC = proportion of days covered PS = propensity score PSM = propensity score matching Quan-CCI = Quan-Charlson comorbidity index SGLT2 = sodium-glucose cotransporter 2 T2DM = type 2 diabetes mellitus WAC = wholesale acquisition cost.

Distribution of Glycated Haemoglobin According to Early-Life and Contemporary Characteristics in Adolescents and Adults without Diabetes: The 1982 and 1993 Pelotas Birth Cohorts.

PubMed

Buffarini, Romina; Restrepo-Méndez, María Clara; Silveira, Vera M; Miranda, Jaime J; Gonçalves, Helen D; Oliveira, Isabel O; Horta, Bernardo L; Gigante, Denise P; Menezes, Ana Maria; Assunção, Maria Cecília F

2016-01-01

Glycated haemoglobin (HbA1c), a marker of glucose control in individuals with diabetes mellitus, is also related with the incidence of cardiometabolic risk in populations free of disease. The aim of this study was to describe the distribution of HbA1c levels according to early-life and contemporary factors in adolescents and adults without diabetes mellitus. HbA1c was measured in adults aged 30 years and adolescents aged 18 years who are participants in the 1982 and 1993 Pelotas Birth Cohorts, respectively. Bivariate and multivariate analyses were performed to describe the HbA1c mean values according to early-life and contemporary characteristics collected prospectively since birth. The distribution of the HbA1c was approximately normal in both cohorts, with a mean (SD) 5.10% (0.43) in the 1982 cohort, and 4.89% (0.50) in the 1993 cohort. HbA1c mean levels were significantly higher in individuals self-reported as black/brown skin color compared to those self-reported as white in both cohorts. Parental history of diabetes was associated with higher HbA1c mean in adults, while stunting at one year old presented an inverse relation with the outcome in adolescents. No other early and contemporary factors were associated with HbA1c levels in adults or adolescents. We found a consistent relationship between HbA1c and skin color in both cohorts. Further research is needed to understand the role of genomic ancestry on levels of HbA1c concentrations which may inform policies and preventive actions for diabetes mellitus and cardiometabolic risk.

Association between glycated hemoglobin A1c levels with age and gender in Chinese adults with no prior diagnosis of diabetes mellitus

PubMed Central

MA, QINGLIN; LIU, HOUMING; XIANG, GUANGXIN; SHAN, WANSHUI; XING, WANLI

2016-01-01

The present cross-sectional study consisted of 18,265 Chinese patients not previously diagnosed with diabetes mellitus, and who underwent physical examination at the Third People's Hospital of Shenzhen between June 2014 and May 2015 (mean patient age, 51.312±15.252 years). The study was composed of 11,770 males and 6,495 females. The aim was to investigate the association between glycated hemoglobin A1c (HbA1c) levels, gender and age. HbA1c values were measured using a Bio-Rad VARIANT™ II HbA1c Reorder Pack. All data was collected for analysis of the HbA1c levels in different gender and age groups, in order to investigate the association between HbA1c levels and age. Analysis of the 18,265 total cases and 16,734 cases with HbA1c levels <6.5%, demonstrated a positive correlation between levels of HbA1c and patient age. Linear regression for patient age and HbA1c levels demonstrated that HbA1c (%) = 0.020 × age (years) + 4.523 (r=0.369, P<0.0001) and HbA1c (%) = 0.014 × age (years) + 4.659 (r=0.485, P<0.0001), respectively. HbA1c levels of the male group were significantly higher than those of the female group (P<0.0001). Furthermore, in different gender groups, HbA1c levels gradually rose with increasing age. Therefore, HbA1c levels are associated with age and gender in Chinese populations, and this should be considered when selecting HbA1c as a criterion for future diabetes screening. PMID:27284415

The impact of baseline hemoglobin A1c levels prior to initiation of pump therapy on long-term metabolic control.

PubMed

Pinhas-Hamiel, Orit; Tzadok, Michal; Hirsh, Galit; Boyko, Valentina; Graph-Barel, Chana; Lerner-Geva, Liat; Reichman, Brian

2010-07-01

This study was done to identify factors influencing long-term metabolic control in youth with type 1 diabetes mellitus (T1DM) treated with an insulin pump. Data were obtained from retrospective chart review of 113 patients (52 males) with T1DM treated with an insulin pump for up to 7 years. Their mean +/- SD age at diagnosis of T1DM was 9.7 +/- 5.1 years, and that at pump therapy initiation was 13.8 +/- 6.1 years. Linear trends and changes in hemoglobin A1c (HbA1c) levels following pump insertion were evaluated according to gender, metabolic control prior to initiation of pump therapy, time from diagnosis of diabetes until pump therapy, age at initiation, and the duration of pump treatment. Mean HbA1c levels of patients with good baseline metabolic control (HbA1c level 9%) control groups (8.1 +/- 0.9% and 8.2 +/- 1.1%, respectively; P < 0.001). However, with time a significant trend for increasing HbA1c level was demonstrated in the group with good metabolic control (P value for trend = 0.004). HbA1c levels of patients with poor baseline metabolic control decreased significantly immediately after pump initiation (9.4 +/- 1.6% vs. 8.0 +/- 1.2%, P = 0.0001) and thereafter remained stable (P value for trend = 0.54). In the multivariable analyses, baseline HbA1c level

Efficacy of acarbose and metformin in newly diagnosed type 2 diabetes patients stratified by HbA1c levels.

PubMed

Zhang, Jin-Ping; Wang, Na; Xing, Xiao-Yan; Yang, Zhao-Jun; Wang, Xin; Yang, Wen-Ying

2016-07-01

The aim of the present study was to investigate whether the therapeutic efficacy of acarbose and metformin is correlated with baseline HbA1c levels in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM). Data for 711 subjects were retrieved from the MARCH (Metformin and AcaRbose in Chinese as initial Hypoglycemic treatment) trial database and reviewed retrospectively. Patients were grouped according to baseline HbA1c levels (<7%, 7%-8%, and >8%) and the results for these three groups were compared between acarbose and metformin treatments. Acarbose and metformin treatment significantly improved T2DM-associated parameters (weight, fasting plasma glucose [FPG], postprandial glucose [PPG], glucagon-like peptide-1 [GLP-1], HOMA-IR, and total cholesterol) across all HbA1c levels. Acarbose decreased PPG and HOMA-β significantly more than metformin, but only in subjects with lower baseline HbA1c (PPG in the <7% and 7%-8%, HOMA-β in the <7% groups; all P < 0.05). Acarbose decreased triglyceride (TG) levels, and the areas under the curve (AUC) for insulin and glucagon more than metformin at all HbA1c levels (P < 0.05). After 24 weeks treatment, metformin decreased FPG levels significantly more than acarbose for all baseline HbA1c groups (all P < 0.001). With the exception of FPG, PPG, and TG levels, differences between the two treatment groups observed at 24 weeks were not detected at 48 weeks. Acarbose decreased PPG and TG and spared the AUC for insulin more effectively in patients with low-to-moderate baseline HbA1c levels, whereas metformin induced greater reductions in FPG. These results may help guide selection of initial therapy based on baseline HbA1c. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Extreme Levels of HbA1c Increase Incident ESRD Risk in Chinese Patients with Type 2 Diabetes: Competing Risk Analysis in National Cohort of Taiwan Diabetes Study

PubMed Central

Liu, Chiu-Shong; Huang, Chiu-Ching; Lin, Wen-Yuan; Chiang, Jen-Huai; Lin, Cheng-Chieh; Li, Tsai-Chung

2015-01-01

Background Whether HbA1c is a predictor of end-stage renal disease (ESRD) in type 2 diabetes patients remains unclear. This study evaluated relationship between HbA1c and ESRD in Chinese patients with type 2 diabetes. Methods Patients aged ≥ 30 years who were free of ESRD (n = 51 681) were included from National Diabetes Care Management Program from 2002–2003. Extended Cox proportional hazard model with competing risk of death served to evaluate association between HbA1c level and ESRD. Results A total of 2613 (5.06%) people developed ESRD during a follow-up period of 8.1 years. Overall incidence rate of ESRD was 6.26 per 1000 person-years. Patients with high levels of HbA1c had a high incidence rate of ESRD, from 4.29 for HbA1c of  6.0%–6.9% to 10.33 for HbA1c ≥ 10.0% per 1000 person-years. Patients with HbA1c < 6.0% particularly had a slightly higher ESRD incidence (4.34 per 1000 person-years) than those with HbA1c  of 6.0%–6.9%. A J-shaped relationship between HbA1c level and ESRD risk was observed. After adjustment, patients with HbA1c < 6.0% and ≥ 10.0% exhibited an increased risk of ESRD (HR: 1.99, 95% CI: 1.62–2.44; HR: 4.42, 95% CI: 3.80–5.14, respectively) compared with those with HbA1c of 6.0%–6.9%. Conclusions Diabetes care has focused on preventing hyperglycemia, but not hypoglycemia. Our study revealed that HbA1c level ≥ 7.0% was linked with increased ESRD risk in type 2 diabetes patients, and that HbA1c < 6.0% also had the potential to increase ESRD risk. Our study provides epidemiological evidence that appropriate glycemic control is essential for diabetes care to meet HbA1c targets and improve outcomes without increasing the risk to this population. Clinicians need to pay attention to HbA1c results on diabetic nephropathy. PMID:26098901

The Associations Between Smoking Habits and Serum Triglyceride or Hemoglobin A1c Levels Differ According to Visceral Fat Accumulation

PubMed Central

Koda, Michiko; Kitamura, Itsuko; Okura, Tomohiro; Otsuka, Rei; Ando, Fujiko; Shimokata, Hiroshi

2016-01-01

Background Whether smokers and former smokers have worse lipid profiles or glucose levels than non-smokers remains unclear. Methods The subjects were 1152 Japanese males aged 42 to 81 years. The subjects were divided according to their smoking habits (nonsmokers, former smokers, and current smokers) and their visceral fat area (VFA) (<100 cm2 and ≥100 cm2). Results The serum triglyceride (TG) levels of 835 males were assessed. In the VFA ≥100 cm2 group, a significantly greater proportion of current smokers (47.3%) exhibited TG levels of ≥150 mg/dL compared with former smokers (36.4%) and non-smokers (18.8%). The difference in TG level distribution between former smokers and non-smokers was also significant. However, among the subjects with VFA of <100 cm2, the TG levels of the three smoking habit groups did not differ. The serum hemoglobin A1c (HbA1c) levels of 877 males were also assessed. In the VFA <100 cm2 group, significantly higher proportions of current smokers (17.9%) and former smokers (14.9%) demonstrated HbA1c levels of ≥5.6% compared with non-smokers (6.3%). In contrast, in the VFA ≥100 cm2 group, significantly fewer former smokers displayed HbA1c levels of ≥5.6% compared with non-smokers and current smokers. Furthermore, the interaction between smoking habits and VFA was associated with the subjects’ TG and HbA1c concentrations, and the associations of TG and HbA1c concentrations and smoking habits varied according to VFA. Conclusions Both smoking habits and VFA exhibited associations with TG and HbA1c concentrations. The associations between smoking habits and these parameters differed according to VFA. PMID:26616395

Prevalence of high HbA1c levels in Brazilian adolescents: The Study of Cardiovascular Risk in Adolescents.

PubMed

de Cássia Lima Fernandes, Rita; Teló, Gabriela H; Cureau, Felipe V; Barufaldi, Laura A; Kuschnir, Maria Cristina C; Schaan, Beatriz D; Szklo, Moyses; Bloch, Katia V

2017-03-01

To evaluate the prevalence of elevated glycated haemoglobin (HbA1c) levels in a population of adolescents participating in the Study of Cardiovascular Risk in Adolescents. This is a school-based cross-sectional study based on a complex sample of adolescents 12-17years old representative at the national and macro-regional levels and for each Brazilian state capital. Blood was collected in schools and then evaluated in a single laboratory. HbA1c levels were considered elevated if ⩾5.7% (39mmol/mol) and were analyzed according to sex, age, macro-region, type of school, skin color, and nutritional status. Data from 37,804 adolescents were analyzed. The mean level of HbA1c was 5.4% (95%CI 5.4-5.4) (36mmol/mol [95%CI 36-36]), and 20.5% (95%CI 19.1-22.0) of adolescents presented values ⩾5.7% (⩾39mmol/mol). Among males, 23.6% (95%CI 21.8-25.6) showed elevated HbA1c levels compared to 17.5% (95%CI 15.9-19.2) observed in females. The prevalence of elevated levels of HbA1c was higher in adolescents with black skin color (27.6%; 95%CI 23.2-32.4) vs. white skin color (16.9%; 95%CI 15.4-18.5), and higher in those who studied in public schools (21.6%; 95%CI 20.0-23.4) vs. private schools (16.7%; 95%CI 14.7-19.0). Among obese adolescents, 29.7% (95%CI 25.4-34.3) had elevated levels of HbA1c, compared to 19.3% (95%CI 18.0-20.7) in normal weight students and 19.7% (95%CI 17.1-22.6) in overweight adolescents. Obese male adolescents of lower socioeconomic status had a higher prevalence of elevated HbA1c levels. Our findings highlight the importance of focusing on this high risk group for interventions to prevent diabetes. Copyright © 2017 Elsevier B.V. All rights reserved.

Different strategies for detection of HbA1c emphasizing on biosensors and point-of-care analyzers.

PubMed

Kaur, Jagjit; Jiang, Cheng; Liu, Guozhen

2018-06-07

Measurement of glycosylated hemoglobin (HbA1c) is a gold standard procedure for assessing long term glycemic control in individuals with diabetes mellitus as it gives the stable and reliable value of blood glucose levels for a period of 90-120 days. HbA1c is formed by the non-enzymatic glycation of terminal valine of hemoglobin. The analysis of HbA1c tends to be complicated because there are more than 300 different assay methods for measuring HbA1c which leads to variations in reported values from same samples. Therefore, standardization of detection methods is recommended. The review outlines the current research activities on developing assays including biosensors for the detection of HbA1c. The pros and cons of different techniques for measuring HbA1c are outlined. The performance of current point-of-care HbA1c analyzers available on the market are also compared and discussed. The future perspectives for HbA1c detection and diabetes management are proposed. Copyright © 2018 Elsevier B.V. All rights reserved.

Baseline Body Mass Index and the Efficacy of Hypoglycemic Treatment in Type 2 Diabetes: A Meta-Analysis.

PubMed

Cai, Xiaoling; Yang, Wenjia; Gao, Xueying; Zhou, Lingli; Han, Xueyao; Ji, Linong

2016-01-01

The aim of this study is to compare the effects of hypoglycemic treatments in groups of patients categorized according to the mean baseline body mass indexes (BMIs). Studies were identified by a literature search and all the studies were double blind, placebo-controlled randomized trials in type 2 diabetes patients; study length of ≥12 weeks with the efficacy evaluated by changes in HbA1c from baseline in groups. The electronic search was first conducted in January 2015 and repeated in June 2015. 227 studies were included. Treatment with sulfonylureas was compared with placebo in overweight patients and resulted in a significantly greater change in the HbA1c levels (weighted mean difference (WMD), -1.39%) compared to obese patients (WMD, -0.77%)(p<0.05). Treatment with metformin in overweight patients resulted in a comparable change in the HbA1c levels (WMD, -0.99%) compared to obese patients (WMD, -1.06%)(p>0.05). Treatment with alpha glucosidase inhibitors in normal weight patients was associated with a HbA1c change (WMD, -0.94%) that was comparable that in overweight (WMD, -0.72%) and obese patients (WMD, -0.56%)(p>0.05). Treatment with thiazolidinediones in normal weight patients was associated with a HbA1c change (WMD, -1.04%) that was comparable with that in overweight (WMD, -1.02%) and obese patients (WMD, -0.88%)(p>0.05). Treatment with DPP-4 inhibitors in normal weight patients was associated with a HbA1c change (WMD, -0.93%) that was comparable with that in overweight (WMD, -0.66%) and obese patients (WMD, -0.61%)(p>0.05). In total, of the seven hypoglycemic agents, regression analysis indicated that the mean baseline BMI was not associated with the mean HbA1c changes from baseline. In each kind of hypoglycemic therapy in type 2 diabetes, the baseline BMI was not associated with the efficacy of HbA1c changes from baseline.

Baseline Body Mass Index and the Efficacy of Hypoglycemic Treatment in Type 2 Diabetes: A Meta-Analysis

PubMed Central

Cai, Xiaoling; Yang, Wenjia; Gao, Xueying; Zhou, Lingli; Han, Xueyao; Ji, Linong

2016-01-01

Aim The aim of this study is to compare the effects of hypoglycemic treatments in groups of patients categorized according to the mean baseline body mass indexes (BMIs). Methods Studies were identified by a literature search and all the studies were double blind, placebo-controlled randomized trials in type 2 diabetes patients; study length of ≥12 weeks with the efficacy evaluated by changes in HbA1c from baseline in groups. The electronic search was first conducted in January 2015 and repeated in June 2015. Results 227 studies were included. Treatment with sulfonylureas was compared with placebo in overweight patients and resulted in a significantly greater change in the HbA1c levels (weighted mean difference (WMD), −1.39%) compared to obese patients (WMD, −0.77%)(p<0.05). Treatment with metformin in overweight patients resulted in a comparable change in the HbA1c levels (WMD, −0.99%) compared to obese patients (WMD, −1.06%)(p>0.05). Treatment with alpha glucosidase inhibitors in normal weight patients was associated with a HbA1c change (WMD, −0.94%) that was comparable that in overweight (WMD, −0.72%) and obese patients (WMD, −0.56%)(p>0.05). Treatment with thiazolidinediones in normal weight patients was associated with a HbA1c change (WMD, −1.04%) that was comparable with that in overweight (WMD, −1.02%) and obese patients (WMD, −0.88%)(p>0.05). Treatment with DPP-4 inhibitors in normal weight patients was associated with a HbA1c change (WMD, −0.93%) that was comparable with that in overweight (WMD, −0.66%) and obese patients (WMD, −0.61%)(p>0.05). In total, of the seven hypoglycemic agents, regression analysis indicated that the mean baseline BMI was not associated with the mean HbA1c changes from baseline. Conclusion In each kind of hypoglycemic therapy in type 2 diabetes, the baseline BMI was not associated with the efficacy of HbA1c changes from baseline. PMID:27935975

HbA1c and Glycated Albumin Levels Are High in Gastrectomized Subjects with Iron-Deficiency Anemia.

PubMed

Inada, Shinya; Koga, Masafumi

2017-01-01

We report that glycated albumin (GA) is higher relative to HbA1c in non-diabetic, gastrectomized subjects without anemia, and thus is a sign of oxyhyperglycemia. It is known that gastrectomized subjects are prone to iron-deficiency anemia (IDA), and that the HbA1c levels of subjects with IDA are falsely high. In the present study, the HbA1c and GA levels of gastrectomized subjects with IDA were compared with gastrectomized subjects without anemia. Seven non-diabetic gastrectomized subjects with IDA were enrolled in the present study. Twenty-eight non-diabetic gastrectomized subjects without anemia matched with the subjects with IDA in terms of age, gender, and body mass index were used as the controls. Although there were no significant differences in fasting plasma glucose and OGTT 2-hour plasma glucose (2-h PG) between the two groups, the HbA1c and GA levels in gastrectomized subjects with IDA were significantly higher than the controls. For all of the gastrectomized subjects (n=35), ferritin exhibited a significant negative correlation with HbA1c and GA, and a significant positive correlation with 2-h PG. In addition, the HbA1c and GA levels exhibited a significant negative correlation with the mean corpuscular hemoglobin and hemoglobin. The HbA1c and GA levels in gastrectomized subjects with IDA were significantly higher than those in controls. The high GA levels are attributed to a tendency in which patients with total gastrectomy, who are prone to IDA, are susceptible to postprandial hyperglycemia and reactive hypoglycemia, which in turn leads to large fluctuations in plasma glucose. © 2017 by the Association of Clinical Scientists, Inc.

Glycosylation Gap in Patients with Diabetes with Chronic Kidney Disease and Healthy Participants: A Comparative Study.

PubMed

Neelofar, Km; Ahmad, Jamal

2017-01-01

The aim of this study it to determine the level of glycosylation gap in patients with type 2 diabetes and its relation with kidney dysfunction. In this study, 150 individuals were enrolled (aged 20-75 year) and divided into three groups. Group 1 included 50 nondiabetic individuals who served as control. Group 2 included 50 patients with type 2 diabetes without chronic kidney disease (CKD), and in Group 3, there were 50 patients with type 2 diabetes with CKD. Glycated hemoglobin (HbA1c) and fructosamine (FA) were measured in all groups to determine the glycosylation gap (GG), predicted HbA1c, and mean blood glucose (MBG). GG is defined as the difference between measured HbA1c and HbA1c predicted from FA based on the population regression of HbA1c on FA. The variables were compared by correlation analysis. Serum creatinine level was significantly high in patients with CKD (1.93 ± 0.99) as compared to patients with diabetes and control (0.891 ± 0.16; 0.912 ± 0.1), respectively. The study demonstrated a significant elevation in serum FA, measured HbA1c and predicted HbA1c, MBG in patients with diabetes with CKD as compared with those of without CKD, and controls. GG was found in healthy control (0.51 ± 0.78), patients with type 2 diabetes without CKD (0.62 ± 0.45), and patients with diabetes with CKD (1.0 ± 0.91), respectively. It is concluded that GG may be a useful clinical research tool for evaluating pathological source of variation in diabetes complications such as kidney disease.

Translating HbA1c measurements into estimated average glucose values in pregnant women with diabetes.

PubMed

Law, Graham R; Gilthorpe, Mark S; Secher, Anna L; Temple, Rosemary; Bilous, Rudolf; Mathiesen, Elisabeth R; Murphy, Helen R; Scott, Eleanor M

2017-04-01

This study aimed to examine the relationship between average glucose levels, assessed by continuous glucose monitoring (CGM), and HbA 1c levels in pregnant women with diabetes to determine whether calculations of standard estimated average glucose (eAG) levels from HbA 1c measurements are applicable to pregnant women with diabetes. CGM data from 117 pregnant women (89 women with type 1 diabetes; 28 women with type 2 diabetes) were analysed. Average glucose levels were calculated from 5-7 day CGM profiles (mean 1275 glucose values per profile) and paired with a corresponding (±1 week) HbA 1c measure. In total, 688 average glucose-HbA 1c pairs were obtained across pregnancy (mean six pairs per participant). Average glucose level was used as the dependent variable in a regression model. Covariates were gestational week, study centre and HbA 1c . There was a strong association between HbA 1c and average glucose values in pregnancy (coefficient 0.67 [95% CI 0.57, 0.78]), i.e. a 1% (11 mmol/mol) difference in HbA 1c corresponded to a 0.67 mmol/l difference in average glucose. The random effects model that included gestational week as a curvilinear (quadratic) covariate fitted best, allowing calculation of a pregnancy-specific eAG (PeAG). This showed that an HbA 1c of 8.0% (64 mmol/mol) gave a PeAG of 7.4-7.7 mmol/l (depending on gestational week), compared with a standard eAG of 10.2 mmol/l. The PeAG associated with maintaining an HbA 1c level of 6.0% (42 mmol/mol) during pregnancy was between 6.4 and 6.7 mmol/l, depending on gestational week. The HbA 1c -average glucose relationship is altered by pregnancy. Routinely generated standard eAG values do not account for this difference between pregnant and non-pregnant individuals and, thus, should not be used during pregnancy. Instead, the PeAG values deduced in the current study are recommended for antenatal clinical care.

HbA1c Alone Is a Poor Indicator of Cardiometabolic Risk in Middle-Aged Subjects with Pre-Diabetes but Is Suitable for Type 2 Diabetes Diagnosis: A Cross-Sectional Study

PubMed Central

Millar, Seán R.; Perry, Ivan J.; Phillips, Catherine M.

2015-01-01

Objectives Glycated haemoglobin A1c (HbA1c) measurement is recommended as an alternative to fasting plasma glucose (FPG) for the diagnosis of pre-diabetes and type 2 diabetes. However, evidence suggests discordance between HbA1c and FPG. In this study we examine a range of metabolic risk features, pro-inflammatory cytokines, acute-phase response proteins, coagulation factors and white blood cell counts to determine which assay more accurately identifies individuals at increased cardiometabolic risk. Materials and Methods This was a cross-sectional study involving a random sample of 2,047 men and women aged 46-73 years. Binary and multinomial logistic regression were employed to examine risk feature associations with pre-diabetes [either HbA1c levels 5.7-6.4% (39-46 mmol/mol) or impaired FPG levels 5.6-6.9 mmol/l] and type 2 diabetes [either HbA1c levels >6.5% (>48 mmol/mol) or FPG levels >7.0 mmol/l]. Receiver operating characteristic curve analysis was used to evaluate the ability of HbA1c to discriminate pre-diabetes and diabetes defined by FPG. Results Stronger associations with diabetes-related phenotypes were observed in pre-diabetic subjects diagnosed by FPG compared to those detected by HbA1c. Individuals with type 2 diabetes exhibited cardiometabolic profiles that were broadly similar according to diagnosis by either assay. Pre-diabetic participants classified by both assays displayed a more pro-inflammatory, pro-atherogenic, hypertensive and insulin resistant profile. Odds ratios of having three or more metabolic syndrome features were also noticeably increased (OR: 4.0, 95% CI: 2.8-5.8) when compared to subjects diagnosed by either HbA1c (OR: 1.4, 95% CI: 1.2-1.8) or FPG (OR: 3.0, 95% CI: 1.7-5.1) separately. Conclusions In middle-aged Caucasian-Europeans, HbA1c alone is a poor indicator of cardiometabolic risk but is suitable for diagnosing diabetes. Combined use of HbA1c and FPG may be of additional benefit for detecting individuals at highest odds of type 2 diabetes development. PMID:26266799

Excess body weight affects HbA1c progression irrespective of baseline HbA1c levels in Japanese individuals: a longitudinal retrospective study.

PubMed

Nakajima, Kei; Suwa, Kaname

2015-01-01

Obese individuals with normal HbA1c levels and low-body-weight individuals with high-normal HbA1c levels are frequently encountered in clinical settings, but the effects of these phenotypes on the onset of diabetes are poorly understood. Therefore, we addressed this issue in a longitudinal study. We analyzed clinical parameters, including body mass index (BMI) and HbA1c levels, in 5325 non-diabetic Japanese people aged 20-75 years who underwent four medical checkups between 1999 (baseline) and 2007. The subjects were then classified into six baseline BMI categories, each of which was divided into two HbA1c groups, resulting in a total of 12 groups. In 405 obese subjects with a normal baseline HbA1c (BMI ≥ 27.0 kg/m(2), HbA1c 5.2-5.6%), the mean HbA1c level increased during the study period, and 50.9% developed prediabetes/diabetes. In contrast, in 77 low-body-weight subjects with a high-normal baseline HbA1c (BMI ≤ 18.9 kg/m(2), HbA1c 5.7-6.4%), the mean HbA1c level remained constant. Similar changes occurred in the other groups during the study, resulting in a linear increase in HbA1c levels with increasing BMI. Our results suggest that approximately half of the obese individuals with HbA1c in the normal range develop prediabetes or diabetes within 8 years, whereas low-body-weight individuals with high-normal HbA1c are less likely to exhibit worsening in glycemia. Thus, excess body weight may be the primary therapeutic target to prevent the early onset of diabetes, regardless of the individual's HbA1c.

Comparison of 1,5-anhydroglucitol, HbA1c, and fructosamine for detection of diabetes mellitus.

PubMed

Yamanouchi, T; Akanuma, Y; Toyota, T; Kuzuya, T; Kawai, T; Kawazu, S; Yoshioka, S; Kanazawa, Y; Ohta, M; Baba, S

1991-01-01

To evaluate the use of serum 1,5-anhydroglucitol (AG) levels in screening for diabetes mellitus, we compared the sensitivity and specificity of HbA1c, fructosamine (FA), and AG in 1620 randomly selected subjects in 11 institutions throughout Japan. Most individuals were receiving diet and/or drug therapy for diabetes. Subjects were separated into four groups based on World Health Organization criteria: nondiabetic control subjects, subjects with impaired glucose tolerance (IGT), patients with diabetes, and patients with other disorders without IGT. The overlap of AG values between each group was less than that of HbA1c or FA values. AG levels were significantly correlated with fasting plasma glucose (r = -0.627), HbA1c (r = -0.629), and FA (r = -0.590) levels. If we took 14 micrograms/ml as the normal lower limit, AG level was highly specific (93.1%), and a decreased AG level indicated diabetes mellitus (84.2% sensitivity). According to the selectivity index (sensitivity value times specificity value), AG determinations were superior to both HbA1c and FA measurements for diabetes screening. When combinations of these tests were used, only AG and HbA1c together were slightly better than AG alone. Thus, together with other advantages of AG, e.g., its wide variance with relatively fair glycemic control and the negligible influence of the sampling conditions, AG level has more potential than HbA1c or FA level as a screening criterion for diabetes.

A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination.

PubMed

Wu, Xiaobin; Chao, Yan; Wan, Zemin; Wang, Yunxiu; Ma, Yan; Ke, Peifeng; Wu, Xinzhong; Xu, Jianhua; Zhuang, Junhua; Huang, Xianzhang

2016-10-15

Haemoglobin A 1c (HbA 1c ) is widely used in the management of diabetes. Therefore, the reliability and comparability among different analytical methods for its detection have become very important. A comparative evaluation of the analytical performances (precision, linearity, accuracy, method comparison, and interferences including bilirubin, triglyceride, cholesterol, labile HbA 1c (LA 1c ), vitamin C, aspirin, fetal haemoglobin (HbF), and haemoglobin E (Hb E)) were performed on Capillarys 2 Flex Piercing (Capillarys 2FP) (Sebia, France), Tosoh HLC-723 G8 (Tosoh G8) (Tosoh, Japan), Premier Hb9210 (Trinity Biotech, Ireland) and Roche Cobas c501 (Roche c501) (Roche Diagnostics, Germany). A good precision was shown at both low and high HbA 1c levels on all four systems, with all individual CVs below 2% (IFCC units) or 1.5% (NGSP units). Linearity analysis for each analyzer had achieved a good correlation coefficient (R 2 > 0.99) over the entire range tested. The analytical bias of the four systems against the IFCC targets was less than ± 6% (NGSP units), indicating a good accuracy. Method comparison showed a great correlation and agreement between methods. Very high levels of triglycerides and cholesterol (≥ 15.28 and ≥ 8.72 mmol/L, respectively) led to falsely low HbA 1c concentrations on Roche c501. Elevated HbF induced false HbA 1c detection on Capillarys 2FP (> 10%), Tosoh G8 (> 30%), Premier Hb9210 (> 15%), and Roche c501 (> 5%). On Tosoh G8, HbE induced an extra peak on chromatogram, and significantly lower results were reported. The four HbA 1c methods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.

Association of plasma PCB levels and HbA1c concentration in Iran.

PubMed

Eftekhari, Sahar; Aminian, Omid; Moinfar, Zeinab; Schettgen, Thomas; Kaifie, Andrea; Felten, Michael; Kraus, Thomas; Esser, André

2018-01-01

The rapid increase in prevalence of diabetes mellitus over the last decades warrants more attention to the effects of environmental and occupational exposures on glucose metabolism. Our study aimed to assess the association between the plasma levels of various congeners of polychlorinated biphenyls (PCBs) and the serum concentration of glycated haemoglobin (HbA1c). Our study population consisted of 140 Iranian adults from seven different occupational groups and a group of non-occupationally exposed female participants. The plasma concentration of PCBs were determined at the laboratory of occupational toxicology at RWTH Aachen University, Germany. We considered an HbA1c concentration of 5.7% and more as indicating a disturbed glucose metabolism. Logistic regression was used to assess the association between quartiles of concentrations of PCB congeners and serum HbA1c. Participants with an increased HbA1c value had higher plasma levels of PCB 138, 153, 180 and the PCB sum, although this association was statistically not significant. There was no significant difference between the levels of PCB 138, 153, 180, the sum of these congeners, and PCB 118 in their quartiles when comparing with HbA1c concentrations. For our cohort, we could not demonstrate a significant association between PCB and HbA1c concentrations indicating a disturbance of glucose metabolism.

Earlier triple therapy with pioglitazone in patients with type 2 diabetes.

PubMed

Charpentier, G; Halimi, S

2009-09-01

This study assessed the efficacy of add-on pioglitazone vs. placebo in patients with type 2 diabetes uncontrolled by metformin and a sulphonylurea or a glinide. This multicentre, double-blind, parallel-group study randomized 299 patients with type 2 diabetes to receive 30 mg/day pioglitazone or placebo for 3 months. After this time, patients continued with pioglitazone, either 30 mg [if glycated haemoglobin A1c (HbA(1c)) 6.5%), or placebo for a further 4 months. The primary efficacy end-point was improvement in HbA(1c) (per cent change). Secondary end-points included changes in fasting plasma glucose (FPG), insulin, C-peptide, proinsulin and lipids. The proinsulin/insulin ratio and homeostasis model assessment of insulin resistance (HOMA-IR) and homeostasis model assessment of beta-cell function (HOMA-B) were calculated. Pioglitazone add-on therapy to failing metformin and sulphonylurea or glinide combination therapy showed statistically more significant glycaemic control than placebo addition. The between-group difference after 7 months of triple therapy was 1.18% in HbA(1c) and -2.56 mmol/l for FPG (p < 0.001). Almost half (44.4%) of the patients in the pioglitazone group who had a baseline HbA(1c) level of <8.5% achieved the HbA(1c) target of < 7.0% by final visit compared with 4.9% in the placebo group. When the baseline HbA(1c) level was >or= 8.5%, 13% achieved the HbA(1c) target of < 7.0% in the pioglitazone group and none in the placebo group. HOMA-IR, insulin, proinsulin and C-peptide decreased and HOMA-B increased in the pioglitazone group relative to the placebo group. In patients who were not well controlled with dual combination therapy, the early addition of pioglitazone improved HbA(1c), FPG and surrogate measures of beta-cell function. Patients were more likely to reach target HbA(1c) levels (< 7.0%) with pioglitazone treatment if their baseline HbA(1c) levels were < 8.5%, highlighting the importance of early triple therapy.

Association Between the Presence of Iron Deficiency Anemia and Hemoglobin A1c in Korean Adults

PubMed Central

Hong, Jae W.; Ku, Cheol R.; Noh, Jung H.; Ko, Kyung S.; Rhee, Byoung D.; Kim, Dong-Jun

2015-01-01

Abstract Few studies have investigated the clinical effect of iron deficiency anemia (IDA) on the use of the Hemoglobin A1c (HbA1c) as a screening parameter for diabetes or prediabetes. We investigated the association between IDA and HbA1c levels in Korean adults. Among the 11,472 adults (≥19 years of age) who participated in the 2011–2012 Korea National Health and Nutrition Examination Survey (a cross-sectional and nationally representative survey conducted by the Korean Center for Disease Control for Health Statistics), 807 patients with diabetes currently taking anti-diabetes medications were excluded from this study. We compared the weighted HbA1c levels and weighted proportion (%) of HbA1c levels of ≥5.7%, ≥6.1%, and ≥6.5% according to the range of fasting plasma glucose (FPG) levels and the presence of IDA. Among 10,665 participants (weighted n = 35,229,108), the prevalence of anemia and IDA was 7.3% and 4.3%, respectively. The HbA1c levels were higher in participants with IDA (5.70% ± 0.02%) than in normal participants (5.59% ± 0.01%; P < 0.001), whereas there was no significant difference in FPG levels. In participants with an FPG level of <100 mg/dL and 100 to 125 mg/dL, the weighted HbA1c level was higher in those with IDA (5.59% ± 0.02% and 6.00% ± 0.05%) than in normal participants (5.44% ± 0.01% and 5.82% ± 0.01%) after adjusting for confounders such as age, sex, FPG level, heavy alcohol drinking, waist circumference, and smoking status as well as after exclusion of an estimated glomerular filtration rate of <60 mL/min/1.73 m2 (P < 0.001, <0.01). The weighted proportions (%) of an HbA1c level of ≥5.7% and ≥6.1% were also higher in participants with IDA than in normal participants (P < 0.001, <0.05). However, the weighted HbA1c levels in individuals with an FPG level ≥126 mg/dL and a weighted proportion (%) of an HbA1c level of ≥6.5% showed no significant differences according to the presence of IDA. In conclusion, the presence of IDA shifted the HbA1c level upward only in the normoglycemic and prediabetic ranges, not in the diabetic range. Therefore, IDA should be considered before using HbA1c as a screening test for prediabetes. PMID:25997055

One-Hour Postload Hyperglycemia Confers Higher Risk of Hepatic Steatosis to HbA1c-Defined Prediabetic Subjects.

PubMed

Fiorentino, Teresa Vanessa; Andreozzi, Francesco; Mannino, Gaia Chiara; Pedace, Elisabetta; Perticone, Maria; Sciacqua, Angela; Perticone, Francesco; Sesti, Giorgio

2016-11-01

Individuals with glycated hemoglobin (HbA1c)-defined prediabetes (HbA1c value of 5.7-6.4%) and 1-hour plasma glucose ≥155 mg/dL during an oral glucose tolerance test have an increased risk of developing type 2 diabetes. To evaluate the degree to which HbA1c-defined prediabetes and 1-hour postload glucose ≥155 mg/dL individually and jointly associate with hepatic steatosis and related biomarkers. A cross-sectional analysis was performed on 1108 White individuals. Ambulatory care. Anthropometric and metabolic characteristics including hepatic steatosis assessed by ultrasonography. Compared with the normal group (HbA1c <5.7%), HbA1c-defined prediabetic and diabetic individuals exhibit higher values of fasting, 1-hour, and 2-hour postload glucose; fasting and 2-hour postload insulin; triglycerides; uric acid; homeostasis model of assessment for insulin resistance; liver insulin resistance index; liver enzymes; and inflammatory biomarkers; and lower levels of high-density lipoprotein cholesterol and IGF-1. Prediabetic and diabetic subjects have increased risk of hepatic steatosis (1.5- and 2.46-fold, respectively). Stratifying participants according to HbA1c and 1-hour postload glucose, we found that individuals with HbA1c-defined prediabetes and 1-hour postload glucose ≥155 mg/dL have significantly higher risk of hepatic steatosis as compared with individuals with HbA1c-defined prediabetes but 1-hour postload glucose <155 mg/dL. Individuals with HbA1c-defined prediabetes and 1-hour postload glucose ≥155 mg/dL exhibit higher values of liver enzymes; fasting, 1-hour, and 2-hour postload glucose; insulin; triglycerides; uric acid; and inflammatory biomarkers; and lower levels of high-density lipoprotein and IGF-1. These data suggest that a value of 1-hour postload glucose ≥155 mg/dL may be helpful to identify a subset of individuals within HbA1c-defined glycemic categories at higher risk of hepatic steatosis.

Canagliflozin as an Initial Therapy in Drug-Naïve Subjects with Type 2 Diabetes Mellitus: A Potential Involvement of Atherogenic Lipids in its Glycemic Efficacy.

PubMed

Kutoh, Eiji; Wada, Asuka; Murayama, Teruma; Takizawa, Yui

2017-06-01

The aim of this study is to investigate canagliflozin as an initial therapy in type 2 diabetes mellitus and to explore the effects on metabolic parameters in relation to effects on glycemic control. Treatment-naïve subjects with type 2 diabetes mellitus received canagliflozin 50-100 mg/day monotherapy. At 3 months, levels of glycemic and non-glycemic parameters were compared with those at baseline (n = 39). As a comparator, our previous data of baseline glycosylated hemoglobin (HbA 1c )-matched treatment-naïve subjects with ipragliflozin 25-50 mg monotherapy (n = 27) were employed. Significant reductions in HbA 1c (from 9.96 to 8.33%), fasting blood glucose (-23.9%), homeostasis model assessment-R (HOMA-R, -33.5%), body mass index (-1.8%), and uric acid (UA, -5.2%) levels and significant increases in homeostasis model assessment-B (HOMA-B, 30.1%) levels were observed. Approximately one third of the subjects experienced certain adverse events. Similar results were obtained with ipragliflozin. Baseline levels of HbA 1c , triglycerides, non-high-density lipoprotein-cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C) were chosen as significant contributing factors for the changes in HbA 1c levels with canagliflzoin, while only baseline HbA 1c levels were selected as such a factor with ipragliflozin. Significant positive correlations between the changes in HbA 1c and changes in non-HDL-C (R = 0.3954) or between changes in HbA 1c and changes in LDL-C (R = 0.4317) were observed with canagliflozin. With ipragliflozin, no such correlations were noted. No correlations between the changes in HbA 1c and changes in body mass index were seen with both drugs. These results suggest that (1) canagliflozin appears to offer clinically beneficial outcomes as an initial therapy in subjects with type 2 diabetes mellitus, although with certain adverse events. (2) Atherogenic cholesterols including non-HDL-C and LDL-C could be involved in the glycemic efficacy of canagliflozin. This was not the case with ipragliflozin. (3) Unexpectedly, weight reductions with canagliflozin are not associated with its glycemic efficacy.

The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading.

PubMed

Beck, Roy W; Connor, Crystal G; Mullen, Deborah M; Wesley, David M; Bergenstal, Richard M

2017-08-01

HbA 1c is a v aluable metric for comparing treatment groups in a randomized trial, for assessing glycemic trends in a population over time, or for cross-sectional comparisons of glycemic control in different populations. However, what is not widely appreciated is that HbA 1c may not be a good indicator of an individual patient's glycemic control because of the wide range of mean glucose concentrations and glucose profiles that can be associated with a given HbA 1c level. To illustrate this point, we plotted mean glucose measured with continuous glucose monitoring (CGM) versus central laboratory-measured HbA 1c in 387 participants in three randomized trials, showing that not infrequently HbA 1c may underestimate or overestimate mean glucose, sometimes substantially. Thus, if HbA 1c is to be used to assess glycemic control, it is imperative to know the patient's actual mean glucose to understand how well HbA 1c is an indicator of the patient's glycemic control. With knowledge of the mean glucose, an estimated HbA 1c (eA1C) can be calculated with the formula provided in this article to compare with the measured HbA 1c . Estimating glycemic control from HbA 1c alone is in essence applying a population average to an individual, which can be misleading. Thus, a patient's CGM glucose profile has considerable value for optimizing his or her diabetes management. In this era of personalized, precision medicine, there are few better examples with respect to the fallacy of applying a population average to a specific patient rather than using specific information about the patient to determine the optimal approach to treatment. © 2017 by the American Diabetes Association.

The Glycated Albumin (GA) to HbA1c Ratio Reflects Shorter-Term Glycemic Control than GA: Analysis of Patients with Fulminant Type 1 Diabetes.

PubMed

Koga, Masafumi; Inada, Shinya; Nakao, Taisei; Kawamori, Ryuzo; Kasayama, Soji

2017-01-01

Glycated albumin (GA) reflects shorter-term glycemic control than HbA1c. We have reported that HbA1c is paradoxically increased in diabetic patients whose glycemic control deteriorated before ameliorating. In this study, we analyzed paradoxical increases of glycemic control indicators after treatment in patients with fulminant type 1 diabetes (FT1D). We also investigated whether the GA/HbA1c ratio may reflect shorter-term glycemic control than GA. Five FT1D patients whose post-treatment HbA1c and GA levels were measured were enrolled. We also used a formula to estimate HbA1c and GA from the fictitious models of changes in plasma glucose in FT1D patients. In this model, the periods during which HbA1c, GA, and the GA/HbA1c ratio were higher than at the first visit were compared. In addition, the half-life for the GA/HbA1c ratio was calculated in accordance with the half-lives for HbA1c and GA (36 and 14 days, respectively). In all FT1D patients, HbA1c levels 2-4 weeks after treatment were increased, with three patients (60%) experiencing an increase of GA levels. In contrast, an increase of the GA/HbA1c ratio was observed in only one patient. In all of the different models of changes in plasma glucose in FT1D patients, the length of time during which the values were higher than at the first visit was in the order of HbA1c > GA > GA/HbA1c ratio. The half-life for the GA/HbA1c ratio was 9 days, shorter than GA. These findings suggest that the GA/HbA1c ratio reflects shorter-term glycemic control than GA. © 2016 Wiley Periodicals, Inc.

Alcohol consumption reduces HbA1c and glycated albumin concentrations but not 1,5-anhydroglucitol.

PubMed

Inada, Shinya; Koga, Masafumi

2017-11-01

Background The effect of alcohol consumption on glycaemic control indicators is not well known. In this study, we studied the effect of alcohol consumption on the plasma glucose and glycaemic control indicators in non-diabetic men. Methods The study enrolled 300 non-diabetic men who received a complete medical checkup (age: 52.8 ± 6.5 years, body mass index: 24.4 ± 2.8 kg/m 2 ). The subjects were divided into four groups by the amount of alcohol consumed, and the plasma glucose, HbA1c, glycated albumin (GA) and 1,5-anhydroglucitol (1,5-AG) concentrations of the groups were compared. Results As the level of alcohol consumption increased, significantly high concentrations of fasting plasma glucose (FPG) were observed, and the oral glucose tolerance test 2-h plasma glucose concentrations tended to rise. While no significant effect of alcohol consumption on HbA1c, 1,5-AG, and the 1,5-AG/FPG ratio was observed, the HbA1c/FPG ratio, GA and the GA/FPG ratio exhibited significantly low values as the level of alcohol consumption increased. In stepwise multivariate regression analysis, alcohol consumption was a significant negative independent variable for HbA1c and GA, but not for 1,5-AG. Conclusions As the level of alcohol consumption increased, the plasma glucose concentrations rose, but the HbA1c and GA concentrations were lower compared with the plasma glucose concentrations. These findings suggest that alcohol consumption may reduce HbA1c and GA concentrations, but not 1,5-AG.

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

HbA1c measurement and relationship to incident stroke.

PubMed

Robson, R; Lacey, A S; Luzio, S D; Van Woerden, H; Heaven, M L; Wani, M; Halcox, J P J; Castilla-Guerra, L; Dawson, J; Hewitt, J

2016-04-01

To determine the proportion of people with diabetes who have HbA1c measured, what proportion achieve an HbA1c level of < 58 mmol/mol (7.5%), the frequency of testing and if there was any change in HbA1c level in the year before and the year after an incident stroke. This study used the Secure Anonymised Information Linkage (SAIL) databank, which stores hospital data for the whole of Wales and ~ 65% of Welsh general practice records, to identify cases of stroke in patients with diabetes between 2000 and 2010. These were matched against patients with diabetes but without stroke disease. We assessed the frequency of HbA1c testing and change in HbA1c in the first year after stroke. Estimation was made of the proportion of patients achieving an HbA1c measurement ≤ 58 mmol/mol (7.5%). There were 1741 patients with diabetes and stroke. Of these, 1173 (67.4%) had their HbA1c checked before their stroke and 1137 (65.3%) after their stroke. In the control group of 16 838 patients with diabetes but no stroke, 8413 (49.9%) and 9288 (55.1%) had their HbA1c checked before and after the case-matched stroke date, respectively. In patients with diabetes and stroke, HbA1c fell from 61-56 mmol/mol (7.7-7.3%) after their stroke (P < 0.001). Before the study, 55.0% of patients with stroke had an HbA1c ≥ 58 mmol/mol compared with 65.2% of control patients, these figures were 62.5% and 65.3% after the stroke. The frequency of diabetes testing was higher in patients who had experienced a stroke before and after their incident stroke compared with control patients but did not increase after their stroke. Glucose control improved significantly in the year after a stroke. © 2015 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

HbA1c levels in individuals heterozygous for hemoglobin variants.

PubMed

Tavares, Ricardo Silva; Souza, Fábio Oliveira de; Francescantonio, Isabel Cristina Carvalho Medeiros; Soares, Weslley Carvalho; Mesquita, Mauro Meira

2017-04-01

To evaluate the levels of glycated hemoglobin (HbA1c) in patients heterozygous for hemoglobin variants and compare the results of this test with those of a control group. This was an experimental study based on the comparison of HbA1c tests in two different populations, with a test group represented by individuals heterozygous for hemoglobin variants (AS and AC) and a control group consisting of people with electrophoretic profile AA. The two populations were required to meet the following inclusion criteria: Normal levels of fasting glucose, hemoglobin, urea and triglycerides, bilirubin > 20 mg/dL and non-use of acetylsalicylic acid. 50 heterozygous subjects and 50 controls were evaluated between August 2013 and May 2014. The comparison of HbA1c levels between heterozygous individuals and control subjects was performed based on standard deviation, mean and G-Test. The study assessed a test group and a control group, both with 39 adults and 11 children. The mean among heterozygous adults for HbA1c was 5.0%, while the control group showed a rate of 5.74%. Heterozygous children presented mean HbA1c at 5.11%, while the controls were at 5.78%. G-Test yielded p=0.93 for children and p=0.89 for adults. Our study evaluated HbA1c using ion exchange chromatography resins, and the patients heterozygous for hemoglobin variants showed no significant difference from the control group.

Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference

PubMed Central

Selvin, Elizabeth

2016-01-01

Studies that have compared HbA1c levels by race have consistently demonstrated higher HbA1c levels in African Americans than in whites. These racial differences in HbA1c have not been explained by measured differences in glycemia, sociodemographic factors, clinical factors, access to care, or quality of care. Recently, a number of nonglycemic factors and several genetic polymorphisms that operate through nonglycemic mechanisms have been associated with HbA1c. Their distributions across racial groups and their impact on hemoglobin glycation need to be systematically explored. Thus, on the basis of evidence for racial differences in HbA1c, current clinical guidelines from the American Diabetes Association state: “It is important to take…race/ethnicity…into consideration when using the A1C to diagnose diabetes.” However, it is not clear from the guidelines how this recommendation might be actualized. So, the critical question is not whether racial differences in HbA1c exist between African Americans and whites; the important question is whether the observed differences in HbA1c level are clinically meaningful. Therefore, given the current controversy, we provide a Point-Counterpoint debate on this issue. In the preceding point narrative, Dr. Herman provides his argument that the failure to acknowledge that HbA1c might be a biased measure of average glycemia and an unwillingness to rigorously investigate this hypothesis will slow scientific progress and has the potential to do great harm. In the counterpoint narrative below, Dr. Selvin argues that there is no compelling evidence for racial differences in the validity of HbA1c as a measure of hyperglycemia and that race is a poor surrogate for differences in underlying causes of disease risk. —William T. Cefalu Editor in Chief, Diabetes Care PMID:27457637

Variables associated with HbA1c and weight reductions when adding liraglutide to multiple daily insulin injections in persons with type 2 diabetes (MDI Liraglutide trial 3).

PubMed

Dahlqvist, Sofia; Ahlén, Elsa; Filipsson, Karin; Gustafsson, Thomas; Hirsch, Irl B; Tuomilehto, Jaakko; Imberg, Henrik; Ahrén, Bo; Attvall, Stig; Lind, Marcus

2018-01-01

To evaluate variables associated with hemoglobin A1c (HbA1c) and weight reduction when adding liraglutide to persons with type 2 diabetes treated with multiple daily insulin injections (MDI). This was a reanalysis of a previous trial where 124 patients were enrolled in a double-blind, placebo-controlled, multicenter randomized trial carried out over 24 weeks. Predictors for effect on change in HbA1c and weight were analyzed within the treatment group and with concurrent interaction analyses. Correlation analyses for change in HbA1c and weight from baseline to week 24 were made. The mean age at baseline was 63.7 years, 64.8% were men, the mean number of insulin injections was 4.4 per day, the mean daily insulin dose was 105 units and the mean HbA1c was 74.5 mmol/mol (9.0%). The mean HbA1c and weight reductions were 12.3 mmol/mol (1.13%; P<0.001) and 3.8 kg (P<0.001) greater in liraglutide than placebo-treated persons. There was no significant predictor for greater effect on HbA1c that existed in all analyses (univariate, multivariate and interaction analyses against controls). For a greater weight reduction when adding liraglutide, a lower HbA1c level at baseline was a predictor (liraglutide group P=0.002, P=0.020 for liraglutide group vs placebo). During follow-up in the liraglutide group, no significant correlation was found between change in weight and change in HbA1c (r=0.09, P=0.46), whereas a correlation existed between weight and insulin dose reduction (r=0.44, P<0.001). Weight reduction becomes greater when adding liraglutide in patients with type 2 diabetes treated with MDI who had a lower HbA1c level compared with those with a higher HbA1c level. There was no correlation between reductions in HbA1c and weight when liraglutide was added, that is, different patient groups responded with HbA1c and weight reductions. EudraCT nr: 2012-001941-42.

HbA1c in relation to incident diabetes and diabetes-related complications in non-diabetic adults at baseline.

PubMed

Metcalf, Patricia Anne; Kyle, Cam; Kenealy, Tim; Jackson, Rod T

2017-05-01

We compared the utility of glycated hemoglobin (HbA 1c ) and oral glucose tolerance (oGTT) in non-diabetic patients for identifying incident diabetes; all-cause mortality; cardiovascular disease (CVD) mortality; CVD, coronary heart disease (CHD), and ischemic stroke events; and diabetes microvascular complications. Data from a New Zealand community setting were prospectively linked to hospitalization, mortality, pharmaceutical and laboratory test results data. After applying exclusion criteria (prior laboratory diagnosis or history of drug treatment for diabetes or hospitalization for diabetes or CVD event), there were 31,148 adults who had an HbA 1c and 2-h 75g oGTT. HbA 1c was measured by ion-exchange high-performance liquid chromatography, and glucose using a commercial enzymatic method. We compared glycemic measures and outcomes using multivariable Cox proportional hazards regression. The median follow-up time was 4years (range 0 to 13). The mean age was 57·6years and 53·0% were male. After adjusting for other glycemic measures (fasting glucose, 2-h glucose and/or HbA 1c where relevant) in addition to age, sex, ethnicity and smoking habit, the hazard ratios for incident diabetes and diabetes complications of retinopathy and nephropathy were highest for 2-h glucose levels, followed by HbA 1c and lastly by fasting glucose. However, all-cause mortality and CHD were significantly associated with HbA 1c concentrations only, and ischemic stroke and CVD events with 2-h glucose only. Circulatory complications showed a stronger association with HbA 1c . Apart from neuropathy, HbA 1c showed stronger associations with outcomes compared to fasting glucose and provides a convenient alternative to an oGTT. Copyright © 2017 Elsevier Inc. All rights reserved.

CLD (chronic liver diseases)-HbA1C as a suitable indicator for estimation of mean plasma glucose in patients with chronic liver diseases.

PubMed

Koga, Masafumi; Kasayama, Soji; Kanehara, Hideo; Bando, Yukihiro

2008-08-01

In patients with chronic liver diseases (CLD), turnover of erythrocytes is increased whereas that of serum albumin is decreased. Thus, glycated hemoglobin (HbA(1C)) and glycated albumin (GA) cannot be used as adequate indicators for chronic plasma glucose control in diabetic patients with CLD. In this investigation, we have proposed CLD-HbA(1C), a novel long-term glycemic control marker by using measured HbA(1C) and GA. We studied 82 patients with CLD in whom glycemic control was regarded as to be stable. Daily plasma glucose profiles were monitored and estimated levels of HbA(1C) were calculated on the conversion formula established by Rohlfing et al. [C.L. Rohlfing, J.D. England, H.M. Wiedmeyer, A. Tennill, R.R. Little, D.E. Goldstein, Defining the relationship between plasma glucose and HbA1c, Diabetes Care 25 (2002) 275-278]. Cholinesterase (ChE) as an indicator for hepatic function was determined at the same time when HbA(1C) and GA levels were measured. CLD-HbA(1C) was defined as the average of measured HbA(1C) and GA/3, based upon the results that among healthy individuals, GA levels were roughly estimated at approximately threefold higher than HbA(1C) levels. While measured HbA(1C) levels in patients with CLD were generally lower than estimated HbA(1C) levels, GA/3 values were generally higher than estimated HbA(1C) levels. Such discrepancies lineally increased in accordance with a decrease in ChE levels. On the other hand, CLD-HbA(1C) levels were highly correlated with estimated HbA(1C) levels (R=0.883), while no significant correlation between CLD-HbA(1C) and ChE was noted. In conclusion, CLD-HbA(1C) has been found a superior chronic glycemic control marker than HbA(1C) or GA in diabetic patients with chronic liver diseases.

Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial.

PubMed

Long, Judith A; Jahnle, Erica C; Richardson, Diane M; Loewenstein, George; Volpp, Kevin G

2012-03-20

Compared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels. A 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956) Philadelphia Veterans Affairs Medical Center. African American veterans aged 50 to 70 years with persistently poor diabetes control. 118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ≤7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%. Change in HbA(1c) level at 6 months. Mentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group. The study included only veterans and lasted only 6 months. Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. National Institute on Aging Roybal Center.

Validity of glycated hemoglobin in screening and diagnosing type 2 diabetes mellitus in Chinese subjects.

PubMed

Yu, Yun; Ouyang, Xiao-Jun; Lou, Qing-Lin; Gu, Liu-Bao; Mo, Yong-Zhen; Ko, Gary T; Chow, Chun-Chung; So, Wing-Yee; Ma, Ronald; Kong, Alice; Brown, Nicola; Nan, Jennifer; Chan, Juliana; Bian, Rong-Wen

2012-03-01

The application of glycated hemoglobin (HbA(1c)) for the diagnosis of diabetes is currently under extensive discussion. In this study, we explored the validity of using HbA(1c) as a screening and diagnostic test in Chinese subjects recruited in Nanjing, China. In total, 497 subjects (361 men and 136 women) with fasting plasma glucose (PG) ≥ 5.6 mmol/L were recruited to undergo the oral glucose tolerance test (OGTT) and HbA(1c) test. Plasma lipid, uric acid, and blood pressure were also measured. Using a receiver operating characteristic curve, the optimal cutoff point of HbA(1c) related to diabetes diagnosed by the OGTT was 6.3%, with a sensitivity and specificity of 79.6% and 82.2%, respectively, and the area under the curve was 0.87 (95% confidence interval, 0.83 to 0.92). A HbA(1c) level of 6.5% had a sensitivity and specificity of 62.7% and 93.5%, respectively. When comparing the HbA(1c) ≥ 6.5% or OGTT methods for diagnosing diabetes, the former group had significantly higher HbA(1c) levels and lower levels of fasting and 2-hour PG than the latter group. No significant difference was observed in the other metabolism indexes between the two groups. Our results suggest that HbA(1c) ≥ 6.5% has reasonably good specificity for diagnosing diabetes in Chinese subjects, which is in concordance with the American Diabetes Association recommendations.

Distribution of glycated haemoglobin and its determinants in Korean youth and young adults: a nationwide population-based study.

PubMed

Seo, Ji-Young; Hwang, Seung-Sik; Kim, Jae Hyun; Lee, Young Ah; Lee, Seong Yong; Shin, Choong Ho; Yang, Sei Won

2018-01-31

The present study aimed to describe the distribution of and to investigate the factors associated with glycated haemoglobin (HbA1c) values in Korean youth (10-19 years old) and young adults (20-29 years old). Data from the Korea Health and Nutrition Examination Survey (2011-2015) were used. A total of 6,418 participants (male 3,140 [53.2%]) aged 10-29 years were included in the analysis. Percentiles of HbA1c were calculated and HbA1c values were compared according to age, sex, and associated factors. The mean HbA1c values (% [mmol/mol]) were 5.42 ± 0.01 (35.7 ± 0.1) for youths and 5.32 ± 0.01 (34.7 ± 0.1) for young adults (P < 0.001). Male participants showed significantly higher HbA1c level than females (P < 0.001). When age was grouped into 5-year intervals, HbA1c was the highest in those aged 10-14 years and the lowest in those aged 20-24 years. After controlling for confounding variables, the HbA1c values of youths and male participants were significantly higher than those of young adults and female participants. The present study provides nationally representative data on the distribution of HbA1c values in Korean youth and young adults. There were significant differences in the level of HbA1c according to age and sex.

Relationship between Hb and HbA1c in Japanese adults: an analysis of the 2009 Japan Society of Ningen Dock database.

PubMed

Takahashi, Eiko; Moriyama, Kengo; Yamakado, Minoru

2014-06-01

We investigated the effect of Hb on HbA1c levels in 265,427 Japanese individuals. The divergence between fasting plasma glucose (FPG) and HbA1c levels increased with lower Hb, resulting in HbA1c levels that were higher in relation to than the FPG levels. Similarly, the correlation between FPG and HbA1c levels, stratified by Hb, weakened as Hb decreased. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Associations of mid-pregnancy HbA1c with gestational diabetes and risk of adverse pregnancy outcomes in high-risk Taiwanese women.

PubMed

Ho, Yi-Ran; Wang, Panchalli; Lu, Mei-Chun; Tseng, Shih-Ting; Yang, Chun-Pai; Yan, Yuan-Horng

2017-01-01

The objective of this study was to investigate the associations among the mid-pregnancy glycated hemoglobin A1c (HbA1c) level, gestational diabetes (GDM), and risk of adverse pregnancy outcomes in women without overt diabetes and with positive 50-g, 1-h glucose challenge test (GCT) results (140 mg/dL or greater). This prospective study enrolled 1,989 pregnant Taiwanese women. A two-step approach, including a 50-g, 1-h GCT and 100-g, 3-h oral glucose tolerance test (OGTT), was employed for the diagnosis of GDM at weeks 23-32. The mid-pregnancy HbA1c level was measured at the time the OGTT was performed. A receiver operating characteristic (ROC) curve was used to determine the relationship between the mid-pregnancy HbA1c level and GDM. Multiple logistic regression models were implemented to assess the relationships between the mid-pregnancy HbA1c level and adverse pregnancy outcomes. An ROC curve demonstrated that the optimal mid-pregnancy HbA1c cut-off point to predict GDM, as diagnosed by the Carpenter-Coustan criteria using a two-step approach, was 5.7%. The area under the ROC curve of the mid-pregnancy HbA1c level for GDM was 0.70. Compared with the levels of 4.5-4.9%, higher mid-pregnancy HbA1c levels (5.0-5.4, 5.5-5.9, 6.0-6.4, 6.5-6.9, and >7.0%) were significantly associated with increased risks of gestational hypertension or preeclampsia, preterm delivery, admission to the neonatal intensive care unit, low birth weight, and macrosomia (the odds ratio [OR] ranges were 1.20-9.98, 1.31-5.16, 0.88-3.15, 0.89-4.10, and 2.22-27.86, respectively). The mid-pregnancy HbA1c level was associated with various adverse pregnancy outcomes in high-risk Taiwanese women. However, it lacked adequate sensitivity and specificity to replace the two-step approach in the diagnosis of GDM. The current study comprised a single-center prospective study; thus, additional, randomized control design studies are required.

Associations of mid-pregnancy HbA1c with gestational diabetes and risk of adverse pregnancy outcomes in high-risk Taiwanese women

PubMed Central

Lu, Mei-Chun; Tseng, Shih-Ting; Yang, Chun-Pai

2017-01-01

Background The objective of this study was to investigate the associations among the mid-pregnancy glycated hemoglobin A1c (HbA1c) level, gestational diabetes (GDM), and risk of adverse pregnancy outcomes in women without overt diabetes and with positive 50-g, 1-h glucose challenge test (GCT) results (140 mg/dL or greater). Methods This prospective study enrolled 1,989 pregnant Taiwanese women. A two-step approach, including a 50-g, 1-h GCT and 100-g, 3-h oral glucose tolerance test (OGTT), was employed for the diagnosis of GDM at weeks 23–32. The mid-pregnancy HbA1c level was measured at the time the OGTT was performed. A receiver operating characteristic (ROC) curve was used to determine the relationship between the mid-pregnancy HbA1c level and GDM. Multiple logistic regression models were implemented to assess the relationships between the mid-pregnancy HbA1c level and adverse pregnancy outcomes. Results An ROC curve demonstrated that the optimal mid-pregnancy HbA1c cut-off point to predict GDM, as diagnosed by the Carpenter-Coustan criteria using a two-step approach, was 5.7%. The area under the ROC curve of the mid-pregnancy HbA1c level for GDM was 0.70. Compared with the levels of 4.5–4.9%, higher mid-pregnancy HbA1c levels (5.0–5.4, 5.5–5.9, 6.0–6.4, 6.5–6.9, and >7.0%) were significantly associated with increased risks of gestational hypertension or preeclampsia, preterm delivery, admission to the neonatal intensive care unit, low birth weight, and macrosomia (the odds ratio [OR] ranges were 1.20–9.98, 1.31–5.16, 0.88–3.15, 0.89–4.10, and 2.22–27.86, respectively). Conclusions The mid-pregnancy HbA1c level was associated with various adverse pregnancy outcomes in high-risk Taiwanese women. However, it lacked adequate sensitivity and specificity to replace the two-step approach in the diagnosis of GDM. The current study comprised a single-center prospective study; thus, additional, randomized control design studies are required. PMID:28505205

No difference in pain reduction after epidural steroid injections in diabetic versus nondiabetic patients: A retrospective cohort study

PubMed Central

Wong, Francis; Namdari, Bahram; Dupler, Suzanne; Kovac, Mario Farias; Makarova, Natalya; Dalton, Jarrod E.; Turan, Alparslan

2016-01-01

Background and Aims: Diabetes affects peripheral and central neurons causing paresthesia, allodynia, hyperalgesia, and spontaneous pain. However, the effect of diabetes on response to epidural steroid injection (ESI) remains unknown. We hypothesized that diabetic patients receiving ESI will have different pain scores compared to nondiabetic patients. We tested a secondary hypothesis that pain reduction differs at different levels of hemoglobin A1c (HbA1c) for patients with diabetes. Material and Methods: Data from 284 consecutive patients given ESIs for radiculopathy were obtained via a manual review of electronic medical records. We initially compared diabetic and nondiabetic groups with respect to balance on baseline demographic and morphometric characteristics. Next, a linear regression model was developed to evaluate the association between existing diabetes and postinjection reduction in pain scores. And finally, we univariably characterized the association between HbA1c and pain reduction. Results: After exclusion of nine patients, 275 patients were analysed, including 55 (20%) who were diabetic. Pain reduction after ESI was comparable in diabetic and nondiabetic patients (Wald test P = 0.61). The degree of pain reduction generally decreased with the level of HbA1c until reaching HbA1c levels of approximately 7.5%, after which point it stayed fairly constant. Conclusion: There was no difference in pain reduction after ESIs comparing diabetic with nondiabetic patients; however, for diabetic patients, pain reduction may decrease with uncontrolled diabetes determined by high HbA1c values, thus suggesting pain physicians to take an active role in guiding their patients to have their blood glucose levels better regulated to improve outcomes of their ESIs. PMID:27006548

Impact of sexual activity on glycated hemoglobin levels in patients with type 2 diabetes mellitus after penile prosthesis implantation.

PubMed

Talib, Raidh A; Canguven, Onder; Al Ansari, Abdulla

2014-09-06

To examine the benefits of sexual activity on glycated hemoglobin (HbA1c)in penile prosthesis implanted patients with type 2 diabetes mellitus (DM). Sixty-seven male subjects who had HbA1c levels of ≥ 6.5% before and could perform regular sexual activity after the implantations were enrolled. The contribution of sexual activity on glycemic control assessed by HbA1c level as well as age, duration of DM and frequency of sexual activity were evaluated. Mean age and mean time from the surgery of the study patients was 59.9 years (range,30-82) and 22.6 months (range, 10-63), respectively. The average of penile prosthesis usage for sexual activity was 9.9 times per month (range, 2-28). Compared with the preimplantation, the absolute mean change in HbA1c after penile prosthesis implantation was found as - 0.2% (P > .05). This study also revealed that more sexual activity was associated with more reduction in HbA1c. The present study demonstrated that sexual activity is associated with HbA1c reduction, which is clinically important in patients with type 2 DM after penile prosthesis implantation.

[About the HbA1c in the elderly].

PubMed

Farcet, Anaïs; Delalande, Géraldine; Oliver, Charles; Retornaz, Frédérique

2016-03-01

HbA1c product of non enzymatic glycation of HbA increases in relation with the mean blood glucose level during the former 2-3 months. HbA1c levels are correlated with the development of diabetic complications and HbA1c assessment is now the gold standard for evaluation of diabetes control. HbA1c level should not be higher than 7% to avoid these complications. However, in aged peoples, the objectives of diabetes control vary according to their health status. It must be good with HbA1c lower than 7-7.5% in healthy subjects and more relax in subjects with symptoms of frailty and risks of non perceived and self corrected hypoglycemia. Under these conditions, HbA1c values lower than 8 to 9% are advised. Nevertheless, hypoglycemia episodes may occur in patients with high HbA1c and capillary glucose follow-up is necessary for detection of such complications.

Impact of differing glucose-lowering regimens on the pattern of association between glucose control and survival.

PubMed

Currie, Craig J; Holden, Sarah E; Jenkins-Jones, Sara; Morgan, Christopher Ll; Voss, Bernd; Rajpathak, Swapnil N; Alemayehu, Berhanu; Peters, John R; Engel, Samuel S

2018-04-01

To characterize survival in relation to achieved glycated haemoglobin (HbA1c) level within alternative glucose-lowering regimens with differing risks of hypoglycaemia. Data were extracted from the UK Clinical Practice Research Datalink and the corresponding Hospital Episode Statistics. Patients with type 2 diabetes prescribed glucose-lowering therapy in monotherapy or dual therapy with metformin between 2004 and 2013 were identified. Risk of all-cause mortality within treatment cohorts was evaluated using the Cox proportional hazards model, introducing mean HbA1c as a quarterly updated, time-dependent covariable. There were 6646 deaths in a total follow-up period of 374 591 years. Survival for lower (<7%) vs moderate HbA1c levels (≥7%, <8.5%) differed by cohort: metformin, adjusted hazard ratio (aHR) 1.03 (95% confidence interval [CI] 0.95-1.12); sulphonylurea, aHR 1.11 (95% CI 0.99-1.25); insulin, aHR 1.47 (95% CI 1.25-1.72); combined regimens with low hypoglycaemia risk, aHR 1.02 (95% CI 0.94-1.10); and combined regimens with higher hypoglycaemia risk excluding insulin, aHR 1.24 (95% CI 1.13-1.35) and including insulin, aHR 1.28 (95% CI 1.18-1.37). Higher HbA1c levels were associated with increased mortality in regimens with low hypoglycaemia risk. Post hoc analysis by HbA1c deciles revealed an elevated risk of all-cause mortality for the lowest deciles across all cohorts, but particularly in those regimens associated with hypoglycaemia. High HbA1c was associated with no difference, or a small increase in mortality risk in regimens with increased risk of hypoglycaemia. The pattern of mortality risk across the range of HbA1c differed by glucose-lowering regimen. Lower HbA1c was associated with increased mortality risk compared with moderate control, especially in those regimens associated with hypoglycaemia. High levels of HbA1c were associated with the expected elevated mortality risk in regimens with low hypoglycaemia risk. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Impact of Disease Management Programs on HbA1c Values in Type 2 Diabetes Patients in Germany.

PubMed

Kostev, Karel; Rockel, Timo; Jacob, Louis

2017-01-01

The aim was to analyze the impact of disease management programs on HbA1c values in type 2 diabetes mellitus (T2DM) patients in Germany. This study included 9017 patients followed in disease management programs (DMPs) who started an antihyperglycemic treatment upon inclusion in a DMP. Standard care (SC) patients were included after individual matching (1:1) to DMP cases based on age, gender, physician (diabetologist versus nondiabetologist care), HbA1c values at baseline, and index year. The main outcome was the share of patients with HbA1c <7.5% or 6.5% after at least 6 months and less than 12 months of therapy in DMP and SC groups. Multivariate logistic regression models were fitted with HbA1c level as a dependent variable and the potential predictor (DMP versus SC). The mean age was 64.3 years and 54.7% of the patients were men. The mean HbA1c level at baseline was equal to 8.7%. In diabetologist practices, 64.7% of DMP patients and 55.1% of SC patients had HbA1c levels <7.5%, while 23.4% of DMP patients and 16.9% of SC patients had HbA1c levels <6.5% ( P values < .001). By comparison, in general practices, 72.4% of DMP patients and 65.7% of SC patients had HbA1c levels <7.5%, while 29.0% of DMP patients and 25.4% of SC patients had HbA1c levels <6.5% ( P values < .001). DMPs increased the likelihood of HbA1c levels lower than 7.5% or 6.5% after 6 months of therapy in both diabetologist and general care practices. The present study indicates that the enrollment of T2DM patients in DMPs has a positive impact on HbA1c values in Germany.

Contribution of fasting and postprandial hyperglycemia to hemoglobin A1c in insulin-treated Japanese diabetic patients.

PubMed

Shimizu, Hiroyuki; Uehara, Yutaka; Okada, Shuichi; Mori, Masatomo

2008-08-01

The contribution of fasting and postprandial glucose to hemoglobin A(1c) (HbA(1c)) levels was evaluated in insulin-treated patients. In 57 insulin-treated, diabetic out-patients, fasting glucose (before breakfast (B-FG), lunch (L-FG) and dinner (D-FG)) and postprandial glucose (B-PPG, L-PPG and D-PPG) levels were determined by the patients themselves at home using glucose self-monitoring apparatus over the course of one week. The correlation between HbA(1c) levels and self monitored blood glucose levels were calculated. In the conventionally treated group, there was a significant correlation between HbA(1c) and fasting glucose (FG) levels only before lunch, but at 2 hr after (PPG) all meals. In the intensively treated group, a significant correlation between HbA(1c) levels and FG levels was found before lunch and at 2 hr after breakfast and dinner. In all subjects, only FG levels before lunch correlated significantly with HbA(1c) levels, although PPG levels were significantly correlated with HbA(1c) at all points. The correlation was highest with PPG after breakfast and dinner. The sum of all FG, PPG and FG + PPG levels was significantly correlated with HbA(1c) levels. Postprandial hyperglycemia after breakfast and dinner should be regarded as most important for improving HbA(1c) levels in insulin treated diabetic patients.

Association of Sickle Cell Trait With Hemoglobin A1c in African Americans.

PubMed

Lacy, Mary E; Wellenius, Gregory A; Sumner, Anne E; Correa, Adolfo; Carnethon, Mercedes R; Liem, Robert I; Wilson, James G; Sacks, David B; Jacobs, David R; Carson, April P; Luo, Xi; Gjelsvik, Annie; Reiner, Alexander P; Naik, Rakhi P; Liu, Simin; Musani, Solomon K; Eaton, Charles B; Wu, Wen-Chih

2017-02-07

Hemoglobin A1c (HbA1c) reflects past glucose concentrations, but this relationship may differ between those with sickle cell trait (SCT) and those without it. To evaluate the association between SCT and HbA1c for given levels of fasting or 2-hour glucose levels among African Americans. Retrospective cohort study using data collected from 7938 participants in 2 community-based cohorts, the Coronary Artery Risk Development in Young Adults (CARDIA) study and the Jackson Heart Study (JHS). From the CARDIA study, 2637 patients contributed a maximum of 2 visits (2005-2011); from the JHS, 5301 participants contributed a maximum of 3 visits (2000-2013). All visits were scheduled at approximately 5-year intervals. Participants without SCT data, those without any concurrent HbA1c and glucose measurements, and those with hemoglobin variants HbSS, HbCC, or HbAC were excluded. Analysis of the primary outcome was conducted using generalized estimating equations (GEE) to examine the association of SCT with HbA1c levels, controlling for fasting or 2-hour glucose measures. Presence of SCT. Hemoglobin A1c stratified by the presence or absence of SCT was the primary outcome measure. The analytic sample included 4620 participants (mean age, 52.3 [SD, 11.8] years; 2835 women [61.3%]; 367 [7.9%] with SCT) with 9062 concurrent measures of fasting glucose and HbA1c levels. In unadjusted GEE analyses, for a given fasting glucose, HbA1c values were statistically significantly lower in those with (5.72%) vs those without (6.01%) SCT (mean HbA1c difference, -0.29%; 95% CI, -0.35% to -0.23%). Findings were similar in models adjusted for key risk factors and in analyses using 2001 concurrent measures of 2-hour glucose and HbA1c concentration for those with SCT (mean, 5.35%) vs those without SCT (mean, 5.65%) for a mean HbA1c difference of -0.30% (95% CI, -0.39% to -0.21%). The HbA1c difference by SCT was greater at higher fasting (P = .02 for interaction) and 2-hour (P = .03) glucose concentrations. The prevalence of prediabetes and diabetes was statistically significantly lower among participants with SCT when defined using HbA1c values (29.2% vs 48.6% for prediabetes and 3.8% vs 7.3% for diabetes in 572 observations from participants with SCT and 6877 observations from participants without SCT; P<.001 for both comparisons). Among African Americans from 2 large, well-established cohorts, participants with SCT had lower levels of HbA1c at any given concentration of fasting or 2-hour glucose compared with participants without SCT. These findings suggest that HbA1c may systematically underestimate past glycemia in black patients with SCT and may require further evaluation.

Twenty-four-hour variations in blood glucose level in Japanese type 2 diabetes patients based on continuous glucose monitoring.

PubMed

Hajime, Maiko; Okada, Yosuke; Mori, Hiroko; Otsuka, Takashi; Kawaguchi, Mayuko; Miyazaki, Megumi; Kuno, Fumi; Sugai, Kei; Sonoda, Satomi; Tanaka, Kenichi; Kurozumi, Akira; Narisawa, Manabu; Torimoto, Keiichi; Arao, Tadashi; Tanaka, Yoshiya

2018-01-01

High fluctuations in blood glucose are associated with various complications. The correlation between glycated hemoglobin (HbA1c) level and fluctuations in blood glucose level has not been studied in Japanese patients with type 2 diabetes. In the present study, blood glucose profile stratified by HbA1c level was evaluated by continuous glucose monitoring (CGM) in Japanese type 2 diabetes patients. Our retrospective study included 294 patients with type 2 diabetes who were divided by HbA1c level into five groups (≥6.0 to <7.0%, ≥7.0 to <8.0%, ≥8.0 to <9.0%, ≥9.0 to <10.0% and ≥10%). The correlation between HbA1c level and CGM data was analyzed. The primary end-point was the difference in blood glucose fluctuations among the HbA1c groups. The mean blood glucose level increased significantly with increasing HbA1c (P trend  < 0.01). The standard deviation increased with increases in HbA1c (P trend  < 0.01). The mean amplitude of glycemic excursions did not vary significantly with HbA1c. The levels of maximum blood glucose, minimum blood glucose, each preprandial blood glucose, each postprandial maximum blood glucose, range of increase in postprandial glucose from pre-meal to after breakfast, the area under the blood concentration-time curve >180 mg/dL and percentage of the area under the blood concentration-time curve >180 mg/dL were higher with higher HbA1c. Mean glucose level and pre-breakfast blood glucose level were significant and independent determinants of HbA1c. In Japanese patients treated for type 2 diabetes, the mean amplitude of glycemic excursions did not correlate with HbA1c, making it difficult to assess blood glucose fluctuations using HbA1c. Parameters other than HbA1c are required to evaluate fluctuations in blood glucose level in patients receiving treatment for type 2 diabetes. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Visit-to-visit glycemic variability is a strong predictor of chronic obstructive pulmonary disease in patients with type 2 diabetes mellitus: Competing risk analysis using a national cohort from the Taiwan diabetes study.

PubMed

Chiu, Hsien-Tsai; Li, Tsai-Chung; Li, Chia-Ing; Liu, Chiu-Shong; Lin, Wen-Yuan; Lin, Cheng-Chieh

2017-01-01

This study aims to examine the association between visit-to-visit glucose variability, which was measured by coefficient of variation (CV) of fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c), and risk of chronic obstructive pulmonary disease (COPD) in a large number of patients with type 2 diabetes with an average follow-up of 7.58 years. We conducted a retrospective cohort study on 27,257 patients with type 2 diabetes who participated in the National Diabetes Case Management Program in Taiwan. Visit-to-visit variability in HbA1c and FPG at baseline and the incidence of COPD were analyzed using a modified Cox proportional hazards model considering competing risks. A total of 2,346 incident cases of COPD. Patients were grouped into tertiles of FPG-CV and HbA1c-CV. The incidence rates in the first, second, and third tertiles were 9.87, 11.06, and 13.19, respectively, for FPG-CV and 10.2, 11.81, and 12.07, for HbA1c-CV per 1000 person-years. After adjusting for age, gender, diabetes duration, treatment type, smoking, hypertension, hyperlipidemia, baseline FPG and HbA1c levels, and complications, both FPG-CV and HbA1c-CV were independently associated with COPD. The hazard ratios of COPD for the third terile compared with the first tertile of FPG-CV were 1.26 (95% confidence interval [CI]: 1.13-1.40). Moreover, the hazard ratios of COPD for the third and second tertiles compared with the first tertile of HbA1c-CV were 1.13 (1.02-1.25) and 1.13 (1.02-1.26), respectively. Patients with FPG-CV higher than 34.6% or HbA1c-CV higher than 8.4% exhibited an increased risk of COPD. This finding confirmed the linear relationship of FPG-CV and HbA1c-CV to COPD. Visit-to-visit variability in FPG and HbA1c levels are strong predictors of COPD in patients with type 2 diabetes. Future studies should focus on lung dysfunction in diabetes, and adequate glucose control strategy in regular clinical practices must be established for COPD prevention.

Predictors of HbA1c levels in patients initiating metformin.

PubMed

Martono, Doti P; Hak, Eelko; Lambers Heerspink, Hiddo; Wilffert, Bob; Denig, Petra

2016-12-01

The aim was to assess demographic and clinical factors as predictors of short (6 months) and long term (18 months) HbA1c levels in diabetes patients initiating metformin treatment. We conducted a cohort study including type 2 diabetes patients who received their first metformin prescription between 2007 and 2013 in the Groningen Initiative to Analyze Type 2 Diabetes Treatment (GIANTT) database. The primary outcome was HbA1c level at follow-up adjusted for baseline HbA1c; the secondary outcome was failing to achieve the target HbA1c level of 53 mmol/mol. Associations were analyzed by linear and logistic regression. Multiple imputation was used for missing data. Additional analyses stratified by dose and adherence level were conducted. The cohort included 6050 patients initiating metformin. Baseline HbA1c at target consistently predicted better HbA1c outcomes. Longer diabetes duration and lower total cholesterol level at baseline were predictors for higher HbA1c levels at 6 months. At 18 months, cholesterol level was not a predictor. Longer diabetes duration was also associated with not achieving the target HbA1c at follow-up. The association for longer diabetes duration was especially seen in patients starting on low dose treatment. No consistent associations were found for comorbidity and comedication. Diabetes duration was a relevant predictor of HbA1c levels after 6 and 18 months of follow-up in patients initiating metformin treatment. Given the study design, no causal inference can be made. Our study suggests that prompt treatment intensification may be needed in patients who have a longer diabetes duration at treatment initiation.

Lipid and liver abnormalities in haemoglobin A1c-defined prediabetes and type 2 diabetes.

PubMed

Calanna, S; Scicali, R; Di Pino, A; Knop, F K; Piro, S; Rabuazzo, A M; Purrello, F

2014-06-01

We aimed to investigate lipid abnormalities and liver steatosis in patients with HbA1c-defined prediabetes and type 2 diabetes compared to individuals with HbA1c-defined normoglycaemia. Ninety-one subjects with prediabetes according to HbA1c, i.e. from 5.7 to 6.4% (39-46 mmol/mol), 50 newly diagnosed patients with HbA1c-defined type 2 diabetes (HbA1c ≥6.5% [≥48 mmol/mol]), and 67 controls with HbA1c lower than 5.7% (<39 mmol/mol), were studied. Fasting blood samples for lipid profiles, fatty liver index (FLI), bioimpedance analysis, ultrasound scan of the liver, and BARD (body mass index, aspartate aminotransferase/alanine aminotransferase ratio, diabetes) score for evaluation of liver fibrosis, were performed in all subjects. In comparison to controls, subjects with prediabetes were characterised by: lower apolipoprotein AI and HDL cholesterol levels, higher blood pressure, triglycerides levels and apolipoprotein B/apolipoprotein AI ratio, higher FLI, increased prevalence of and more severe hepatic steatosis, similar BARD score, and higher total body fat mass. In comparison to subjects with diabetes, subjects with prediabetes exhibited: similar blood pressure and apolipoprotein B/apolipoprotein AI ratio, similar FLI, reduced prevalence of and less severe hepatic steatosis, lower BARD score, increased percent fat and lower total body muscle mass. In comparison to controls, subjects with diabetes showed: lower apolipoprotein AI and HDL cholesterol levels, higher blood pressure and triglycerides levels, higher FLI, increased prevalence of and more severe hepatic steatosis, higher BARD score, and higher total body muscle mass. Moreover, HbA1c was correlated with BMI, HOMA-IR, triglycerides, HDL cholesterol, AST, and ALT. Subjects with HbA1c-defined prediabetes and type 2 diabetes, respectively, are characterised by abnormalities in lipid profile and liver steatosis, thus exhibiting a severe risk profile for cardiovascular and liver diseases. Copyright © 2014 Elsevier B.V. All rights reserved.

Heterogeneous behavior of lipids according to HbA1c levels undermines the plausibility of metabolic syndrome in type 1 diabetes: data from a nationwide multicenter survey

PubMed Central

2012-01-01

Background Cardiovascular risk factors (CVRF) may cluster in type 1 diabetes, analogously to the metabolic syndrome described in type 2 diabetes. The threshold of HbA1c above which lipid variables start changing behavior is unclear. This study aims to 1) assess the behavior of dyslipidemia according to HbA1c values; 2) detect a threshold of HbA1c beyond which lipids start to change and 3) compare the clustering of lipids and other non-lipid CVRF among strata of HbA1c individuals with type 1 diabetes. Methods Effects of HbA1c quintiles (1st: ≤7.4%; 2nd: 7.5-8.5%; 3rd: 8.6-9.6%; 4th: 9.7-11.3%; and 5th: >11.5%) and covariates (gender, BMI, blood pressure, insulin daily dose, lipids, statin use, diabetes duration) on dyslipidemia were studied in 1275 individuals from the Brazilian multi-centre type 1 diabetes study and 171 normal controls. Results Body size and blood pressure were not correlated to lipids and glycemic control. OR (99% CI) for high-LDL were 2.07 (1.21-3.54) and 2.51 (1.46-4.31), in the 4th and 5th HbA1c quintiles, respectively. Hypertriglyceridemia increased in the 5th quintile of HbA1c, OR 2.76 (1.20-6.37). OR of low-HDL-cholesterol were 0.48 (0.24-0.98) and 0.41 (0.19-0.85) in the 3rd and 4th HbA1c quintiles, respectively. HDL-cholesterol correlated positively (0.437) with HbA1c in the 3rd quintile. HDL-cholesterol and insulin dose correlated inversely in all levels of glycemic control. Conclusions Correlation of serum lipids with HbA1c is heterogeneous across the spectrum of glycemic control in type 1 diabetes individuals. LDL-cholesterol and triglycerides worsened alongside HbA1c with distinct thresholds. Association of lower HDL-cholesterol with higher daily insulin dose is consistent and it points out to a role of exogenous hyperinsulinemia in the pathophysiology of the CVRF clustering. These data suggest diverse pathophysiological processes depending on HbA1c, refuting a unified explanation for cardiovascular risk in type 1 diabetes. PMID:23270560

Factors associated with reaching or not reaching target HbA1c after initiation of basal or premixed insulin in patients with type 2 diabetes.

PubMed

Scheen, A J; Schmitt, H; Jiang, H H; Ivanyi, T

2017-02-01

To evaluate factors associated with reaching or not reaching target glycated haemoglobin (HbA 1c ) levels by analysing the respective contributions of fasting hyperglycaemia (FHG), also referred to as basal hyperglycaemia, vs postprandial hyperglycaemia (PHG) before and after initiation of a basal or premixed insulin regimen in patients with type 2 diabetes. This post-hoc analysis of insulin-naïve patients in the DURABLE study randomised to receive either insulin glargine or insulin lispro mix 25 evaluated the percentages of patients achieving a target HbA 1c of <7.0% (<53mmol/mol) per baseline HbA 1c quartiles, and the effect of each insulin regimen on the relative contributions of PHG and FHG to overall hyperglycaemia. Patients had comparable demographic characteristics and similar HbA 1c and FHG values at baseline in each HbA 1c quartile regardless of whether they reached the target HbA 1c . The higher the HbA 1c quartile, the greater was the decrease in HbA 1c , but also the smaller the percentage of patients achieving the target HbA 1c . HbA 1c and FHG decreased more in patients reaching the target, resulting in significantly lower values at endpoint in all baseline HbA 1c quartiles with either insulin treatment. Patients not achieving the target HbA 1c had slightly higher insulin doses, but lower total hypoglycaemia rates. Smaller decreases in FHG were associated with not reaching the target HbA 1c , suggesting a need to increase basal or premixed insulin doses to achieve targeted fasting plasma glucose and improve patient response before introducing more intensive prandial insulin regimens. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Factors associated with high levels of glycated haemoglobin in patients with type 1 diabetes: a multicentre study in Brazil

PubMed Central

Andrade, Carine Sousa; Ribeiro, Guilherme Sousa; Santos, Carlos Antonio Souza Teles; Neves, Raimundo Celestino Silva; Moreira, Edson Duarte

2017-01-01

Objective Long-term complications of type 1 diabetes mellitus (DM1) can be prevented with adequate glycaemic control. However, high levels of glycated haemoglobin (HbA1c) occur in 60%–90% of the patients with DM1. Thus, we aimed to investigate the role of sociodemographic, behavioural and clinical factors on the HbA1c levels of patients with DM1 in Brazil. Design, setting and participants A cross-sectional study was conducted in ambulatory patients with DM1 aged ≥18 years from 10 Brazilian cities. Sociodemographic, behavioural and clinical data were obtained through interviews. Main outcome measures HbA1c level was measured by liquid chromatography. Hierarchical multiple variable linear regression models were used to identify factors correlated with high levels of HbA1c. Results Of 979 patients with DM1, 63.8% were women, and the mean age was 40 (SD 14.6) years. The mean HbA1c level was 9.4% (SD 2.2%), and 89.6% of the patients had HbA1c ≥7.0%. Factors independently correlated with increased HbA1c levels included: lower education, non-participation in diabetes classes/lecture during the year before, having a self-perception of poor adherence to diet and insulin, not having private medical care and not measuring the HbA1c levels in the prior year. Of note, poor adherence to diet and insulin were the independent factors most strongly associated with high levels of HbA1c (mean increment in HbA1c levels of 0.88% and 1.25%, respectively). Conclusion Poor glycaemic control, which is common among Brazilian patients with DM1, is associated with lower education, self-perception of insufficient adherence to diet and insulin and inadequate monitoring of HbA1c levels. Specific actions, particularly those targeting improving adherence to diet and insulin, may contribute to successful management of patients with DM1. PMID:29247092

Prevalence of Aspirin Resistance in Diabetic Patients and its Associated Factors

PubMed Central

HABIZAL, Nor Halwani; ABDUL HALIM, Sanihah; BHASKAR, Shalini; WAN BEBAKAR, Wan Mohamed; ABDULLAH, Jafri Malin

2015-01-01

Background: Aspirin resistance has posed a major dilemma in the prevention of cardiovascular disease and stroke. There have been many factors that have been associated with aspirin resistance. Among these factors, the inflammatory processes of diabetes and glycaemic control have been significantly associated with aspirin resistance. Our study evaluated the prevalence of aspirin resistance and its associated factors. Methods: This was a cross-sectional, interventional study, which was implemented from October to November 2012 at the Hospital Universiti Sains Malaysia (HUSM). Sixty-nine patients with diabetes who were taking aspirin were enrolled. The glycosylated haemoglobin (HbA1c) and C-reactive protein (CRP) levels were measured in these patients. The thromboelastography (TEG) level was measured using a TEG machine by a trained technician employing standard methods. The variables obtained were analysed for prevalence of aspirin resistance, HbA1c, CRP, and TEG level. The Chi-square test (and Fisher exact test where applicable) were used to evaluate the associations between aspirin resistance with glycaemic control (HbA1c) and inflammatory markers (CRP). Results: The prevalence of aspirin resistance was 17.4% (95%; CI 9.3, 28.4). Glycaemic control (HbA1c) and inflammatory markers (CRP) were not associated with aspirin resistance. Aspirin resistance was prevalent in our study population and was comparable to other studies. The mean HbA1c in the aspirin-resistant group was 8.9%, whereas the mean HbA1c in the aspirin-sensitive group was 8.6%. Conclusion: There was no significant difference in HbA1c between the two groups. There was no significant association between CRP levels and aspirin resistance. PMID:25892950

Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference.

PubMed

Selvin, Elizabeth

2016-08-01

Studies that have compared HbA1c levels by race have consistently demonstrated higher HbA1c levels in African Americans than in whites. These racial differences in HbA1c have not been explained by measured differences in glycemia, sociodemographic factors, clinical factors, access to care, or quality of care. Recently, a number of nonglycemic factors and several genetic polymorphisms that operate through nonglycemic mechanisms have been associated with HbA1c Their distributions across racial groups and their impact on hemoglobin glycation need to be systematically explored. Thus, on the basis of evidence for racial differences in HbA1c, current clinical guidelines from the American Diabetes Association state: "It is important to take…race/ethnicity…into consideration when using the A1C to diagnose diabetes." However, it is not clear from the guidelines how this recommendation might be actualized. So, the critical question is not whether racial differences in HbA1c exist between African Americans and whites; the important question is whether the observed differences in HbA1c level are clinically meaningful. Therefore, given the current controversy, we provide a Point-Counterpoint debate on this issue. In the preceding point narrative, Dr. Herman provides his argument that the failure to acknowledge that HbA1c might be a biased measure of average glycemia and an unwillingness to rigorously investigate this hypothesis will slow scientific progress and has the potential to do great harm. In the counterpoint narrative below, Dr. Selvin argues that there is no compelling evidence for racial differences in the validity of HbA1c as a measure of hyperglycemia and that race is a poor surrogate for differences in underlying causes of disease risk.-William T. CefaluEditor in Chief, Diabetes Care. © 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.

Both the frequency of HbA1c testing and the frequency of self-monitoring of blood glucose predict metabolic control: A multicentre analysis of 15 199 adult type 1 diabetes patients from Germany and Austria.

PubMed

Schwandt, A; Best, F; Biester, T; Grünerbel, A; Kopp, F; Krakow, D; Laimer, M; Wagner, C; Holl, R W

2017-10-01

The objective of this study was to examine the association between metabolic control and frequency of haemoglobin A 1c (HbA 1c ) measurements and of self-monitoring of blood glucose, as well as the interaction of both. Data of 15 199 adult type 1 diabetes patients registered in a standardized electronic health record (DPV) were included. To model the association between metabolic control and frequency of HbA 1c testing or of self-monitoring of blood glucose, multiple hierarchic regression models with adjustment for confounders were fitted. Tukey-Kramer test was used to adjust P values for multiple comparisons. Vuong test was used to compare non-nested models. The baseline variables of the study population were median age 19.9 [Q1; Q3: 18.4; 32.2] years and diabetes duration 10.4 [6.8; 15.7] years. Haemoglobin A 1c was 60.4 [51.5; 72.5] mmol/mol. Frequency of HbA 1c testing was 8.0 [5.0; 9.0] within 2 years, and daily self-monitoring of blood glucose frequency was 5.0 [4.0; 6.0]. After adjustment, a U-shaped association between metabolic control and frequency of HbA 1c testing was observed with lowest HbA 1c levels in the 3-monthly HbA 1c testing group. There was an inverse relationship between self-monitoring of blood glucose and HbA 1c with lower HbA 1c associated with highest frequency of testing (>6 daily measurements). Quarterly HbA 1c testing and frequent self-monitoring of blood glucose were associated with best metabolic control. The adjusted Vuong Z statistic suggests that metabolic control might be better explained by HbA 1c testing compared to self-monitoring of blood glucose (P < .0001). This research reveals the importance of quarterly clinical HbA 1c monitoring together with frequent self-monitoring of blood glucose in diabetes management to reach and maintain target HbA 1c . Copyright © 2017 John Wiley & Sons, Ltd.

Identifying the independent effect of HbA1c variability on adverse health outcomes in patients with Type 2 diabetes.

PubMed

Prentice, J C; Pizer, S D; Conlin, P R

2016-12-01

To characterize the relationship between HbA 1c variability and adverse health outcomes among US military veterans with Type 2 diabetes. This retrospective cohort study used Veterans Affairs and Medicare claims for veterans with Type 2 diabetes taking metformin who initiated a second diabetes medication (n = 50 861). The main exposure of interest was HbA 1c variability during a 3-year baseline period. HbA 1c variability, categorized into quartiles, was defined as standard deviation, coefficient of variation and adjusted standard deviation, which accounted for the number and mean number of days between HbA 1c tests. Cox proportional hazard models predicted mortality, hospitalization for ambulatory care-sensitive conditions, and myocardial infarction or stroke and were controlled for mean HbA 1c levels and the direction of change in HbA 1c levels during the baseline period. Over a mean 3.3 years of follow-up, all HbA 1c variability measures significantly predicted each outcome. Using the adjusted standard deviation measure for HbA 1c variability, the hazard ratios for the third and fourth quartile predicting mortality were 1.14 (95% CI 1.04, 1.25) and 1.42 (95% CI 1.28, 1.58), for myocardial infarction and stroke they were 1.25 (95% CI 1.10, 1.41) and 1.23 (95% CI 1.07, 1.42) and for ambulatory-care sensitive condition hospitalization they were 1.10 (95% CI 1.03, 1.18) and 1.11 (95% CI 1.03, 1.20). Higher baseline HbA 1c levels independently predicted the likelihood of each outcome. In veterans with Type 2 diabetes, greater HbA 1c variability was associated with an increased risk of adverse long-term outcomes, independently of HbA 1c levels and direction of change. Limiting HbA 1c fluctuations over time may reduce complications. © 2016 Diabetes UK.

Impact of generalist care managers on patients with diabetes.

PubMed

Dorr, David A; Wilcox, Adam; Donnelly, Steven M; Burns, Laurie; Clayton, Paul D

2005-10-01

To determine how the addition of generalist care managers and collaborative information technology to an ambulatory team affects the care of patients with diabetes. Multiple ambulatory clinics within Intermountain Health Care (IHC), a large integrated delivery network. A retrospective cohort study comparing diabetic patients treated by generalist care managers with matched controls was completed. Exposure patients had one or more contacts with a care manager; controls were matched on utilization, demographics, testing, and baseline glucose control. Using role-specific information technology to support their efforts, care managers assessed patients' readiness for change, followed guidelines, and educated and motivated patients. Patient data collected as part of an electronic patient record were combined with care manager-created databases to assess timely testing of glycosylated hemoglobin (HbA1c) and low-density lipoprotein (LDL) levels and changes in LDL and HbA1c levels. In a multivariable model, the odds of being overdue for testing for HbA1c decreased by 21 percent in the exposure group (n=1,185) versus the control group (n=4,740). The odds of being tested when overdue for HbA1c or LDL increased by 49 and 26 percent, respectively, and the odds of HbA1c <7.0 percent also increased by 19 percent in the exposure group. The average HbA1c levels decreased more in the exposure group than in the controls. The effect on LDL was not significant. Generalist care managers using computer-supported diabetes management helped increase adherence to guidelines for testing and control of HbA1c levels, leading to improved health status of patients with diabetes.

Hair cortisol concentration and glycated hemoglobin in African American adults.

PubMed

Lehrer, H Matthew; Dubois, Susan K; Maslowsky, Julie; Laudenslager, Mark L; Steinhardt, Mary A

2016-10-01

African Americans have higher diabetes prevalence compared to Whites. They also have elevated cortisol levels - indicating possible HPA axis dysregulation - which may raise blood glucose as part of the biological response to physiological and psychosocial stress. Little is known about chronic cortisol levels in African Americans, and even less about the role of chronically elevated cortisol in type 2 diabetes development in this racial group. We used analysis of cortisol in hair to examine associations of long-term (∼3months) cortisol levels with glycated hemoglobin (HbA1c) in a group of African American adults. In exploratory analyses, we also studied the relationship of hair dehydroepiandrosterone (DHEA) with HbA1c. Participants were 61 community-dwelling African American adults (85% female; mean age 54.30 years). The first 3cm of scalp-near hair were analyzed for cortisol and DHEA concentration using enzyme-linked immunoassay analysis. Glycated hemoglobin was assessed, and regression analyses predicting HbA1c from hair cortisol and DHEA were performed in the full sample and in a subsample of participants (n=20) meeting the National Institute of Diabetes and Digestive Kidney Disease (NIDDK) criteria for type 2 diabetes (HbA1c≥6.5%). In the full sample, HbA1c increased with hair cortisol level (β=0.22, p=0.04, f(2)=0.10), independent of age, sex, chronic health conditions, diabetes medication use, exercise, and depressive symptoms. In the subsample of participants with an HbA1c≥6.5%, hair cortisol was also positively related to HbA1c (β=0.45, p=0.04, f(2)=0.32), independent of diabetes medication use. Glycated hemoglobin was unrelated to hair DHEA in both the full sample and HbA1c≥6.5% subsample. Long-term HPA axis dysregulation in the form of elevated hair cortisol is associated with elevated HbA1c in African American adults. Copyright © 2016 Elsevier Ltd. All rights reserved.

A microfluidic device integrating dual CMOS polysilicon nanowire sensors for on-chip whole blood processing and simultaneous detection of multiple analytes.

PubMed

Kuan, Da-Han; Wang, I-Shun; Lin, Jiun-Rue; Yang, Chao-Han; Huang, Chi-Hsien; Lin, Yen-Hung; Lin, Chih-Ting; Huang, Nien-Tsu

2016-08-02

The hemoglobin-A1c test, measuring the ratio of glycated hemoglobin (HbA1c) to hemoglobin (Hb) levels, has been a standard assay in diabetes diagnosis that removes the day-to-day glucose level variation. Currently, the HbA1c test is restricted to hospitals and central laboratories due to the laborious, time-consuming whole blood processing and bulky instruments. In this paper, we have developed a microfluidic device integrating dual CMOS polysilicon nanowire sensors (MINS) for on-chip whole blood processing and simultaneous detection of multiple analytes. The micromachined polymethylmethacrylate (PMMA) microfluidic device consisted of a serpentine microchannel with multiple dam structures designed for non-lysed cells or debris trapping, uniform plasma/buffer mixing and dilution. The CMOS-fabricated polysilicon nanowire sensors integrated with the microfluidic device were designed for the simultaneous, label-free electrical detection of multiple analytes. Our study first measured the Hb and HbA1c levels in 11 clinical samples via these nanowire sensors. The results were compared with those of standard Hb and HbA1c measurement methods (Hb: the sodium lauryl sulfate hemoglobin detection method; HbA1c: cation-exchange high-performance liquid chromatography) and showed comparable outcomes. Finally, we successfully demonstrated the efficacy of the MINS device's on-chip whole blood processing followed by simultaneous Hb and HbA1c measurement in a clinical sample. Compared to current Hb and HbA1c sensing instruments, the MINS platform is compact and can simultaneously detect two analytes with only 5 μL of whole blood, which corresponds to a 300-fold blood volume reduction. The total assay time, including the in situ sample processing and analyte detection, was just 30 minutes. Based on its on-chip whole blood processing and simultaneous multiple analyte detection functionalities with a lower sample volume requirement and shorter process time, the MINS device can be effectively applied to real-time diabetes diagnostics and monitoring in point-of-care settings.

SERUM magnesium levels as an indicator of status of Diabetes Mellitus type 2.

PubMed

Ramadass, S; Basu, Sharbari; Srinivasan, A R

2015-01-01

Magnesium deficiency is commonly associated with endocrine and metabolic disorders, especially with Diabetes Mellitus type 2 though the mechanism of hypomagnesemia in Diabetes Mellitus is not completely known. There is a close association between metabolic control of Diabetes Mellitus and impaired magnesium balance. To estimate the serum levels of magnesium in patients of with Diabetes Mellitus type 2 and to find a correlation if any, with the duration and control (by estimating HbA1c) of Diabetes Mellitus type 2. Fifty patients of Diabetes Mellitus type 2 were included in the study. Blood samples were analyzed for fasting and post prandial glucose, HbA1c and magnesium. The patients were grouped into three categories based upon their HbA1c levels into those with good control, need intervention and poor control. The three groups were compared with reference to their mean levels of blood glucose and magnesium. Association of serum magnesium levels with HbA1c, Fasting and postprandial blood glucose and duration of Diabetes Mellitus was also done. Serum magnesium levels were found to decline with rise in HbA1c levels and with duration of Diabetes Mellitus type 2. Hypomagnesemia is linked to poor control of Diabetes Mellitus type 2 and depletion of serum magnesium occurs exponentially with duration of disease. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Group diabetes self-management education in a primary care setting: a quality improvement project.

PubMed

Harris, Tara; Silva, Susan; Intini, Ronald; Smith, Tommy; Vorderstrasse, Allison

2014-01-01

This quality improvement project evaluated the effectiveness of a monthly diabetes self-management education intervention on HbA1C and knowledge levels in patients with type 2 diabetes mellitus. A retrospective analysis evaluating 51 patients found no significant improvement in HbA1C levels; however, there was a significant improvement in knowledge levels. Race was an influential factor on HbA1C levels showing a significant elevation in mean HbA1C in African Americans, while there was a decrease in mean HbA1c in Caucasians over the 6-month evaluation period.

Correlation of placental pathology and perinatal outcomes with Hemoglobin A1c in early pregnancy in gravidas with pregestational diabetes mellitus.

PubMed

Starikov, Roman S; Inman, Kyle; Has, Phinnara; Iqbal, Sara N; Coviello, Elizabeth; He, Mai

2017-04-01

Data on the correlation among Hemoglobin A1c (HbA1c), placental pathology, and perinatal outcome in the pregestational diabetic population is severely lacking. We believe that this knowledge will enhance the management of pregnancies complicated by pregestational diabetes. We hypothesize that placental pathology correlates with glycemic control at an early gestational age. This is a retrospective cohort study conducted from 2003 to 2011 at a large tertiary care center. Women included had a singleton gestation, preexisting diabetes mellitus, and information about delivery and placental pathology available for review. Placental pathology and perinatal outcomes were compared across three groups of patients with differing HbA1c levels (<6.5%, 6.5-8.4%, and ≥8.5%). 293 placentas were examined. HbA1c was measured at a mean of 9.5week gestation. Median HbA1c was 7.5%, interquartile range 6.5%-8.9%. 23% of the cohort had HbA1c <6.5%, 41.9% between 6.5% and 8.4%, and 34.8% > 8.5%. BMI varied significantly by group (35.4 vs. 34.4 vs. 32.0 respectively, P = 0.04). Individual placental lesions did not vary with HbA1c levels. The incidence of acute chorioamnionitis differed significantly in the type 1 population and "distal villous hypoplasia" varied in the type 2 population. The results show that HbA1c values in early pregnancy are poor predictors of future placental pathologies. As a result, HbA1c values obtained during early gestation (which reflect the level of glycemic control over an extended period of time) do not correlate with any particular placental pathology, despite reflecting the potential for placental insults secondary to pre-gestational diabetes. Copyright © 2017. Published by Elsevier Ltd.

Associations between HbA1c and depressive symptoms in young adults with early-onset type 1 diabetes.

PubMed

Bächle, Christina; Lange, Karin; Stahl-Pehe, Anna; Castillo, Katty; Holl, Reinhard W; Giani, Guido; Rosenbauer, Joachim

2015-05-01

This study sought to evaluate the associations between metabolic control and each DSM-5 (Diagnostic and Statistical Manual, fifth edition) symptom of depression among young women and men with early-onset long-duration type 1 diabetes. The data of 202 18-21-year-old patients with type 1 diabetes from a population-based, nationwide survey (40.1% male) with a mean age of 19.4 (standard deviation 0.9) years, a mean HbA1c level of 8.3% (1.6%) (i.e., 67 [17.5]mmol/mol), and a mean diabetes duration of 15.7 (1.0) years were included. The German version of the Patient Health Questionnaire (PHQ-9) was used to assess depression symptoms. For each PHQ-9 depressive symptom, the mean HbA1c values of screening-positive and screening-negative patients were compared via t-test. The associations between HbA1c levels and depressive symptoms were analyzed using multiple linear regression analyses and stepwise adjustments for individual, socioeconomic and health-related covariates. Exactly 43.0% and 33.3% of female and male participants reported at least one depressive symptom, and 5.0% and 2.5% met the DSM-5 criteria for major depressive syndrome. HbA1c levels increased with psychomotor agitation/retardation (women), overeating/poor appetite (men/women), lethargy (men), and sleep difficulty (men). Overeating/poor appetite, lethargy, and total PHQ-9 score (per score increase by one) were associated with increased HbA1c levels of 1.10, 0.96 and 0.09 units (%), respectively. The associations between depressive symptoms and HbA1c levels vary by symptom and sex. Differentiating the symptoms of depression and targeted interventions might help to improve metabolic outcomes in young adults with early-onset type 1 diabetes and depression. Copyright © 2015 Elsevier Ltd. All rights reserved.

Association between Self-Reported Smoking and Hemoglobin A1c in a Korean Population without Diabetes: The 2011–2012 Korean National Health and Nutrition Examination Survey

PubMed Central

Hong, Jae Won; Ku, Cheol Ryong; Noh, Jung Hyun; Ko, Kyung Soo; Rhee, Byoung Doo; Kim, Dong-Jun

2015-01-01

Background Several Western studies have revealed that among non-diabetics, glycosylated hemoglobin A1c (HbA1c) levels are higher in smokers than non-smokers. While studies conducted in Western populations consistently support this association, a recent meta-analysis reported that studies carried out in non-Western populations, including studies of Chinese, Egyptian, and Japanese-Americans, did not detect any significant differences in HbA1c levels between smokers and non-smokers. Objectives We assessed the association between smoking habits and HbA1c levels in the general Korean adult population using data from the Korean National Health and Nutrition Examination Survey (KNHANES) performed in 2011–2012. Methods A total of 10,241 participants (weighted n=33,946,561 including 16,769,320 men and 17,177,241 women) without diabetes were divided into four categories according to their smoking habits: never smokers (unweighted n/ weighted n= 6,349/19,105,564), ex-smokers (unweighted n/ weighted n= 1,912/6,207,144), current light smokers (<15 cigarettes per day, unweighted n/ weighted n=1,205/5,130,073), and current heavy smokers (≥15 cigarettes per day, unweighted n/ weighted n=775/3,503,781). Results In age- and gender-adjusted comparisons, the HbA1c levels of each group were 5.52 ± 0.01% in non-smokers, 5.49 ± 0.01% in ex-smokers, 5.53 ± 0.01% in light smokers, and 5.61 ± 0.02% in heavy smokers. HbA1c levels were significantly higher in light smokers than in ex-smokers (p = 0.033), and in heavy smokers compared with light smokers (p < 0.001). The significant differences remained after adjusting for age, gender, fasting plasma glucose, heavy alcohol drinking, hematocrit, college graduation, and waist circumference. Linear regression analyses for HbA1c using the above-mentioned variables as covariates revealed that a significant association between current smoking and HbA1c (coefficient 0.021, 95% CI 0.003–0.039, p = 0.019). Conclusions Current smoking was independently associated with higher HbA1c levels in a cigarette exposure-dependent manner in a representative population of Korean non-diabetic adults. In this study, we have observed an association between smoking status and HbA1c levels in non-diabetics drawn from a non-Western population, consistent with previous findings in Western populations. PMID:26011526

Diagnostic accuracy of HbA1c in diabetes between Eastern and Western.

PubMed

Yan, Shuang; Liu, Siying; Zhao, Yashuang; Zhang, Wencui; Sun, Xiaohui; Li, Jianing; Jiang, Fuli; Ju, Jiaming; Lang, Ning; Zhang, Yingqi; Zhou, Weiyu; Li, Qiang

2013-07-01

In 2010, the American Diabetes Association recommended the use of HbA1c as a diagnostic criterion for diabetes. However, HbA1c is not an accepted diagnostic tool for diabetes in Eastern Asia, because genetic differences compromise the standardization of the diagnostic cut-off point. This study evaluated differences in the use of HbA1c for diagnosing diabetes in Eastern and Western populations and investigated whether HbA1c cut-off point of ≥ 6.5% is diagnostic of diabetes in patients from Eastern Asia. Literature was obtained from MEDLINE, EMBASE and Cochrane databases. The pooled sensitivity and specificity of each HbA1c cut-off point were extracted and compared between Western and Eastern populations. Differences in the cut-off point for diagnosing diabetes in each region were compared by examining differences in the area under summary receiver operating characteristic (SROC) curves. Twelve publications from Eastern countries (n = 59,735) and 13 from Western countries (n = 22,954) were included in the analysis. Areas under SROC curves in the Eastern and Western groups were 0.9331 and 0.9120, respectively (P = 0.98). The cut-off point of the highest Youden index was 6.0%. At the HbA1c cut-off point of 6.5%, the pooled sensitivity and specificity were 58.7% and 98.4% for Eastern countries and 65.5% and 98.1% for Western countries, respectively. HbA1c exhibits the same diagnostic value for diabetes in Eastern and Western populations. In both populations, HbA1c levels > 6.0% identify the population at high risk of diabetes, and HbA1c > 6.5% is diagnostic of clinically established diabetes. © 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

Medication Adherence Mediates the Association between Type D Personality and High HbA1c Level in Chinese Patients with Type 2 Diabetes Mellitus: A Six-Month Follow-Up Study

PubMed Central

Li, Xuemei; Gao, Min; Zhang, Shengfa; Xu, Huiwen; Zhou, Huixuan; Wang, Xiaohua; Qu, Zhiyong; Guo, Jing

2017-01-01

Aims. To examine the association between Type D personality and HbA1c level and to explore the mediating role of medication adherence between them in patients with type 2 diabetes mellitus (T2DM). Methods. 330 patients went on to complete a self-report measure of medication adherence and the HbA1c tests. Chi-square test, T test, Ordinary Least Square Regression (OLS), and Recentered Influence Function Regression (RIF) were employed. Results. Patients with Type D personality had significantly higher HbA1c value (P < 0.01). When Type D personality was operationalized as a categorical variable, SI was associated with HbA1c (P < 0.01). When NA, SI, and their interaction term were entered into regression, all of them were no longer associated with HbA1c level (P > 0.1). On the other hand, when Type D personality was operationalized as a continuous variable, only SI trait was associated with HbA1c level (P < 0.01). When NA, SI, and NA × SI term together were entered into regression, only SI was not related to HbA1c level. Furthermore, medication adherence had a significant mediation effect between Type D personality and HbA1c, accounting for 54.43% of the total effect. Conclusion. Type D personality was associated with HbA1c in direct and indirect ways, and medication adherence acted as a mediator role. PMID:28280745

Medication Adherence Mediates the Association between Type D Personality and High HbA1c Level in Chinese Patients with Type 2 Diabetes Mellitus: A Six-Month Follow-Up Study.

PubMed

Li, Xuemei; Gao, Min; Zhang, Shengfa; Xu, Huiwen; Zhou, Huixuan; Wang, Xiaohua; Qu, Zhiyong; Guo, Jing; Zhang, Weijun; Tian, Donghua

2017-01-01

Aims . To examine the association between Type D personality and HbA1c level and to explore the mediating role of medication adherence between them in patients with type 2 diabetes mellitus (T2DM). Methods . 330 patients went on to complete a self-report measure of medication adherence and the HbA1c tests. Chi-square test, T test, Ordinary Least Square Regression (OLS), and Recentered Influence Function Regression (RIF) were employed. Results . Patients with Type D personality had significantly higher HbA1c value ( P < 0.01). When Type D personality was operationalized as a categorical variable, SI was associated with HbA1c ( P < 0.01). When NA, SI, and their interaction term were entered into regression, all of them were no longer associated with HbA1c level ( P > 0.1). On the other hand, when Type D personality was operationalized as a continuous variable, only SI trait was associated with HbA1c level ( P < 0.01). When NA, SI, and NA × SI term together were entered into regression, only SI was not related to HbA1c level. Furthermore, medication adherence had a significant mediation effect between Type D personality and HbA1c, accounting for 54.43% of the total effect. Conclusion . Type D personality was associated with HbA1c in direct and indirect ways, and medication adherence acted as a mediator role.

Comparative study of glycated hemoglobin by ion exchange chromatography and affinity binding nycocard reader in type 2 diabetes mellitus.

PubMed

Gautam, N; Dubey, R K; Jayan, A; Nepaune, Y; Padmavathi, P; Chaudhary, S; Jha, S K; Sinha, A K

2014-12-01

The aim of this study was to compare the level of glycated hemoglobin (HbA1c) in type 2 Diabetes Mellitus (DM) patients by two different methods namely Ion Exchange Chromatography and Affinity Binding Nycocard Reader. This is a cross-sectional study conducted on confirmed type 2 diabetes mellitus patients (n = 100) who visited Out Patients Department of the Universal College of Medical Sciences Teaching hospital, Bhairahawa, Nepal from November 2012 to March 2013. The diagnosis of diabetes mellitus was done on the basis of their fasting (164.46 ± 45.33 mg/dl) and random (187.93 ± 78.02 mg/dl) serum glucose level along with clinical history highly suggestive of type 2 DM. The HbA1c values of (7.8 ± 1.9%) and (8.0 ± 2.2%) were found in DM patients as estimated by those two different methods respectively. The highest frequency was observed in HbA1c > 8.0% indicating maximum cases were under very poor glycemic control. However, there were no significant differences observed in HbA1c value showing both methods are comparable in nature and can be used in lab for ease of estimation. The significant raised in HbA1c indicates complications associated with DM and monitoring of therapy become hard for those patients. Despite having standard reference method for HbA1c determination, the availability of report at the time of the patient visit can be made easy by using Nycocard Reader and Ion Exchange Chromatography techniques without any delay in communicating glycemic control, clinical decision-making and changes in treatment regimen.

Hemoglobin A1c Level Is Not Related to the Severity of Atherosclerosis in Patients with Acute Coronary Syndrome.

PubMed

Wang, Xinhong; Han, Zhenhua; Hao, Guanghua; Li, Yongqin; Dong, Xin; Wang, Congxia

2015-01-01

The relationship between hemoglobin A1c (HbA1c) levels and the extent of coronary artery stenosis in patients with acute coronary syndrome (ACS) remains uncertain. The present study aimed to assess the correlation of HbA1c level with angiographic coronary atherosclerosis. 292 consecutive ACS patients were enrolled and stratified into three groups according to HbA1c levels (group 1: < 6.0%, n = 137; group 2: 6.0-6.4%, n = 67; group 3: ≥ 6.5%, n = 88). The severity of coronary arteriosclerosis was assessed by Gensini score. The relationship between HbA1c and Gensini score was analyzed by multiple variables analysis. HbA1c level was not associated with the severity of CAD assessed by Gensini score in patients with ACS, even after the adjustment for other risk factors. However, NT-proBNP, ApoA1 and LVEF levels were independent predictors for CAD severity. Moreover, HbA1c level was not associated with the risk of high Gensini score (> 40) by logistic regression analysis. Diabetes mellitus (DM) and LVEF levels were two independent risk factors for high Gensini score. HbA1c level is not a significant and independent marker for the severity of angiography in ACS patients, even in high-risk patients.

Hemoglobin A1c and Mortality in Older Adults With and Without Diabetes: Results From the National Health and Nutrition Examination Surveys (1988-2011).

PubMed

Palta, Priya; Huang, Elbert S; Kalyani, Rita R; Golden, Sherita H; Yeh, Hsin-Chieh

2017-04-01

Hemoglobin A 1c (HbA 1c ) level has been associated with increased mortality in middle-aged populations. The optimal intensity of glucose control in older adults with diabetes remains uncertain. We sought to estimate the risk of mortality by HbA 1c levels among older adults with and without diabetes. We analyzed data from adults aged ≥65 years ( n = 7,333) from the Third National Health and Nutrition Examination Survey (NHANES III) (1998-1994) and Continuous NHANES (1999-2004) and their linked mortality data (through December 2011). Cox proportional hazards models were used to examine the relationship of HbA 1c with the risk of all-cause and cause-specific (cardiovascular disease [CVD], cancer, and non-CVD/noncancer) mortality, separately for adults with diabetes and without diabetes. Over a median follow-up of 8.9 years, 4,729 participants died (1,262 from CVD, 850 from cancer, and 2,617 from non-CVD/noncancer causes). Compared with those with diagnosed diabetes and an HbA 1c <6.5%, the hazard ratio (HR) for all-cause mortality was significantly greater for adults with diabetes with an HbA 1c >8.0%. HRs were 1.6 (95% CI 1.02, 2.6) and 1.8 (95% CI 1.3, 2.6) for HbA 1c 8.0-8.9% and ≥9.0%, respectively ( P for trend <0.001). Participants with undiagnosed diabetes and HbA 1c >6.5% had a 1.3 (95% CI 1.03, 1.8) times greater risk of all-cause mortality compared with participants without diabetes and HbA 1c 5.0-5.6%. An HbA 1c >8.0% was associated with increased risk of all-cause and cause-specific mortality in older adults with diabetes. Our results support the idea that better glycemic control is important for reducing mortality; however, in light of the conflicting evidence base, there is also a need for individualized glycemic targets for older adults with diabetes depending on their demographics, duration of diabetes, and existing comorbidities. © 2017 by the American Diabetes Association.

Hemoglobin A1c and Mortality in Older Adults With and Without Diabetes: Results From the National Health and Nutrition Examination Surveys (1988–2011)

PubMed Central

Palta, Priya; Huang, Elbert S.; Kalyani, Rita R.; Golden, Sherita H.; Yeh, Hsin-Chieh

2017-01-01

OBJECTIVE Hemoglobin A1c (HbA1c) level has been associated with increased mortality in middle-aged populations. The optimal intensity of glucose control in older adults with diabetes remains uncertain. We sought to estimate the risk of mortality by HbA1c levels among older adults with and without diabetes. RESEARCH DESIGN AND METHODS We analyzed data from adults aged ≥65 years (n = 7,333) from the Third National Health and Nutrition Examination Survey (NHANES III) (1998–1994) and Continuous NHANES (1999–2004) and their linked mortality data (through December 2011). Cox proportional hazards models were used to examine the relationship of HbA1c with the risk of all-cause and cause-specific (cardiovascular disease [CVD], cancer, and non-CVD/noncancer) mortality, separately for adults with diabetes and without diabetes. RESULTS Over a median follow-up of 8.9 years, 4,729 participants died (1,262 from CVD, 850 from cancer, and 2,617 from non-CVD/noncancer causes). Compared with those with diagnosed diabetes and an HbA1c <6.5%, the hazard ratio (HR) for all-cause mortality was significantly greater for adults with diabetes with an HbA1c >8.0%. HRs were 1.6 (95% CI 1.02, 2.6) and 1.8 (95% CI 1.3, 2.6) for HbA1c 8.0–8.9% and ≥9.0%, respectively (P for trend <0.001). Participants with undiagnosed diabetes and HbA1c >6.5% had a 1.3 (95% CI 1.03, 1.8) times greater risk of all-cause mortality compared with participants without diabetes and HbA1c 5.0–5.6%. CONCLUSIONS An HbA1c >8.0% was associated with increased risk of all-cause and cause-specific mortality in older adults with diabetes. Our results support the idea that better glycemic control is important for reducing mortality; however, in light of the conflicting evidence base, there is also a need for individualized glycemic targets for older adults with diabetes depending on their demographics, duration of diabetes, and existing comorbidities. PMID:28223299

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.

Glycated hemoglobin A1c level is associated with high urinary albumin/creatinine ratio in non-diabetic adult population.

PubMed

Kang, Seok Hui; Park, Jong Won; Do, Jun Young; Cho, Kyu Hyang

2016-09-01

Regarding the association between glycated hemoglobin A1c (HbA1c) levels and microvascular complications, high HbA1c level in participants without diabetes mellitus (DM) may be associated with a high urinary albumin-to-creatinine ratio (UACR). Twelve thousand seven hundred and seventy four participants without DM were included in this study. The participants were divided into three groups according to HbA1c levels: a Low group (<5.7%), Middle group (5.7-6.0%), and High group (>6.0%). A high UACR was defined as UACR ≥3.9 mg/g for men and UACR ≥7.5 mg/g for women. The proportions of participants with a high UACR in the Low, Middle, and High groups were 22.4%, 27.9%, and 38.1%, respectively. Both univariate and multivariate analyses showed that logUACR was greatest in the High group compared to the other groups. For participants without metabolic syndrome (MetS), the proportions of participants with high UACR and logUACR values were greatest in the High group compared to the other groups. For participants with MetS, no differences were found for proportions of participants with high UACR and logUACR values in the Low, Middle, and High groups. Non-DM participants with relatively high HbA1c levels should be closely monitored for UACR, especially if participants do not have MetS. KEY MESSAGES HbA1c level was positively associated with the proportion of participants with a high UACR and logUACR in participants without DM. For participants without MetS, the proportion of participants with a high UACR was greater in the High group than in the other groups and logUACR was greatest in the High group compared to the other groups. For participants with MetS, there were significant associations between HbA1c and the proportion of participants with a high UACR as a categorical variable or logUACR as a continuous variable, but the statistical significance of this finding was weak. No differences were found for proportions of participants with high UACR and logUACR values in the Low, Middle, and High groups.

Hemorheological alterations in adults with prediabetes identified by hemoglobin A1c levels.

PubMed

Marini, M A; Fiorentino, T V; Andreozzi, F; Mannino, G C; Succurro, E; Sciacqua, A; Perticone, F; Sesti, G

2017-07-01

A link between increased blood viscosity and type 2 diabetes has been previously reported. Herein, we investigated the association of blood viscosity with prediabetes, identified by glycated hemoglobin A1c (HbA1c) according to the new American Diabetes Association criteria, and subclinical atherosclerosis. The study cohort includes 1136 non-diabetic adults submitted to anthropometrical evaluation, an oral glucose tolerance test and ultrasound measurement of carotid intima-media thickness (IMT). Whole blood viscosity was estimated using a validated formula based on hematocrit and total plasma proteins. After adjusting for age, and gender, individuals with HbA1c-defined prediabetes (HbA1c 5.7-6.4% [39-47 mmol/mol]) exhibited significantly higher values of hematocrit, and predicted blood viscosity as compared with controls. Increased levels of IMT were observed in subjects with HbA1c-defined prediabetes in comparison to controls. Predicted blood viscosity was positively correlated with age, waist circumference, blood pressure, cholesterol, triglycerides, fibrinogen, white blood cell, HbA1c, fasting and 2-h post-load glucose levels, fasting insulin, IMT and inversely correlated with HDL and Matsuda index of insulin sensitivity. Of the three glycemic parameters, i.e. HbA1c, fasting and 2-h post-load glucose, only HbA1c showed a significant correlation with predicted blood viscosity (β = 0.054, P = 0.04) in a multivariate regression analysis model including multiple atherosclerosis risk factors. The study shows that individuals with HbA1c-defined prediabetes have increased predicted blood viscosity and IMT. The HbA1c criterion may be helpful to capture individuals with an increased risk of diabetes and cardiovascular disease who may benefit from an intensive lifestyle intervention. Copyright © 2017 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.

Glycated Hemoglobin (HbA1c) Correlation with Severity of Coronary Artery Disease in Non-diabetic Patients - A Hospital based Study from North-Eastern India

PubMed Central

Dutta, Bornali; Neginhal, Mahesh

2016-01-01

Introduction Glycated Hemoglobin (HbA1c) levels are predictive of cardiovascular disease and mortality in patients with diabetes mellitus, however, association of HbA1c with Coronary Artery Disease (CAD) in non-diabetics is inconsistent. Aim To evaluate the correlation between HbA1c level and severity of CAD in non-diabetic patients using SYNTAX score in a cohort of proven CAD on angiography at Gauhati Medical College, Guwahati, Assam, India, which is a major tertiary care hospital of North-Eastern India. Materials and Methods We prospectively collected data of non-diabetic patients with proven CAD on angiography from June 2014 to June 2015. Patients were divided into four groups (interquartiles) according to HbA1c levels, less than 4.8%, 4.8% to 5.1%, 5.1% to 5.6%, and 5.6% to 6.5%. Severity of CAD was assessed using SYNTAX score and the number of coronary vessels diseased. We compared different quartiles of HbA1c with regard to SYNTAX score and number of diseased vessels. Results A total of 346 patients were included in the study. Mean age was 58.1±10.4 years. Of the total 91.9% (318) were males, 44.8% (155) were hypertensives, 29.2% (101) were smokers and 34.7% (120) were dyslipidemic. We found that CAD severity by SYNTAX score as well as number of vessels involved was significantly different among quartiles (p-values <0.001 and <0.001 respectively). Increase in HbA1c level was strongly correlated with disease severity and higher SYNTAX score. A significant increase was noted in the mean number of diseased vessels (p-value <0.001) as HbA1c level increases. Age, gender, hypertension and dyslipidemia did not show significant difference among quartiles however smoking was found to be an independent predictor of severity of CAD by SYNTAX score (p <0.05). Conclusion From this clinical study, we can conclude that a significant correlation exists between HbA1c and severity of CAD by SYNTAX score as well as number of vessels involved in non- diabetes. PMID:27790487

Patient-level predictors of achieving early glycaemic control in Type 2 diabetes mellitus: a population-based study.

PubMed

Svensson, E; Baggesen, L M; Thomsen, R W; Lyngaa, T; Pedersen, L; Nørrelund, H; Buhl, E S; Haase, C L; Johnsen, S P

2016-11-01

To identify individual predictors of early glycaemic control in people with Type 2 diabetes mellitus after initiation of first glucose-lowering drug treatment in everyday clinical practice. Using medical registries, we identified a population-based cohort of people with a first-time glucose-lowering drug prescription in Northern Denmark in the period 2000-2012. We used Poisson regression analysis to examine patient-level predictors of success in reaching early glycaemic control [HbA 1c target of < 53 mmol/mol (7%)] < 6 months after treatment start. Among the 38 418 people (median age 63 years), 27 545 (72%) achieved early glycaemic control. The strongest predictor of achieving early control was pre-treatment HbA 1c level; compared with a pre-treatment HbA 1c level of ≤ 58 mmol/mol (7.5%), the adjusted relative risks of attaining early control were 0.63 (95% CI 0.61-0.64) for baseline HbA 1c levels of > 58 and ≤ 75 mmol/mol (> 7.5 and ≤ 9%), and 0.58 (95% CI 0.57-0.59) for a baseline HbA 1c level of > 9% (> 75 mmol/mol). All other examined predictors were only weakly associated with the chance of achieving early control. After adjustment, the only characteristics that remained independently associated with early control (in addition to high baseline HbA 1c ) were being widowed (adjusted relative risk 0.95; 95% CI 0.93-0.97) and having a high Charlson comorbidity index score (score ≥ 3; adjusted relative risk 0.94; 95% CI 0.90-0.97). In a real-world clinical setting, people with Type 2 diabetes mellitus initiating glucose-lowering medication had a similar likelihood of achieving glycaemic control, regardless of sex, age, comorbidities and other individual factors; the only strong and potentially modifiable predictor was HbA 1c before therapy start. © 2016 Diabetes UK.

Defining a glycated haemoglobin (HbA1c) level that predicts increased risk of penile implant infection.

PubMed

Habous, Mohamad; Tal, Raanan; Tealab, Alaa; Soliman, Tarek; Nassar, Mohammed; Mekawi, Zenhom; Mahmoud, Saad; Abdelwahab, Osama; Elkhouly, Mohamed; Kamr, Hatem; Remeah, Abdallah; Binsaleh, Saleh; Ralph, David; Mulhall, John

2018-02-01

To re-evaluate the role of diabetes mellitus (DM) as a risk factor for penile implant infection by exploring the association between glycated haemoglobin (HbA1c) levels and penile implant infection rates and to define a threshold value that predicts implant infection. We conducted a multicentre prospective study including all patients undergoing penile implant surgery between 2009 and 2015. Preoperative, perioperative and postoperative management were identical for the entire cohort. Univariate analysis was performed to define predictors of implant infection. The HbA1c levels were analysed as continuous variables and sequential analysis was conducted using 0.5% increments to define a threshold level predicting implant infection. Multivariable analysis was performed with the following factors entered in the model: DM, HbA1C level, patient age, implant type, number of vascular risk factors (VRFs), presence of Peyronie's disease (PD), body mass index (BMI), and surgeon volume. A receiver operating characteristic (ROC) curve was generated to define the optimal HbA1C threshold for infection prediction. In all, 902 implant procedures were performed over the study period. The mean patient age was 56.6 years. The mean HbA1c level was 8.0%, with 81% of men having a HbA1c level of >6%. In all, 685 (76%) implants were malleable and 217 (24%) were inflatable devices; 302 (33.5%) patients also had a diagnosis of PD. The overall infection rate was 8.9% (80/902). Patients who had implant infection had significantly higher mean HbA1c levels, 9.5% vs 7.8% (P < 0.001). Grouping the cases by HbA1c level, we found infection rates were: 1.3% with HbA1c level of <6.5%, 1.5% for 6.5-7.5%, 6.5% for 7.6-8.5%, 14.7% for 8.6-9.5%, 22.4% for >9.5% (P < 0.001). Patient age, implant type, and number of VRFs were not predictive. Predictors defined on multivariable analysis were: PD, high BMI, and high HbA1c level, whilst a high-volume surgeon had a protective effect and was associated with a reduced infection risk. Using ROC analysis, we determined that a HbA1c threshold level of 8.5% predicted infection with a sensitivity of 80% and a specificity of 65%. Uncontrolled DM is associated with increased risk of infection after penile implant surgery. The risk is directly related to the HbA1c level. A threshold HbA1c level of 8.5% is suggested for clinical use to identify patients at increased infection risk. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

Cross-sectional comparison of point-of-care with laboratory HbA1c in detecting diabetes in real-world remote Aboriginal settings

PubMed Central

Marley, Julia V; Oh, May S; Hadgraft, Nyssa; Singleton, Sally; Isaacs, Kim; Atkinson, David

2015-01-01

Objectives To determine if point-of-care (POC) glycated haemoglobin (HbA1c) is sufficiently accurate in real-world remote settings to predict or exclude the diagnosis of diabetes based on laboratory HbA1c measurements. Design Cross-sectional study comparing POC capillary HbA1c results with corresponding venous HbA1c levels measured in a reference laboratory. Participants Aboriginal patients ≥15 years old who were due for diabetes screening at the participating clinics were invited to participate. Two hundred and fifty-five Aboriginal participants were enrolled and 241 were included in the analysis. Setting 6 primary healthcare sites in the remote Kimberley region of Western Australia from September 2011 to November 2013. Main outcome measures Concordance and mean differences between POC capillary blood HbA1c measurement and laboratory measurement of venous blood HbA1c level; POC capillary blood HbA1c equivalence value for screening for diabetes or a high risk of developing diabetes; sensitivity, specificity and positive-predictive value for diagnosing and screening for diabetes; barriers to conducting POC testing. Results Concordance between POC and laboratory results was good (ρ=0.88, p<0.001). The mean difference was −0.15% (95% limits of agreement, −0.67% to 0.36%). POC HbA1c measurements ≥6.5%, 48 mmol/mol had a specificity of 98.2% and sensitivity of 73.7% for laboratory measurements ≥6.5%. The POC equivalence value for screening for diabetes or a high risk of developing diabetes was ≥5.7%, 39 mmol/mol (sensitivity, 91%; specificity, 76.7% for laboratory measurements ≥6.0%, 42 mmol/mol). Staff trained by other clinic staff ‘on the job’ performed as well as people with formal accredited training. Staff reported difficulty in maintaining formal accreditation. Conclusions POC HbA1c testing is sufficiently accurate to be a useful component in screening for, and diagnosing, diabetes in remote communities. Limited local training is adequate to produce results comparable to laboratory results and accreditation processes need to reflect this. PMID:25765020

Hemoglobin A1c levels and aortic arterial stiffness: the Cardiometabolic Risk in Chinese (CRC) study.

PubMed

Liang, Jun; Zhou, Na; Teng, Fei; Zou, Caiyan; Xue, Ying; Yang, Manqing; Song, Huaidong; Qi, Lu

2012-01-01

The American Diabetes Association (ADA) recently published new clinical guidelines in which hemoglobin A1c (HbA1c) was recommended as a diagnostic test for diabetes. The present study was to investigate the association between HbA1c and cardiovascular risk, and compare the associations with fasting glucose and 2-hour oral glucose tolerance test (2 h OGTT). The study samples are from a community-based health examination survey in central China. Carotid-to-femoral pulse wave velocity (cfPWV) and HbA1c were measured in 5,098 men and women. After adjustment for age, sex, and BMI, the levels of HbA1c were significantly associated with an increasing trend of cfPWV in a dose-dependent fashion (P for trend <0.0001). The associations remained significant after further adjustment for blood pressure, heart rate, and lipids (P = 0.004), and the difference in cfPWV between the highest and the lowest quintiles of HbA1c was 0.31 m/s. Fasting glucose and 2 h OGTT were not associated with cfPWV in the multivariate analyses. HbA1c showed additive effects with fasting glucose or 2 h OGTT on cfPWV. In addition, age and blood pressure significantly modified the associations between HbA1c and cfPWV (P for interactions <0.0001 for age; and  = 0.019 for blood pressure). The associations were stronger in subjects who were older (≥60 y; P for trend = 0.004) and had higher blood pressure (≥120 [systolic blood pressure]/80 mmHg [diastolic blood pressure]; P for trend = 0.028) than those who were younger and had lower blood pressure (P for trend >0.05). HbA1c was related to high cfPWV, independent of conventional cardiovascular risk factors. Senior age and high blood pressure might amplify the adverse effects of HbA1c on cardiovascular risk.

HbA1c values calculated from blood glucose levels using truncated Fourier series and implementation in standard SQL database language.

PubMed

Temsch, W; Luger, A; Riedl, M

2008-01-01

This article presents a mathematical model to calculate HbA1c values based on self-measured blood glucose and past HbA1c levels, thereby enabling patients to monitor diabetes therapy between scheduled checkups. This method could help physicians to make treatment decisions if implemented in a system where glucose data are transferred to a remote server. The method, however, cannot replace HbA1c measurements; past HbA1c values are needed to gauge the method. The mathematical model of HbA1c formation was developed based on biochemical principles. Unlike an existing HbA1c formula, the new model respects the decreasing contribution of older glucose levels to current HbA1c values. About 12 standard SQL statements embedded in a php program were used to perform Fourier transform. Regression analysis was used to gauge results with previous HbA1c values. The method can be readily implemented in any SQL database. The predicted HbA1c values thus obtained were in accordance with measured values. They also matched the results of the HbA1c formula in the elevated range. By contrast, the formula was too "optimistic" in the range of better glycemic control. Individual analysis of two subjects improved the accuracy of values and reflected the bias introduced by different glucometers and individual measurement habits.

Exploring factors influencing HbA1c and psychosocial outcomes in people with type 1 diabetes after training in advanced carbohydrate counting.

PubMed

Schmidt, Signe; Vistisen, Dorte; Almdal, Thomas; Hommel, Eva; Nørgaard, Kirsten

2017-08-01

The purpose of this secondary analysis of the StenoABC Study was to identify determinants of the changes in HbA1c observed after training of people with type 1 diabetes in advanced carbohydrate counting (ACC) and automated bolus calculator (ABC) use, and further to investigate psychosocial effects of these insulin dosing approaches. Validated diabetes-specific questionnaires were used to assess diabetes treatment satisfaction, problem areas in diabetes, fear of hypoglycemia and diabetes dependent quality of life before and one year after the training. In addition, numeracy was tested (using a non-validated test developed specifically for this study) and behavioral measures (number of daily blood glucose measurements and self-reported use of ACC) were obtained. Associations between change in HbA1c and these measures plus sex, age, diabetes duration and BMI were tested. Numeracy was the only baseline predictor of yearly change in HbA1c identified. Higher levels of numeracy were associated with greater reductions in HbA1c (P=0.031). No associations between change in HbA1c and the behavioral measures investigated were found, nor were any clinically relevant associations between changes in HbA1c and questionnaire scores. Treatment satisfaction increased in all users of ACC (P<0.001). People who also used an ABC reported significantly lower levels of fear of hypoglycemia than people who practiced ACC without such device (P=0.005). Improvements in HbA1c after training in ACC were inversely related to numeracy. Use of an ABC did not compensate for poor numeracy skills. However, device use reduced fear of hypoglycemia compared with ACC without ABC use. Copyright © 2017 Elsevier B.V. All rights reserved.

Diabetes Camp as Continuing Education for Diabetes Self-Management in Middle-Aged and Elderly People with Type 2 Diabetes Mellitus

PubMed Central

Park, So Young; Kim, Sun Young; Lee, Hye Mi; Hur, Kyu Yeon; Kim, Jae Hyeon; Lee, Moon-Kyu

2017-01-01

Background Despite the established benefits of diabetes camps for the continuing education of children with type 1 diabetes mellitus, little is known about the long-term metabolic benefits of diabetes camps for middle-aged and elderly people with type 2 diabetes mellitus (T2DM), especially in terms of glycosylated hemoglobin (HbA1c) variability. Methods The 1-year mean and variability of HbA1c before and after the diabetes camp was compared between the participants of the diabetes camp (n=57; median age 65 years [range, 50 to 86 years]; median diabetes duration 14 years [range, 1 to 48 years]). Additional case-control analysis compared the metabolic outcomes of the participants of the diabetes camp and their propensity score-matched controls who underwent conventional diabetes education (n=93). Results The levels of HbA1c during the first year after the diabetes camp were comparable to those of the matched controls (P=0.341). In an analysis of all participants of the diabetes camp, the 1-year mean±standard deviation (SD) of HbA1c decreased (P=0.010 and P=0.041) after the diabetes camp, whereas the adjusted SD and coefficient of variance (CV) of HbA1c did not decrease. The adjusted SD and CV significantly decreased after the diabetes camp in participants whose 1-year mean HbA1c was ≥6.5% before the diabetes camp (n=40) and those with a duration of diabetes less than 15 years (n=32). Conclusion The 1-year mean and SD of HbA1c decreased after the diabetes camp, with significant reduction in the adjusted SD and CV in those with higher baseline HbA1c and a shorter duration of diabetes. PMID:28447438

Associations between glycaemic deterioration and aortic stiffness and central blood pressure: the ADDITION-PRO Study.

PubMed

Johansen, Nanna B; Rasmussen, Signe S; Wiinberg, Niels; Vistisen, Dorte; Jørgensen, Marit E; Pedersen, Erling B; Lauritzen, Torsten; Sandbæk, Annelli; Witte, Daniel R

2017-09-01

In the context of screening for diabetes, we examined levels of central haemodynamics among individuals with different levels of diabetes risk and analysed the impact of glycated haemoglobin A (HbA1c) and HbA1c changes on central haemodynamics. A Danish population-based stepwise screening programme for diabetes including a diabetes risk score (DRS) questionnaire and glucose measurements identified seven groups of individuals at increasing levels of diabetes risk. After 7.8 years of follow-up, 2048 individuals underwent aortic stiffness assessment by carotid-femoral pulse wave velocity (aPWV) and assessment of central blood pressure (BP). We compared differences in central haemodynamics at follow-up between the diabetes risk groups and analysed the impact of HbA1c at screening and HbA1c change on central haemodynamics at follow-up adjusting for relevant confounders. At screening, median age was 59.0 years, and median HbA1c was 5.7%. At follow-up, median aPWV was 8.0 m/s, and median central SBP was 123.5 mmHg. Among individuals with high DRS, aPWV, central SBP and DBP, and pulse pressure were higher in individuals with impaired glucose tolerance than normal glucose tolerance. Per 1%-point higher HbA1c at screening, aPWV was 0.23 m/s (95% confidence interval: 0.00; 0.46) higher, and central DBP was 1.35 mmHg (95% confidence interval: 0.19; 2.51) lower, whereas HbA1c change was not associated with any of the central haemodynamics. Dysglycaemia is associated with future aortic stiffness. However, glycaemic deterioration over 7.8 years does not affect aortic stiffness or central BP independently of other cardiometabolic risk factors.

Glycated albumin is set lower in relation to plasma glucose levels in patients with Cushing's syndrome.

PubMed

Kitamura, Tetsuhiro; Otsuki, Michio; Tamada, Daisuke; Tabuchi, Yukiko; Mukai, Kosuke; Morita, Shinya; Kasayama, Soji; Shimomura, Iichiro; Koga, Masafumi

2013-09-23

Glycated albumin (GA) is an indicator of glycemic control, which has some specific characters in comparison with HbA1c. Since glucocorticoids (GC) promote protein catabolism including serum albumin, GC excess state would influence GA levels. We therefore investigated GA levels in patients with Cushing's syndrome. We studied 16 patients with Cushing's syndrome (8 patients had diabetes mellitus and the remaining 8 patients were non-diabetic). Thirty-two patients with type 2 diabetes mellitus and 32 non-diabetic subjects matched for age, sex and BMI were used as controls. In the patients with Cushing's syndrome, GA was significantly correlated with HbA1c, but the regression line shifted downwards as compared with the controls. The GA/HbA1c ratio in the patients with Cushing's syndrome was also significantly lower than the controls. HbA1c in the non-diabetic patients with Cushing's syndrome was not different from the non-diabetic controls, whereas GA was significantly lower. In 7 patients with Cushing's syndrome who performed self-monitoring of blood glucose, the measured HbA1c was matched with HbA1c estimated from mean blood glucose, whereas the measured GA was significantly lower than the estimated GA. We clarified that GA is set lower in relation to plasma glucose levels in patients with Cushing's syndrome. Copyright © 2013 Elsevier B.V. All rights reserved.

Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis

PubMed Central

2014-01-01

Background The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. Objectives To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings. Data Sources The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes. Review Methods Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results. Results Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens’ DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960–0.973). Limitations Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing. Conclusions Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five observational studies compared 3 point-of-care HbA1c devices with laboratory HbA1c assays, and all reported strong correlation between the 2 tests. PMID:26316922

A Simple and Easy Process for the Determination of Estimated Plasma Glucose Level in Patients Presenting to Hospital: An Example of Multicentric Data Mining.

PubMed

Serdar, Muhittin A; Koldaş, Macit; Serteser, Mustafa; Akın, Okhan; Sonmez, Cigdem; Gülbahar, Ozlem; Akbıyık, Filiz; Ünsal, Ibrahim

2016-12-01

The aim of the present study was to determine the relation between the simultaneous fasting plasma glucose level and HbA1c in a large population of patients presenting to the hospital, based on various measurement methods available for HbA1c. HbA1c levels of 162,210 patients presenting to various hospitals and laboratories were measured based on seven different systems, and at the same time, eAG levels were calculated based on HbA1c levels. The correlation coefficients (r) between serum plasma glucose and HbA1c levels were found to be 0.809, 0.774, 0.779, 0.817, 0.704, 0.796, and 0.747 in Bio-Rad Variant II, Tosoh G8, ADAMS A1c, Trinity Boronate Affinity, Chromsystems HPLC, Roche Tina-quant, and Abbott Architect, respectively. The concordance correlation coefficients between the eAG levels as calculated with the formulas provided in the text and the eAG levels as calculated according to NGSP directions (where eAG = (28.7*HbA1c) - 46.7) were found to be between 0.9339 and 0.9866. Despite the progress made for the standardization of HbA1c measurements, the relation between serum glucose and HbA1c still demonstrated certain discrepancies pertaining to the differences in measurement methodologies. As a conclusion, each laboratory could determine different eAG levels depending on the data originated by their individual analyzer. © 2016 Society for Laboratory Automation and Screening.

Association between blood glucose level derived using the oral glucose tolerance test and glycated hemoglobin level.

PubMed

Kim, Hyoung Joo; Kim, Young Geon; Park, Jin Soo; Ahn, Young Hwan; Ha, Kyoung Hwa; Kim, Dae Jung

2016-05-01

Glycated hemoglobin (HbA1c) is widely used as a marker of glycemic control. Translation of the HbA1c level to an average blood glucose level is useful because the latter figure is easily understood by patients. We studied the association between blood glucose levels revealed by the oral glucose tolerance test (OGTT) and HbA1c levels in a Korean population. A total of 1,000 subjects aged 30 to 64 years from the Cardiovascular and Metabolic Diseases Etiology Research Center cohort were included. Fasting glucose levels, post-load glucose levels at 30, 60, and 120 minutes into the OGTT, and HbA1c levels were measured. Linear regression of HbA1c with mean blood glucose levels derived using the OGTT revealed a significant correlation between these measures (predicted mean glucose [mg/dL] = 49.4 × HbA1c [%] - 149.6; R (2) = 0.54, p < 0.001). Our linear regression equation was quite different from that of the Alc-Derived Average Glucose (ADAG) study and Diabetes Control and Complications Trial (DCCT) cohort. Discrepancies between our results and those of the ADAG study and DCCT cohort may be attributable to differences in the test methods used and the extent of insulin secretion. More studies are needed to evaluate the association between HbA1c and self monitoring blood glucose levels.

Improvement of Glycosylated Hemoglobin in Patients with Type 2 Diabetes Mellitus under Insulin Treatment by Reimbursement for Self-Monitoring of Blood Glucose.

PubMed

Song, Young Shin; Koo, Bo Kyung; Kim, Sang Wan; Yi, Ka Hee; Shin, Kichul; Moon, Min Kyong

2018-02-01

In Korea, the costs associated with self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes mellitus (T2DM) under insulin treatment have been reimbursed since November 2015. We investigated whether this new reimbursement program for SMBG has improved the glycemic control in the beneficiaries of this policy. Among all adult T2DM patients with ≥3 months of reimbursement (n=854), subjects without any changes in anti-hyperglycemic agents during the study period were selected. The improvement of glycosylated hemoglobin (HbA1c) was defined as an absolute reduction in HbA1c ≥0.6% or an HbA1c level at follow-up <7%. HbA1c levels significantly decreased from 8.5%±1.3% to 8.2%±1.2% during the follow-up (P<0.001) in all the study subjects (n=409). Among them, 35.5% (n=145) showed a significant improvement in HbA1c. Subjects covered under the Medical Aid system showed a higher prevalence of improvement in HbA1c than those with medical insurance (52.2% vs. 33.3%, respectively, P=0.012). In the improvement group, the baseline HbA1c (P<0.001), fasting C-peptide (P=0.016), and daily dose of insulin/body weight (P=0.024) showed significant negative correlations with the degree of HbA1c change. Multivariate analysis showed that subjects in the Medical Aid system were about 2.5-fold more likely to improve in HbA1c compared to those with medical insurance (odds ratio, 2.459; 95% confidence interval, 1.138 to 5.314; P=0.022). The reimbursement for SMBG resulted in a significant improvement in HbA1c in T2DM subjects using insulin, which was more prominent in subjects with poor glucose control at baseline or covered under the Medical Aid system. Copyright © 2018 Korean Diabetes Association

Relationship Between HbA1c and Complex Regional Pain Syndrome in Stroke Patients With Type 2 Diabetes Mellitus

PubMed Central

2016-01-01

Objective To investigate the relationship between glycosylated hemoglobin A (HbA1c) and complex regional pain syndrome (CRPS) in stroke patients with type 2 diabetes mellitus (T2DM). Methods A retrospective chart review was performed of stroke patients from January 2012 to December 2013. We reviewed 331 patients and included 200 in the analysis. We divided them into CRPS and non-CRPS groups and compared them by age, gender, stroke lesion, cause of stroke, duration of T2DM, HbA1c (%), National Institutes of Health Stroke Scale score, affected shoulder flexor muscle strength, Fugl-Meyer Assessment score, motricity index, Functional Independence Measure, Korean version of Modified Barthel Index, blood glucose level on admission day, duration from stroke onset to HbA1c check, and duration from stroke onset to three-phase bone scan for CRPS diagnosis. Thereafter, we classified the patients into five groups by HbA1c level (group 1, 5.0%–5.9%; group 2, 6.0%–6.9%; group 3, 7.0%–7.9%; group 4, 8.0%–8.9%; and group 5, 9.0%–9.9%) and we investigated the difference in CRPS prevalence between the two groups. Results Of the 200 patients, 108 were in the CRPS group and 92 were in the non-CRPS group. There were significant differences in HbA1c (p<0.05) between the two groups but no significant differences in any other factors. Across the five HbA1c groups, there were significant differences in CRPS prevalence (p<0.01); specifically, it increased as HbA1c increased. Conclusion This study suggests that higher HbA1c relates to higher CRPS prevalence and thus that uncontrolled blood glucose can affect CRPS occurrence in stroke patients with diabetes. PMID:27847707

The effectiveness of regular leisure-time physical activities on long-term glycemic control in people with type 2 diabetes: A systematic review and meta-analysis.

PubMed

Pai, Lee-Wen; Li, Tsai-Chung; Hwu, Yueh-Juen; Chang, Shu-Chuan; Chen, Li-Li; Chang, Pi-Ying

2016-03-01

The objective of this study was to systematically review the effectiveness of different types of regular leisure-time physical activities and pooled the effect sizes of those activities on long-term glycemic control in people with type 2 diabetes compared with routine care. This review included randomized controlled trials from 1960 to May 2014. A total of 10 Chinese and English databases were searched, following selection and critical appraisal, 18 randomized controlled trials with 915 participants were included. The standardized mean difference was reported as the summary statistic for the overall effect size in a random effects model. The results indicated yoga was the most effective in lowering glycated haemoglobin A1c (HbA1c) levels. Meta-analysis also revealed that the decrease in HbA1c levels of the subjects who took part in regular leisure-time physical activities was 0.60% more than that of control group participants. A higher frequency of regular leisure-time physical activities was found to be more effective in reducing HbA1c levels. The results of this review provide evidence of the benefits associated with regular leisure-time physical activities compared with routine care for lowering HbA1c levels in people with type 2 diabetes. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

A1c Gear: Laboratory quality HbA1c measurement at the point of care.

PubMed

Ejilemele, Adetoun; Unabia, Jamie; Ju, Hyunsu; Petersen, John R

2015-05-20

HbA1c is an important part of assessing the diabetic control and since the use of point-of-care devices for monitoring HbA1c is increasing, it is important to determine how these devices compare to the central laboratory. One hundred and twenty patient samples were analyzed on the Bio-Rad Variant™II and one POC analyzer (Sakae A1c Gear). Three patient sample pools containing ~5%, ~7%, and ~10% HbA1c levels were run over 20 days. Three reagent lots and three instruments were evaluated for the A1c Gear. The 120 patient samples showed strong correlation (R(2)>0.989) when compared to the Variant™II with means=8.06% and 7.81%, for Variant IIand A1c Gear, respectively. Changing reagent lots or instruments had no impact for the A1c Gear. The ~5%, ~7%, and ~10% pools within-run and between-run imprecision was between 0.87-1.33% and 1.03-1.32%, and 1.41-2.35% and 1.24-1.89% with total imprecision of 1.67-2.35% and 1.61-2.31% for the A1c Gear and Variant II, respectively. The A1c Gear showed a small negative bias (0.25% HbA1c) across HbA1c measurement ranges of <11.5%. This bias was, however, acceptable and not considered to be clinically significant. The A1c Gear meets the criteria of total CV <3% leading us to the conclusion that the A1c Gear can give results as precise as the laboratory at the POC. Copyright © 2015. Published by Elsevier B.V.

Effect of combined application insulin and insulin detemir on continous glucose monitor in children with type 1 diabetes mellitus.

PubMed

Chen, Xiao-Yun; Dong, Qing; Li, Gui-Mei

2015-01-01

Insulin detemir is a soluble long-acting human insulin analogue at neutral pH with a unique mechanism of action, which could strengthen the effects of insulin. This study aims to explore the effects of insulin combined with insulin detemir on the continous glucose in children with type 1 diabetes mellitus. In this study, 150 patients with type 1 diabetes enrolled were included and randomly divided into 3 groups: insulin group (group A), insulin detemir group (group B) and insulin combined with insulin detemir group (group C). Each subject underwent 72 h of continuous glucose monitoring (CGM). MAGE, HbA1c and Noctumal Hypoglycemia levels were examined by using the ELISA kits. The body weight changes were also detected in this study. The results indicated that the information including age, body weight, disease duration and glucose level and HbA1c percentage on the start time point among three groups indicated no statistical differences. Insulin combined with insulin detemir decrease MAGE and HbA1c level in Group C compared to Group A and Group A (P < 0.05). Insulin combined with insulin detemir decreas noctumal hypoglycemia levels and body weight changes (P < 0.05). In conclusion, this study confirmed efficacy of insulin detemir by demonstrating non-inferiority of insulin detemir compared with insulin with respect to HbA1c, with an improved safety profile including significantly fewer hypoglycaemic episodes and less undesirable weight gain in children.

Associations of HbA1c and fasting plasma glucose with incident diabetes: Implications for pre-diabetes thresholds in a Japanese population.

PubMed

Nakagami, Tomoko; Tanaka, Yuki; Oya, Junko; Kurita, Moritoshi; Isago, Chisato; Hasegawa, Yukiko; Ito, Arata; Hirota, Naoki; Tsuzura, Reika; Uchigata, Yasuko

2016-12-01

This study assessed pre-diabetes (pre-DM) cutoffs for HbA1c and fasting plasma glucose (FPG) that were associated with an increased risk of incident DM. We evaluated 2267 non-diabetic Japanese health-check examinees (HbA1c: <6.5% [<48mmol/mol] and FPG: <7.0mmol/L) who were 30-79 years old and were followed-up for 5 years. Incident DM was defined as HbA1c of ≥6.5% (≥48mmol/mol), FPG of ≥7.0mmol/L, or physician-diagnosed DM. During 11047 person-years, we identified 99 incident DM cases (4.3%). The incidence of DM increased with increasing baseline HbA1c or FPG levels, and the change points (95% confidence intervals) were 5.7% (5.6-5.7%; 39mmol/mol [38-39mmol/mol]) for HbA1c and 5.5mmol/L (5.5-5.6mmol/L) for FPG. The adjusted hazard ratios (HRs) for incident DM per one standard deviation-increase in HbA1c and FPG were 5.5 (4.4-6.8) and 4.0 (3.2-4.8), respectively. The adjusted HRs for incident DM were significantly higher at HbA1c of 5.7-6.4% (39-46mmol/mol) or FPG of 5.5-6.9mmol/L, compared to HbA1c of <5.7% (<39mmol/mol) or FPG of <5.5mmol/L. The lower cut-offs for pre-DM may be 5.7% (39mmol/mol) for HbA1c and 5.5mmol/L for FPG in this Japanese population. Copyright © 2016 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Contemporary risk estimates of three HbA1c variables in relation to heart failure following diagnosis of type 2 diabetes.

PubMed

Skrtic, Stanko; Cabrera, Claudia; Olsson, Marita; Schnecke, Volker; Lind, Marcus

2017-03-01

We evaluated the association between glycaemic control and the risk of heart failure (HF) in a contemporary cohort of persons followed after diagnosis of type 2 diabetes (T2D). Persons with T2D diagnosed between 1998 and 2012 were retrieved from the Clinical Practice Research Data Link in the UK and followed from diagnosis until the event of HF, mortality, drop out from the database due to any other reason, or the end of the study on 1 July 2015. The association between each of three different haemoglobin A 1C (HbA 1c ) metrics and HF was estimated using adjusted proportional hazard models. In the overall cohort (n=94 332), the increased risk for HF per 1% (10 mmol/mol) increase in HbA 1c was 1.15 (95% CI 1.13 to 1.18) for updated mean HbA 1c , and 1.06 (1.04 to 1.07) and 1.06 (1.04 to 1.08) for baseline HbA 1c and updated latest HbA 1c , respectively. When categorised, the hazard risk (HR) for the updated mean HbA 1c in relation to HF became higher than for baseline and updated latest HbA 1c above HbA 1c levels of 9%, but did not differ at lower HbA 1c levels. The updated latest variable showed an increased risk for HbA 1c <6% (42 mmol/mol) of 1.16 (1.07 to 1.25), relative category 6-7%, while the HRs for updated mean and baseline HbA 1c showed no such J-shaped pattern. Hyperglycaemia is still a risk factor for HF in persons with T2D of similar magnitude as in earlier cohorts. Such a relationship exists for current glycaemic levels, at diagnosis and the overall level but the pattern differs for these variables. 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/.

Contemporary risk estimates of three HbA1c variables in relation to heart failure following diagnosis of type 2 diabetes

PubMed Central

Skrtic, Stanko; Cabrera, Claudia; Olsson, Marita; Schnecke, Volker; Lind, Marcus

2017-01-01

Background We evaluated the association between glycaemic control and the risk of heart failure (HF) in a contemporary cohort of persons followed after diagnosis of type 2 diabetes (T2D). Methods and results Persons with T2D diagnosed between 1998 and 2012 were retrieved from the Clinical Practice Research Data Link in the UK and followed from diagnosis until the event of HF, mortality, drop out from the database due to any other reason, or the end of the study on 1 July 2015. The association between each of three different haemoglobin A1C (HbA1c) metrics and HF was estimated using adjusted proportional hazard models. In the overall cohort (n=94 332), the increased risk for HF per 1% (10 mmol/mol) increase in HbA1c was 1.15 (95% CI 1.13 to 1.18) for updated mean HbA1c, and 1.06 (1.04 to 1.07) and 1.06 (1.04 to 1.08) for baseline HbA1c and updated latest HbA1c, respectively. When categorised, the hazard risk (HR) for the updated mean HbA1c in relation to HF became higher than for baseline and updated latest HbA1c above HbA1c levels of 9%, but did not differ at lower HbA1c levels. The updated latest variable showed an increased risk for HbA1c <6% (42 mmol/mol) of 1.16 (1.07 to 1.25), relative category 6–7%, while the HRs for updated mean and baseline HbA1c showed no such J-shaped pattern. Conclusions Hyperglycaemia is still a risk factor for HF in persons with T2D of similar magnitude as in earlier cohorts. Such a relationship exists for current glycaemic levels, at diagnosis and the overall level but the pattern differs for these variables. PMID:27647169

Glycated haemoglobin (HbA1c ) and fasting plasma glucose relationships in sea-level and high-altitude settings.

PubMed

Bazo-Alvarez, J C; Quispe, R; Pillay, T D; Bernabé-Ortiz, A; Smeeth, L; Checkley, W; Gilman, R H; Málaga, G; Miranda, J J

2017-06-01

Higher haemoglobin levels and differences in glucose metabolism have been reported among high-altitude residents, which may influence the diagnostic performance of HbA 1c . This study explores the relationship between HbA 1c and fasting plasma glucose (FPG) in populations living at sea level and at an altitude of > 3000 m. Data from 3613 Peruvian adults without a known diagnosis of diabetes from sea-level and high-altitude settings were evaluated. Linear, quadratic and cubic regression models were performed adjusting for potential confounders. Receiver operating characteristic (ROC) curves were constructed and concordance between HbA 1c and FPG was assessed using a Kappa index. At sea level and high altitude, means were 13.5 and 16.7 g/dl (P > 0.05) for haemoglobin level; 41 and 40 mmol/mol (5.9% and 5.8%; P < 0.01) for HbA 1c ; and 5.8 and 5.1 mmol/l (105 and 91.3 mg/dl; P < 0.001) for FPG, respectively. The adjusted relationship between HbA 1c and FPG was quadratic at sea level and linear at high altitude. Adjusted models showed that, to predict an HbA 1c value of 48 mmol/mol (6.5%), the corresponding mean FPG values at sea level and high altitude were 6.6 and 14.8 mmol/l (120 and 266 mg/dl), respectively. An HbA 1c cut-off of 48 mmol/mol (6.5%) had a sensitivity for high FPG of 87.3% (95% confidence interval (95% CI) 76.5 to 94.4) at sea level and 40.9% (95% CI 20.7 to 63.6) at high altitude. The relationship between HbA 1c and FPG is less clear at high altitude than at sea level. Caution is warranted when using HbA 1c to diagnose diabetes mellitus in this setting. © 2017 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Association of hemoglobin A1c and glycated albumin with carotid atherosclerosis in community-dwelling Japanese subjects: the Hisayama Study.

PubMed

Mukai, Naoko; Ninomiya, Toshiharu; Hata, Jun; Hirakawa, Yoichiro; Ikeda, Fumie; Fukuhara, Masayo; Hotta, Taeko; Koga, Masafumi; Nakamura, Udai; Kang, Dongchon; Kitazono, Takanari; Kiyohara, Yutaka

2015-06-24

It is not clear which glucose measure is more useful in the assessment of atherosclerosis. We investigated the associations of hemoglobin A1c (HbA1c), glycated albumin (GA), 1,5-anhydroglucitol (1,5-AG), fasting plasma glucose (FPG), and 2-hour postload glucose (PG) with carotid intima-media thickness (IMT) in community-dwelling Japanese subjects. A total of 2702 subjects aged 40-79 years underwent a 75-g oral glucose tolerance test and measurements of HbA1c, GA, 1,5-AG, and carotid IMT by ultrasonography in 2007-2008. Carotid wall thickening was defined as a maximum IMT of >1.0 mm. The crude and multivariable-adjusted linear and logistic regression models were used to analyze cross-sectional associations between levels of glycemic measures and carotid IMT. The crude average of the maximum IMT increased significantly with rising quartiles of HbA1c, GA, FPG, and 2-hour PG levels in subjects with and without glucose intolerance (GI), while no clear association was observed for 1,5-AG. After adjustment for other confounding factors, positive trends for HbA1c, GA, and FPG (all p for trend < 0.05), but not 2-hour PG (p = 0.07) remained robust in subjects with GI, but no such associations were found in those without GI. When estimating multivariable-adjusted β values for the associations of 1 SD change in glycemic measures with the maximum IMT in subjects with GI, the magnitude of the influence of HbA1c (β = 0.021), GA (β = 0.024), and FPG (β = 0.024) was larger than that of 2-hour PG (β = 0.014) and 1,5-AG (β = 0.003). The multivariable-adjusted odds ratios for the presence of carotid wall thickening increased significantly with elevating HbA1c, GA, and FPG levels only in subjects with GI (all p for trend < 0.001). Among subjects with GI, the area under the receiver operating characteristic curve significantly increased by adding HbA1c (p = 0.04) or GA (p = 0.04), but not 1,5-AG, FPG, or 2-hour PG, to the model including other cardiovascular risk factors. In community-dwelling Japanese subjects with GI, elevated HbA1c, GA, and FPG levels were significantly associated with increased carotid IMT, and HbA1c and GA provided superior discrimination for carotid wall thickening compared to 1,5-AG, FPG, and 2-hour PG, suggesting that HbA1c and GA are useful for assessing carotid atherosclerosis.

Exenatide once weekly versus daily basal insulin as add-on treatment to metformin with or without a sulfonylurea: a retrospective pooled analysis in patients with poor glycemic control.

PubMed

Grimm, Michael; Li, Yan; Brunell, Steven C; Blase, Erich

2013-09-01

Basal insulin (b-INS) is typically the add-on treatment of choice for patients with poor glycemic control (ie, glycated hemoglobin [HbA1c] level ≥ 8.5%), but it is unclear whether b-INS is the best option. In this post hoc analysis, the efficacy and tolerability of exenatide once weekly (EQW) were compared with those of b-INS in patients with type 2 diabetes mellitus and a baseline HbA1c level 8.5% who were undergoing treatment with metformin ± a sulfonylurea. Data were pooled from two 26-week, randomized, controlled trials (EQW vs insulin glargine and EQW vs insulin detemir [EQW, N = 137; b-INS, N = 126]). Treatment with either EQW or b-INS for 26 weeks was associated with significant improvements in HbA1c level compared with baseline, although patients treated with EQW experienced a significantly greater decrease in HbA1c level than those treated with b-INS (least squares [LS] mean ± SE: -2.0% ± 0.08% vs -1.6% ± 0.08%; P = 0.0008). Treatment with EQW was associated with a weight loss of 2.4 kg ± 0.23 kg (LS mean ± SE), whereas treatment with b-INS was associated with a weight gain of 2.0 kg ± 0.24 kg (LS mean difference between groups, -4.4 kg ± 0.33; P < 0.0001). Patients in the EQW group were significantly more likely to achieve the composite endpoint of an HbA1c level < 7.0%, no weight gain, and no hypoglycemic events (defined as a blood glucose level < 54 mg/dL requiring self-treatment or assistance to resolve) than patients in the b-INS group (33.6% vs 3.2%; P < 0.0001). The exposure-adjusted hypoglycemic event rates were 0.08 and 0.37 events per patient-year in the EQW and b-INS groups, respectively. Gastrointestinal adverse events occurred at a higher rate in patients who underwent EQW treatment than those who were treated with b-INS. These results show that EQW treatment was associated with significantly greater improvement in HbA1c level compared with b-INS treatment among patients with poor glycemic control, with the added benefits of weight loss (vs weight gain with b-INS therapy) and a lower incidence of hypoglycemic events. These results suggest that EQW is an alternative treatment to b-INS for patients with type 2 diabetes mellitus and a baseline HbA1c level ≥ 8.5%.

Hba1c, Blood Pressure, and Lipid Control in People with Diabetes: Japan Epidemiology Collaboration on Occupational Health Study

PubMed Central

Hu, Huanhuan; Hori, Ai; Nishiura, Chihiro; Sasaki, Naoko; Okazaki, Hiroko; Nakagawa, Tohru; Honda, Toru; Yamamoto, Shuichiro; Tomita, Kentaro; Miyamoto, Toshiaki; Nagahama, Satsue; Uehara, Akihiko; Yamamoto, Makoto; Murakami, Taizo; Shimizu, Chii; Shimizu, Makiko; Eguchi, Masafumi; Kochi, Takeshi; Imai, Teppei; Okino, Akiko; Kuwahara, Keisuke; Kashino, Ikuko; Akter, Shamima; Kurotani, Kayo; Nanri, Akiko; Kabe, Isamu; Mizoue, Tetsuya; Kunugita, Naoki; Dohi, Seitaro

2016-01-01

Aims The control of blood glucose levels, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C) levels reduces the risk of diabetes complications; however, data are scarce on control status of these factors among workers with diabetes. The present study aimed to estimate the prevalence of participants with diabetes who meet glycated hemoglobin (HbA1c), BP, and LDL-C recommendations, and to investigate correlates of poor glycemic control in a large working population in Japan. Methods The Japan Epidemiology Collaboration on Occupational Health (J-ECOH) Study is an ongoing cohort investigation, consisting mainly of employees in large manufacturing companies. We conducted a cross-sectional analysis of 3,070 employees with diabetes (2,854 men and 216 women) aged 20–69 years who attended periodic health examinations. BP was measured and recorded using different company protocols. Risk factor targets were defined using both American Diabetes Association (ADA) guidelines (HbA1c < 7.0%, BP < 140/90 mmHg, and LDL-C < 100 mg/dL) and Japan Diabetes Society (JDS) guidelines (HbA1c < 7.0%, BP < 130/80 mmHg, and LDL-C < 120 mg/dL). Logistic regression models were used to explore correlates of poor glycemic control (defined as HbA1c ≥ 8.0%). Results The percentages of participants who met ADA (and JDS) targets were 44.9% (44.9%) for HbA1c, 76.6% (36.3%) for BP, 27.1% (56.2%) for LDL-C, and 11.2% (10.8%) for simultaneous control of all three risk factors. Younger age, obesity, smoking, and uncontrolled dyslipidemia were associated with poor glycemic control. The adjusted odds ratio of poor glycemic control was 0.58 (95% confidence interval, 0.46–0.73) for participants with treated but uncontrolled hypertension, and 0.47 (0.33–0.66) for participants with treated and controlled hypertension, as compared with participants without hypertension. There was no significant difference in HbA1c levels between participants with treated but uncontrolled hypertension and those with treated and controlled hypertension. Conclusion Data from a large working population, predominantly composed of men, suggest that achievement of HbA1c, BP, and LDL-C targets was less than optimal, especially in younger participants. Uncontrolled dyslipidemia was associated with poor glycemic control. Participants not receiving antihypertensive treatment had higher HbA1c levels. PMID:27437997

Association Between Preoperative Hemoglobin A1c Levels, Postoperative Hyperglycemia, and Readmissions Following Gastrointestinal Surgery.

PubMed

Jones, Caroline E; Graham, Laura A; Morris, Melanie S; Richman, Joshua S; Hollis, Robert H; Wahl, Tyler S; Copeland, Laurel A; Burns, Edith A; Itani, Kamal M F; Hawn, Mary T

2017-11-01

Preoperative hyperglycemia is associated with adverse postoperative outcomes among patients who undergo surgery. Whether preoperative hemoglobin A1c (HbA1c) or postoperative glucose levels are more useful in predicting adverse events following surgery is uncertain in the current literature. To examine the use of preoperative HbA1c and early postoperative glucose levels for predicting postoperative complications and readmission. In this observational cohort study, inpatient gastrointestinal surgical procedures performed at 117 Veterans Affairs hospitals from 2007 to 2014 were identified, and cases of known infection within 3 days before surgery were excluded. Preoperative HbA1c levels were examined as a continuous and categorical variable (<5.7%, 5.7%-6.5%, and >6.5%). A logistic regression modeled postoperative complications and readmissions with the closest preoperative HbA1c within 90 days and the highest postoperative glucose levels within 48 hours of undergoing surgery. Postoperative complications and 30-day unplanned readmission following discharge. Of 21 541 participants, 1193 (5.5%) were women, and the mean (SD) age was 63.7 (10.6) years. The cohort included 23 094 operations with measurements of preoperative HbA1c levels and postoperative glucose levels. The complication and 30-day readmission rates were 27.2% and 14.7%, respectively. In logistic regression models adjusting for HbA1c, postoperative glucose levels, postoperative insulin use, diabetes, body mass index (calculated as weight in kilograms divided by height in meters squared), and other patient and procedural factors, peak postoperative glucose levels of more than 250 mg/dL were associated with increased 30-day readmissions (odds ratio, 1.18; 95% CI, 0.99-1.41; P = .07). By contrast, a preoperative HbA1c of more than 6.5% was associated with decreased 30-day readmissions (odds ratio, 0.85; 95% CI, 0.74-0.96; P = .01). As preoperative HbA1c increased, the frequency of 48-hour postoperative glucose checks increased (4.92, 6.89, and 9.71 for an HbA1c <5.7%, 5.7%-6.4%, and >6.5%, respectively; P < .001). Patients with a preoperative HbA1c of more than 6.5% had lower thresholds for postoperative insulin use. Early postoperative hyperglycemia was associated with increased readmission, but elevated preoperative HbA1c was not. A higher preoperative HbA1c was associated with increased postoperative glucose level checks and insulin use, suggesting that heightened postoperative vigilance and a lower threshold to treat hyperglycemia may explain this finding.

Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

PubMed

Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

2016-01-01

Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

Impact and duration effect of telemonitoring on ΗbA1c, BMI and cost in insulin-treated Diabetes Mellitus patients with inadequate glycemic control: A randomized controlled study.

PubMed

Fountoulakis, Stelios; Papanastasiou, Labrini; Gryparis, Alexandros; Markou, Athina; Piaditis, George

2015-01-01

To monitor and control the blood glucose levels in inefficiently insulin-treated patients with type 1 and 2 diabetes mellitus (DM) using a telemonitoring system and determine whether the improvement of HbA1c has a lasting effect following its discontinuation. Seventy inefficiently controlled insulin-treated DM patients using telemonitoring (telemonitoring group-TG) [HbA1c 9.9±2.3% (85±24.9mmol/mol)] and 35 age-, body mass index (BMI)- and Hba1c-matched insulin-treated patients receiving outpatient care (control group-CG) [HbA1c 9.7±2.1% (82±23.4mmol/mol)] were enrolled. Data of TG were transmitted from the glucose-meters to our computers via modem. Communication was achieved via e-mails and mobile phone text-messages through integrated software. HbA1c and BMI were evaluated at enrollment, 3 and 6 months, and 6 months after telemonitoring discontinuation. Frequency of hypo- and hyperglycemias and cost were also analyzed. Significant reduction in HbA1c was observed in TG both at 3 [7.1±1.0% (54±10.5mmol/mol) p<0.001] and 6 months [6.9±0.9% (52±9.5mmol/mol) p<0.001], compared to the CG group at the same timepoints. Significant reduction was also observed in the TG subgroups with ΗbA1c≥10% and 10>HbA1c≥7.5% at 3 and 6 months, compared to CG. No statistically significant differences in BMI were observed between TG and CG. Six months after telemonitoring discontinuation, HbA1c in TG was slightly increased [7.3±1.0% (56±10.4mol/mol)]. Attenuation was also observed in both TG subgroups. Compared to CG, the number of monthly hypo- and hyperglycemias was reduced in TG. The intervention had a financial benefit for patients living more than 100 km from the health care provider. Telemonitoring can result in reduction of HbA1c and frequency of hypo- and hyperglycemias. This beneficial effect is slightly attenuated 6 months after terminating telemonitoring.

Use of a plastic insulin dosage guide to correct blood glucose levels out of the target range and for carbohydrate counting in subjects with type 1 diabetes.

PubMed

Kaufman, F R; Halvorson, M; Carpenter, S

1999-08-01

To improve glycemic control, a hand-held plastic Insulin Dosage Guide was developed to correct blood glucose levels outside of the target range. Protocol 1: Some 40 children (mean age 10.6+/-4.6 years) were randomly assigned for 3 months to use a written-on-paper algorithm or the Insulin Dosage Guide to correct abnormal blood glucose levels. Mean HbA1c and blood glucose levels and time to teach insulin dosage correction were compared. Protocol 2: The Insulin Dosage Guide was used by 83 subjects (mean age 11.4+/-4.3 years) for 1 year, and mean HbA1c levels, blood glucose levels, and number of consecutive high blood glucose values taken before and after the year were compared. Protocol 3: Some 20 patients (mean age 10.1+/-3.7 years) using rapid-acting insulin and 64 patients (mean age 15.9+/-3.6 years) using an insulin pump and rapid-acting insulin used the Insulin Dosage Guide and had mean blood glucose levels, HbA1c, and percentage of blood glucose levels outside of the target range determined. Protocol 1: There was a significant reduction in mean HbA1c (P = 0.04) and blood glucose levels (P = 0.05) and in the time needed to teach how to correct blood glucose values using the Insulin Dosage Guide compared with the paper algorithm. Protocol 2: There was a decrease in mean HbA1c levels (P = 0.0001) and a decrease in the mean number of consecutive blood glucose levels (P = 0.001) over the 1-year time period. Protocol 3: With rapid-acting insulin, there was a significant increase in the percentage of blood glucose levels within the target range (1 month, P = 0.04; at 3 months, P = 0.03). With the insulin pump, there was a high rate (90%) of blood glucose levels in the target range during pump initiation when the Insulin Dosage Guide was used. This inexpensive hand-held plastic card, which is portable and easy to use, may help patients improve glycemia and successfully manage diabetes.

High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS).

PubMed

Daida, Hiroyuki; Takayama, Tadateru; Hiro, Takafumi; Yamagishi, Masakazu; Hirayama, Atsushi; Saito, Satoshi; Yamaguchi, Tetsu; Matsuzaki, Masunori

2012-07-25

The incidence of cardiac events is higher in patients with diabetes than in people without diabetes. The Coronary Atherosclerosis Study Measuring Effects of Rosuvastatin Using Intravascular Ultrasound in Japanese Subjects (COSMOS) demonstrated significant plaque regression in Japanese patients with chronic coronary disease after 76 weeks of rosuvastatin (2.5 mg once daily, up-titrated to a maximum of 20 mg/day to achieve LDL cholesterol <80 mg/dl). In this subanalysis of COSMOS, we examined the association between HbA1c and plaque regression in 40 patients with HbA1c ≥6.5% (high group) and 86 patients with HbA1c <6.5% (low group). In multivariate analyses, HbA1c and plaque volume at baseline were major determinants of plaque regression. LDL cholesterol decreased by 37% and 39% in the high and low groups, respectively, while HDL cholesterol increased by 16% and 22%, respectively. The reduction in plaque volume was significantly (p = 0.04) greater in the low group (from 71.0 ± 39.9 to 64.7 ± 34.7 mm(3)) than in the high group (from 74.3 ± 34.2 to 71.4 ± 32.3 mm(3)). Vessel volume increased in the high group but not in the low group (change from baseline: +4.2% vs -0.8%, p = 0.02). Change in plaque volume was significantly correlated with baseline HbA1c. Despite similar improvements in lipid levels, plaque regression was less pronounced in patients with high HbA1c levels compared with those with low levels. Tight glucose control during statin therapy may enhance plaque regression in patients with stable coronary disease. ClinicalTrials.gov, Identifier NCT00329160.

HbA1c and Gestational Weight Gain Are Factors that Influence Neonatal Outcome in Mothers with Gestational Diabetes.

PubMed

Barquiel, Beatriz; Herranz, Lucrecia; Hillman, Natalia; Burgos, Ma Ángeles; Grande, Cristina; Tukia, Keleni M; Bartha, José Luis; Pallardo, Luis Felipe

2016-06-01

Maternal glucose and weight gain are related to neonatal outcome in women with gestational diabetes mellitus (GDM). The aim of this study was to explore the influence of average third-trimester HbA1c and excess gestational weight gain on GDM neonatal complications. This observational study included 2037 Spanish singleton pregnant women with GDM followed in our Diabetes and Pregnancy Unit. The maternal HbA1c level was measured monthly from GDM diagnosis to delivery. Women were compared by average HbA1c level and weight gain categorized into ≤ or > the current Institute of Medicine (IOM) recommendations for body mass index. The differential effects of these factors on large-for-gestational-age birth weight and a composite of neonatal complications were assessed. Women with an average third-trimester HbA1c ≥5.0% (n = 1319) gave birth to 7.3% versus 3.8% (p = 0.005) of large-for-gestational-age neonates and 22.0% versus 16.0% (p = 0.006) of neonates with complications. Women with excess gestational weight gain (n = 299) delivered 12.5% versus 5.2% (p < 0.001) of large-for-gestational-age neonates and 24.7% versus 19.0% (p = 0.022) of neonates with complications. In an adjusted multiple logistic regression analysis among mothers exposed to the respective risk factors, ∼47% and 52% of large-for-gestational-age neonates and 32% and 37% of neonatal complications were potentially preventable by attaining an average third-trimester HbA1c level <5.0% and optimizing gestational weight gain. Average third-trimester HbA1c level ≥5% and gestational weight gain above the IOM recommendation are relevant risk factors for neonatal complications in mothers with gestational diabetes.

Impact of poor glycemic control of type 2 diabetes mellitus on serum prostate-specific antigen concentrations in men.

PubMed

Atalay, Hasan Anıl; Akarsu, Murat; Canat, Lutfi; Ülker, Volkan; Alkan, İlter; Ozkuvancı, Unsal

2017-09-01

To evaluate the impact of poor glycemic control of type 2 diabetes mellitus (T2DM) on serum prostate-specific antigen (PSA) concentrations in men. We performed a prospective analysis of 215 consecutive patients affected by erectile dysfunction (ED). ED was evaluated using the IIEF-5 questionnaire and the poor glycemic control (PGC) of T2DM was assessed according to the HbA1c criteria (International Diabetes Federation). Patients were divided into PGC group (HbA1c ≥ 7%) and control group (CG) (HbA1c < 6%). Correlations between serum HbA1c levels and various variables were evaluated and multivariate logistic regression analyses were carried out to identify variables for PGC. We compared 110 cases to 105 controls men ranging from 44 to 81 years of age, lower PSA concentrations were observed in men with PGC (PGC mean PSA: 0.9 ng/dl, CG mean PSA: 2.1 ng/dl, p < 0.001). Also mean prostate volume was 60% was smaller among men with PGC compared with men with CG (PGC mean prostate volume: 26 ml, CG prostate volume: 43 ml, p < 0.001). A strong negative correlation was found between serum HbA1c levels and serum PSA (p < 0.001 and r = -0.665) concentrations in men with PGC. We also found at the multivariate logistic regression model that PSA, prostate volume and peak systolic velocity were independent predictors of PGC. Our results suggest that there is significant impact of PGC on serum PSA levels in T2DM. Poor glycemic control of type 2 diabetes was associated with lower serum PSA levels and smaller prostate volumes.

Comparative clinical evaluation of glycosylated haemoglobin level in healthy and chronic periodontitis patients: A chairside diagnostic method.

PubMed

Srinivasa, T S; Agrawal, Parul; Goyal, Pravesh; Farista, Sana; Sowmya, N K; Deonani, Sushmita

2015-01-01

Glycosylated haemoglobin (HbA1c) level can consequently be interpreted as an average of the blood glucose present over the past 3-4 months. Periodontitis is associated with glycemic control in patients with diabetes. The purpose of this study was to determine the level of HbA1c in healthy and periodontitis patients who were previously not diagnosed with diabetes mellitus. A total of 40 patients were selected for study and divided into two groups. Group 1 included patients with a healthy periodontium, and Group 2 included patients suffering from chronic periodontitis. Finger stick blood was collected by special collection unit (A1CNOW+® Bayer Health Care, Tarrytown New York, USA), for estimating level of HbA1c. Both groups showed similar HbA1c levels clinically with slight increase in levels in the test group, but was statistically significant (test--5.66 ± 0.35%, control--5.17 ± 0.3% P = 0.003). Indians are at a high-risk of developing periodontitis and diabetes. These data suggest a possible link between periodontitis and glycemic control in nondiabetic individuals, periodontal disease may be a potential contributor to the development of type 2 diabetes.

A Pilot Study to Compare Meal-Triggered Gastric Electrical Stimulation and Insulin Treatment in Chinese Obese Type 2 Diabetes

PubMed Central

Wong, Simon Kin-Hung; Kong, Alice Pik-Shan; Luk, Andrea On-Yan; Ozaki, Risa; Ng, Vanessa Wan-Sze; Lebovitz, Harold E.; Chan, Juliana Chung-Ngor

2015-01-01

Abstract Background: Gastrointestinal electromodulation therapy is a novel alternative for achieving diabetes control without traditional bariatric surgery. We compared the efficacy of a meal-initiated implantable gastric contractility modulation (GCM) device with that of insulin therapy in obese Chinese type 2 diabetes (T2D) patients, for whom oral antidiabetes drugs (OADs) had failed. Patients and Methods: Sixteen obese (body mass index, 27.5–40.0 kg/m2) T2D patients with a glycated hemoglobin (HbA1c) level of >7.5% on maximal doses of two or more OADs were offered either insulin therapy (n=8) or laparoscopic implantation of a GCM (n=8). We compared changes in body weight, waist circumference (WC), and HbA1c level 1 year after surgery. Results: The GCM and insulin groups had similar baseline body weight and HbA1c. At 12 months, body weight (−3.2±5.2 kg, P=0.043) and WC (−3.8±4.5 cm, P=0.021) fell in the GCM group but not in the insulin group (P<0.05 for between-group difference). At 6 and 12 months, the HbA1c level fell by 1.6±1.1% and 0.9±1.6% (P=0.011), compared with 0.6±0.3% and 0.6±0.3% (P=0.08) for the insulin group (P=0.15 for between-group difference). The mean 24-h systolic blood pressure (BP) fell by 4.5±1.0 mm Hg in the GCM group (P=0.017) but not in the insulin group. The GCM group required fewer antidiabetes medications (P<0.05) and BP-lowering drugs (P<0.05) than the insulin group. A subgroup analysis showed that patients with a triglyceride level of <1.7 mmol/L had a tendency toward a lower HbA1c level (P=0.090) compared with the controls. Conclusions: In obese T2D patients for whom OADs had failed, GCM implantation was a well-tolerated alternative to insulin therapy, with a low triglyceride level as a possible predictor for glycemic response. PMID:25710812

Dietary Fiber Intake Is Associated with HbA1c Level among Prevalent Patients with Type 2 Diabetes in Pudong New Area of Shanghai, China

PubMed Central

Jiang, Junyi; Qiu, Hua; Zhao, Genming; Zhou, Yi; Zhang, Zhijie; Zhang, Hong; Jiang, Qingwu; Sun, Qiao; Wu, Hongyan; Yang, Liming; Ruan, Xiaonan; Xu, Wang-Hong

2012-01-01

Background Dietary factors play an important role in glycemic control in diabetic patients. However, little is known about their effects among Chinese diabetic patients, whose diets are typically abundant in fiber and high in glycemic index (GI) values. Methodology/Principal Findings 934 patients with type 2 diabetes and 918 healthy volunteers from Pudong New Area, Shanghai, China, were interviewed during the period of Oct-Dec, 2006 to elicit demographic characteristics and lifestyle factors. Dietary habits were assessed using a validated food frequency questionnaire. Anthropometric measurements, bio-specimen collection and biochemical assays were conducted at the interview according to a standard protocol. In this population, diabetic patients consumed lower levels of energy and macronutrients but had higher levels of fasting plasma glucose (FPG), glycolated hemoglobin A1c (HbA1c), triglyceride and body mass index than healthy adults. While the average consumption levels of the nutrients among diabetic patients did not vary along duration of the disease, the average levels of FPG and HbA1c increased with increasing duration. Regardless of diabetes duration, HbA1c level was observed lower in patients having a higher fiber or lower GI intake. Compared with those with the lowest tertile intake of fiber, the adjusted odds ratios (ORs) for poor glycemic control reduced from 0.75 (95%CI: 0.54–1.06) to 0.51 (95%CI: 0.34–0.75) with increasing tertile intake (P for trend <0.001). Conclusions Dietary fiber may play an important role in reducing HbA1c level. Increasing fiber intake may be an effective approach to improve glycemic control among Chinese diabetic patients. PMID:23077514

Protein Mediated Oxidative Stress in Patients with Diabetes and its Associated Neuropathy: Correlation with Protein Carbonylation and Disease Activity Markers

PubMed Central

Almogbel, Ebtehal

2017-01-01

Introduction Free radicals have been implicated as Diabetes Mellitus (DM) contributors in type 2 DM and its associated Diabetes Mellitus Neuropathy (DMN). However, the potential for protein mediated oxidative stress to contribute disease pathogenesis remains largely unexplored. Aim To investigate the status and contribution of protein mediated oxidative stress in patients with DM or DMN and to explore whether oxidative protein modification has a role in DM progression to DM associated neuropathy. Materials and Methods Sera from 42 DM and 37 DMN patients with varying levels of disease activities biomarkers (HbA1C, patients’ age or disease duration) and 21 age- and sex-matched healthy controls were evaluated for serum levels of protein mediated oxidative stress. Results Serum analysis showed significantly higher levels of protein carbonyl contents in both DM and DMN patients compared with healthy controls. Importantly, not only was there an increased number of subjects positive for protein carbonylation, but also the levels of protein carbonyl contents were significantly higher among DM and DMN patients, whose HbA1C were ≥8.8 as compared with patients with lower HbA1C (HbA1C<8.8). Similar pattern of protein carbonyls formation was also observed with patients’ ages or with patient’s disease durations, suggesting a possible relationship between protein oxidation and disease progression. Furthermore, sera from DMN patients had higher levels of protein carbonylation compared with non-neuropathic DM patients’ sera, suggesting an involvement of protein oxidation in the progression of diabetes to diabetes neuropathy. Conclusion These findings support an association between protein oxidation and DM or DMN progression. The stronger response observed in patients with higher HbA1C or patients’ ages or disease durations suggests, that protein mediated oxidative stress may be useful in evaluating the progression of DM and its associated DMN and in elucidating the mechanisms of these disorders pathogenesis. PMID:28384853

Metabolic and Cardiovascular Ageing Indices in Relation to Glycated Haemoglobin in Healthy and Diabetic Subjects.

PubMed

Suvarna H I, Shruthi; Moodithaya, Shailaja; Sharma, Raghava

2017-01-01

Ageing is a natural phenomenon that has tremendous amount of control over normal physiological functions. Diabetes mellitus and ageing share common symptoms like stiffness and loss of functioning of tissues due to cross-liked proteins and free radicals. Glycated Haemoglobin (HbA1c) is often used as a stable cumulative index of glycemic control and has shown that even in non-diabetic adults, there is a steady increase in HbA1c levels with age. Aim of the study is to evaluate the strength of association of HbA1c with metabolic and cardiovascular ageing indices in subjects between the age group of 40 to 60 yrs. A total of 220 subjects, with (n=110) and without (n=110) diabetes were assessed for the metabolic and cardiovascular ageing indices. BMI, waist hip ratio, fat percentage, Fasting blood sugar and HbA1c were assessed as metabolic ageing indices. The cardiovascular ageing indices measured were resting heart rate, blood pressure and heart rate variability. Ageing indices were compared between subjects with and without diabetes using independent' t' test and showed that the T2DM group exhibit significant accelerated ageing as compared to that of the controls. Pearson's and partial correlation coefficient was used to assess the association of HbA1c with the ageing indices without and with controlling for chronological age, indicated that, strength of association of levels of HBA1c with cardiovascular and other metabolic indices of ageing is statistically significant. The study concludes that the tightness of glycemic control has a significant impact on the biological ageing process. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Influence of smoking and diet on glycated haemoglobin and 'pre-diabetes' categorisation: a cross-sectional analysis.

PubMed

Vlassopoulos, Antonis; Lean, Michael E J; Combet, Emilie

2013-10-26

The new HbA1c criteria for diagnosis of pre-diabetes have been criticised for misdiagnosis. It is possible that some elevation of HbA1c is not driven by hyperglycaemia. This study assesses associations of HbA1c, commonly assumed to relate solely to glucose concentration, with (i) smoking, a major source of reactive oxygen species (ROS) and (ii) fruit & vegetables consumption associated with improved redox status. One-way ANOVA, Chi-squared and multivariate linear regressions, adjusted for all known confounders were used to explore associations of HbA1c with self-reported smoking status and fruit & vegetables consumptions in the Scottish Health Surveys 2003-2010, among individuals without known diabetes and HbA1c < 6.5%. Compared to non-smokers (n = 2831), smokers (n = 1457) were younger, consumed less fruit & vegetables, had lower physical activity levels, lower BMI, higher HbA1c and CRP (p < 0.05). HbA1c was higher in smokers by 0.25 SDs (0.08%), and 0.38 SDs higher (0.14%) in heavy smokers (>20 cigarettes/day) than non-smokers (p < 0.001 both). Smokers were twice as likely to have HbA1c in the 'pre-diabetic' range (5.7-6.4%) (p < 0.001, adj.model). Pre-diabetes and low grade inflammation did not affect the associations. For every extra 80 g vegetable portion consumed, HbA1c was 0.03 SDs (0.01%) lower (p = 0.02), but fruit consumption did not impact on HbA1c, within the low range of consumptions in this population. This study adds evidence to relate smoking (an oxidative stress proxy) with protein glycation in normoglycaemic subjects, with implications for individuals exposed to ROS and for epidemiological interpretation of HbA1c.

Screening obese children and adolescents for prediabetes and/or type 2 diabetes in pediatric practices: a validation study.

PubMed

Brar, Preneet C; Mengwall, Lisa; Franklin, Bonita H; Fierman, Arthur H

2014-07-01

Increased prevalence of type 2 diabetes mellitus (T2DM) makes it important for pediatricians to use effective screening tools for risk assessment of prediabetes/T2DM in children. Children (n = 149) who had an oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) were studied. American Diabetes Association recommended screening criteria-HbA1c ≥5.7% and fasting plasma glucose (FPG) ≥100 mg/dL-were compared against OGTT. The homeostatic model assessment of insulin resistance (HOMA-IR), a mathematical index derived from fasting insulin and glucose, was compared with OGTT. We studied whether combining screening tests (HbA1c and fasting glucose or HbA1c and HOMA-IR) improved accuracy of prediction of the OGTT. HbA1c of ≥5.7% had a sensitivity of 75% and specificity of 57% when compared with the OGTT. Combining screening tests (HbA1c ≥5.7% and FPG ≥100 mg/dL; HbA1c ≥5.7% and HOMA-IR ≥3.4) resulted in improved sensitivity (95.5% for each), with the HbA1c-FPG doing better than the HbA1c-HOMA-IR combination in terms of ability to rule out prediabetes (likelihood ratio [LR]) negative. 0.07 vs 0.14). HbA1c of ≥5.7% provided fair discrimination of glucose tolerance compared with the OGTT. The combination of HbA1c and FPG is a useful method for identifying children who require an OGTT. © The Author(s) 2014.

The HbA1c and All-Cause Mortality Relationship in Patients with Type 2 Diabetes is J-Shaped: A Meta-Analysis of Observational Studies

PubMed Central

Arnold, Luke W.; Wang, Zhiqiang

2014-01-01

BACKGROUND: Low blood glucose and HbA1c levels are recommended in the literature on management of diabetes. However, data have shown that low blood glucose is associated with serious adverse effects for the patients and the recommendation has been criticized. Therefore, this article revisits the relationship between HbA1c and all-cause mortality by a meta-analysis of observational studies. AIM: The aim of this study is to determine whether there is a J- or U-shaped non-linear relationship between HbA1c and all-cause mortality in type 2 diabetes patients, implying an increased risk to premature all-cause mortality at high and low levels of HbA1c. METHODS: A comprehensive literature search was conducted using PubMed, Medline, and Cochrane Library databases with strict inclusion/exclusion criteria. The published adjusted hazard ratios (HR) with 95% confidence intervals of all-cause mortality for each HbA1c category and per study were analyzed. Fractional polynomial regression was used with random effect modeling to assess the non-linear relationship of the HR trends between studies. Seven eligible observational studies with a total of 147,424 participants were included in the study. RESULTS: A significant J-shaped relationship was observed between HbA1c and all-cause mortality. Crude relative risk for all-cause mortality identified a decreased risk per 1% increase in HbA1c below 7.5% (58 mmol/mol) (0.90, CI 0.86-0.94) and an increased risk per 1% increase in HbA1c above 7.5% (58 mmol/mol) (1.04, CI 1.01-1.06). Observational studies revealed a J-shaped relationship between HbA1c and all-cause mortality, equivalent to an increased risk of mortality at high and low HbA1c levels. CONCLUSIONS: This increased mortality at high and low HbA1c levels has significant implications on investigating optimum clinical HbA1c targets as it suggests that there are upper and lower limits for creating a 'security zone' for diabetes management. PMID:25396402

Children and young people with diabetes in Yorkshire: a population-based clinical audit of patient data 2005/2006.

PubMed

McKinney, P A; Feltbower, R G; Stephenson, C R; Reynolds, C

2008-11-01

To provide a population-based clinical audit of children and young people with diabetes, reporting outcomes, including glycaemic control, for named individual units. Clinical audit data on care processes and glycated haemoglobin (HbA(1c)) were collected for 1742 children and young people treated in 16 paediatric units in Yorkshire, from January 2005 to March 2006. The Yorkshire Register of Diabetes in Children and Young People provided information technology support and validation that enhanced data quality. Multi-level linear regression modelling investigated factors affecting glycaemic control. An HbA(1c) measure was recorded for 91.6% of patients. The National Institute for Clinical Excellence-recommended target level for HbA(1c) of < 7.5% was achieved for 14.7% of patients. HbA(1c) was positively associated with duration of diabetes and later age at diagnosis. Patients living in deprived areas had significantly poorer control compared with those from affluent areas. Significant between-unit variation in HbA(1c) was not reflected by any association with unit size. Our population-based clinical audit of children with diabetes is the product of an effective collaboration between those who deliver care and health services researchers. High levels of recording the key care process measuring diabetes control, compared with national figures, suggests collaboration has translated into improved services. The interesting association between poor diabetes control and higher deprivation is noteworthy and requires further investigation. Future audits require recording of clinical management and clinic structures, in addition to resources to record, assemble and analyse data.

Association of pre-pregnancy BMI and postpartum weight retention with postpartum HbA1c among women with Type 1 diabetes

PubMed Central

Huang, T.; Brown, F. M.; Curran, A.; James-Todd, T.

2015-01-01

Aim To examine the association of pre-pregnancy BMI and postpartum weight retention with postpartum HbA1c levels in women with Type 1 diabetes. Methods We longitudinally evaluated 136 women with Type 1 diabetes who received prenatal and postpartum care through the Joslin Diabetes Center’s Diabetes and Pregnancy Program between 2004 and 2009. Weight, BMI and HbA1c concentration were assessed before the index pregnancy and repeatedly monitored after delivery until 12 months postpartum. We used a linear mixed model to assess the association of postpartum HbA1c with pre-pregnancy BMI and postpartum weight retention. Results The mean HbA1c concentration increased from 49 mmol/mol (6.6%) at 6 weeks postpartum to 58 mmol/mol (7.5%) by 10 months postpartum, a level similar to the mean pre-pregnancy HbA1c concentration. Postpartum weight retention showed a linearly decreasing trend of 0.06 kg/week (P<0.0001), with −0.1 kg average postpartum weight retention by 1 year postpartum. Compared with women with a pre-pregnancy BMI≥25 kg/m2, women with a lower pre-pregnancy BMI maintained a 3.4 mmol/mol (0.31%) lower HbA1c concentration, after adjusting for several sociodemographic, reproductive and diabetes-related factors (P=0.03). There was a suggestion of a time-varying positive association between HbA1c and postpartum weight retention, with the most significant difference of 3.7 mmol/mol (0.34%; P=0.05) at 30 weeks postpartum among women with postpartum weight retention ≥5 kg vs those with postpartum weight retention <5 kg. Conclusions Pre-pregnancy BMI and postpartum weight retention were positively associated with HbA1c during the first postpartum year in women with Type 1 diabetes. Interventions to modify the behaviours associated with these body weight factors before pregnancy and after delivery may help women with Type 1 diabetes maintain good glycaemic control after pregnancy. PMID:25346003

Hemoglobin A1c (HbA1c) changes over time among adolescent and young adult participants in the T1D exchange clinic registry.

PubMed

Clements, Mark A; Foster, Nicole C; Maahs, David M; Schatz, Desmond A; Olson, Beth A; Tsalikian, Eva; Lee, Joyce M; Burt-Solorzano, Christine M; Tamborlane, William V; Chen, Vincent; Miller, Kellee M; Beck, Roy W

2016-08-01

Hemoglobin A1c (HbA1c) levels among individuals with type 1 diabetes (T1D) influence the longitudinal risk for diabetes-related complications. Few studies have examined HbA1c trends across time in children, adolescents, and young adults with T1D. This study examines changes in glycemic control across the specific transition periods of pre-adolescence-to-adolescence and adolescence-to-young adulthood, and the demographic and clinical factors associated with these changes. Available HbA1c lab results for up to 10 yr were collected from medical records at 67 T1D Exchange clinics. Two retrospective cohorts were evaluated: the pre-adolescent-to-adolescent cohort consisting of 85 016 HbA1c measurements from 6574 participants collected when the participants were 8-18 yr old and the adolescent-to-young adult cohort, 2200 participants who were 16-26 yr old at the time of 17 279 HbA1c measurements. HbA1c in the 8-18 cohort increased over time after age 10 yr until ages 16-17; followed by a plateau. HbA1c levels in the 16-26 cohort remained steady from 16-18, and then gradually declined. For both cohorts, race/ethnicity, income, health insurance, and pump use were all significant in explaining individual variations in age-centered HbA1c (p < 0.001). For the 8-18 cohort, insulin pump use, age of onset, and health insurance were significant in predicting individual HbA1c trajectory. Glycemic control among patients 8-18 yr old worsens over time, through age 16. Elevated HbA1c levels observed in 18 yr-olds begin a steady improvement into early adulthood. Focused interventions to prevent deterioration in glucose control in pre-adolescence, adolescence, and early adulthood are needed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Sleep and biological parameters in professional burnout: A psychophysiological characterization

PubMed Central

Sauvet, Fabien; Gomez-Merino, Danielle; Boucher, Thierry; Elbaz, Maxime; Delafosse, Jean Yves; Leger, Damien; Chennaoui, Mounir

2018-01-01

Professional burnout syndrome has been described in association with insomnia and metabolic, inflammatory and immune correlates. We investigated the interest of exploring biological parameters and sleep disturbances in relation to burnout symptoms among white-collar workers. Fifty-four participants with burnout were compared to 86 healthy control participants in terms of professional rank level, sleep, job strain (Karasek questionnaire), social support, anxiety and depression (HAD scale). Fasting concentrations of glycaemia, glycosylated hemoglobin (HbA1C), total-cholesterol, triglycerides, C-reactive protein (CRP), thyroid stimulating hormone (TSH), 25-hydroxyvitamin D (25[OH]D), and white blood cell (WBC) counts were assessed. Analysis of variance and a forward Stepwise Multiple Logistic Regression were made to identify predictive factors of burnout. Besides reporting more job strain (in particular job control p = 0.02), higher levels of anxiety (p<0.001), and sleep disorders related to insomnia (OR = 21.5, 95%CI = 8.8–52.3), participants with burnout presented higher levels of HbA1C, glycaemia, CRP, lower levels of 25(OH)D, higher number of leukocytes, neutrophils and monocytes (P<0.001 for all) and higher total-cholesterol (P = 0.01). In particular, when HbA1c is > 3.5%, the prevalence of burnout increases from 16.6% to 60.0% (OR = 4.3, 95%CI = 2.8–6.9). Strong significant positive correlation existed between HbA1C and the two dimensions (emotional exhaustion and depersonalization (r = 0.79 and r = 0.71, p<0.01)) of burnout. Models including job strain, job satisfaction, anxiety and insomnia did not predict burnout (p = 0.30 and p = 0.50). However, when HbA1C levels is included, the prediction of burnout became significant (P = 0.03). Our findings demonstrated the interest of sleep and biological parameters, in particular HbA1C levels, in the characterization of professional burnout. PMID:29385150

Sleep and biological parameters in professional burnout: A psychophysiological characterization.

PubMed

Metlaine, Arnaud; Sauvet, Fabien; Gomez-Merino, Danielle; Boucher, Thierry; Elbaz, Maxime; Delafosse, Jean Yves; Leger, Damien; Chennaoui, Mounir

2018-01-01

Professional burnout syndrome has been described in association with insomnia and metabolic, inflammatory and immune correlates. We investigated the interest of exploring biological parameters and sleep disturbances in relation to burnout symptoms among white-collar workers. Fifty-four participants with burnout were compared to 86 healthy control participants in terms of professional rank level, sleep, job strain (Karasek questionnaire), social support, anxiety and depression (HAD scale). Fasting concentrations of glycaemia, glycosylated hemoglobin (HbA1C), total-cholesterol, triglycerides, C-reactive protein (CRP), thyroid stimulating hormone (TSH), 25-hydroxyvitamin D (25[OH]D), and white blood cell (WBC) counts were assessed. Analysis of variance and a forward Stepwise Multiple Logistic Regression were made to identify predictive factors of burnout. Besides reporting more job strain (in particular job control p = 0.02), higher levels of anxiety (p<0.001), and sleep disorders related to insomnia (OR = 21.5, 95%CI = 8.8-52.3), participants with burnout presented higher levels of HbA1C, glycaemia, CRP, lower levels of 25(OH)D, higher number of leukocytes, neutrophils and monocytes (P<0.001 for all) and higher total-cholesterol (P = 0.01). In particular, when HbA1c is > 3.5%, the prevalence of burnout increases from 16.6% to 60.0% (OR = 4.3, 95%CI = 2.8-6.9). Strong significant positive correlation existed between HbA1C and the two dimensions (emotional exhaustion and depersonalization (r = 0.79 and r = 0.71, p<0.01)) of burnout. Models including job strain, job satisfaction, anxiety and insomnia did not predict burnout (p = 0.30 and p = 0.50). However, when HbA1C levels is included, the prediction of burnout became significant (P = 0.03). Our findings demonstrated the interest of sleep and biological parameters, in particular HbA1C levels, in the characterization of professional burnout.

Impact of night sleep duration on glycemic and triglyceride levels in Chinese with different glycemic status.

PubMed

Zheng, Yu; Wang, Anping; Pan, Changyu; Lu, Juming; Dou, Jingtao; Lu, Zhaohui; Ba, Jianming; Wang, Baoan; Mu, Yiming

2015-01-01

The aim of the present study was to assess the relationship between night sleep duration and glycemic and triglyceride (TG) levels among people with different glycemic status. In all, 18,121 subjects aged ≥40 years were enrolled in this cross-sectional study, including 4318 with impaired glucose regulation (IGR), 4225 with diabetes, and 9578 with normal glucose regulation (NGR). The IGR + diabetes and NGR groups were divided into three subgroups according to self-reported night sleep duration as follows: (i) <6 h; (ii) 6-9 h; and (iii) >9 h. The associations of sleep duration with HbA1c, fasting plasma glucose (FPG), 2-h post-load plasma glucose (PPG), and TG levels were examined. Long night sleep duration (>9 h) was associated with higher HbA1c, FPG, PPG, and TG levels compared with sleep duration of 6-9 h (P < 0.01 for all) in the IGR + diabetes group, but not in the NGR group. This association was adjusted for potential confounders, including body mass index and depressive symptoms, and remained significant even after adjusting for snoring. A significant interaction between sleep duration and TG or snoring was observed for HbA1c levels, which attenuated the sleep-HbA1c association in the IGR + diabetes group. However, no significant association was observed between short night sleep duration and HbA1c levels. Long night sleep duration is associated with higher HbA1c, FPG, PPG, and TG levels in IGR and diabetes patients, independent of potential confounders. This may be important in clinical management of IGR and diabetes patients. © 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Measurement of HbA1c in Gingival Crevicular Blood Using a High Pressure Liquid Chromatography Procedure

PubMed Central

Pesce, Michael A.; Strauss, Shiela M.; Rosedale, Mary; Netterwald, Jane; Wang, Hangli

2016-01-01

Objectives To validate an ion exchange high-pressure liquid chromatography (HPLC) method for measuring glycated hemoglobin (HbA1c) in gingival crevicular blood (GCB) spotted on filter paper, for use in screening dental patients for diabetes. Methods We collected the GCB specimens for this study from the oral cavities of patients during dental visits, using rigorous strategies to obtain GCB that was as free of debris as possible. The analytical performance of the HPLC method was determined by measuring the precision, linearity, carryover, stability of HbA1c in GCB, and correlation of HbA1c results in GCB specimens with finger-stick blood (FSB) specimens spotted on filter paper. Results The coefficients of variation (CVs) for the inter- and intrarun precision of the method were less than 2.0%. Linearity ranged between 4.2% and 12.4%; carryover was less than 2.0%, and the stability of the specimen was 6 days at 4°C and as many as 14 days at −70°C. Linear regression analysis comparing the HbA1c results in GCB with FSB yielded a correlation coefficient of 0.993, a slope of 0.981, and an intercept of 0.13. The Bland-Altman plot showed no difference in the HbA1c results from the GCB and FSB specimens at normal, prediabetes, and diabetes HbA1c levels. Conclusion We validated an HPLC method for measuring HbA1c in GCB; this method can be used to screen dental patients for diabetes. PMID:26489673

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

Influencing Pathways to Quality of Life and HbA1c in Patients With Diabetes: A Longitudinal Study That Inform Evidence-Based Practice.

PubMed

Hsu, Hui-Chun; Lee, Yau-Jiunn; Wang, Ruey-Hsia

2018-04-01

Determining possible associated factors and the influencing pathways to hemoglobin A1C (HbA1C) levels and quality of life (QoL) will facilitate the development of effective interventions to improve the physical and psychosocial health of patients with type 2 diabetes mellitus (T2DM). To test a hypothesized model that addressed the pathways among personal characteristics, social support, diabetes distress, and self-care behaviors to HbA1C and QoL. A total of 382 adults with T2DM were recruited. Self-reported questionnaires and medical records were used to collect data regarding personal characteristics, diabetes distress, and social support at baseline. The self-care behaviors characters were collected 6 months later, as well as QoL and HbA1C levels 1 year later. The 12-month QoL directly affected 12-month HbA1C levels. The 6-month self-care behaviors directly affected 12-month QoL, and indirectly affected 12-month HbA1C levels through 12-month QoL. Baseline diabetes distress directly affected 12-month QoL. Moreover, baseline diabetes distress indirectly affected 12-month HbA1C levels through 12-month QoL. Baseline social support directly affected baseline diabetes distress and 6-month self-care behaviors. In addition, baseline social support indirectly affected 12-month QoL through baseline diabetes distress. Baseline social support also indirectly affected 12-month QoL through 6-month self-care behaviors. Enhancing QoL is important to improve HbA1C levels. Enhancing self-care behaviors is essential to improve subsequent HbA1C control and QoL. Reducing diabetes distress is crucial to improve subsequent QoL. Improving social support is suggested a favorable strategy to reduce diabetes distress and enhance subsequent self-care behaviors in patients with T2DM. © 2018 Sigma Theta Tau International.

Adherence to a diabetic care plan provides better glycemic control in ambulatory patients with type 2 diabetes.

PubMed

Chiu, Yi-Wen; Chang, Jer-Ming; Lin, Li-Ing; Chang, Pi-Yu; Lo, Wan-Ching; Wu, Ling-Chu; Chen, Tun-Chieh; Hwang, Shang-Jyh

2009-04-01

Tight control of blood sugar improves the outcomes for diabetic patients, but it can only be achieved by adhering to a well-organized care plan. To evaluate the effect of a diabetes care plan with reinforcement of glycemic control in diabetic patients, 98 ambulatory patients with type 2 diabetes who visited our diabetes clinic every 3-4 months and who completed four education courses given by certified diabetes educators within 3 months after the first visit, were defined as the Intervention group. A total of 82 patients fulfilling the inclusion criteria for the Intervention group but who missed at least half of the diabetes education sessions were selected as controls. Both groups had comparable mean hemoglobin A1c (HbA1c) levels at baseline, which decreased significantly at 3 months and were maintained at approximately constant levels at intervals for up to 1 year. The HbA1c decrement in the Intervention group was significantly greater than that in the Control group over the 1-year follow-up period (HbA1c change: -2.5 +/- 1.8% vs. -1.1 +/- 1.7%, p < 0.01). The maximal HbA1c decrement occurred during the first 3 months, and accounted for 95.6% and 94.6% of the total HbA1c decrements in the Intervention and Control groups, respectively. In the multiple regression model, after adjustment for age, body mass index, and duration of diabetes, the Intervention group may still have a 12.6% improvement in HbA1c from their original value to the end of 1 year treatment compared with the Control group (p < 0.05). Diabetes care, with reinforcement from certified diabetes educators, significantly improved and maintained the effects on glycemic control in ambulatory patients with type 2 diabetes.

Comparison of Enzymatic Assay for HBA1C Measurement (Abbott Architect) With Capillary Electrophoresis (Sebia Minicap Flex Piercing Analyser).

PubMed

Tesija Kuna, Andrea; Dukic, Kristina; Nikolac Gabaj, Nora; Miler, Marijana; Vukasovic, Ines; Langer, Sanja; Simundic, Ana-Maria; Vrkic, Nada

2018-03-08

To compare the analytical performances of the enzymatic method (EM) and capillary electrophoresis (CE) for hemoglobin A1c (HbA1c) measurement. Imprecision, carryover, stability, linearity, method comparison, and interferences were evaluated for HbA1c via EM (Abbott Laboratories, Inc) and CE (Sebia). Both methods have shown overall within-laboratory imprecision of less than 3% for International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) units (<2% National Glycohemoglobin Standardization Program [NGSP] units). Carryover effects were within acceptable criteria. The linearity of both methods has proven to be excellent (R2 = 0.999). Significant proportional and constant difference were found for EM, compared with CE, but were not clinically relevant (<5 mmol/mol; NGSP <0.5%). At the clinically relevant HbA1c concentration, stability observed with both methods was acceptable (bias, <3%). Triglyceride levels of 8.11 mmol per L or greater showed to interfere with EM and fetal hemoglobin (HbF) of 10.6% or greater with CE. The enzymatic method proved to be comparable to the CE method in analytical performances; however, certain interferences can influence the measurements of each method.

Continuous glucose monitoring and HbA1c in the evaluation of glucose metabolism in children at high risk for type 1 diabetes mellitus.

PubMed

Helminen, Olli; Pokka, Tytti; Tossavainen, Päivi; Ilonen, Jorma; Knip, Mikael; Veijola, Riitta

2016-10-01

Continuous glucose monitoring (CGM) parameters, self-monitored blood glucose (SMBG), HbA1c and oral glucose tolerance test (OGTT) were studied during preclinical type 1 diabetes mellitus. Ten asymptomatic children with multiple (⩾2) islet autoantibodies (cases) and 10 age and sex-matched autoantibody-negative controls from the Type 1 Diabetes Prediction and Prevention (DIPP) Study were invited to 7-day CGM with Dexcom G4 Platinum Sensor. HbA1c and two daily SMBG values (morning and evening) were analyzed. Five-point OGTTs were performed and carbohydrate intake was assessed by food records. The matched pairs were compared with the paired sample t-test. The cases showed higher mean values and higher variation in glucose levels during CGM compared to the controls. The time spent ⩾7.8mmol/l was 5.8% in the cases compared to 0.4% in the controls (p=0.040). Postprandial CGM values were similar except after the dinner (6.6mmol/l in cases vs. 6.1mmol/l in controls; p=0.023). When analyzing the SMBG values higher mean level, higher evening levels, as well as higher variation were observed in the cases when compared to the controls. HbA1c was significantly higher in the cases [5.7% (39mmol/mol) vs. 5.3% (34mmol/mol); p=0.045]. No differences were observed in glucose or C-peptide levels during OGTT. Daily carbohydrate intake was slightly higher in the cases (254.2g vs. 217.7g; p=0.034). Glucose levels measured by CGM and SMBG are useful indicators of dysglycemia during preclinical type 1 diabetes mellitus. Increased evening glucose values seem to be common in children with preclinical type 1 diabetes mellitus. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Perioperative glycemic control and postoperative complications in patients undergoing emergency general surgery: What is the role of Plasma Hemoglobin A1c?

PubMed

Jehan, Faisal; Khan, Muhammad; Sakran, Joseph V; Khreiss, Mohammad; O'Keeffe, Terence; Chi, Albert; Kulvatunyou, Narong; Jain, Arpana; Zakaria, El Rasheid; Joseph, Bellal

2018-01-01

Plasma hemoglobin A1c (HbA1c) reflects quality of glucose control in diabetic patients. Literature reports that patients undergoing surgery with an elevated HbA1c level are associated with increased postoperative morbidity and mortality. The aim of our study was to evaluate the impact of HbA1c level on outcomes after emergency general surgery (EGS). We performed a 3-year analysis of our prospectively maintained EGS database. Patients who had HbA1c levels measured within 3 months before surgery were included. Patients were divided into two groups (HbA1c < 6 and HbA1c ≥ 6). Our primary outcome measures included in-hospital complications (major and minor complications), hospital and intensive care unit length of stay, and mortality. Secondary outcomes measures were 30-day complications, readmissions, and mortality. Multivariate and linear regressions were performed. Of the 402 study patients, mean age was 61 ± 12 years, 53% were females, and 63.8% were diabetics. Overall, 49% had an HbA1c ≥ 6%; the mortality rate was 6%. Those with hypertension, history of coronary artery disease, and body mass index of 30 kg/m or greater were more likely to have HbA1c of 6.0% or greater. 7.9% patients experienced major complications. Patients with HbA1c of 6% or greater had a higher complication rate (36% vs 11%, p < 0.001) than those with HbA1c less than 6%. However there was no difference in mortality between two groups (p = 0.09). After controlling for confounders, HbA1c ≥ 6.0% (odds ratio [OR], 2.9; p < 0.01) and a postoperative random blood sugar (RBS) of 200 mg/dL or greater (OR, 2.3; p < 0.01) were independent predictors of major complications. Patients with both HbA1c of 6.0% or greater and postoperative RBS of 200 or greater had higher odds (OR, 4.2; p < 0.01) of developing major complication. After adjusting for confounders, a higher HbA1c was independently correlated with a higher postoperative RBS (b = 0.494, [19.7-28.4], p = 0.02), but there was no correlation with the preoperative RBS. Patients with HbA1c of 6.0% or greater and a postoperative RBS of 200 mg/dL or greater have a four times higher risk of developing major complications after EGS. A preoperative HbA1c can stratify patients prone to develop postoperative hyperglycemia, regardless of their preoperative RBS. Prognostic, level III.

Patterns of type 2 diabetes monitoring in rural towns: How does frequency of HbA1c and lipid testing compare with existing guidelines?

PubMed

Paul, Christine L; Piterman, Leon; Shaw, Jonathan E; Kirby, Catherine; Barker, Daniel; Robinson, Jennifer; Forshaw, Kristy L; Sikaris, Kenneth A; Bisquera, Alessandra; Sanson-Fisher, Robert W

2016-12-01

To indicate levels of monitoring of type 2 diabetes in rural and regional Australia by examining patterns of glycated haemoglobin (HbA1c) and blood lipid testing. Retrospective analysis of pathology services data from twenty regional and rural towns in eastern Australia over 24 months. Of 13 105 individuals who had either a single HbA1c result ≥7.0% (53 mmol mol -1 ); or two or more HbA1c tests within the study period. Frequency of testing of HbA1c and blood lipids (cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides) were compared with guideline recommendations. About 58.3% of patients did not have the recommended 6-monthly HbA1c tests and 30.6% did not have annual lipid testing. For those who did not receive tests at the recommended interval, the mean between-test interval was 10.5 months (95% CI = 7.5-13.5) rather than 6 months for HbA1c testing; and 15.7 (95% CI = 13.3-18.1) months rather than annually for blood lipids. For those with at least one out-of-range test result, 77% of patients failed to receive a follow-up HbA1c test and 86.5% failed to receive a follow-up blood lipid test within the recommended 3 months. Patients less than 50 years of age, living in a more remote area and with poor diabetes control were less likely to have testing at the recommended intervals (P < 0.0001). Although poor diabetes testing is not limited to rural areas, more intensive diabetes monitoring is likely to be needed for patients living in non-metropolitan areas, particularly for some subgroups. © 2016 National Rural Health Alliance Inc.

Chromium picolinate and biotin combination improves glucose metabolism in treated, uncontrolled overweight to obese patients with type 2 diabetes.

PubMed

Albarracin, Cesar A; Fuqua, Burcham C; Evans, Joseph L; Goldfine, Ira D

2008-01-01

Chromium and biotin play essential roles in regulating carbohydrate metabolism. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the combination of chromium picolinate and biotin on glycaemic control. Four hundred and forty-seven subjects with poorly controlled type 2 diabetes (HbA(1c) > or = 7.0%) were enrolled and received either chromium picolinate (600 microg Cr(+3)) with biotin (2 mg), or matching placebo, for 90 days in combination with stable oral anti-diabetic agents (OADs). Major endpoints were reductions in HbA(1c), fasting glucose, and lipids. Safety and tolerability were assessed. Change in HbA(1c) was significantly different between treatment groups (p = 0.03). HbA(1c) in the chromium picolinate/biotin group decreased 0.54%. The decrease in HbA(1c) was most pronounced in chromium picolinate/biotin subjects whose baseline HbA(1c) > or = 10%, and highly significant when compared with placebo (-1.76% vs - 0.68%; p = 0.005). Fasting glucose levels were reduced in the entire chromium picolinate/biotin group versus placebo (-9.8 mg/dL vs 0.7 mg/dL; p = 0.02). Reductions in fasting glucose were also most marked in those subjects whose baseline HbA(1c) > or = 10.0%, and significant when compared to placebo (-35.8 mg/dL vs. 16.2 mg/dL; p = 0.01). Treatment was well tolerated with no adverse effects dissimilar from placebo. These results suggest that the chromium picolinate/biotin combination, administered as an adjuvant to current prescription anti-diabetic medication, can improve glycaemic control in overweight to obese individuals with type 2 diabetes; especially those patients with poor glycaemic control on oral therapy. 2007 John Wiley & Sons, Ltd

Influence of HbA1c levels on platelet function profiles associated with tight glycemic control in patients presenting with hyperglycemia and an acute coronary syndrome. A subanalysis of the CHIPS Study ("Control de HIperglucemia y Actividad Plaquetaria en Pacientes con Síndrome Coronario Agudo").

PubMed

Vivas, David; García-Rubira, Juan C; Bernardo, Esther; Angiolillo, Dominick J; Martín, Patricia; Calle-Pascual, Alfonso; Núñez-Gil, Iván; Macaya, Carlos; Fernández-Ortiz, Antonio

2013-02-01

Patients with hyperglycemia, an acute coronary syndrome and poor glycemic control have increased platelet reactivity and poor prognosis. However, it is unclear the influence of a tight glycemic control on platelet reactivity in these patients. This is a subanalysis of the CHIPS study. This trial randomized patients with hyperglycemia to undergo an intensive glucose control (target blood glucose 80-120 mg/dL), or conventional glucose control (target blood glucose <180 mg/dL). We analyzed platelet function at discharge on the subgroup of patients with poor glycemic control, defined with admission levels of HbA1c higher than 6.5%. The primary endpoint was maximal platelet aggregation following stimuli with 20 μM ADP. We also measured aggregation following collagen, epinephrine, and thrombin receptor-activated peptide, as well as P2Y12 reactivity index and surface expression of glycoprotein IIb/IIIa and P-selectin. A total of 67 patients presented HbA1c ≥ 6.5% (37 intensive, 30 conventional), while 42 had HbA1c < 6.5% (20 intensive, 22 conventional). There were no differences in baseline characteristics between groups. At discharge, patients with HbA1c ≥6.5% had significantly reduced MPA with intensive glucose control compared with conventional control (46.1 ± 22.3 vs. 60.4 ± 20.0%; p = 0.004). Similar findings were shown with other measures of platelet function. However, glucose control strategy did not affect platelet function parameters in patients with HbA1c < 6.5%. Intensive glucose control in patients presenting with an acute coronary syndrome and hyperglycemia results in a reduction of platelet reactivity only in the presence of elevated HbA1c levels.

The efficacy of black cumin seed (Nigella sativa) oil and hypoglycemic drug combination to reduce HbA1c level in patients with metabolic syndrome risk

NASA Astrophysics Data System (ADS)

Rachman, P. N. R.; Akrom; Darmawan, E.

2017-11-01

Metabolic syndrome is a conditions caused by metabolic abnormalities include central obesity, atherogenic dyslipidemia, hypertension, and insulin resistance. HbA1c examination is required to study the long-term glycemic status and to prevent diabetic complications of metabolic syndrome. The purpose of this study is to determine the efficacy of black cumin seed (Nigella sativa) oil and hypoglycemic drug combination to reduce HbA1c level in patients with metabolic syndrome risk. This research performed using an experimental randomized single - blind controlled trial design. A total of 99 outpatients at the Jetis I Public Health Center, Yogyakarta, Indonesia with metabolic syndrome risk were divided into three groups: The control group received placebo and two treatment groups received black seed oil orally at dose of 1.5 mL/day and 3 mL/day, respectively, for 20 days. The clinical conditions such as blood pressure, pulse rate, BMI, blood glucose serum and HbA1c levels were examined on day 0 and 21. The results obtained were analyzed with one-way ANOVA test. The mean of HbA1c levels of all groups before treatment was higher than the normal values and there was no significant difference in HbA1c value on day 0. Administration of 1.5 and 3 mL/day of black seed oil for 20 days decreased (p<0.05) HbA1c levels. It can be concluded that administration of black cumin seed oil and hypoglycemic drug combination for 20 days in patients at risk of metabolic syndrome may reduce to HbA1c levels.

Oxidized LDL but not total LDL is associated with HbA1c in individuals without diabetes.

PubMed

Spessatto, Débora; Brum, Liz Marina Bueno Dos Passos; Camargo, Joíza Lins

2017-08-01

This study investigates the association between HbA1c, LDL and oxi-LDL in individuals without diabetes (DM). One hundred and ninety-six individuals, without DM, were enrolled and divided into three groups according to HbA1c and fasting plasma glucose values. HbA1c, oxi-LDL, LDL, and other biochemical measurements of lipid profile were also carried out. oxi-LDL levels showed significant differences among all groups and group 3 presented higher values [34U/L (27-46); 44U/L (37-70); and 86U/L (49-136); p<0.001; for groups 1, 2 and 3, respectively]. There was also a significant difference in oxi-LDL/HDL and oxi-LDL/LDL ratios among all groups (p<0.001). There was no significant difference in total cholesterol (TC), triglycerides and LDL values among groups. HbA1c showed moderate positive associations with oxi-LDL (r=0.431; p<0.001), oxi-LDL/HDL ratio (r=0.423, p<0.001), and oxi-LDL/LDL ratio (r=0.359, p<0.001). There were lower associations between HbA1c and TC (r=0.142; p=0.048), triglycerides (r=0.155; p=0.030), LDL (r=0.148; p=0.039), non-HDL (r=0.192; p=0.007) and Apo B (r=0.171, p<0.001). The positive associations between HbA1c and oxi-LDL, oxi-LDL/HDL and oxi-LDL/LDL ratios remained significant even after adjustment by multiple linear regression analysis for the variables alcohol consumption, use of medicine, BMI, and age. oxi-LDL levels are significantly associated with HbA1c in non-diabetic individuals. However, the levels of traditional atherogenic lipids only showed a weak association with HbA1c levels. Those at high risk of developing DM or cardiovascular disease have higher levels of oxi-LDL. These data favor to the use of HbA1c as a biomarker to identify individuals at risk of developing complications even in non-diabetic glycemic levels. Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes.

PubMed

Mathieu, Chantal; Ranetti, Aurelian Emil; Li, Danshi; Ekholm, Ella; Cook, William; Hirshberg, Boaz; Chen, Hungta; Hansen, Lars; Iqbal, Nayyar

2015-11-01

To compare the efficacy and safety of treatment with dapagliflozin versus that with placebo add-on to saxagliptin plus metformin in patients whose type 2 diabetes is inadequately controlled with saxagliptin plus metformin treatment. Patients receiving treatment with stable metformin (stratum A) (screening HbA1c level 8.0-11.5% [64-102 mmol/mol]) or stable metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor (stratum B) (HbA1c 7.5-10.5% [58-91 mmol/mol]) for ≥8 weeks received open-label saxagliptin 5 mg/day and metformin for 16 weeks (stratum A) or 8 weeks (stratum B) (saxagliptin replaced any DPP-4 inhibitor). Patients with inadequate glycemic control (HbA1c 7-10.5% [53-91 mmol/mol]) were randomized to receive placebo or dapagliflozin 10 mg/day plus saxagliptin and metformin. The primary end point was the change in HbA1c from baseline to week 24. Secondary end points included fasting plasma glucose (FPG) level, 2-h postprandial glucose (PPG) level, body weight, and proportion of patients achieving an HbA1c level of <7% (53 mmol/mol). Treatment with dapagliflozin add-on to saxagliptin plus metformin resulted in a greater mean HbA1c reduction than placebo (-0.82 vs. -0.10% [-9 vs. -1.1 mmol/mol], P < 0.0001). Significantly greater reductions in FPG level, 2-h PPG level, and body weight were observed, and more patients achieved an HbA1c level of <7% (53 mmol/mol) with treatment with dapagliflozin versus placebo. Adverse events were similar across treatment groups, with a low overall risk of hypoglycemia (∼1%). Genital infections developed in more patients with dapagliflozin treatment (5%) than with placebo (0.6%). Triple therapy with dapagliflozin add-on to saxagliptin plus metformin improves glycemic control and is well tolerated in patients whose type 2 diabetes is inadequately controlled with saxagliptin plus metformin therapy. © 2015 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.

Longitudinal Trajectories of Metabolic Control From Childhood to Young Adulthood in Type 1 Diabetes From a Large German/Austrian Registry: A Group-Based Modeling Approach.

PubMed

Schwandt, Anke; Hermann, Julia M; Rosenbauer, Joachim; Boettcher, Claudia; Dunstheimer, Désirée; Grulich-Henn, Jürgen; Kuss, Oliver; Rami-Merhar, Birgit; Vogel, Christian; Holl, Reinhard W

2017-03-01

Worsening of glycemic control in type 1 diabetes during puberty is a common observation. However, HbA 1c remains stable or even improves for some youths. The aim is to identify distinct patterns of glycemic control in type 1 diabetes from childhood to young adulthood. A total of 6,433 patients with type 1 diabetes were selected from the prospective, multicenter diabetes patient registry Diabetes-Patienten-Verlaufsdokumentation (DPV) (follow-up from age 8 to 19 years, baseline diabetes duration ≥2 years, HbA 1c aggregated per year of life). We used latent class growth modeling as the trajectory approach to determine distinct subgroups following a similar trajectory for HbA 1c over time. Five distinct longitudinal trajectories of HbA 1c were determined, comprising group 1 = 40%, group 2 = 27%, group 3 = 15%, group 4 = 13%, and group 5 = 5% of patients. Groups 1-3 indicated stable glycemic control at different HbA 1c levels. At baseline, similar HbA 1c was observed in group 1 and group 4, but HbA 1c deteriorated in group 4 from age 8 to 19 years. Similar patterns were present in group 3 and group 5. We observed differences in self-monitoring of blood glucose, insulin therapy, daily insulin dose, physical activity, BMI SD score, body-height SD score, and migration background across all HbA 1c trajectories (all P ≤ 0.001). No sex differences were present. Comparing groups with similar initial HbA 1c but different patterns, groups with higher HbA 1c increase were characterized by lower frequency of self-monitoring of blood glucose and physical activity and reduced height (all P < 0.01). Using a trajectory approach, we determined five distinct longitudinal patterns of glycemic control from childhood to early adulthood. Diabetes self-care, treatment differences, and demographics were related to different HbA 1c courses. © 2017 by the American Diabetes Association.

Association of fibrinogen with HbA1C in diabetic foot ulcer

NASA Astrophysics Data System (ADS)

Pase, M. A.; Gatot, D.; Lindarto, D.

2018-03-01

Fibrinogen is one of the inflammatory markers of vascular changes and endothelial dysfunction in diabetic patients. The aim of this study to associate serum fibrinogen levels with HbA1C in diabetic foot ulcer (DFU). This study was cross-sectional and retrospective in DFU patients from January to July 2017 in Haji Adam Malik Central General Hospital. The patients enrolled in the study were T2DM with DFU as a complication. The grading of DFU was evaluated according to the Wagner’s Classification. Serum fibrinogen level, HbA1C and ankle-brachial index (ABI) were carried out directly in the patients. Fibrinogen serum levels were found significantly with HbA1C (P=0.001, r=0.387) and ABI (P=0.008, r=-0.454). Fibrinogen serum levels in DFU patients were positively correlated with HbA1C and significantly higher in patients with poor glycemic control.

The 1-hour post-load glucose level is more effective than HbA1c for screening dysglycemia.

PubMed

Jagannathan, Ram; Sevick, Mary Ann; Fink, Dorothy; Dankner, Rachel; Chetrit, Angela; Roth, Jesse; Buysschaert, Martin; Bergman, Michael

2016-08-01

To assess the performance of HbA1c and the 1-h plasma glucose (PG ≥ 155 mg/dl; 8.6 mmol/l) in identifying dysglycemia based on the oral glucose tolerance test (OGTT) from a real-world clinical care setting. This was a diagnostic test accuracy study. For this analysis, we tested the HbA1c diagnostic criteria advocated by the American Diabetes Association (ADA 5.7-6.4 %) and International Expert Committee (IEC 6.0-6.4 %) against conventional OGTT criteria. We also tested the utility of 1-h PG ≥ mg/dl; 8.6 mmol/l. Prediabetes was defined according to ADA-OGTT guidelines. Spearman correlation tests were used to determine the relationships between HbA1c, 1-h PG with fasting, 2-h PG and indices of insulin sensitivity and β-cell function. The levels of agreement between diagnostic methods were ascertained using Cohen's kappa coefficient (Κ). Receiver operating characteristic (ROC) curve was used to analyze the performance of the HbA1c and 1-h PG test in identifying prediabetes considering OGTT as reference diagnostic criteria. The diagnostic properties of different HbA1c thresholds were contrasted by determining sensitivity, specificity and likelihood ratios (LR). Of the 212 high-risk individuals, 70 (33 %) were identified with prediabetes, and 1-h PG showed a stronger association with 2-h PG, insulin sensitivity index, and β-cell function than HbA1c (P < 0.05). Furthermore, the level of agreement between 1-h PG ≥ 155 mg/dl (8.6 mmol/l) and the OGTT (Κ[95 % CI]: 0.40[0.28-0.53]) diagnostic test was stronger than that of ADA-HbA1c criteria 0.1[0.03-0.16] and IEC criteria (0.17[0.04-0.30]). The ROC (AUC[95 % CI]) for HbA1c and 1-h PG were 0.65[0.57-0.73] and 0.79[0.72-0.85], respectively. Importantly, 1-h PG ≥ 155 mg/dl (8.6 mmol/l) showed good sensitivity (74.3 % [62.4-84.0]) and specificity 69.7 % [61.5-77.1]) with a LR of 2.45. The ability of 1-h PG to discriminate prediabetes was better than that of HbA1c (∆AUC: -0.14; Z value: 2.5683; P = 0.01022). In a real-world clinical practice setting, the 1-h PG ≥ 155 mg/dl (8.6 mmol/l) is superior for detecting high-risk individuals compared with HbA1c. Furthermore, HbA1c is a less precise correlate of insulin sensitivity and β-cell function than the 1-h PG and correlates poorly with the 2-h PG during the OGTT.

Comparison of the Current Diagnostic Criterion of HbA1c with Fasting and 2-Hour Plasma Glucose Concentration

PubMed Central

Karnchanasorn, Rudruidee; Huang, Jean; Feng, Wei; Chuang, Lee-Ming

2016-01-01

To determine the effectiveness of hemoglobin A1c (HbA1c) ≥ 6.5% in diagnosing diabetes compared to fasting plasma glucose (FPG) ≥ 126 mg/dL and 2-hour plasma glucose (2hPG) ≥ 200 mg/dL in a previously undiagnosed diabetic cohort, we included 5,764 adult subjects without established diabetes for whom HbA1c, FPG, 2hPG, and BMI measurements were collected. Compared to the FPG criterion, the sensitivity of HbA1c ≥ 6.5% was only 43.3% (106 subjects). Compared to the 2hPG criterion, the sensitivity of HbA1c ≥ 6.5% was only 28.1% (110 subjects). Patients who were diabetic using 2hPG criterion but had HbA1c < 6.5% were more likely to be older (64 ± 15 versus 60 ± 15 years old, P = 0.01, mean ± STD), female (53.2% versus 38.2%, P = 0.008), leaner (29.7 ± 6.1 versus 33.0 ± 6.6 kg/m2, P = 0.000005), and less likely to be current smokers (18.1% versus 29.1%, P = 0.02) as compared to those with HbA1c ≥ 6.5%. The diagnostic agreement in the clinical setting revealed the current HbA1c ≥ 6.5% is less likely to detect diabetes than those defined by FPG and 2hPG. HbA1c ≥ 6.5% detects less than 50% of diabetic patients defined by FPG and less than 30% of diabetic patients defined by 2hPG. When the diagnosis of diabetes is in doubt by HbA1c, FPG and/or 2hPG should be obtained. PMID:27597979

Hemoglobin glycation index as a useful predictor of therapeutic responses to dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes

PubMed Central

Chen, Yu-Wei; Wang, Jun-Sing; Sheu, Wayne H-H; Lin, Shih-Yi; Lee, I-Te; Song, Yuh-Min; Fu, Chia-Po; Lee, Chia-Lin

2017-01-01

Introduction A high hemoglobin glycation index (HGI) and glycated hemoglobin (HbA1c) level are associated with greater inflammatory status, and dipeptidyl peptidase-4 (DPP-4) inhibitors can suppress inflammation. We aimed to evaluate the relationship between HGI and the therapeutic effect of DPP-4 inhibitors. Methods This retrospective cohort study followed 468 patients with type 2 diabetes receiving DPP-4 inhibitor treatment for 1 year. Estimated HbA1c was calculated using a linear regression equation derived from another 2969 randomly extracted patients with type 2 diabetes based on fasting plasma glucose (FPG) level. The subjects were divided into two groups based on HGI (HGI = observed HbA1c - estimated HbA1c). Mixed model repeated measures were used to compare the treatment efficacy after 1 year in patients with a low (HGI<0, n = 199) and high HGI (HGI≧0, n = 269). Results There were no significant group differences in mean changes of FPG after 1 year (-12.8 and -13.4 mg/dL in the low and high HGI groups, respectively). However, the patients with a high HGI had a significantly greater reduction in HbA1c from baseline compared to those with a low HGI (-1.9 versus -0.3% [-20.8 versus -3.3 mmol/mol]). Improvements in glycemic control were statistically significantly associated with the tested DPP-4 inhibitors in the high HGI group (-2.4, -1.4, -1.2 and -2.2% [-26.2, -15.3, -13.1 and -24.0 mmol/mol] for vildagliptin, linagliptin, saxagliptin and sitagliptin, respectively) but not in the low HGI group. Conclusions The HGI index derived from FPG and HbA1c may be able to identify who will have a better response to DPP-4 inhibitors. PMID:28182722

A study assessing the association of glycated hemoglobin A1C (HbA1C) associated variants with HbA1C, chronic kidney disease and diabetic retinopathy in populations of Asian ancestry.

PubMed

Chen, Peng; Ong, Rick Twee-Hee; Tay, Wan-Ting; Sim, Xueling; Ali, Mohammad; Xu, Haiyan; Suo, Chen; Liu, Jianjun; Chia, Kee-Seng; Vithana, Eranga; Young, Terri L; Aung, Tin; Lim, Wei-Yen; Khor, Chiea-Chuen; Cheng, Ching-Yu; Wong, Tien-Yin; Teo, Yik-Ying; Tai, E-Shyong

2013-01-01

Glycated hemoglobin A1C (HbA1C) level is used as a diagnostic marker for diabetes mellitus and a predictor of diabetes associated complications. Genome-wide association studies have identified genetic variants associated with HbA1C level. Most of these studies have been conducted in populations of European ancestry. Here we report the findings from a meta-analysis of genome-wide association studies of HbA1C levels in 6,682 non-diabetic subjects of Chinese, Malay and South Asian ancestries. We also sought to examine the associations between HbA1C associated SNPs and microvascular complications associated with diabetes mellitus, namely chronic kidney disease and retinopathy. A cluster of 6 SNPs on chromosome 17 showed an association with HbA1C which achieved genome-wide significance in the Malays but not in Chinese and Asian Indians. No other variants achieved genome-wide significance in the individual studies or in the meta-analysis. When we investigated the reproducibility of the findings that emerged from the European studies, six loci out of fifteen were found to be associated with HbA1C with effect sizes similar to those reported in the populations of European ancestry and P-value ≤ 0.05. No convincing associations with chronic kidney disease and retinopathy were identified in this study.

A Study Assessing the Association of Glycated Hemoglobin A1C (HbA1C) Associated Variants with HbA1C, Chronic Kidney Disease and Diabetic Retinopathy in Populations of Asian Ancestry

PubMed Central

Chen, Peng; Ong, Rick Twee-Hee; Tay, Wan-Ting; Sim, Xueling; Ali, Mohammad; Xu, Haiyan; Suo, Chen; Liu, Jianjun; Chia, Kee-Seng; Vithana, Eranga; Young, Terri L.; Aung, Tin; Lim, Wei-Yen; Khor, Chiea-Chuen; Cheng, Ching-Yu; Wong, Tien-Yin; Teo, Yik-Ying; Tai, E-Shyong

2013-01-01

Glycated hemoglobin A1C (HbA1C) level is used as a diagnostic marker for diabetes mellitus and a predictor of diabetes associated complications. Genome-wide association studies have identified genetic variants associated with HbA1C level. Most of these studies have been conducted in populations of European ancestry. Here we report the findings from a meta-analysis of genome-wide association studies of HbA1C levels in 6,682 non-diabetic subjects of Chinese, Malay and South Asian ancestries. We also sought to examine the associations between HbA1C associated SNPs and microvascular complications associated with diabetes mellitus, namely chronic kidney disease and retinopathy. A cluster of 6 SNPs on chromosome 17 showed an association with HbA1C which achieved genome-wide significance in the Malays but not in Chinese and Asian Indians. No other variants achieved genome-wide significance in the individual studies or in the meta-analysis. When we investigated the reproducibility of the findings that emerged from the European studies, six loci out of fifteen were found to be associated with HbA1C with effect sizes similar to those reported in the populations of European ancestry and P-value ≤ 0.05. No convincing associations with chronic kidney disease and retinopathy were identified in this study. PMID:24244560

Regional variations in frequency of glycosylated hemoglobin (HbA1c) monitoring in Korea: A multilevel analysis of nationwide data.

PubMed

Yoo, Kyoung-Hun; Shin, Dong-Wook; Cho, Mi-Hee; Kim, Sang-Hyuck; Bahk, Hyun-Jung; Kim, Shin-Hye; Jeong, Su-Min; Yun, Jae-Moon; Park, Jin-Ho; Kim, Heesun; Cho, BeLong

2017-09-01

Suboptimal frequency of glycosylated hemoglobin (HbA1c) monitoring is associated with poor diabetes control. We aimed to analyze compliance to HbA1c testing guidelines and explore associated individual and area-level determinants, focusing on regional variation. This cross-sectional study between the period of 2012-2013 was conducted by using the Korean National Health Insurance Research Database, and included 45,634 patients diagnosed with diabetes mellitus, who were prescribed any anti-diabetic medications, including insulin. We calculated the proportion of each HbA1c testing frequency (≥1, ≥2, or ≥4 times per year) stratified by 17 administrative regions. Multilevel and multivariate logistic analyses were performed with regional (proportion of farmer population) and individual characteristics (age, sex, income level, duration of diabetes, and most visited medical institution). Overall, 67.3% of the patients received≥1 HbA1c test per year; 37.8% and 6.1% received ≥2 and ≥4 tests per year, respectively. Those managed in secondary-level hospitals or clinics and those living in rural areas were less likely to receive HbA1c testing. Even after adjusting for individual and regional level characteristics, significant area level variation was observed (variance participant coefficients were 7.91%, 9.58%, and 14.43% for testing frequencies of ≥1, ≥2, and ≥4 times a year, respectively). The frequency of HbA1c monitoring is suboptimal in Korea, especially in rural areas. Moreover, significant regional variation was observed, implying a contextual effect. This suggests the need for developing policy actions to improve HbA1c monitoring. In particular, access to HbA1c testing in rural primary care clinics must be improved. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study.

PubMed

Madsbad, S; Kilhovd, B; Lager, I; Mustajoki, P; Dejgaard, A

2001-05-01

To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. Changes in fasting blood glucose (FBG) and HbA1c during the 12 months of treatment showed a significant difference in favour of repaglinide. In oral hypoglycaemic agents (OHA)-naive patients, HbA1c decreased in the repaglinide and glipizide groups by 1.5% and 0.3%, respectively (P < 0.05 between groups). Fasting blood glucose decreased in the repaglinide group by 2.4 mmol/l and increased in the glipizide group by 1.0 mmol/l (P < 0.05 between groups). In the study population as a whole, repaglinide was able to maintain glycaemic control (HbA1c level) during the 1-year study period, whereas control deteriorated significantly with glipizide. Change in HbA1c from baseline was significantly better with repaglinide than with glipizide after 12 months (P < 0.05). In addition, FBG deteriorated significantly in the glipizide group compared with the repaglinide group (P < 0.05). No patients in either group experienced a major hypoglycaemic event; the number of patients experiencing minor hypoglycaemia was similar in the repaglinide and glipizide groups (15% and 19%, respectively). Repaglinide, given as a prandial glucose regulator, is shown to be an effective and safe treatment of patients with Type 2 diabetes, and is better than glipizide in controlling HbA1c and FBG levels, overall, and in OHA-naive patients.

Relationship between glycaemic levels and arterial stiffness in non-diabetic adults.

PubMed

Cavero-Redondo, Iván; Martínez-Vizcaíno, Vicente; Álvarez-Bueno, Celia; Recio-Rodríguez, José Ignacio; Gómez-Marcos, Manuel Ángel; García-Ortiz, Luis

2018-01-23

To examine, in a non-diabetic population, whether the association between arterial stiffness and glycaemic levels depends on the test used as a glycaemic indicator, fasting plasma glucose (FPG) or glycated haemoglobin A1c (HbA1c). A cross-sectional analysis of a 220 non-diabetic subsample from the EVIDENT II study in which FPG, HbA1c and arterial stiffness-related parameters (pulse wave velocity, radial and central augmentation index, and central pulse pressure) were determined. Mean differences in arterial stiffness-related parameters by HbA1c and FPG tertiles were tested using analysis of covariance. All means of arterial stiffness-related parameters increased by HbA1c tertiles, although mean differences were only statistically significant in pulse wave velocity (p ≤.001), even after controlling for potential confounders (HbA1c <5.30% = 6.88 m/s; HbA1c 5.30%-5.59% = 7.06 m/s; and HbA1c ≥5.60% = 8.16 m/s, p =.004). Conversely, mean differences in pulse wave velocity by FPG tertiles did not reach statistically significant differences after controlling for potential confounders (FPG 4.44 mmol/l = 7.18 m/s; FPG 4.44 mmol/l-4.87 mmol/l = 7.26 m/s; and FPG ≥4.88 mmol/l = 7.93 m/s, p =.066). Glucose levels in a non-diabetic population were associated with arterial stiffness but better when levels were determined using HbA1c. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

How does CKD affect HbA1c?

PubMed

Bloomgarden, Zachary; Handelsman, Yehuda

2018-04-01

HOW DOES CHRONIC KIDNEY DISEASE AFFECT HBA1C?: A number of factors determine HbA1c other than the level of glucose exposure alone. In an subset analysis of the Atherosclerosis Risk in Communities study of 941 diabetic people with varying degrees of chronic kidney disease (CKD), as well as 724 who did not have CKD, and mean age in the eighth decade, Jung et al. ask whether HbA1c is reliable as an indicator of glycemia in people with kidney disease (CKD) to the same degree as in those not having kidney disease, and, if not, whether measures of glycated serum proteins may be more useful. The only available measure of glycemia for comparison was a single fasting glucose level, and the authors acknowledge that this gives an incomplete measure, particularly in people with relatively mild diabetes, whose mean HbA1c was 6.4%, with most having levels of 7.5% or lower. In patients of this sort, postprandial glucose levels may better explain variations in mean HbA1c. Recognizing that the dataset may be limited, Jung et al. nevertheless give an intriguingly negative answer to the first question, of the reliability of HbA1c with kidney disease. Using Deming regression analysis, Jung et al. showed that the correlation between HbA1c and fasting glucose weakens as renal function worsens, and, moreover, that this appears particularly to be the case in people with anemia (hemoglobin <130 and <120 g/L for men and women, respectively), confirming earlier observations. Among those diabetic people with neither anemia nor CKD, the correlation coefficient between HbA1c and fasting glucose was r = 0.70, compared with r = 0.35 among those with both anemia and very severe CKD (estimated glomerular filtration rate [eGFR] <30 or <45 mL/min per 1.73 m 2 with at least microalbuminuria, or eGFR <60 mL/min per 1.73 m 2 with macroalbuminuria). As far as the second question, of whether the alternative measures, namely fructosamine and glycated albumin, may be more useful with CKD, Jung et al. found that these parameters are equally flawed with CKD. Intriguingly, this suggests that anemia affects indirect measures of glycemic exposure not only by its association with more rapid erythrocyte turnover, but, more generally, also as a marker of a catabolic state with altered plasma protein turnover. How, then, should we assess a given diabetic person's degree of glycemic control in the presence of CKD (or of anemia, which, per Jung et al., was, even without CKD, also associated with a reduction in the correlation between HbA1c and fasting glucose)? Jung et al. suggest the use of continuous glucose monitoring to estimate average glucose. Although becoming recognized as an important tool, this technology is not as generally available as the simpler self-monitoring of blood glucose (SMBG). In an earlier analysis of potential complexities of HbA1c as a measure of glycemic exposure, we showed that self-monitored plasma glucose profiles suggest that approximately 10% of individuals with diabetes have HbA1c substantially above and another 10% have HbA1c substantially below those that may be anticipated based on mean glucose levels. In clinical practice, then, we should consider encouraging older people with diabetes and CKD to perform SMBG to more adequately interpret HbA1c results. © 2017 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

[Relationship between brachial-ankle pulse wave velocity and glycemic control of type 2 diabetes mellitus patients in Beijing community population].

PubMed

Sun, Ke-xin; Liu, Zhi-ke; Cao, Ya-ying; Juan, Juan; Xiang, Xiao; Yang, Cheng; Huang, Shao-ping; Liu, Xiao-fen; Li, Na; Tang, Xun; Li, Jin; Wu, Tao; Chen, Da-fang; Hu, Yong-hua

2015-06-18

To explore the correlation between glycemic control of type 2 diabetes mellitus (T2DM) patients and brachial-ankle pulse velocity (baPWV). A community-based cross-sectional study was conducted in Beijing, China. Every subject underwent physical examinations, glycated hemoglobin (HbA1c), blood lipid and baPWV measurements and completed a standardized questionnaire. T2DM patients were divided into well controlled and poorly controlled groups according to HbA1c levels. The correlation between glycemic control of T2DM patients and baPWV was analyzed. In this study, 1 341 subjects were recruited, including 733 T2DM patients and 608 non-diabetes subjects. Compared with non-diabetes subjects, abnormal baPWV (baPWV≥1 700 cm/s) rate for T2DM patients was higher (40.8% vs. 26.8%, P<0.001). With HbA1c<6.5% or <7.0% as the aim of glycemic control in T2DM patients, the abnormal baPWV rates for non-diabetes subjects, well controlled and poorly controlled T2DM patients were significantly different (non-diabetes vs. HbA1c<6.5% T2DM vs. HbA1c≥6.5% T2DM: 26.8% vs. 32.8% vs. 42.6%, P<0.001; non-diabetes vs. HbA1c<7.0% T2DM vs. HbA1c≥7.0% T2DM: 26.8% vs. 36.1% vs. 43.4%, P<0.001). After being adjusted for gender, age, smoking status, diabetes mellitus family history, T2DM duration, cardiovascular diseases (CVD), waist hip ratio (WHR), systolic blood pressure (SBP), diastolic blood pressure (DBP), total triglycerides (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C), the Logistic regression models suggested that glycemic control status of T2DM patients was associated with abnormal baPWV. Compared with non-diabetes subjects, the ORs for abnormal baPWV in HbA1c<6.5% T2DM patients and HbA1c≥6.5% T2DM patients were 0.927(95%CI 0.560-1.537) and 1.826 (95%CI 1.287-2.591). Compared with non-diabetes subjects, the ORs for abnormal baPWV in HbA1c<7.0% T2DM patients and HbA1c≥7.0% T2DM patients were 1.210 (95%CI 0.808-1.811) and 1.898 (95%CI 1.313-2.745). The glycemic control status of T2DM patients from communities is significantly associated with baPWV. Poor glycemic control is a risk factor for abnormal baPWV. Keeping HbA1c under control might lower the risk of cardiovascular diseases in T2DM patients.

Measurement of HbA1c in Gingival Crevicular Blood Using a High-Pressure Liquid Chromatography Procedure.

PubMed

Pesce, Michael A; Strauss, Shiela M; Rosedale, Mary; Netterwald, Jane; Wang, Hangli

2015-01-01

To validate an ion exchange high-pressure liquid chromatography (HPLC) method for measuring glycated hemoglobin (HbA1c) in gingival crevicular blood (GCB) spotted on filter paper, for use in screening dental patients for diabetes. We collected the GCB specimens for this study from the oral cavities of patients during dental visits, using rigorous strategies to obtain GCB that was as free of debris as possible. The analytical performance of the HPLC method was determined by measuring the precision, linearity, carryover, stability of HbA1c in GCB, and correlation of HbA1c results in GCB specimens with finger-stick blood (FSB) specimens spotted on filter paper. The coefficients of variation (CVs) for the inter- and intrarun precision of the method were less than 2.0%. Linearity ranged between 4.2% and 12.4%; carryover was less than 2.0%, and the stability of the specimen was 6 days at 4°C and as many as 14 days at -70°C. Linear regression analysis comparing the HbA1c results in GCB with FSB yielded a correlation coefficient of 0.993, a slope of 0.981, and an intercept of 0.13. The Bland-Altman plot showed no difference in the HbA1c results from the GCB and FSB specimens at normal, prediabetes, and diabetes HbA1c levels. We validated an HPLC method for measuring HbA1c in GCB; this method can be used to screen dental patients for diabetes. Copyright© by the American Society for Clinical Pathology (ASCP).

[Association between smoking/smoking cessation and glycemic control in male patients with type 2 diabetes].

PubMed

Su, J; Qin, Y; Shen, C; Gao, Y; Pan, E C; Pan, X Q; Tao, R; Zhang, Y Q; Wu, M

2017-11-10

Objective: To explore the association of smoking and smoking cessation with glycemic control in male patients with type 2 diabetes. Methods: From December 2013 to January 2014, a total of 7 763 male patients with type 2 diabetes, who received national basic public health service in Changshu county of Suzhou city, Huai'an and Qinghe districts of Huai'an city, Jiangsu province, were recruited by cluster sampling. Questionnaire survey and anthropometric measurements were conducted, and fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) levels were measured. Multiple linear regression model was used to evaluate the association of smoking and smoking cessation with glycemic control. Results: The prevalence of current smoking was 45.5% in male patients with type 2 diabetes. The levels of FPG and HbA1c increased with number of cigarettes smoked per day compared with non-smokers ( P <0.001). Among patients with drug treatment, the average increase of HbA1c level in current smokers with smoking duration ≥30 years and smoking index ≥40 pack-years were 0.27% (95 %CI : 0.05%-0.49%) and 0.38% (95 %CI : 0.23%-0.53%), respectively. FPG and HbA1c level decreased obviously with smoking cessation years among former smokers ( P <0.05). Among the patients receiving no drug treatment, no dose-response relationships were observed between smoking duration, smoking cessation years and levels of FPG and HbA1c. Conclusion: Cigarette smoking was negatively related with glycemic control in male type 2 diabetes patients, especially in patients with drug treatment. Smoking cessation may be beneficial for glycemic control. Smoking cessation should be encouraged for diabetes patients as early as possible.

Predictive ability of visit-to-visit variability in HbA1c and systolic blood pressure for the development of microalbuminuria and retinopathy in people with type 2 diabetes.

PubMed

Takao, Toshiko; Suka, Machi; Yanagisawa, Hiroyuki; Matsuyama, Yutaka; Iwamoto, Yasuhiko

2017-06-01

We explored whether visit-to-visit variability in both glycated hemoglobin (HbA1c) and systolic blood pressure (SBP) simultaneously predicted the development of microalbuminuria and retinopathy, and whether the predictive ability of these measurements changed according to mean HbA1c and SBP levels in people with type 2 diabetes. A retrospective observational cohort study was conducted on 243 type 2 diabetes patients with normoalbuminuria and 486 without retinopathy at the first visit and within 1year thereafter. The two cohorts were followed up from 1995 until 2012. Multivariate and stratified analyses were performed using Cox proportional hazard models. Microalbuminuria developed in 84 patients and retinopathy in 108. Hazard ratios (HRs) for the development of microalbuminuria associated with the coefficient of variation (CV) and variation independent of mean (VIM) of both HbA1c and SBP significantly increased. In participants with a mean SBP <130mmHg, the HRs for the development of retinopathy associated with CV and VIM of HbA1c were abruptly elevated and significant compared with those with a mean SBP ≥130mmHg. Visit-to-visit variability in both HbA1c and SBP simultaneously predict the development of microalbuminuria. HbA1c variability may predict the development of retinopathy when the mean SBP is normal (<130mmHg). Copyright © 2017 Elsevier B.V. All rights reserved.

Limited Effectiveness of Diabetes Risk Assessment Tools in Seniors' Facility Residents.

PubMed

Featherstone, Travis; Eurich, Dean T; Simpson, Scot H

2017-03-01

Undiagnosed diabetes can create significant management issues for seniors. To evaluate the effectiveness of two diabetes risk surveys-the Canadian Diabetes Risk Assessment Questionnaire (CANRISK) and the Finnish Diabetes Risk Score (FINDRISC)-to identify elevated blood glucose levels in seniors. A cross-sectional study was conducted in senior living facilities in Edmonton, Alberta, Canada. Those with known diabetes, without capacity, considered frail, or unable to communicate in English were excluded. Participants completed the CANRISK and FINDRISC surveys and had their glycated hemoglobin A 1c (HbA 1c ) measured. Correlations between seniors with elevated risk on the surveys and an HbA 1c value of 6.5% or higher or 6.0% and higher were assessed. In this study, 290 residents participated; their mean age was 84.3 ± 7.3 years, 82 (28%) were men, and their mean HbA 1c level was 5.7% ± 0.4%. Mean CANRISK score was 29.4 ± 8.0, and of the 254 (88%) considered to be moderate or high risk, 10 (4%) had an HbA 1c level of 6.5% or higher and 49 (19%) had an HbA 1c level of 6.0% or higher. Mean FINDRISC score was 10.8 ± 4.2, and of the 58 (20%) considered to be high or very high risk, 4 (7%) had an HbA 1c level of 6.5% or higher and 15 (26%) had an HbA 1c level of 6.0% or higher. The area under the receiver-operating characteristic curve was 0.57 (95% confidence interval 0.42-0.72) for the CANRISK survey identifying participants with an HbA 1c level of 6.5% or higher and 0.59 (95% confidence interval 0.51-0.67) for identifying participants with an HbA 1c level of 6.0% or higher. Similar characteristics were observed for the FINDRISC survey. In this group of seniors with no known diabetes history, mean HbA 1c level approximated that in the general population and neither survey effectively identified those with elevated blood glucose levels. These findings should be confirmed in a larger study; nevertheless, routine use of these surveys as a diabetes screening strategy does not appear to be warranted at this time. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Sense of coherence, self-esteem, and health locus of control in subjects with type 1 diabetes mellitus with/without satisfactory metabolic control.

PubMed

Nuccitelli, C; Valentini, A; Caletti, M T; Caselli, C; Mazzella, N; Forlani, G; Marchesini, G

2018-03-01

Despite intensive training, a few individuals with Type 1 diabetes mellitus (T1DM) fail to reach the desired metabolic targets. To evaluate the association between disease-related emotional and cognitive aspects and metabolic control in subjects with T1DM. Health locus of control (HLOC), sense of coherence (SOC), and self-esteem were assessed in T1DM subjects using validated questionnaires. Sixty-seven consecutive subjects who did not attain the desired HbA1c target (mean HbA1c, 8.3% [67 mmol/mol]) were compared with 30 cases in satisfactory metabolic control (HbA1c levels <7%-53 mmol/mol). In the overall population, SOC was negatively associated with BMI and average HbA1c, as was the association of self-esteem with HbA1c. Subjects attaining the desired metabolic target were characterized by higher SOC scores, higher Internal HLOC and prevalent Internal vs. Powerful-others HLOC. Compared to subjects in good metabolic control, subjects with unsatisfactory control had lower scores of SOC, Internal HLOC and Self-esteem, with no difference in Powerful others, or Chance HLOC. In the same group, SOC in the upper tertile was significantly associated with self-esteem (OR 1.35; 95% CI 1.08-1.69) and PHLOC (OR 1.24; 95% CI 1.03-1.49), after adjustment for age, sex, educational level, and comorbidities. Patients who fail to reach a satisfactory metabolic control tend to rely on significant others, trusting in the physicians' skills or on the efficiency of the health-care system. Strategies aimed at increasing self-efficacy and SOC, based on personal ability, are eagerly awaited to help patients improve diabetes care.

Glycaemic responses in Asian and non-Asian people with type 2 diabetes initiating insulin glargine 100 units/mL: A patient-level pooled analysis of 16 randomised controlled trials.

PubMed

Chan, Juliana C N; Bunnag, Pongamorn; Chan, Siew P; Tan, Iris T I; Tsai, Shih-Tzer; Gao, Ling; Landgraf, Wolfgang

2018-01-01

To compare outcomes between Asian and non-Asian patients with type 2 diabetes (T2D) inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin glargine 100 units (U)/mL (Gla-100) in randomised controlled clinical trials. Post hoc analysis of patient-level data (Asian n = 235; non-Asian n = 3351) from 16 trials. At baseline, Asian patients were younger with lower body mass index (BMI), fasting C-peptide, and fasting plasma glucose (FPG) than non-Asian patients (all P < .001). Asian patients had a higher mean glycosylated haemoglobin (HbA1c) at Week 24 and less reduction in HbA1c from baseline (7.4% vs. 7.2%; -1.3% vs. -1.6%, respectively; P = .0001), and were less likely to achieve HbA1c <7.0% (40% vs. 47%; P = .002) than non-Asian patients. Reductions in FPG and rates of hypoglycaemia were similar between Asian and non-Asian patients. Asian patients had less weight gain than non-Asian patients (+1.3 vs. +1.9 kg, respectively, P = .013). In our post hoc meta-analysis, Gla-100 effectively lowers HbA1c and FPG in Asian patients with T2D uncontrolled on OADs with similar incidence of hypoglycaemia and less absolute weight gain compared with non-Asian patients. At a similar FPG reduction, fewer Asian patients achieved HbA1c target <7.0%, suggesting that prandial glucose needs to be addressed. Copyright © 2017. Published by Elsevier B.V.

Benchmarking by HbA1c in a national diabetes quality register--does measurement bias matter?

PubMed

Carlsen, Siri; Thue, Geir; Cooper, John Graham; Røraas, Thomas; Gøransson, Lasse Gunnar; Løvaas, Karianne; Sandberg, Sverre

2015-08-01

Bias in HbA1c measurement could give a wrong impression of the standard of care when benchmarking diabetes care. The aim of this study was to evaluate how measurement bias in HbA1c results may influence the benchmarking process performed by a national diabetes register. Using data from 2012 from the Norwegian Diabetes Register for Adults, we included HbA1c results from 3584 patients with type 1 diabetes attending 13 hospital clinics, and 1366 patients with type 2 diabetes attending 18 GP offices. Correction factors for HbA1c were obtained by comparing the results of the hospital laboratories'/GP offices' external quality assurance scheme with the target value from a reference method. Compared with the uncorrected yearly median HbA1c values for hospital clinics and GP offices, EQA corrected HbA1c values were within ±0.2% (2 mmol/mol) for all but one hospital clinic whose value was reduced by 0.4% (4 mmol/mol). Three hospital clinics reduced the proportion of patients with poor glycemic control, one by 9% and two by 4%. For most participants in our study, correcting for measurement bias had little effect on the yearly median HbA1c value or the percentage of patients achieving glycemic goals. However, at three hospital clinics correcting for measurement bias had an important effect on HbA1c benchmarking results especially with regard to percentages of patients achieving glycemic targets. The analytical quality of HbA1c should be taken into account when comparing benchmarking results.

Impact of baseline body mass index status on glucose lowering and weight change during sitagliptin treatment for type 2 diabetics.

PubMed

Chen, Jung-Fu; Chang, Chih-Min; Kuo, Ming-Chun; Tung, Shih-Chen; Tsao, Cheng-Feng; Tsai, Chia-Jen

2016-10-01

This study was designed to evaluate the efficacy of sitagliptin in Taiwanese diabetic subjects with different baseline BMI status. This was a single-center, hospital-based, retrospective chart review in subjects (n=1874) with type 2 diabetes who received sitagliptin. Subjects were classified into subgroups depending upon their baseline BMI by Taiwan national weight classification: normal (BMI<24kg/m(2)) (n=504), overweight (BMI: 24-27kg/m(2)) (n=615), and obese (BMI⩾27kg/m(2)) (n=755). Changes in HbA1c and weight were evaluated over a 12month treatment period. For all three groups, the HbA1c levels declined over the first three months by about 8%, and subsequently plateaued for the next nine months. Obese subjects were slower in reducing HbA1c compared with normal and overweight subjects (P<0.05), but at nine months the reduction was similar across groups. Mean body weight increased over the first nine months of sitagliptin therapy in subjects with normal BMI (57.12-58.30kg), but there was no change in mean body weight in the overweight group. After three months the obese groups had significantly greater loss in body weight compared with the normal group. Baseline BMI status may influence the reduction of HbA1c levels within the first six months of sitagliptin therapy and affect weight change after three months. Being obese was associated with an initial lag in HbA1c reduction and greater weight loss compared with normal and overweight subjects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Physical Activity Throughout Adolescence and Hba1c in Early Adulthood: Birth Cohort Study.

PubMed

Nakamura, Priscila M; Mielke, Grégore I; Horta, Bernardo L; Assunção, Maria Cecília; Gonçalves, Helen; Menezes, Ana M B; Barros, Fernando C; Ekelund, Ulf; Brage, Soren; Wehrmeister, Fernando C; Oliveira, Isabel O; Hallal, Pedro C

2017-05-01

Physical inactivity is responsible for 7% of diabetes deaths worldwide, but little is known whether low levels of physical activity (PA) during adolescence increase the risk of diabetes in early adulthood. We evaluated the cross-sectional and longitudinal associations between PA throughout adolescence and HbA1c concentration in early adulthood. HbA1c was measured by high performance liquid chromatography. PA was assessed by self-report at the ages of 11, 15, and 18 years and by accelerometry at the ages of 13 (subsample) and 18 years. The loss percentages of follow up were 12.5% at 11 years, 14.4% at 15 years, and 18.7% at 18 years. At 18 years, boys showed higher HbA1c than girls. At age 18 years, accelerometrybased PA at 18 years was inversely related to HbA1c levels in boys. Self-reported leisure-time PA at ages 11, 15, and 18 were unrelated to HbA1c in both genders. PA at 13 years of age was unrelated to HbA1c among both genders. In trajectory analysis, PA and accelerometer PA trajectories were not associated with later HbA1c. Objectively measured PA at 18 years was cross-sectionally inversely associated with HbA1c in boys only. No prospective associations were identified.

[Evaluation of DCA vantage for rapid in-clinic measurement of HbA1c on capillary blood in young type 1 diabetic patients].

PubMed

El Arabi, H; Willems, D; Mélot, C; Dorchy, H

2013-01-01

Rapid in clinic measurement of glycated hemoglogin (HbA1c) allows to determine the level of metabolic control within a few minutes on capillary blood. We have evaluated the new DCA Vantage (Siemens) based on an immunological technique, replacing the DCA 2000+ (Siemens). The study included 120 unselected young type 1 diabetic patients, with different degrees of metabolic control. The DCA Vantage was compared with the HPLC system (Menarini HA 8160) whose deviation from the DCCT was < 0.1% across the clinical range. The mean underestimation of the DCA Vantage was -0.40%. The agreement limits (+/- 1.96 SD) were between 0.14% and -0.93%; this means +/- 0.53% around -0.40%. In conclusion, the DCA Vantage underestimates HbA1c levels; however it met the acceptance criteria of having a coefficient of variation < 3%.

Periodontal Pocket Depth, Hyperglycemia, and Progression of Chronic Kidney Disease: A Population-Based Longitudinal Study.

PubMed

Chang, Jia-Feng; Yeh, Jih-Chen; Chiu, Ya-Lin; Liou, Jian-Chiun; Hsiung, Jing-Ru; Tung, Tao-Hsin

2017-01-01

No large epidemiological study has been conducted to investigate the interaction and joint effects of periodontal pocket depth and hyperglycemia on progression of chronic kidney disease in patients with periodontal diseases. Periodontal pocket depth was utilized for the grading severity of periodontal disease in 2831 patients from January 2002 to June 2013. Progression of chronic kidney disease was defined as progression of color intensity in glomerular filtration rate and albuminuria grid of updated Kidney Disease-Improving Global Outcomes guidelines. Multivariable-adjusted hazard ratios (aHR) in various models were presented across different levels of periodontal pocket depth and hemoglobin A1c (HbA1c) in forest plots and 3-dimensional histograms. During 7621 person-years of follow-up, periodontal pocket depth and HbA1C levels were robustly associated with incremental risks for progression of chronic kidney disease (aHR 3.1; 95% confidence interval [CI], 2.0-4.6 for periodontal pocket depth >4.5 mm, and 2.5; 95% CI, 1.1-5.4 for HbA1C >6.5%, respectively). The interaction between periodontal pocket depth and HbA1C on progression of chronic kidney disease was strong (P <.01). Patients with higher periodontal pocket depth (>4.5 mm) and higher HbA1C (>6.5%) had the greatest risk (aHR 4.2; 95% CI, 1.7-6.8) compared with the lowest aHR group (periodontal pocket depth ≤3.8 mm and HbA1C ≤6%). Our study identified combined periodontal pocket depth and HbA1C as a valuable predictor of progression of chronic kidney disease in patients with periodontal diseases. While considering the interaction between periodontal diseases and hyperglycemia, periodontal survey and optimizing glycemic control are warranted to minimize the risk of worsening renal function. Copyright © 2016 Elsevier Inc. All rights reserved.

Longitudinal association between eating frequency and HbA1c and serum lipids in diabetes in the SEARCH for Diabetes in Youth Study.

PubMed

Li, Chao; D'Agostino, Ralph B; Dabelea, Dana; Liese, Angela D; Mayer-Davis, Elizabeth J; Pate, Russell; Merchant, Anwar T

2018-04-30

Few studies have evaluated the prospective association of eating frequency with HbA1c levels and cardiovascular disease risk markers among youth with diabetes. To examine the 5-year longitudinal association of eating frequency with HbA1c and serum lipid levels among youth with type 1 diabetes (T1D) or type 2 diabetes (T2D). 1,049 youth (≥10 years old) with incident T1D (n=821) or T2D (n=228) who participated in the SEARCH for Diabetes in Youth Study were included. Eating frequency (≤3, 4-5 or 6-10 times/day) measured at baseline and follow-up visits was related to HbA1c and serum lipid levels measured repeatedly over 5 years. Increased eating frequency was associated with larger increases in HbA1c among youth T1D. For example, for youth with T1D who ate ≤ 3 times/day at the outset and ate 6-10 times/day 5 years later, the longitudinal model predicted greater absolute increases in HbA1c (2.77%); whereas for youth with T1D who ate 6-10 times/day at the outset and ate ≤3 times/day 5 years later, the model predicted lesser absolute increases in HbA1c (1.33%). Eating frequency was not associated with changes in serum lipid levels among youth with T1D or T2D. Youth with T1D who increased their eating frequency vs. those who decreased it had larger increases in HbA1c over 5 years. This article is protected by copyright. All rights reserved.

Agreement between the 'point of care' tests for microalbuminuria and HbA1c performed in mexican family medicine units and the results of standard laboratory tests.

PubMed

Valdez-González, Leticia A; Méndez-Padrón, Araceli; Gómez-Díaz, Rita A; Valladares-Salgado, Adán; Sánchez-Becerra, Martha Catalina; Mondragón-González, Rafael; Hernández-Rubí, Jaime; González-Hermosillo, Arturo; Cruz, Miguel; Borja, Víctor; Wacher, Niels H

The albumin-creatinine ratio is considered an indicator of microalbuminuria, precursor to chronic kidney disease, while HbA1c is used to measure glycemic control. Given the prevalence of diabetes-related nephropathy, spot testing of albumin has long been recommended as a preventative measure, for the timely detection of microalbuminuria. However, many countries do not have this testing available in primary care, and sometimes not even in second- and third-level care. The objective of this study was to compare agreement of the microalbuminuria and HbA1c results obtained in the laboratory with 'gold standard' techniques, with those obtained on site with a 'Point of Care' DCA Vantage™ device by Siemens. Results for the albumin-creatinine ratio and HbA1c from the Siemens DCA Vantage™ point of care device were compared with those from standard laboratory tests in 25 family medicine units in Mexico City and Toluca, State of Mexico, in patients diagnosed with type-2 diabetes. Agreement between the albumin values of the 2 tests was 0.745 (CI 95% 0.655-0.812). Agreement between the two measurement techniques for HbA1c was 0.970 (CI 95% 0.966-0.973). The results obtained were sufficiently comparative (R i = 0.74 for albumin-creatinine ratio and R i  = 0.97 for HbA1c) to justify the use of the point of care device. Given the high agreement between the point of care device and laboratory tests, this device could be used to identify chronic kidney disease and glycemic control for more adequate treatment in patients with diabetes, especially in remote areas.

Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

PubMed Central

Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

2016-01-01

Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

HOMA-IR Values are Associated With Glycemic Control in Japanese Subjects Without Diabetes or Obesity: The KOBE Study.

PubMed

Hirata, Takumi; Higashiyama, Aya; Kubota, Yoshimi; Nishimura, Kunihiro; Sugiyama, Daisuke; Kadota, Aya; Nishida, Yoko; Imano, Hironori; Nishikawa, Tomofumi; Miyamatsu, Naomi; Miyamoto, Yoshihiro; Okamura, Tomonori

2015-01-01

Several studies have reported that insulin resistance was a major risk factor for the onset of type 2 diabetes mellitus in individuals without diabetes or obesity. We aimed to clarify the association between insulin resistance and glycemic control in Japanese subjects without diabetes or obesity. We conducted a community-based cross-sectional study including 1083 healthy subjects (323 men and 760 women) in an urban area. We performed multivariate regression analyses to estimate the association between the homeostasis model assessment of insulin resistance (HOMA-IR) values and markers of glycemic control, including glycated haemoglobin (HbA1c), 1,5-anhydroglucitol (1,5-AG), and fasting plasma glucose (FPG) levels, after adjustment for potential confounders. Compared with the lowest tertile of HOMA-IR values, the highest tertile was significantly associated with HbA1c and FPG levels after adjustment for potential confounders, both in men (HbA1c: β = 1.83, P = 0.001; FPG: β = 0.49, P < 0.001) and women (HbA1c: β = 0.82, P = 0.008; FPG: β = 0.39, P < 0.001). The highest tertile of HOMA-IR values was inversely associated with 1,5-AG levels compared with the lowest tertile (β = -18.42, P = 0.009) only in men. HOMA-IR values were associated with markers of glycemic control in Japanese subjects without diabetes or obesity. Insulin resistance may influence glycemic control even in a lean, non-diabetic Asian population.

A Pharmacy Student-Facilitated Interprofessional Diabetes Clinic With the Penobscot Nation.

PubMed

Martin, Sarah Levin; Williams, Evan; Huerth, Benjamin; Robinson, J Daniel

2015-11-05

American Indians/Alaska Natives have a greater increased risk for diabetes than non-Hispanic whites. Lifestyle interventions are effective in preventing and treating diabetes, and an interprofessional approach is important in diabetes management. The Penobscot Nation has a health center with a wide range of services. Our goal with the Nation was to 1) establish an interprofessional, student-facilitated diabetes clinic in the health center; 2) assess the clinic's preliminary impact. Relationship building and problem solving was instrumental in working toward the first goal. A survey was developed to assess satisfaction with the clinic. The clinical outcomes, mean and median values of HbA1c, were calculated at baseline (spring 2013) and were used to establish 2 groups of patients: those with controlled levels (<7%) and those with uncontrolled levels (≥ 7%). HbA1c was reassessed in fall 2013. Changes in HbA1c were calculated and compared using the Wilcoxon signed-rank test. The student-facilitated, interprofessional diabetes clinic has operated for 2 years, and changes are under way. More than 90% of participants reported being well satisfied with the clinic in the first year. Among the group with uncontrolled HbA1c (n = 18), mean HbA1c values declined from 9.3% to 7.6% (P = .004). Among the group with controlled HbA1c (n = 30), 83% were controlled at follow-up. The Penobscot diabetes clinic is evolving to meet the needs of community members, and pharmacy students have an interprofessional practice site well suited for experiential learning.

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial

PubMed Central

Mayer-Davis, E. J.; Seid, M.; Crandell, J.; Dolan, L.; Lagarde, W. H.; Letourneau, L.; Maahs, D. M.; Marcovina, S.; Nachreiner, J.; Standiford, D.; Thomas, J.; Wysocki, T.

2014-01-01

Aim To determine the potential effect sizes for the Flexible Lifestyle for Youth (FL3X) behavioural intervention to improve glycaemic control (HbA1c) and quality of life for at-risk adolescents with Type 1 diabetes. Methods Participants [n=61; age 12–16 years, HbA1c 64–119 mmol/mol (8–13%)] were randomized to FL3X (minimum three sessions) or usual care. Effect sizes (Cohen’s d), comparing the mean difference between the groups, were calculated. Results Study retention (95%), attendance at intervention sessions (87% attended all three sessions) and acceptability were high (100% of the adolescents and 91% of parents would recommend the programme to others). Overall, 41% of participants in the intervention group and 24% of participants in the control group were ‘responders’ [HbA1c decreased by > 6 mmol/mol (0.5%); d=0.37]. HbA1c levels decreased (d= −0.18), diabetes-specific quality of life increased (d=0.29), but generic quality of life decreased (d= −0.23) in the intervention compared with the control group. Conclusions The FL3X programme merits further study for improving HbA1c and diabetes-specific quality of life in adolescents with Type 1 diabetes. PMID:25424501

Comparison of the hypoglycemic effect of acarbose monotherapy in patients with type 2 diabetes mellitus consuming an Eastern or Western diet: a systematic meta-analysis.

PubMed

Zhu, Qibo; Tong, Yuzhen; Wu, Taixiang; Li, Jieqing; Tong, Nanwei

2013-06-01

Because of its mechanism of action, the starch content of a diet might alter the hypoglycemic effect of acarbose. We aimed to determine whether differences in this hypoglycemic effect existed between individuals consuming Eastern and Western diets with significantly different starch contents, a systematic meta-analysis of studies comparing acarbose with placebo or other hypoglycemic agents in patients with type 2 diabetes mellitus (T2DM) was performed. Records were retrieved from the Cochrane clinical controlled trials, MEDLINE, EMBASE, Wanfang, Chinese Technical Periodicals, and ongoing trials databases, and full texts and reference lists were screened. Because no study has directly compared patients consuming different types of diet, fixed- and random-effect models were used to indirectly compare the hypoglycemic effect of acarbose monotherapy with that of placebo and/or comparator drugs in patients with T2DM consuming an Eastern (Eastern Asia) or Western (including Europe and North America) diet. A total of 46 studies were included in the meta-analysis. The results revealed that, compared with placebo, hemoglobin A1c (HbA1c) levels were reduced to a significantly greater extent (1.02%) in the Eastern diet (mean [SD], 1.54% [2.00%]) than in the Western diet (mean [SD], 0.52% [1.20%]) P < 0.00001). The ability of acarbose to reduce HbA1c levels in the Eastern (P = 0.20) and Western (P = 0.10) diet groups was similar to that of sulfonylureas, and HbA1c levels were reduced significantly more (0.39%; P < 0.00001) in the Eastern than in the Western diet group. The ability of acarbose to reduce HbA1c levels was similar to those of metformin and nateglinide/repaglinide, but a comparison of its efficacy with different diets was difficult because of the inclusion of few studies in these categories. Analysis of all included studies revealed that acarbose achieved a greater absolute reduction of HbA1c levels in the Eastern diet (mean [SD], 1.26% [1.20%]) than in the Western diet (mean [SD], 0.62% [1.28%]; P < 0.00001) group. However, the poor quality of Eastern diet trials may have affected the outcomes of the meta-analysis. The hypoglycemic effect of acarbose is superior in patients with T2DM consuming an Eastern diet than in those consuming a Western diet and is similar to that of sulfonylureas, metformin, and glinide drugs. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: Results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS)

PubMed Central

2012-01-01

Background The incidence of cardiac events is higher in patients with diabetes than in people without diabetes. The Coronary Atherosclerosis Study Measuring Effects of Rosuvastatin Using Intravascular Ultrasound in Japanese Subjects (COSMOS) demonstrated significant plaque regression in Japanese patients with chronic coronary disease after 76 weeks of rosuvastatin (2.5 mg once daily, up-titrated to a maximum of 20 mg/day to achieve LDL cholesterol <80 mg/dl). Methods In this subanalysis of COSMOS, we examined the association between HbA1c and plaque regression in 40 patients with HbA1c ≥6.5% (high group) and 86 patients with HbA1c <6.5% (low group). Results In multivariate analyses, HbA1c and plaque volume at baseline were major determinants of plaque regression. LDL cholesterol decreased by 37% and 39% in the high and low groups, respectively, while HDL cholesterol increased by 16% and 22%, respectively. The reduction in plaque volume was significantly (p = 0.04) greater in the low group (from 71.0 ± 39.9 to 64.7 ± 34.7 mm3) than in the high group (from 74.3 ± 34.2 to 71.4 ± 32.3 mm3). Vessel volume increased in the high group but not in the low group (change from baseline: +4.2% vs −0.8%, p = 0.02). Change in plaque volume was significantly correlated with baseline HbA1c. Conclusions Despite similar improvements in lipid levels, plaque regression was less pronounced in patients with high HbA1c levels compared with those with low levels. Tight glucose control during statin therapy may enhance plaque regression in patients with stable coronary disease. Trial registration ClinicalTrials.gov, Identifier NCT00329160 PMID:22831708

Global standardisation of HbA1c.

PubMed

Lai, Leslie C

2008-12-01

HbA1c is used for assessing glycaemic control in patients with diabetes. It is also used for treatment goals and as a target for therapeutic intervention. The Direct Control and Complications Trial in the USA showed that HbA1c can be used to predict the risk of complications. Hence, it is important for HbA1c assays to be standardised. The National Glycohemoglobin Standardization Program (NGSP) in the USA was formed in 1996 so that HbA1c results from different laboratories would be comparable to those reported in the DCCT study. There were also HbA1c standardisation programmes in Sweden and Japan. These three standardisation programmes are, in fact, direct comparison methods (DCMs), and yield different HbA1c results. In 1994, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Working Group on Standardisation of HbA1c. This working group has developed a global HbA1c reference system with very much improved intra-assay and inter-assay coefficients of variation. Recommendations have been made to report HbA1c results as IFCC-HbA1c values in SI units (mmol HbA1c/mol Hb) and NGSP-HbA1c (%) as well as estimated average glucose (eAG), once a tight relationship has been shown to exist between eAG and HbA1c.

Metabolic control after years of completing a clinical trial on sensor-augmented pump therapy.

PubMed

Quirós, Carmen; Giménez, Marga; Orois, Aida; Conget, Ignacio

2015-11-01

Sensor-augmented pump (SAP) therapy has been shown to be effective and safe for improving metabolic control in patients with type 1 diabetes mellitus (T1DM) in a number of trials. Our objective was to assess glycemic control in a group of T1DM patients on insulin pump or SAP therapy after years of participating in the SWITCH (Sensing With Insulin pump Therapy To Control HbA1c) trial and their return to routine medical monitoring. A retrospective, observational study of 20 patients who participated in the SWITCH trial at our hospital from 2008 to 2010. HbA1c values were compared at the start, during (at the end of the periods with/without SAP use - Sensor On/Sensor Off period respectively - of the cross-over design), and 3 years after study completion. HbA1c values of patients who continued SAP therapy (n=6) or only used insulin pump (n=14) were also compared. Twenty patients with T1DM (44.4±9.3 years, 60% women, baseline HbA1c level 8.43±0.55%) were enrolled into the SWITCH study). Three years after study completion, HbA1c level was 7.79±0.77 in patients on pump alone, with no significant change from the value at the end of the Off period of the study (7.85±0.57%; p=0.961). As compared to the end of the On period, HbA1c worsened less in patients who remained on SAP than in those on pump alone (0.18±0.42 vs. 0.55±0.71%; p=0.171), despite the fact that levels were similar at study start (8.41±0.60 vs. 8.47±0.45; p=0.831) and at the end of the On period (7.24±0.48 vs. 7.38±0.61; p=0.566). Frequency of CGM use in patients who continued SAP therapy was high (61.2% of the time in the last 3 months). Our study suggests that the additional benefit of SAP therapy achieved in a clinical trial may persist in the long term in routine clinical care of patients with T1DM. Copyright © 2015 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

Cardiovascular Risk Factors Increase the Risks of Diabetic Peripheral Neuropathy in Patients With Type 2 Diabetes Mellitus

PubMed Central

Yang, Chun-Pai; Lin, Cheng-Chieh; Li, Chia-Ing; Liu, Chiu-Shong; Lin, Wen-Yuan; Hwang, Kai-Lin; Yang, Sing-Yu; Chen, Hsuan-Ju; Li, Tsai-Chung

2015-01-01

Abstract This study aimed to examine whether poor glycemic control, measured by glycated hemoglobin A1C (HbA1c) and other cardiovascular risk factors, can predict diabetic peripheral neuropathy (DPN) in patients with type 2 diabetes mellitus (DM). Patients aged ≥30 years with type 2 DM, enrolled in the National Diabetes Care Management Program, and free of DPN (n = 37,375) in the period 2002 to 2004 were included and followed up until 2011. The related factors were analyzed using Cox proportional hazards regression models. For an average follow-up of 7.00 years, 8379 cases of DPN were identified, with a crude incidence rate of 32.04/1000 person-years. After multivariate adjustment, patients with HbA1c levels 7 to 8%, 8 to 9%, 9 to 10%, and ≥10% exhibited higher risk of DPN (adjusted HR: 1.11 [1.04–1.20], 1.30 [1.21–1.40], 1.32 [1.22–1.43], and 1.62 [1.51–1.74], respectively) compared with patients with HbA1c level 6 to 7%. There was a significant linear trend in DPN incidence with increasing HbA1c (P < 0.001) and significant HRs of DPN for patients with HbA1c level ≥7%, blood pressure ≥130/85 mm Hg, triglycerides (TG) ≥150 mg/dL, high density of lipoprotein-cholesterol (HDL-C) <40 mg/dL in males and <50 mg/dL in females, low density of lipoprotein-cholesterol (LDL-C) ≥100 mg/dL, and estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Patients with type 2 DM and HbA1c ≥7.0% exhibit increased risk of DPN, demonstrating a linear relationship. The incidence of DPN is also associated with poor glucose control and cardiovascular risk factors like hypertension, hyper-triglyceridemia, low HDL-C, high LDL-C, and decreased eGFR. PMID:26496307

Implementation of the Diabetes Practice Guideline in the Army Medical Department: Final Evaluation

DTIC Science & Technology

2005-01-01

Diabetes Quality Improvement Project DRG Diagnosis-Related Group ER Emergency room FMP Family Member Prefix HBA1c Hemoglobin A1c HCSR Health-Care Service...glycemic control by assessing and managing glycosylated hemoglobin, reported as hemoglobin A1c ( HbA1c ) lev- els. Assess HbA1c levels relative to target...frequency involved in adjusting insulin dosages Increase in the percentage of noninsulin patients who fill prescribed medications to control HbA1c

Differential association of body mass index on glycemic control in type 1 diabetes.

PubMed

Lee, Eun Young; Lee, Yong-Ho; Jin, Sang-Man; Yang, Hae Kyung; Jung, Chang Hee; Park, Cheol-Young; Cho, Jae Hyoung; Lee, Woo Je; Lee, Byung-Wan; Kim, Jae Hyeon

2017-01-01

In contrast to type 2 diabetes, the association of body mass index (BMI) with glycemic control in type 1 diabetes (T1D) remains unclear. We investigated the relationship between BMI and average HbA 1c levels in subjects with T1D. In this multi-centre observational study, we analysed 719 subjects with T1D aged ≥18 years. Average HbA 1c levels over 18 months and other clinical and laboratory parameters were evaluated. The mean age and duration of diabetes at baseline were 41.5 ± 13.9 and 11.3 ± 8.7 years, respectively. A U-shaped correlation between BMI and 18-month average HbA 1c levels was documented by a spline curve. Based on this finding, subjects were divided into three groups according to BMI (group I, <21; group II, 21-23; and group III, ≥23 kg/m 2 ). In group I, the BMI negatively correlated with average HbA 1c (r = -0.172, p = 0.011), while a positive relationship was observed (r = 0.162, p = 0.012) in group III. Average HbA 1c levels were lower and the proportion of individuals with well-controlled glycemia (HbA 1c <7%) were increased in the higher BMI tertile group among subjects with group I as well as in the lower BMI tertile group among subjects with group III BMI. After adjustment with additional covariates in the multiple regression model, these associations between BMI and HbA 1c levels according to the different BMI ranges remained significant. In Korean subjects with T1D, an inverse relationship of BMI with HbA 1c levels was observed in the low BMI group, while a positive correlation was shown in the high BMI group. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Does Physical Activity Mediate the Associations Between Local-Area Descriptive Norms, Built Environment Walkability, and Glycosylated Hemoglobin?

PubMed

Carroll, Suzanne J; Niyonsenga, Theo; Coffee, Neil T; Taylor, Anne W; Daniel, Mark

2017-08-23

Associations between local-area residential features and glycosylated hemoglobin (HbA 1c ) may be mediated by individual-level health behaviors. Such indirect effects have rarely been tested. This study assessed whether individual-level self-reported physical activity mediated the influence of local-area descriptive norms and objectively expressed walkability on 10-year change in HbA 1c . HbA 1c was assessed three times for adults in a 10-year population-based biomedical cohort ( n = 4056). Local-area norms specific to each participant were calculated, aggregating responses from a separate statewide surveillance survey for 1600 m road-network buffers centered on participant addresses (local prevalence of overweight/obesity (body mass index ≥25 kg/m²) and physical inactivity (<150 min/week)). Separate latent growth models estimated direct and indirect (through physical activity) effects of local-area exposures on change in HbA 1c , accounting for spatial clustering and covariates (individual-level age, sex, smoking status, marital status, employment and education, and area-level median household income). HbA 1c worsened over time. Local-area norms directly and indirectly predicted worsening HbA 1c trajectories. Walkability was directly and indirectly protective of worsening HbA 1c . Local-area descriptive norms and walkability influence cardiometabolic risk trajectory through individual-level physical activity. Efforts to reduce population cardiometabolic risk should consider the extent of local-area unhealthful behavioral norms and walkability in tailoring strategies to improve physical activity.

Does Physical Activity Mediate the Associations between Local-Area Descriptive Norms, Built Environment Walkability, and Glycosylated Hemoglobin?

PubMed Central

Daniel, Mark

2017-01-01

Associations between local-area residential features and glycosylated hemoglobin (HbA1c) may be mediated by individual-level health behaviors. Such indirect effects have rarely been tested. This study assessed whether individual-level self-reported physical activity mediated the influence of local-area descriptive norms and objectively expressed walkability on 10-year change in HbA1c. HbA1c was assessed three times for adults in a 10-year population-based biomedical cohort (n = 4056). Local-area norms specific to each participant were calculated, aggregating responses from a separate statewide surveillance survey for 1600 m road-network buffers centered on participant addresses (local prevalence of overweight/obesity (body mass index ≥25 kg/m2) and physical inactivity (<150 min/week)). Separate latent growth models estimated direct and indirect (through physical activity) effects of local-area exposures on change in HbA1c, accounting for spatial clustering and covariates (individual-level age, sex, smoking status, marital status, employment and education, and area-level median household income). HbA1c worsened over time. Local-area norms directly and indirectly predicted worsening HbA1c trajectories. Walkability was directly and indirectly protective of worsening HbA1c. Local-area descriptive norms and walkability influence cardiometabolic risk trajectory through individual-level physical activity. Efforts to reduce population cardiometabolic risk should consider the extent of local-area unhealthful behavioral norms and walkability in tailoring strategies to improve physical activity. PMID:28832552

Associations between comorbid anxiety, diabetes control, and overall medical burden in a population with serious mental illness and diabetes

PubMed Central

Bajor, Laura A.; Gunzler, Douglas; Einstadter, Douglas; Thomas, Charles; McCormick, Dick; Perzynski, Adam T.; Kanuch, Stephanie; Cassidy, Kristin; Dawson, Neal V.; Sajatovic, Martha

2015-01-01

Objective While previous work has demonstrated elevation of both comorbid anxiety disorders and diabetes mellitus type II (DM2) in individuals with Serious Mental Illness (SMI), little is known regarding the impact of comorbid anxiety on DM2 outcomes in SMI populations. We analyzed baseline data from a population of SMI patients with DM2 to study relationships between comorbid anxiety, glucose control as measured by HbA1c score, and overall illness burden. Methods Using baseline data from an ongoing prospective treatment study involving 157 individuals with SMI and DM2 we compared individuals with and without a comorbid anxiety disorder and compared HbA1c levels between these groups to assess the relationship between anxiety and management of DM2. We conducted a similar analysis using cumulative number of anxiety diagnoses as a proxy for anxiety load. Finally, we searched for associations between anxiety and overall medical illness burden as measured by Charlson score. Results Anxiety disorders were seen in 33.1 % (N= 52) of individuals with SMI and DM2 and were associated with increased severity of depressive symptoms and decreased function. HbA1c levels were not significantly different in those with or without anxiety and having multiple anxiety disorders was not associated with differences in DM2 control. However, depressive symptoms were significantly associated with higher HbA1c levels. Neither comorbid anxiety nor anxiety load were significantly associated with overall medical burden. Conclusion One in 3 people with SMI and DM2 have anxiety. Depressive symptoms were significantly associated with Hb1Ac levels while anxiety symptoms had no relation to HbA1c; this is consistent with previously published work. More studies are needed to better understand the relationship between depression, anxiety and health management in people with SMI and DM2. PMID:26060262

Klebsiella pneumoniae liver abscess in diabetic patients: association of glycemic control with the clinical characteristics

PubMed Central

2013-01-01

Background Klebsiella pneumoniae liver abscess (KPLA) has been reported with increasing frequency in East Asian countries in the past 3 decades, especially in Taiwan and Korea. Diabetes is a well-known risk factor for KPLA and highly associated with septic metastatic complications from KPLA. We investigated the association of glycemic control in diabetic patients with the clinical characteristics of KPLA in Taiwan. Methods Adult diabetic patients with KPLA were identified retrospectively in a medical center from January 2007 to January 2012. Clinical characteristics were compared among patients with different levels of current hemoglobin A1c (HbA1c). Risk factors for metastatic infection from KPLA were analyzed. Results Patients with uncontrolled glycemia (HbA1c ≥ 7%) were significantly younger than those with controlled glycemia (HbA1c < 7%). Patients with uncontrolled glycemia had the trend to have a higher rate of gas-forming liver abscess, cryptogenic liver abscess, and metastatic infection than those with controlled glycemia. Cryptogenic liver abscess and metastatic infection were more common in the poor glycemic control group (HbA1c value >; 10%) after adjustment with age. HbA1c level and abscess < 5 cm were independent risk factors for metastatic complications from KPLA. Conclusions Glycemic control in diabetic patients played an essential role in the clinical characteristics of KPLA, especially in metastatic complications from KPLA. PMID:23363608

Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care.

PubMed

Östgren, C J; Sundström, J; Svennblad, B; Lohm, L; Nilsson, P M; Johansson, G

2013-05-01

To explore the association of HbA1c and educational level with risk of cardiovascular events and mortality in patients with Type 2 diabetes. A cohort of 32 871 patients with Type 2 diabetes aged 35 years and older identified by extracting data from electronic patient records for all patients who had a diagnosis of Type 2 diabetes and had glucose-lowering agents prescribed between 1999 and 2009 at 84 primary care centres in Sweden. Associations of mean HbA1c levels and educational level with risks of cardiovascular events and all-cause mortality were analysed. The associations of HbA1c with risk of all-cause and cardiovascular mortality were J-shaped, with the lowest risk observed for cardiovascular mortality at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. The lowest risk observed for all-cause mortality was at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. There was an increased risk for cardiovascular death [hazard ratio 1.6 (1.2-2.1), P = 0.0008] at the lowest HbA1c decile for subjects in the low education category. For subjects with higher education there was no evident J curve for cardiovascular death [hazard ratio 1.2 (0.8-1.6), P = 0.3873]. Our results lend support to the recent American Diabetes Association/ European Association for the Study of Diabetes position statement that emphasizes the importance of additional factors, including the propensity for hypoglycaemia, which should influence HbA1c targets and treatment choices for individual patients. (Clinical Trials Registry No; NCT 01121315). © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Effects of α-Thalassemia on HbA1c Measurement.

PubMed

Xu, Anping; Ji, Ling; Chen, Weidong; Xia, Yong; Zhou, Yu

2016-11-01

α-Thalassemia is a benign condition that is often present in patients with diabetes mellitus. Here, we evaluated the effects of different genotypes α-thalassemia on HbA 1c measurement. A total of 189 samples from nondiabetic patients were analyzed. HbA 1c analysis was performed by ion-exchange high-performance liquid chromatography, boronate affinity HPLC, immunoassay, and capillary electrophoresis. Fasting glucose, fructosamin, and HbA 2 were also performed. All samples were confirmed by genotyping for thalassemia. In patients with two or three functional α-genes, HbA 1c values were not significantly different from those of controls (P > 0.05); however, in individuals with α-thalassemia with one functional α-gene (i.e., HbH disease), HbA 1c levels were significantly different from those of controls (P < 0.01). HbA 1c values were significantly lower in individuals with HbH disease than in control individuals and patients in the other two α-thalassemia groups. For patients with HbH disease, there were no significant differences in the four HbA 1c measurement systems (P > 0.05). In this study, HbA 1c values in samples from individuals with two or three functional α-genes basically reflected the normal mean blood glucose level, while those in samples from individuals with one functional α-gene did not. © 2016 Wiley Periodicals, Inc.

HbA1c level cannot predict the treatment outcome of smear-positive non-multi-drug-resistant HIV-negative pulmonary tuberculosis inpatients

PubMed Central

Tashiro, Ken; Horita, Nobuyuki; Nagai, Kenjiro; Ikeda, Misako; Shinkai, Masaharu; Yamamoto, Masaki; Sato, Takashi; Hara, Yu; Nagakura, Hideyuki; Shibata, Yuji; Watanabe, Hiroki; Nakashima, Kentaro; Ushio, Ryota; Nagashima, Akimichi; Narita, Atsuya; Kobayashi, Nobuaki; Kudo, Makoto; Kaneko, Takeshi

2017-01-01

We conducted a single-center retrospective cohort study to evaluate whether the HbA1c level on admission could predict the in-hospital treatment outcome of smear-positive non-multi-drug-resistant HIV-negative culture-proven pulmonary tuberculosis inpatients. Our standard regimens under the direct observation were HRZE or HRE for the first two months followed by combination therapy with isoniazid and rifampicin. Our cohort consisted of consecutive 239 patients consisted of 147 men and 92 women with a median age of 73 years. The HbA1c level of patients whose HbA1c was above 7.0% on admission showed clear declining trends after admission. HbA1c on admission had no Spearman’s rank correlation with time to discharge alive (r = 0.17) and time to becoming non-infective (r = 0.17). By Kaplan-Meier curves and a log-rank trend test, HbA1c quartile subgroups showed no association with times to discharge alive (p = 0.431), becoming non-infective (p = 0.113), and in-hospital death (p = 0.427). Based on multi-variate Cox analysis, HbA1c on admission had no significant impact on time to discharge alive (hazard ratio = 1.03, 95% CI 0.89–1.20, p = 0.659), becoming non-infective (hazard ratio = 0.93, 95% CI 0.80–1.06, p = 0.277), and in-hospital death (hazard ratio = 0.68, 0.43–1.07, p = 0.097). In conclusion, the HbA1c level on admission did not seem to affect in-hospital tuberculosis treatment outcomes in Japanese cohort. PMID:28406247

The Long and Winding Road to Optimal HbA1c Measurement

PubMed Central

Little, Randie R.; Rohlfing, Curt

2016-01-01

The importance of hemoglobin A1c (HbA1c) as an indicator of mean glycemia and risks for complications in patients with diabetes mellitus was established by the results of long-term clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), published in 1993 and 1998 respectively. However, clinical application of recommended HbA1c targets that were based on these studies was difficult due to lack of comparability of HbA1c results among assay methods and laboratories. Thus, the National Glycohemoglobin Standardization Program (NGSP) was initiated in 1996 with the goal of standardizing HbA1c results to those of the DCCT/UKPDS. HbA1c standardization efforts have been highly successful; however, a number of issues have emerged on the “long and winding road” to better HbA1c, including the development of a higher-order HbA1c reference method by the International Federation of Clinical Chemistry (IFCC), recommendations to use HbA1c to diagnose as well as monitor diabetes, and point-of-care (POC) HbA1c testing. Here, we review the past, present and future of HbA1c standardization and describe the current status of HbA1c testing, including limitations that healthcare providers need to be aware of when interpreting HbA1c results. PMID:23318564

HbA1c is significantly associated with arterial stiffness but not with carotid atherosclerosis in a community-based population without type 2 diabetes: The Dong-gu study.

PubMed

Lee, Young-Hoon; Shin, Min-Ho; Choi, Jin-Su; Rhee, Jung-Ae; Nam, Hae-Sung; Jeong, Seul-Ki; Park, Kyeong-Soo; Ryu, So-Yeon; Choi, Seong-Woo; Kim, Bok-Hee; Oh, Gyung-Jae; Kweon, Sun-Seog

2016-04-01

We examined the associations between HbA1c levels and various atherosclerotic vascular parameters among adults without diabetes from the general population. A total of 6500 community-dwelling adults, who were free of type 2 diabetes and ≥50 years of age, were included. High-resolution B-mode ultrasound was used to evaluate carotid artery structure, including intima-media thickness (IMT), plaque, and luminal diameter. Brachial-ankle pulse wave velocity (baPWV), which is a useful indicator of systemic arterial stiffness, was determined using an automatic waveform analysis device. No significant associations were observed between HbA1c, carotid IMT, plaque, or luminal diameter in a fully adjusted model. However, the odds ratio (95% confidence interval) for high baPWV (defined as the highest quartile) increased by 1.43 (1.19-1.71) per 1% HbA1c increase after adjusting for conventional risk factors in a multivariate logistic regression analysis. In addition, HbA1c was independently associated with baPWV in a multivariate linear regression analysis. High-normal HbA1c level was independently associated with arterial stiffness, but not with carotid atherosclerotic parameters, in the general population without diabetes. Our results suggest that the functional atherosclerotic process may already be accelerated according to HbA1c level, even at a level below the diagnostic threshold for diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Difference between observed and predicted glycated hemoglobin at baseline and treatment response to vildagliptin-based dual oral therapy in patients with type 2 diabetes.

PubMed

Wang, Jun-Sing; Hung, Yi-Jen; Lu, Yung-Chuan; Tsai, Cheng-Lin; Yang, Wei-Shiung; Lee, Ting-I; Hsiao, Ya-Chun; Sheu, Wayne Huey-Herng

2018-04-01

We aimed to investigate the association of difference between observed and predicted glycated hemoglobin (dopHbA1c) and HbA1c reduction after vildagliptin-based oral therapy in patients with type 2 diabetes (T2D). This was a prospective observational study. Adults ≥ 20 years old with T2D and HbA1c ≧7% treated with oral anti-diabetic drugs (OADs) were eligible if their OADs were shifted to vildagliptin-based dual oral therapy. Fasting plasma glucose (FPG) and HbA1c were recorded at baseline, week 12, and week 24. To determine baseline dopHbA1c, a predicted HbA1c was calculated by inserting baseline FPG into a regression equation (HbA1c = FPG ∗ 0.0225 + 4.3806) developed from linear relationship between HbA1c and FPG in an independent cohort of 3239 outpatients with T2D (dopHbA1c = observed HbA1c - predicted HbA1c). Patients were assigned to low (≦0) or high (>0) dopHbA1c group according to their baseline dopHbA1c levels. The study endpoint was changes from baseline to week 24 in HbA1c levels. A total of 1224 patients were enrolled. Patients with a dopHbA1c >0 had a greater HbA1c reduction after vildagliptin-based dual oral therapy than those with a dopHbA1c ≦0 (-1.5 ± 2.0 vs. -0.4 ± 1.0%, p < 0.001). Baseline dopHbA1c was positively associated with HbA1c reduction from baseline to week 24 (β coefficient 0.883, 95% CI 0.811 to 0.955, p < 0.001), and the association remained significant after adjustment for confounders. In T2D patients with an HbA1c ≧7%, a higher baseline dopHbA1c was associated with a greater HbA1c reduction after shifting to vildagliptin-based dual oral therapy. Copyright © 2018 Elsevier B.V. All rights reserved.

Long-term Efficacy and Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes Mellitus.

PubMed

Tada, Yuko; Kanazawa, Ippei; Notsu, Masakazu; Tanaka, Ken-Ichiro; Kiyohara, Nobuaki; Sasaki, Motofumi; Sugimoto, Toshitsugu

2016-01-01

Objective We herein conducted a retrospective study to evaluate the long-term efficacy and safety of sitagliptin treatment in elderly patients with type 2 diabetes mellitus. Methods We analyzed the changes in glycemic control in 112 Japanese type 2 diabetes patients over 65 years of age treated with 50 mg/day sitagliptin. Hemoglobin A1c (HbA1c) levels, liver and kidney functions, and usage of hypoglycemic agents were recorded for 24 months. Results HbA1c levels were significantly decreased, and the significance of HbA1c reduction was maintained during the observation period [from 7.7±1.1% to 7.2±0.7% (p<0.001) at the end of observational period]. The %change in HbA1c levels was significantly and negatively correlated with the baseline HbA1c levels (r=-0.51, p<0.001), but not with age, duration of diabetes, or the estimated glomerular filtration rate (eGFR). No patient experienced severe hypoglycemia episodes, and aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, and the eGFR remained unchanged. The dose of sulfonylurea was finally decreased in 72% of patients treated with sulfonylurea. Conclusion Sitagliptin treatment continually decreases the HbA1c level for 24 months and is useful to reduce the dose of sulfonylurea in elderly patients with type 2 diabetes.

Endothelial dysfunction and metabolic control in streptozotocin-induced diabetic rats

PubMed Central

Rodríguez-Mañas, Leocadio; Angulo, Javier; Peiró, Concepción; Llergo, José L; Sánchez-Ferrer, Alberto; López-Dóriga, Pedro; Sánchez-Ferrer, Carlos F

1998-01-01

The aim of this work was to study the influence of the metabolic control, estimated by the levels of glycosylated haemoglobin in total blood samples (HbA1c), in developing vascular endothelial dysfunction in streptozotocin-induced diabetic rats. Four groups of animals with different levels of insulin treatment were established, by determining HbA1c values in 5.5 to 7.4%, 7.5 to 9.4%, 9.5 to 12% and >12%, respectively.The parameters analysed were: (1) the endothelium-dependent relaxations to acetylcholine (ACh) in isolated aorta and mesenteric microvessels; (2) the vasodilator responses to exogenous nitric oxide (NO) in aorta; and (3) the existence of oxidative stress by studying the influence of the free radical scavenger superoxide dismutase (SOD) on the vasodilator responses to both ACh and NO.In both isolated aortic segments and mesenteric microvessels, the endothelium-mediated concentration-dependent relaxant responses elicited by ACh were significantly decreased when the vessels were obtained from diabetic animals but only with HbA1c values higher than 7.5%. There was a high correlation between HbA1c levels and the impairment of ACh-induced relaxations, measured by pD2 values.The concentration-dependent vasorelaxant responses to NO in endothelium-denuded aortic segments were significantly reduced only in vessels from diabetic animals with HbA1c values higher than 7.5%. Again, a very high correlation was found between the HbA1c values and pD2 for NO-evoked responses.In the presence of SOD, the responses to ACh or NO were only increased in the segments from diabetic rats with HbA1c levels higher than 7.5%, but not in those from non-diabetic or diabetic rats with a good metabolic control (HbA1c levels <7.5%).These results suggest the existence of: (1) a close relation between the degree of endothelial dysfunction and the metabolic control of diabetes, estimated by the levels of HbA1c; and (2) an increased production of superoxide anions in the vascular wall of the diabetic rats, which is also related to the metabolic control of the disease. PMID:9605553

Incidence of Type 2 Diabetes Using Proposed HbA1c Diagnostic Criteria in the European Prospective Investigation of Cancer–Norfolk Cohort

PubMed Central

Chamnan, Parinya; Simmons, Rebecca K.; Forouhi, Nita G.; Luben, Robert N.; Khaw, Kay-Tee; Wareham, Nicholas J.; Griffin, Simon J.

2011-01-01

OBJECTIVE To evaluate the incidence and relative risk of type 2 diabetes defined by the newly proposed HbA1c diagnostic criteria in groups categorized by different baseline HbA1c levels. RESEARCH DESIGN AND METHODS Using data from the European Prospective Investigation of Cancer (EPIC)-Norfolk cohort with repeat HbA1c measurements, we estimated the prevalence of known and previously undiagnosed diabetes at baseline (baseline HbA1c ≥6.5%) and the incidence of diabetes over 3 years. We also examined the incidence and corresponding odds ratios (ORs) by different levels of baseline HbA1c. Incident diabetes was defined clinically (self-report at follow-up, prescribed diabetes medication, or inclusion on a diabetes register) or biochemically (HbA1c ≥6.5% at the second health assessment), or both. RESULTS The overall prevalence of diabetes was 4.7%; 41% of prevalent cases were previously undiagnosed. Among 5,735 participants without diabetes at baseline (identified clinically or using HbA1c criteria, or both), 72 developed diabetes over 3 years (1.3% [95% CI 1.0–1.5]), of which 49% were identified using the HbA1c criteria. In 6% of the total population, the baseline HbA1c was 6.0–6.4%; 36% of incident cases arose in this group. The incidence of diabetes in this group was 15 times higher than in those with a baseline HbA1c of <5.0% (OR 15.5 [95% CI 7.2–33.3]). CONCLUSIONS The cumulative incidence of diabetes defined using a newly proposed HbA1c threshold in this middle-aged British cohort was 1.3% over 3 years. Targeting interventions to individuals with an HbA1c of 6.0–6.4% might represent a feasible preventive strategy, although complementary population-based preventive strategies are also needed to reduce the growing burden of diabetes. PMID:20622160

Rates of Deintensification of Blood Pressure and Glycemic Medication Treatment Based on Levels of Control and Life Expectancy in Older Patients With Diabetes Mellitus.

PubMed

Sussman, Jeremy B; Kerr, Eve A; Saini, Sameer D; Holleman, Rob G; Klamerus, Mandi L; Min, Lillian C; Vijan, Sandeep; Hofer, Timothy P

2015-12-01

Older patients with diabetes mellitus receiving medical treatment whose blood pressure (BP) or blood glucose level are potentially dangerously low are rarely deintensified. Given the established risks of low blood pressure and blood glucose, this is a major opportunity to decrease medication harm. To examine the rate of BP- and blood glucose-lowering medicine deintensification among older patients with type 1 or 2 diabetes mellitus who potentially receive overtreatment. Retrospective cohort study conducted using data from the US Veterans Health Administration. Participants included 211 667 patients older than 70 years with diabetes mellitus who were receiving active treatment (defined as BP-lowering medications other than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or glucose-lowering medications other than metformin hydrochloride) from January 1 to December 31, 2012. Data analysis was performed December 10, 2013, to July 20, 2015. Participants were eligible for deintensification of treatment if they had low BP or a low hemoglobin A1c (HbA1c) level in their last measurement in 2012. We defined very low BP as less than 120/65 mm Hg, moderately low as systolic BP of 120 to 129 mm Hg or diastolic BP (DBP) less than 65 mm Hg, very low HbA1c as less than 6.0%, and moderately low HbA1c as 6.0% to 6.4%. All other values were not considered low. Medication deintensification, defined as discontinuation or dosage decrease within 6 months after the index measurement. The actively treated BP cohort included 211,667 participants, more than half of whom had moderately or very low BP levels. Of 104,486 patients with BP levels that were not low, treatment in 15.1% was deintensified. Of 25,955 patients with moderately low BP levels, treatment in 16.0% was deintensified. Among 81,226 patients with very low BP levels, 18.8% underwent BP medication deintensification. Of patients with very low BP levels whose treatment was not deintensified, only 0.2% had a follow-up BP measurement that was elevated (BP ≥140/90 mm Hg). The actively treated HbA1c cohort included 179,991 participants. Of 143,305 patients with HbA1c levels that were not low, treatment in 17.5% was deintensified. Of 23,769 patients with moderately low HbA1c levels, treatment in 20.9% was deintensified. Among 12,917 patients with very low HbA1c levels, 27.0% underwent medication deintensification. Of patients with very low HbA1c levels whose treatment was not deintensified, fewer than 0.8% had a follow-up HbA1c measurement that was elevated (≥7.5%). Among older patients whose treatment resulted in very low levels of HbA1c or BP, 27% or fewer underwent deintensification, representing a lost opportunity to reduce overtreatment. Low HbA1c or BP values or low life expectancy had little association with deintensification events. Practice guidelines and performance measures should place more focus on reducing overtreatment through deintensification.

Associations of Circulating Oxidized LDL and Conventional Biomarkers of Cardiovascular Disease in a Cross-Sectional Study of the Navajo Population

PubMed Central

Harmon, Molly E.; Campen, Matthew J.; Miller, Curtis; Shuey, Chris; Cajero, Miranda; Lucas, Selita; Pacheco, Bernadette; Erdei, Esther; Ramone, Sandy; Nez, Teddy; Lewis, Johnnye

2016-01-01

The prevalences of cardiovascular disease (CVD) and type 2 diabetes (T2D) have increased among the Navajo Native American community in recent decades. Oxidized low-density lipoprotein (oxLDL) is a novel CVD biomarker that has never been assessed in the Navajo population. We examined the relationship of oxLDL to conventional CVD and T2D risk factors and biomarkers in a cross-sectional population of Navajo participants. This cross-sectional study included 252 participants from 20 Navajo communities from the Diné Network for Environmental Health Project. Plasma samples were tested for oxLDL levels by a sandwich enzyme-linked immunosorbent assay. Univariate and multivariate analyses were used to determine the relationship of oxLDL and oxidized- to non-oxidized lipoprotein ratios to glycated hemoglobin (HbA1c), C-reactive protein (CRP), interleukin 6 (IL6) and demographic and health variables. Type 2 diabetes, hypertension and obesity are very prevalent in this Navajo population. HbA1c, CRP, body mass index (BMI), high-density lipoprotein, and triglycerides were at levels that may increase risk for CVD and T2D. Median oxLDL level was 47 (36.8–57) U/L. Correlational analysis showed that although oxLDL alone was not associated with HbA1c, oxLDL/HDL, oxLDL/LDL and CRP were significantly associated with HbA1c and glucose. OxLDL, oxLDL/HDL and oxLDL/LDL were significantly associated with CRP. Multivariate analysis showed that triglycerides were a common and strong predictor of oxLDL, oxLDL/HDL and oxLDL/LDL. OxLDL was trended with HbA1c and glucose but did not reach significance, however, HbA1c was an independent predictor of OxLDL/HDL. CRP trended with oxLDL/HDL and was a weak predictor of oxLDL/LDL. This Navajo subset appears to have oxLDL levels comparable to subjects without evidence of CVD reported in other studies. The high prevalence of T2D, hypertension and obesity along with abnormal levels of other biomarkers including HbA1c indicate that the Navajo population has a worsening CVD risk profile. PMID:26938991

Evaluation of the DCA Vantage analyzer for HbA 1c assay.

PubMed

Szymezak, Jean; Leroy, Nathalie; Lavalard, Emmanuelle; Gillery, Philippe

2008-01-01

Measurement of HbA 1c is key in monitoring diabetic patients in both laboratories and clinical units, where HbA 1c results are used as part of patient education. We have evaluated the DCA Vantage, a new device for immunological assay of HbA 1c. HbA 1c results obtained were evaluated in terms of precision, linearity, specificity and practicability, and were compared with results obtained by a Variant II HPLC method. The method exhibited intra- and inter-assay coefficients of variation lower than 2.6% and 4.0%, respectively, and good correlation with the comparison HPLC method (r2=0.9776). No interference was noted in the presence of labile HbA 1c or carbamylated hemoglobin. The new device exhibited improved practicability characteristics and allowed better sample identification, better management of quality control routines and greater connectivity possibilities compared to the previous DCA 2000 analyzer. This new analyzer exhibited analytical and practical characteristics very suitable for HbA 1c assay for laboratory or point-of-care use according to good laboratory practice.

The Effect of Periodontal Treatment on Hemoglobin A1c Levels of Diabetic Patients: A Systematic Review and Meta-Analysis

PubMed Central

Wang, Xingxing; Han, Xu; Guo, Xiaojing; Luo, Xiaolong; Wang, Dalin

2014-01-01

Background There is growing evidence that periodontal treatment may affect glycemic control in diabetic patients. And several systematic reviews have been conducted to assess the effect of periodontal treatment on diabetes outcomes. Researches of this aspect are widely concerned, and several new controlled trials have been published. The aim of this study was to update the account for recent findings. Methods A literature search (until the end of January 2014) was carried out using various databases with language restriction to English. A randomized controlled trial (RCT) was selected if it investigated periodontal therapy for diabetic subjects compared with a control group received no periodontal treatment for at least 3 months of the follow-up period. The primary outcome was hemoglobin A1c (HbA1c), and secondary outcomes were periodontal parameters included probing pocket depth (PPD) and clinical attachment level (CAL). Results Ten trials of 1135 patients were included in the analysis. After the follow-up of 3 months, treatment substantially lowered HbA1c compared with no treatment after periodontal therapy (–0.36%, 95%CI, −0.52% to −0.19%, P<0.0001). Clinically substantial and statistically significant reduction of PPD and CAL were found between subjects with and without treatment after periodontal therapy (PPD −0.42 mm, 95%CI: −0.60 to −0.23, P<0.00001; CAL −0.34 mm, 95%CI: −0.52 to −0.16, P = 0.0002). And there is no significant change of the level of HbA1c at the 6-month comparing with no treatment (–0.30%, 95%CI, −0.69% to 0.09%, P = 0.13). Conclusions Periodontal treatment leads to the modest reduction in HbA1c along with the improvement of periodontal status in diabetic patients for 3 months, and this result is consistent with previous systematic reviews. And the effect of periodontal treatment on HbA1c cannot be observed at 6-month after treatment. PMID:25255331

Effects of Three Low-Doses of D-Tagatose on Glycemic Control Over Six Months in Subjects with Mild Type 2 Diabetes Mellitus Under Control with Diet and Exercise.

PubMed

Ensor, Mark; Williams, Jarrod; Smith, Rebecca; Banfield, Amy; Lodder, Robert A

2014-10-01

The primary objective of this study was to evaluate the safety and the effect of D-tagatose on the glycemic control of subjects with type 2 diabetes as determined by HbA 1c levels at the end of 6 months of therapy using the subject's own baseline HbA 1c level as a comparator. The determination of the minimal dose required to cause a statistically significant reduction in HbA 1c was of particular interest. Eight weeks after screening, the qualifying subjects were randomized to receive one of three doses of D-tagatose: 2.5 g TID, 5.0 g TID or 7.5 g TID. Blood levels of HbA 1c , fasting blood glucose concentrations, plasma lipids, changes in body weight, changes in body mass index, and change in insulin levels were checked at each study visit and at the end of the study. Treatment success, as measured by the reduction of HbA 1c , was greatest for the 7.5 g D-tagatose dose group, although the difference between the treatments was not statistically significant. For fasting glucose, only the 7.5 g dosage group exhibited reductions from baseline at the 3- and 6-month time points. Mean body weights reduced in a dose-response fashion, with the 5.0 g and the 7.5 g D-tagatose doses providing the greatest reductions. D-tagatose at dosages of 2.5 g, 5.0 g, and 7.5 g TID for six months were well tolerated by this subject population. D-tagatose at 5.0 g TID was the minimal dose required to reduce HbA 1c . D-tagatose at 7.5 g TID provided the greatest effect in most measured efficacy parameters.

Effects of Three Low-Doses of D-Tagatose on Glycemic Control Over Six Months in Subjects with Mild Type 2 Diabetes Mellitus Under Control with Diet and Exercise

PubMed Central

Ensor, Mark; Williams, Jarrod; Smith, Rebecca; Banfield, Amy; Lodder, Robert A.

2014-01-01

The primary objective of this study was to evaluate the safety and the effect of D-tagatose on the glycemic control of subjects with type 2 diabetes as determined by HbA1c levels at the end of 6 months of therapy using the subject’s own baseline HbA1c level as a comparator. The determination of the minimal dose required to cause a statistically significant reduction in HbA1c was of particular interest. Eight weeks after screening, the qualifying subjects were randomized to receive one of three doses of D-tagatose: 2.5 g TID, 5.0 g TID or 7.5 g TID. Blood levels of HbA1c, fasting blood glucose concentrations, plasma lipids, changes in body weight, changes in body mass index, and change in insulin levels were checked at each study visit and at the end of the study. Treatment success, as measured by the reduction of HbA1c, was greatest for the 7.5 g D-tagatose dose group, although the difference between the treatments was not statistically significant. For fasting glucose, only the 7.5 g dosage group exhibited reductions from baseline at the 3- and 6-month time points. Mean body weights reduced in a dose-response fashion, with the 5.0 g and the 7.5 g D-tagatose doses providing the greatest reductions. D-tagatose at dosages of 2.5 g, 5.0 g, and 7.5 g TID for six months were well tolerated by this subject population. D-tagatose at 5.0 g TID was the minimal dose required to reduce HbA1c. D-tagatose at 7.5 g TID provided the greatest effect in most measured efficacy parameters. PMID:25580449

Can HbA1c be Used to Screen for Glucose Abnormalities Among Adults with Severe Mental Illness?

PubMed

Romain, A J; Letendre, E; Akrass, Z; Avignon, A; Karelis, A D; Sultan, A; Abdel-Baki, A

2017-04-01

Aim: Prediabetes and type 2 diabetes are highly prevalent among individuals with serious mental illness and increased by antipsychotic medication. Although widely recommended, many obstacles prevent these patients from obtaining a proper screening for dysglycemia. Currently, glycated hemoglobin (HbA1c), fasting glucose, and 2-hour glucose levels from the oral glucose tolerance test are used for screening prediabetes and type 2 diabetes. The objective of this study was to investigate if HbA1c could be used as the only screening test among individuals with serious mental illness. Methods: Cross sectional study comparing the sensitivity of HbA1c, fasting glucose, and 2-h oral glucose tolerance test to detect dysglycemias in serious mental illness participants referred for metabolic complications. Results: A total of 84 participants (43 female; aged: 38.5±12.8 years; BMI: 35.0±6.8 kg/m²) was included. Regarding prediabetes, 44, 44 and 76% were identified by HbA1c, fasting glucose, and 2 h- oral glucose tolerance test respectively and for type 2 diabetes, 60, 53 and 66% were identified by HbA1c, fasting glucose and 2 h-oral glucose tolerance test. The overlap between the 3 markers was low (8% of participants for prediabetes and 26% for Type 2 diabetes). Sensitivity of HbA1c were moderate (range 40-62.5%), while its specificity was excellent (92-93%). Conclusion: The present study indicates a low agreement between HbA1c, fasting glucose and 2-h oral glucose tolerance test. It appears that these markers do not identify the same participants. Thus, HbA1c may not be used alone to detect all glucose abnormalities among individuals with serious mental illness. © Georg Thieme Verlag KG Stuttgart · New York.

Screening with HbA1c identifies only one in two individuals with diagnosis of prediabetes at oral glucose tolerance test: findings in a real-world Caucasian population.

PubMed

Chilelli, Nino Cristiano; Cosma, Chiara; Ragazzi, Eugenio; Burlina, Silvia; Zaninotto, Martina; Plebani, Mario; Lapolla, Annunziata

2014-10-01

Discordance between HbA1c and OGTT in screening pre-diabetes may occur because of lack of laboratory standardization, distinct underlying pathophysiological processes or different ethnicity. We evaluated HbA1c efficacy for screening OGTT-defined IFG and IGT conditions in a large Caucasian population using the newly revised IFCC protocol. A total of 501 consecutive subjects were screened for pre-diabetic conditions with OGTT with 75 g of glucose. Testing for HbA1c, lipid profile and fasting insulin levels was also performed. For detecting differences between continuous variables, ANOVA followed by Tukey's honestly significant difference (HSD) post hoc test was used. Logistic regression and ROC curve analysis were also performed for assessing HbA1c screening efficacy. ROC curve analysis showed that optimal HbA1c cut-off for detecting IFG was 5.6 % (sensitivity of 78 % and specificity of 63 %), while for IGT, the optimal cut-off was 5.9 % (sensitivity of 46 % and specificity of 84 %), with AUCs < 0.8. Screening with HbA1c identified 53.4 % of the 193 patients with IFG and/or IGT diagnosed at OGTT. As regards surrogate markers of insulin resistance, we observed a trend towards higher values of HOMA-IR and lower QUICKI values in subjects with IFG than in those with IGT. Patients with pre-diabetes at both tests had similar values of HOMA and QUICKI, compared with those with altered OGTT only. IFCC-aligned HbA1c assay proved scarcely effective in detecting IFG and/or IGT in a large Caucasian population, identifying only half of the patients with abnormal OGTT. Moreover, adding HbA1c screening to OGTT may be of little benefit in identifying subjects with a worse metabolic profile.

Association of diet and lifestyle with glycated haemoglobin in type 1 diabetes participants in the EURODIAB prospective complications study.

PubMed

Balk, S N; Schoenaker, D A J M; Mishra, G D; Toeller, M; Chaturvedi, N; Fuller, J H; Soedamah-Muthu, S S

2016-02-01

Diet and lifestyle advice for type 1 diabetes (T1DM) patients is based on little evidence and putative effects on glycaemic control. Therefore, we investigated the longitudinal relation between dietary and lifestyle variables and HbA1c levels in patients with type 1 diabetes. A 7-year prospective cohort analysis was performed in 1659 T1DM patients (52% males, mean age 32.5 years) participating in the EURODIAB Prospective Complications Study. Baseline dietary intake was assessed by 3- day records and physical activity, smoking status and alcohol intake by questionnaires. HbA1c during follow-up was centrally assessed by immunoassay. Analysis of variance (ANOVA) and restricted cubic spline regression analyses were performed to assess dose-response associations between diet and lifestyle variables and HbA1c levels, adjusted for age, sex, lifestyle and body composition measures, baseline HbA1c, medication use and severe hypoglycaemic attacks. Mean follow-up of our study population was 6.8 (s.d. 0.6) years. Mean HbA1c level was 8.25% (s.d. 1.85) (or 66.6 mmol/mol) at baseline and 8.27% (s.d. 1.44) at follow-up. Physical activity, smoking status and alcohol intake were not associated with HbA1c at follow-up in multivariable ANOVA models. Baseline intake below the median of vegetable protein (<29 g/day) and dietary fibre (<18 g/day) was associated with higher HbA1c levels. Restricted cubic splines showed nonlinear associations with HbA1c levels for vegetable protein (P (nonlinear)=0.008) and total dietary fibre (P (nonlinear)=0.0009). This study suggests that low intake of vegetable protein and dietary fibre are associated with worse glycaemic control in type 1 diabetes.

Association between hypoglycemia risk and hemoglobin A1C in patients with type 2 diabetes mellitus.

PubMed

Yu, Shengsheng; Fu, Alex Z; Engel, Samuel S; Shankar, R Ravi; Radican, Larry

2016-08-01

To better manage type 2 diabetes mellitus (T2DM), the tradeoff between improved glycemic control and hypoglycemia should be evaluated. The purpose of this study was to assess the relationship between hypoglycemia and hemoglobin A1c (HbA1c) in a real-world population. Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) was a multi-center, observational study. Patients ≥30 years old using any oral anti-hyperglycemic agent were recruited from seven European and five Asian countries between 2006 and 2007. Hypoglycemia events were collected through patient-reported questionnaires. HbA1c data was collected through chart review. Logistic regression was performed to assess the relationship between hypoglycemia and the most proximate HbA1c levels adjusting for potential confounders (demographics, clinical variables, other medication use, and comorbid conditions). A total of 4399 patients were recruited and analyzed. Mean age was 60 years, 52% were male, and 75% were on sulfonylureas (S.U.s). Respectively, 37% or 42% of patients reported hypoglycemia in the past 6 (Asia) or 12 months (Europe) before recruitment. Prevalence of hypoglycemia increased significantly (33% to 40%) as HbA1c decreased (p = 0.035). The same trend was also observed among S.U.-treated patients (p < 0.01). After adjusting for confounders, hypoglycemia prevalence was significantly higher for HbA1c <7.0% (odds ratio [O.R.] = 1.66 [95% C.I. 1.21, 2.28]; p = 0.002) vs. HbA1c ≥10.0%. Our analyses pooled data from Asia and Europe, which differed in terms of the recall period for ascertaining hypoglycemia symptoms and the timing of latest HbA1c measure. Lower HbA1c level was associated with higher hypoglycemia prevalence among S.U.-treated patients. HbA1c level should be taken into consideration when reporting hypoglycemia prevalence.

Blood Pressure Is the Determinant for the Increased Risk for Intracranial Arterial Stenosis in Subjects with Elevated Glycated Hemoglobin Levels: The Kangbuk Samsung Health Study.

PubMed

Oh, Hyung-Geun; Rhee, Eun-Jung

2016-11-01

Ischemic stroke is known to be an important vascular complication of diabetes. Intracranial arterial stenosis (ICAS) is considered as an important cause of stroke in Asians. We aimed to analyze the risk for ICAS assessed by transcranial Doppler (TCD) ultrasonography in different groups of young Korean subjects divided by glycated hemoglobin (HbA1c) levels. This study included 10,437 participants without history of cardiovascular diseases (81.3% men, mean age 43 years) from a health screening program, in whom TCD ultrasonography was used to detect greater than 50% ICAS based on criteria modified from the SONIA (Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis) trial. The subjects were divided into 3 groups according to HbA1c levels: HbA1c < 5.7%, 5.7 ≤ HbA1c < 6.5%, and HbA1c ≥ 6.5% or under medication for diabetes. Among the participants, 3.0% of the subjects had ICAS. The subjects with ICAS tended to have higher mean HbA1c level compared with those without ICAS (5.8 ± .8 versus 5.7 ± .6, P = .063). The proportion of subjects with ICAS significantly increased as the HbA1c increased from the first to the third group (2.8%, 3.0%, 4.6%, P for linear trend = .022). In logistic regression analysis with ICAS as the dependent variable, the group with HbA1c ≥ 6.5% showed significantly increased odds ratio for ICAS with subjects with HbA1c < 5.7% as the reference after adjustment for confounding variables (1.575, 95% confidence interval 1.056-2.347). However, this significance disappeared with inclusion of presence of hypertension in the model. The risk for ICAS assessed by TCD was increased in young Korean subjects with HbA1c ≥ 6.5%. However, this significance was attenuated after adjustment for presence of hypertension, suggesting the importance of hypertension in ICAS. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Effects of total and green vegetable intakes on glycated hemoglobin A1c and triglycerides in elderly patients with type 2 diabetes mellitus: the Japanese Elderly Intervention Trial.

PubMed

Takahashi, Keiko; Kamada, Chiemi; Yoshimura, Hidenori; Okumura, Ryota; Iimuro, Satoshi; Ohashi, Yasuo; Araki, Atsushi; Umegaki, Hiroyuki; Sakurai, Takashi; Yoshimura, Yukio; Ito, Hideki

2012-04-01

Many reports have shown that vegetable intake is effective in inhibiting the onset and progression of diabetes mellitus, although the amount of vegetable intake required to be effective remains as unclear. The present study therefore aimed to clarify the relationship between the amount of vegetable intake and glycated hemoglobin A1c (HbA1c) and other metabolic parameters using male Japanese type 2 diabetic patients aged 65 years or older as subjects. Participants were 417 male type 2 diabetic patients aged 65 years or older enrolled in the Japanese Elderly Diabetes Intervention Trial. Dietary intakes were measured by using the Food Frequency Questionnaires method. The patients were divided into five groups by their daily total vegetable intake (A1: ~100 g, A2: 100~150 g, A3: 150~200 g, A4: 200~300 g, A5: 300 g~), and compared HbA1c and other metabolic parameters. Furthermore, the relationship between daily green vegetable intake and HbA1c and other metabolic parameters were examined among five groups divided by quintile methods. There were significant decreases in HbA1c, triglycerides and waist circumference with an increase of total vegetable intake. A significant decrease of HbA1c levels was observed in patients with a daily total vegetable intake of 150 g or more. Furthermore, there was a significant decrease of serum triglyceride levels in patients with a total vegetable intake of 200 g or more. HbA1c levels showed a decreasing tendency with the increase of green vegetable intake, and HbA1c levels in the Q1 group (green vegetable intake: less than 40 g) was significantly higher than those in the other four groups (anovaP = 0.025). In addition, there were significant decreases of body mass index, triglyceride levels and waist circumference with the increase of green vegetable intake. Triglyceride levels decreased significantly from the Q3 group (green vegetable intake: 70 g or more) to the Q5 group (green vegetable intake: 130 g or more; anovaP = 0.016). In the group with a lower intake of total vegetables and green vegetables, the protein energy ratio decreased significantly. As a result, the fat energy ratio and energy intake tended to increase with the decrease of total and green vegetable intakes. Furthermore, intake of grains, sweets and alcoholic beverages increased with the decrease of total vegetable intake. In contrast, intake of nuts, potatoes, sugar, legumes, fruit, seaweed and fish increased with the increase of total vegetable intake Daily total vegetable intake of 200 g or more, and green vegetable intake of 70 g or more correlated with improved control of HbA1c and triglyceride levels in elderly type 2 diabetes patients through achieving a well-balanced diet. © 2012 Japan Geriatrics Society.

[Three-year follow up of metabolic control in adolescents with type 1 diabetes with and without eating disorders].

PubMed

Figueroa Sobrero, Angela; Evangelista, Patricia; Mazza, Carmen; Basso, Pablo; López, Stella M; Scaiola, Edith; Honf, Margarita; Ferraro, Mabel; Eandi, María L; Walz, Florencia

2010-04-01

Eating disorders associated to type 1 diabetes (T1D) raise the risk of impairments in metabolic control increasing short and long term complications. To compare the glycosylated hemoglobin (HbA1c) levels variation in a group of T1D adolescents with and without disordered eating behaviour (DEB) during 3-year follow-up and to relate the metabolic control, with pubertal stage, T1D duration, Body Mass Index and gender at the end of the study. Analytyc an observational comparative study of two cohorts: patients were selected from a previous multicentric study done by the Paediatric Committee of the Argentinean Diabetes Association. One DEB sample group and another group without DEB were conformed. HbA1c levels were estimated al baseline and after 3 years. Pubertal stage, BMI, gender and duration of T1D were assessed at the end of the study. Comparison of statistical tests of HbA1c levels and association tests were made. Eighty seven patients, 22 with DEB and 65 without DEB were studied. Patient's mean ages (13.6 vs.14.3 years) and T1D evolution time (4.0 vs. 4.7 years) were similar in both groups. Three years later, there was an increase in the mean HbA1c levels in both groups, with statistical differences only in the DEB group (8.40 vs. 9.93) (p: 0.001), but not in the group without DEB [8.57 vs. 9.01 (p: 0.06)]. An association between metabolic control and the presence of DEB was observed but not with the other studied variables. Presence and persistence DEB in T1D patients implies a worsening prognosis of the metabolic control in the future.

Association of Glycemic Status with Bone Turnover Markers in Type 2 Diabetes Mellitus.

PubMed

Kulkarni, Sweta Vilas; Meenatchi, Suruthi; Reeta, R; Ramesh, Ramasamy; Srinivasan, A R; Lenin, C

2017-01-01

Type 2 diabetes mellitus has profound implications on the skeleton. Even though bone mineral density is increased in type 2 diabetes mellitus patients, they are more prone for fractures. The weakening of bone tissue in type 2 diabetes mellitus can be due to uncontrolled blood sugar levels leading to high levels of bone turnover markers in blood. The aim of this study is to find the association between glycemic status and bone turnover markers in type 2 diabetes mellitus. This case-control study was carried out in a tertiary health care hospital. Fifty clinically diagnosed type 2 diabetes mellitus patients in the age group between 30 and 50 years were included as cases. Fifty age- and gender-matched healthy nondiabetics were included as controls. Patients with complications and chronic illness were excluded from the study. Depending on glycated hemoglobin (HbA1c) levels, patients were grouped into uncontrolled (HbA1c >7%, n = 36) and controlled (HbA1c <7%, n = 14) diabetics. Based on duration of diabetes, patients were grouped into newly diagnosed, 1-2 years, 3-5 years, and >5 years. Serum osteocalcin (OC), bone alkaline phosphatase (BAP), acid phosphatase (ACP), and HbA1c levels were estimated. OC/BAP and OC/ACP ratio was calculated. Student's t -test, analysis of variance, and Chi-square tests were used for analysis. Receiver operating characteristic (ROC) curve analysis was done for OC/BAP and OC/ACP ratios. Serum OC, HbA1c, and OC/BAP ratio were increased in cases when compared to controls and were statistically significant ( P < 0.001). OC/ACP ratio was decreased in type 2 diabetes mellitus and was statistically significant ( P = 0.01). In patients with >5-year duration of diabetes, HbA1c level was high and was statistically significant ( P < 0.042). BAP levels were high in uncontrolled diabetics but statistically not significant. ROC curve showed OC/BAP ratio better marker than OC/ACP ratio. Uncontrolled type 2 diabetes mellitus affects bone tissue resulting in variations in bone turnover markers. Bone turnover markers are better in predicting recent changes in bone morphology and are cost effective.

The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial.

PubMed

Parker, Anna R; Byham-Gray, Laura; Denmark, Robert; Winkle, Peter J

2014-11-01

Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus. The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings. We investigated the effect of medical nutrition therapy (MNT) compared with usual care on fasting plasma glucose values, glycated hemoglobin (HbA1c), serum lipid levels, and Diabetes Risk Score, from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes. Prospective, randomized, parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7% to 6.4%, recruited between April 2010 and May 2011 who completed a 12-week intervention period. The primary outcome measure was fasting plasma glucose. Secondary outcome measures were HbA1c, serum lipid levels, and Diabetes Risk Score. A factorial repeated measures analysis of variance was used to make comparisons between the two groups (the MNT and usual care groups) and two measures of time (baseline and 12 weeks postintervention). Data analysis was performed using the Statistical Package for the Social Sciences (release 19.0, 2010, SPSS Inc). There was a significant interaction for group assignment and HbA1c (P=0.01), with the MNT group experiencing significantly lower HbA1c levels than the usual care group (5.79% vs 6.01%) after the 12-week intervention. There was a significant interaction for group assignment and Diabetes Risk Score (P=0.001). Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score, which went from 17.23±4.69 to 16.83±4.73. Regardless of group assignment, both groups experienced a reduction in total cholesterol (P=0.01) and low-density lipoprotein cholesterol (P=0.04) level. The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Does treatment with an insulin pump improve glycaemic control in children and adolescents with type 1 diabetes? A retrospective case-control study.

PubMed

Brorsson, Anna Lena; Viklund, Gunnel; Örtqvist, Eva; Lindholm Olinder, Anna

2015-11-01

To investigate long-term effects on glycaemic control, ketoacidosis, serious hypoglycaemic events, insulin requirements, and body mass index standard deviation scores (BMI-SDS) in children and adolescents with type 1 diabetes starting on continuous subcutaneous insulin infusion (CSII) compared with children and adolescents treated with multiple daily injections (MDI). This retrospective case-control study compares 216 patients starting CSII with a control group on MDI (n = 215), matched for glycated hemoglobin (HbA1c), sex, and age during a 2-yr period. Variables collected were gender, age, HbA1c, insulin requirement, BMI, BMI-SDS, ketoacidosis, and serious hypoglycaemic events. In the CSII group there was an improvement in HbA1c after 6 and 12 months compared with the MDI group. For boys and girls separately the same effect was detected after 6 months, but only for boys after 12 months. The incidence of ketoacidosis was higher in the CSII group compared with the MDI group (2.8 vs. 0.5/100 person-yr). The incidences of severe hypoglycaemic episodes per 100 person-yr were three in the CSII group and six in the MDI group (p < 0.05). After 6, 12, and 24 months, the insulin requirement was higher in the MDI group. This study shows that treatment with CSII resulted in an improvement in HbA1c levels up to 1 yr and decreased the number of severe hypoglycaemic events, but the frequency of ketoacidosis increased. The major challenge is to identify methods to maintain the HbA1c improvement, especially among older children and teenagers, and reduce the frequency of ketoacidosis. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons 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.

Vitreous Fluid and/or Urine Glucose Concentrations in 1,335 Civil Aviation Accident Pilot Fatalities

DTIC Science & Technology

2008-05-01

glucose, and in those cases wherein glucose levels are elevated, blood hemoglobin A1c ( HbA1c ) is measured. These analyses are conducted to monitor...diabetes. In this study, the prevalence of elevated glucose concentrations in fatally injured civilian pilots is evaluated. Glucose and HbA1c are measured...whom samples were received during 1998–2005 and whose vitreous fluid and/or urine glucose concentrations were measured. HbA1c levels and information

Getting to goal in newly diagnosed type 2 diabetes using combination drug "subtraction therapy".

PubMed

Jennings, Anthony S; Lovett, Alexandra J; George, Tina M; Jennings, Jonathan S

2015-09-01

The treatment of newly diagnosed type 2 diabetes mellitus is diverse, with no clear consensus regarding the initial drug regimen or dosing to achieve optimal glycemic control. We treated 44 consecutive patients with newly diagnosed type 2 diabetes with maximally tolerated doses of pioglitazone 45 mg/day, metformin 1000-2000 mg/day, and repaglinide 1-4 mg before meals. The doses and drugs were subsequently decreased ("subtraction therapy") to achieve optimal glycemic control and minimize side effects. Three primary outcomes were measured: the short term HbA1c response, the long term HbA1c response, and the incidence of hypoglycemia. All 44 patients responded with a rapid, progressive decline in their HbA1c levels from 11.43±2.3% to 6.17±0.72% (101±25.1 mmol/mol to 44±7.9 mmol/mol) by three months, and remained stable thereafter. An HbA1c ≤7.0% (≤53 mmol/mol) was reached within 1-4 months in 42 of 44 patients, and in every patient by 12 months. Each patient's lowest HbA1c level, 5.65±0.6% (38±6.6 mmol/mol), was reached over 6.3±2.9 months. Patients with initial HbA1c levels >10% (>86 mmol/mol) (n=33) responded similarly as those with HbA1c levels <10% (<86 mmol/mol) (n=11). Combination drug therapy maintained HbA1c levels between 5.0 and 7.0% (31 and 53 mmol/mol) for up to 14.83 years. Only one clinically significant hypoglycemic event occurred during 261.08 person-years of follow-up. In our experience, combination drug "subtraction therapy" was safe and effective for treating all newly diagnosed type 2 diabetic patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Serum leptin concentrations in children with type 1 diabetes mellitus: relationship to body mass index, insulin dose, and glycemic control.

PubMed

Soliman, Ashraf T; Omar, Magdi; Assem, Hala M; Nasr, Ibrahim S; Rizk, Mohamed M; El Matary, Wael; El Alaily, Rania K

2002-03-01

Although obesity is a frequent feature of type 2 diabetes mellitus (DM), many patients with type 1 DM are prone to high body mass index (BMI). We measured serum leptin concentrations in a cohort of children (n = 55) with type 1 diabetes mellitus (DM), as well as their anthropometric parameters including BMI, skin fold thickness at multiple sites, and midarm circumference. Glycemic control was assessed by blood glucose (BG) monitoring before meals, and measurement of glycated hemoglobin (HbA1c) and insulin dose/kg/d was recorded. Dietary evaluation and assessment of caloric intake (kg/d) was performed by an expert dietitian. In the newly diagnosed children (n = 10) before initiation of insulin therapy, circulating leptin concentration was significantly lower (1.1 +/- 0.8 ng/dL) versus 5 days after insulin therapy (1.45 +/- 0.7 ng/dL). The decreased leptin level appears to be related to insulinopenia in these patients. In 45 children with type 1 DM on conventional therapy (2 doses of insulin mixture (NPH and regular) subcutaneous (SC) before breakfast and dinner for more than 2 years), serum leptin concentration was significantly higher (2.15 +/- 1 ng/dL) compared with age-matched normal children (1.3 +/- 1 ng/dL). Diabetic children were further divided into 2 groups according to their HbA1c level: group 1 with HbA1C less than 7.5% (less than 2 SD above the mean for normal population) (n = 29) and group 2 with HbA1c greater than 7.5%. (greater than 2 SD above the mean for normal population) (n = 16). Patients with a higher HbA1c level (group 2) had a higher leptin concentration (2.3 +/- 0.8 ng/dL), higher BMI (17.8 +/- 1.7), and were receiving higher insulin dose/kg (0.92 +/- 0.2 U/kg/d) compared with group 1 (lower HbA1c) (1.78 +/- 0.8 ng/dL, 16.7 +/- 1.5, and 0.59 +/- 0.2 U/kg/d, respectively). Group 2 patients had a higher incidence of late morning hypoglycemia (9/29) versus group 1 patients (2/16). Analysis of dietary intake showed that patients with a higher HbA1c (group 2) consumed more calories (73.5 +/- 10.5 kcal/kg/d) versus patients with lower HbA1c (64.2 +/- 8.7 kcal/kg/d). These findings pointed to the unphysiologic nature of injecting a mixture of insulin twice daily. To cover the relatively big lunch meal (40% to 50% of the total caloric intake in the Arab countries) and prevent afternoon hyperglycemia, there is a great tendency to increase NPH dose before breakfast. This, in turn, induces late-morning hypoglycemia and increases appetite and food intake at that time. Multiple regression analysis showed that circulating leptin concentrations (the dependent variable) were best correlated with the mean skinfold thickness (SFT), BMI, and caloric intake/kg/d (together they explained 65% of the variability in leptin concentrations). It appears that oversubstitution by insulin and increased food intake stimulate fat synthesis and subsequently BMI. Increased appetite and BMI contribute to increased leptin secretion and explains the higher leptin levels in undercontrolled diabetic children (higher circulating HbA1c concentrations) who were oversubstituted by insulin. Copyright 2002 by W.B. Saunders Company

Is insulin the most effective injectable antihyperglycaemic therapy?

PubMed

Buse, J B; Peters, A; Russell-Jones, D; Furber, S; Donsmark, M; Han, J; MacConell, L; Maggs, D; Diamant, M

2015-02-01

The recent type 2 diabetes American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) position statement suggested insulin is the most effective glucose-lowering therapy, especially when glycated haemoglobin (HbA1c) is very high. However, randomized studies comparing glucagon-like peptide-1 receptor agonists (GLP-1RAs) exenatide once-weekly [OW; DURATION-3 (Diabetes therapy Utilization: Researching changes in A1c, weight, and other factors Through Intervention with exenatide ONce-Weekly)] and liraglutide once-daily [OD; LEAD-5 (Liraglutide Effect and Action in Diabetes)] with insulin glargine documented greater HbA1c reduction with GLP-1RAs, from baseline HbA1c ∼8.3% (67 mmol/mol). This post hoc analysis of DURATION-3 and LEAD-5 examined changes in HbA1c, fasting glucose and weight with exenatide OW or liraglutide and glargine, by baseline HbA1c quartile. Descriptive statistics were provided for change in HbA1c, fasting glucose, weight, and insulin dose, and subjects (%) achieving HbA1c <7.0%, by baseline HbA1c quartile. Inferential statistical analysis on the effect of baseline HbA1c quartile was performed for change in HbA1c. An analysis of covariance (ANCOVA) model was used to evaluate similarity in change in HbA1c across HbA1c quartiles. At 26 weeks, in both studies, HbA1c reduction, and proportion of subjects reaching HbA1c <7.0%, were similar or numerically greater with the GLP-1RAs than glargine for all baseline HbA1c quartiles. Fasting glucose reduction was similar or numerically greater with glargine. Weight decreased with both GLP-1RAs across all quartiles; subjects taking glargine gained weight, more at higher baseline HbA1c. Adverse events were uncommon although gastrointestinal events occurred more frequently with GLP-1RAs. HbA1c reduction with the GLP-1RAs appears at least equivalent to that with basal insulin, irrespective of baseline HbA1c. This suggests that liraglutide and exenatide OW may be appropriate alternatives to basal insulin in type 2 diabetes, including when baseline HbA1c is very high (≥9.0%). © 2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

HOMA-IR Values are Associated With Glycemic Control in Japanese Subjects Without Diabetes or Obesity: The KOBE Study

PubMed Central

Hirata, Takumi; Higashiyama, Aya; Kubota, Yoshimi; Nishimura, Kunihiro; Sugiyama, Daisuke; Kadota, Aya; Nishida, Yoko; Imano, Hironori; Nishikawa, Tomofumi; Miyamatsu, Naomi; Miyamoto, Yoshihiro; Okamura, Tomonori

2015-01-01

Background Several studies have reported that insulin resistance was a major risk factor for the onset of type 2 diabetes mellitus in individuals without diabetes or obesity. We aimed to clarify the association between insulin resistance and glycemic control in Japanese subjects without diabetes or obesity. Methods We conducted a community-based cross-sectional study including 1083 healthy subjects (323 men and 760 women) in an urban area. We performed multivariate regression analyses to estimate the association between the homeostasis model assessment of insulin resistance (HOMA-IR) values and markers of glycemic control, including glycated haemoglobin (HbA1c), 1,5-anhydroglucitol (1,5-AG), and fasting plasma glucose (FPG) levels, after adjustment for potential confounders. Results Compared with the lowest tertile of HOMA-IR values, the highest tertile was significantly associated with HbA1c and FPG levels after adjustment for potential confounders, both in men (HbA1c: β = 1.83, P = 0.001; FPG: β = 0.49, P < 0.001) and women (HbA1c: β = 0.82, P = 0.008; FPG: β = 0.39, P < 0.001). The highest tertile of HOMA-IR values was inversely associated with 1,5-AG levels compared with the lowest tertile (β = −18.42, P = 0.009) only in men. Conclusions HOMA-IR values were associated with markers of glycemic control in Japanese subjects without diabetes or obesity. Insulin resistance may influence glycemic control even in a lean, non-diabetic Asian population. PMID:26005064

Clinical outcomes and incremental costs from a medication adherence pilot intervention targeting low-income patients with diabetes at risk of cost-related medication nonadherence.

PubMed

Ryan, John G; Fedders, Mark; Jennings, Terri; Vittoria, Isabel; Yanes, Melissa

2014-12-01

The extent to which reducing cost-related barriers affects diabetes outcomes and medication adherence among uninsured patients is not known. The purpose of these analyses was to understand the clinical impact and cost considerations of a prescription assistance program targeting low-income, minority patients with diabetes and at high risk for cost-related medication nonadherence. Patients received diabetes medications without copayments for 12 months. Change in diabetes control was calculated by using glycosylated hemoglobin (HbA1c) level at follow-up compared with baseline. Clinical data were collected from the electronic health record. Medication adherence for diabetes medications was estimated by using proportion of days covered (PDC). Incremental acquisition and per-patient costs, based on actual hospital medication costs, were calculated for different baseline HbA1c levels. Patients with baseline HbA1c levels ≥7%, ≥8%, and ≥9% experienced mean HbA1c reductions of 0.82% (P = 0.008), 1.02% (P = 0.010), and 1.47% (P = 0.010), respectively, during the 12-month period. The average PDC was 70.55%; 45.24% had a PDC ≥80%, indicating an adequate level of medication adherence. Medication adherence ≥80% was associated with ethnicity (P = 0.015), whereas mean PDC was associated with number of diabetes medication classes used (P = 0.031). Acquisition cost for 1242 prescriptions filled by 103 patients was $13,365.82, representing per-patient costs of $132.39; however, as baseline targets increased, acquisition costs decreased and per-patient costs increased from $10,682.59 and $169.56 to $6509.91 and $192.27, respectively. Clinically significant reductions in HbA1c levels were achieved for all patients, although greater reductions were achieved with modest per-patient cost increases when considering patients with uncontrolled diabetes. Incorporating a multifactorial intervention to address cost-related medication nonadherence with a behavior change component may yield greater reductions in HbA1c with improved diabetes outcomes and meaningful hospital-based cost savings. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Associations between long-term exposure to air pollution, glycosylated hemoglobin and diabetes.

PubMed

Honda, Trenton; Pun, Vivian C; Manjourides, Justin; Suh, Helen

2017-10-01

Air pollution exposures have been shown to adversely impact health through a number of biological pathways associated with glucose metabolism. However, few studies have evaluated the associations between air pollution and glycosylated hemoglobin (HbA1c) levels. Further, no studies have evaluated these associations in US populations or investigated whether associations differ in diabetic as compared to non-diabetic populations. To address this knowledge gap, we investigated the associations between airborne fine particulate matter (PM 2.5 ) and nitrogen dioxide (NO 2 ) and HbA1c levels in both diabetic and non-diabetic older Americans. We also examined the impact of PM 2.5 and NO 2 on prevalent diabetes mellitus (DM) in this cohort. We used multilevel logistic and linear regression models to evaluate the association between long-term average air pollutant levels and prevalence of DM and HbA1c levels, respectively, among 4121 older (57+ years) Americans enrolled in the National Social Life, Health, and Aging Project between 2005 and 2011. All models adjusted for age, sex, body mass index, smoking status, race, household income, education level, neighborhood socioeconomic status, geographic region, urbanicity and diabetic medication use. We estimated participant-specific exposures to PM 2.5 on a six-kilometer grid covering the conterminous U.S. using spatio-temporal models, and to NO 2 using nearest measurements from the Environmental Protection Agency's Air Quality System. HbA1c levels were measured for participants in each of two data collection waves from dried blood spots and log-transformed prior to analysis. Participants were considered diabetic if they had HbA1c values≥6.5% or reported taking diabetic medication. The prevalence of diabetes at study entry was 22.2% (n=916) and the mean HbA1c was 6.0±1.1%. Mean one-year moving average PM 2.5 and NO 2 exposures were 10.4±3.0μg/m 3 and 13.1±7.0 ppb, respectively. An inter-quartile range (IQR, 3.9μg/m 3 ) increase in one-year moving average PM 2.5 was positively associated with increased diabetes prevalence (prevalence odds ratio, POR 1.35, 95% CI: 1.19, 1.53). Similarly, an IQR (8.6 ppb) increase in NO 2 was also significantly associated with diabetes prevalence (POR 1.27, 95% CI: 1.10, 1.48). PM 2.5 (1.8%±0.6%, p<0.01) and NO 2 (2.0%±0.7%, p<0.01) exposures were associated with higher HbA1c levels in diabetic participants, while only NO 2 was significantly associated with HbA1c in non-diabetic participants (0.8%±0.2%, p<0.01). Significant dose response relationships were identified for both pollutants in diabetic participants and for NO 2 in non-diabetic participants. In a cohort of older men and women in the United States, PM 2.5 and NO 2 exposures were significantly associated with prevalence of DM and increased HbA1c levels among both non-diabetic and diabetic participants. These associations suggest that air pollution could be a key risk factor for abnormal glucose metabolism and diabetes in the elderly. Copyright © 2017 The Authors. Published by Elsevier GmbH.. All rights reserved.

Hb variants in Korea: effect on HbA1c using five routine methods.

PubMed

Yun, Yeo-Min; Ji, Misuk; Ko, Dae-Hyun; Chun, Sail; Kwon, Gye Cheol; Lee, Kyunghoon; Song, Sang Hoon; Seong, Moon Woo; Park, Sung Sup; Song, Junghan

2017-07-26

Quantification of glycated hemoglobin (HbA1c) is a challenge in patients with hemoglobin (Hb) variants. We evaluated the impact of various Hb variants on five routine HbA1c assays by comparing with the IFCC reference measurement procedure (RMP). Whole blood samples showing warning flags or no results on routine HPLC HbA1c assays were confirmed for Hb variants and were submitted to HbA1c quantification using Sebia Capillarys 2 Flex Piercing, Roche Tina-quant HbA1c Gen. 2, Bio-Rad Variant II Turbo 2.0, ADAMS HA-8180, Tosoh G8 standard mode, and IFCC RMP using LC-MS. Among 114 samples, the most common variants were Hb G-Coushatta (n=47), Queens (n=41), Ube-4 (n=11), Chad (n=4), Yamagata (n=4), G-His-Tsou (n=2), G-Taipei (n=1), Fort de France (n=1), Hoshida (n=1), and two novel variants (Hb α-globin, HBA 52 Gly>Cys and Hb β-globin, HBB 146 His>Asn). In terms of control samples, all the result of HbA1c were "acceptable", within the criteria of ±7% compared to IFCC RMP target values. However, percentage of "unacceptable" results of samples with Hb variants were 16% for Capillarys 2, 7% for Tina-quant, 51% for Variant II Turbo 2.0, 95% for G8 standard mode, and 89% for HA-8180. The Capillarys 2 and HA-8180 assay did not provide the results in 5 and 40 samples with Hb variants, respectively. HbA1c results from five routine assays in patients with relatively common Hb variants in Korea showed various degrees of bias compared to those of IFCC RMP. Therefore, laboratories should be aware of the limitation of their methods with respect to interference from Hb variants found commonly in their local population and suggest an alternative HbA1c quantification method.

Sub-antimicrobial Doxycycline for Periodontitis Reduces Hemoglobin A1c in Subjects with Type 2 Diabetes: a Pilot Study

PubMed Central

Engebretson, Steven P.; Hey-Hadavi, Judith

2011-01-01

In vitro and animal studies suggest a possible role for the tetracycline class of drugs in the inhibition of non-enzymatic protein glycation. We conducted a 3-month, randomized placebo-controlled pilot clinical trial of conventional sub-gingival debridement, (periodontal therapy) combined with either a three month regimen of sub-antimicrobial-dose doxycycline (SDD), a two week regimen of antimicrobial-dose doxycycline (ADD), or placebo in 45 patients with long-standing type 2 diabetes (mean duration 9 years) and untreated chronic periodontitis. Subjects were taking stable doses of oral hypoglycemic medications and/or insulin. Treatment response was assessed by measuring hemoglobin A1c (HbA1c),plasma glucose, and clinical periodontal disease measures. At one-month and three-month follow-up, clinical measures of periodontitis were decreased in all groups(data to be presented elsewhere). At three months, mean HbA1c levels in the SDD group were reduced 0.9% unitsfrom 7.2% units ± 2.2(±SD), to 6.3% units ±1.1, which represents a 12.5% improvement. In contrast, there was no significant change in HbA1c in the ADD (7.5%± 2.0 to 7.8%± 2.1) or placebo (8.5%± 2.0 to 8.5%± 2.6) groups. Mean HbA1c change from baseline was significantly greater in the SDD group compared with the ADD group (p=0.04) but not placebo (p=0.22). Moreover, a larger proportion of subjects in the SDD group experienced improvement (p<0.05) compared to the ADD or placebo groups. Mean plasma glucose levels were not significantly different between or within the groups. The results of this pilot study suggest that the treatment of periodontitis with sub-gingival debridement and 3-months of daily sub-antimicrobial-dose doxycycline may decrease HbA1c in patients with type 2 diabetes taking normally prescribed hypoglycemic agents. PMID:21782948

Reducing racial/ethnic disparities in diabetes: the Coached Care (R2D2C2) project.

PubMed

Kaplan, Sherrie H; Billimek, John; Sorkin, Dara H; Ngo-Metzger, Quyen; Greenfield, Sheldon

2013-10-01

Despite numerous efforts to change healthcare delivery, the profile of disparities in diabetes care and outcomes has not changed substantially over the past decade. To understand potential contributors to disparities in diabetes care and glycemic control. Cross sectional analysis. Seven outpatient clinics affiliated with an academic medical center. Adult patients with type 2 diabetes who were Mexican American, Vietnamese American or non-Hispanic white (n = 1,484). Glycemic control was measured as hemoglobin A1c (HbA1c) level. Patient, provider and system characteristics included demographic characteristics; access to care; quality of process of care including clinical inertia; quality of interpersonal care; illness burden; mastery (diabetes management confidence, passivity); and adherence to treatment. Unadjusted HbA1c values were significantly higher for Mexican American patients (n = 782) (mean = 8.3 % [SD:2.1]) compared with non-Hispanic whites (n = 389) (mean = 7.1 % [SD:1.4]). There were no significant differences in HbA1c values between Vietnamese American and non-Hispanic white patients. There were no statistically significant group differences in glycemic control after adjustment for multiple measures of access, and quality of process and interpersonal care. Disease management mastery and adherence to treatment were related to glycemic control for all patients, independent of race/ethnicity. Generalizability to other minorities or to patients with poorer access to care may be limited. The complex interplay among patient, physician and system characteristics contributed to disparities in HbA1c between Mexican American and non-Hispanic white patients. In contrast, Vietnamese American patients achieved HbA1c levels comparable to non-Hispanic whites and adjustment for numerous characteristics failed to identify confounders that could have masked disparities in this subgroup. Disease management mastery appeared to be an important contributor to glycemic control for all patient subgroups.

Economic evaluation of type 2 diabetes prevention programmes: Markov model of low- and high-intensity lifestyle programmes and metformin in participants with different categories of intermediate hyperglycaemia.

PubMed

Roberts, Samantha; Craig, Dawn; Adler, Amanda; McPherson, Klim; Greenhalgh, Trisha

2018-01-30

National guidance on preventing type 2 diabetes mellitus (T2DM) in the UK recommends low-intensity lifestyle interventions for individuals with intermediate categories of hyperglycaemia defined in terms of impaired fasting glucose (IFG) or 'at-risk' levels of HbA1c. In a recent systematic review of economic evaluations of such interventions, most studies had evaluated intensive trial-based lifestyle programmes in participants with impaired glucose tolerance (IGT). This study examines the costs and effects of different intensity lifestyle programmes and metformin in participants with different categories of intermediate hyperglycaemia. We developed a decision tree and Markov model (50-year horizon) to compare four approaches, namely (1) a low-intensity lifestyle programme based on current NICE guidance, (2) a high-intensity lifestyle programme based on the US Diabetes Prevention Program, (3) metformin, and (4) no intervention, modelled for three different types of intermediate hyperglycaemia (IFG, IGT and HbA1c). A health system perspective was adopted and incremental analysis undertaken at an individual and population-wide level, taking England as a case study. Low-intensity lifestyle programmes were the most cost-effective (£44/QALY, £195/QALY and £186/QALY compared to no intervention in IGT, IFG and HbA1c, respectively). Intensive lifestyle interventions were also cost-effective compared to no intervention (£2775/QALY, £6820/QALY and £7376/QALY, respectively, in IGT, IFG and HbA1c). Metformin was cost-effective relative to no intervention (£5224/QALY, £6842/QALY and £372/QALY in IGT, IFG and HbA1c, respectively), but was only cost-effective relative to other treatments in participants identified with HbA1c. At a willingness-to-pay threshold of £20,000/QALY, low- and high-intensity lifestyle programmes were cost-effective 98%, 99% and 98% and 81%, 81% and 71% of the time in IGT, IFG and HbA1c, respectively. An England-wide programme for 50-59 year olds could reduce T2DM incidence by < 3.5% over 50 years and would cost 0.2-5.2% of the current diabetes budget for 2-9 years. This analysis suggests that current English national policy of low-intensity lifestyle programmes in participants with IFG or HbA1c will be cost-effective and have the most favourable budget impact, but will prevent only a fraction of cases of T2DM. Additional approaches to prevention need to be investigated urgently.

Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.

PubMed

Cook, William; Minervini, Gianmaria; Bryzinski, Brian; Hirshberg, Boaz

2014-10-01

To test the effectiveness and safety of saxagliptin 5 mg/d in patients with type 2 diabetes mellitus (T2DM) with and without history of cardiovascular disease (CVD) or cardiovascular (CV) risk factors. The authors conducted a post hoc analysis of data from 3 randomized studies that compared saxagliptin versus placebo as initial combination therapy with metformin for 24 weeks (N = 648) and versus placebo as an add-on to insulin with and without metformin for 24 weeks (N = 455), and assessed noninferiority to glipizide as an add-on to metformin for 52 weeks (N = 858). Efficacy outcomes were the adjusted mean change from baseline in glycated hemoglobin (HbA1c) level, fasting plasma glucose concentration, and body weight and the proportion of patients achieving an HbA1c level < 7%. Pairwise comparisons were performed in subgroups with 1) history/no history of CVD, 2) ≥ 2 versus 0 to 1 CV risk factors, 3) hypertension/no hypertension, and 4) statin use/no statin use. Adverse events (AE) and hypoglycemia were monitored. In the initial combination therapy study, reductions in HbA1c level from baseline were greater with saxagliptin versus placebo in all subgroups (difference [saxagliptin - placebo], -0.38% to -0.67%). In the add-on to insulin ± metformin study, differences in adjusted mean change in HbA1c level versus placebo ranged from -0.23% to -0.58% across subgroups. In the noninferiority to glipizide study, adjusted mean changes in HbA1c level were comparable between saxagliptin and glipizide, across subgroups (difference, 0.08%-0.21%). No evidence suggested clinically relevant treatment-by-subgroup interactions in pairwise comparison. Incidences of ≥ 1 AE were comparable across subgroups. Incidences of confirmed hypoglycemia with saxagliptin were 0 in both metformin add-on studies and 1.2% to 7.8% with saxagliptin + insulin ± metformin. In patients with T2DM, saxagliptin 5 mg/d was similarly effective in improving glycemic control, with an AE profile similar to that of placebo, irrespective of CVD history, number of CV risk factors, hypertension, or statin use. www.ClinicalTrials.gov identifiers: NCT00327015, NCT00575588, NCT00757588.

Impact of Admission Glycosylated Hemoglobin A1c on Angiographic Characteristics and Short Term Clinical Outcomes of Nondiabetic Patients with Acute ST-Segment Elevation Myocardial Infarction

PubMed Central

El-sherbiny, Islam; Nabil, Baher; Saber, Tamer; Abdelgawad, Fathy Elsayed

2015-01-01

We aimed to assess the predictive value of admission HbA1c level in nondiabetic patients presented by acute STEMI, on outcome of PCI and short term outcome of adverse cardiac events. Methods. 60 nondiabetic patients were admitted to Cardiology Department, Zagazig University Hospital, with acute STMI: 27 patients with HbA1c levels of 4.5% to 6.4% (group 1), 17 patients with HbA1c levels of 6.5% to 8.5% (group 2), and 16 patients with HbA1c levels higher than 8.5% (group 3). Either invasive intervention was done at admission by (pPCI) or coronary angiography was done within month (3–28 days) from taking thrombolytic. Participants were followed up for 6 months. Results. There was significant difference among different groups of HbA1c as regards the number of diseased vessels, severity of CAD lesions (p value < 0.01), and TIMI flow grades (p value < 0.05). There was significant difference among different groups as regards the adverse cardiac events on short term follow-up period (p value < 0.05). Conclusion. The present study showed that admission higher HbA1c level in patients presented by acute STEMI is associated with more severe CAD, lower rate of complete revascularization, and higher incidence of adverse cardiac events. PMID:26697259

Continuous glucose monitoring adds information beyond HbA1c in well-controlled diabetes patients with early cardiovascular autonomic neuropathy.

PubMed

Fleischer, Jesper; Laugesen, Esben; Cichosz, Simon Lebech; Hoeyem, Pernille; Dejgaard, Thomas Fremming; Poulsen, Per Loegstrup; Tarnow, Lise; Hansen, Troels Krarup

2017-09-01

Hyperglycemia as evaluated by HbA1c is a risk factor for the development of cardiovascular autonomic neuropathy (CAN). The aim of the present study was to investigate whether continuous glucose monitoring (CGM) may add information beyond HbA1c in patients with type 2 diabetes and CAN. 81 patients with type 2 diabetes (43 men, mean age 58±11year, HbA1c 6.6±0.5%). Patients were tested for CAN using cardiovascular reflex tests (response to standing, deep breathing and Valsalva maneuver) and underwent CGM for three days. CAN was defined as early (one test abnormal), or manifest (two or three tests abnormal). Twenty patients had early CAN and two patients had manifest CAN. Blood pressure, HbA1c, cholesterol levels and smoking habits were comparable in patients with vs. without CAN. Post-breakfast glycemic peak was significantly higher in patients with CAN (peak 207 vs 176mg/dL, P=0.009). Furthermore, the nocturnal glucose drop and dawn glucose was significantly higher in patients with CAN compared with patients without CAN (mean 134 vs. 118mg/dL, P=0.017 and mean 143 vs. 130mg/dL, P=0.045, respectively). Removing the two patients with manifest CAN from the statistical analysis didn't change the results. These findings emphasize the importance of monitoring glucose patterns over 24-h and not only rely on HbA1c as therapeutic target in patients with type 2 diabetes and CAN. Copyright © 2017 Elsevier Inc. All rights reserved.

Modified HPLC-ESI-MS Method for Glycated Hemoglobin Quantification Based on the IFCC Reference Measurement Procedure and Its Application for Quantitative Analyses in Clinical Laboratories of China.

PubMed

Song, Zhixin; Xie, Baoyuan; Ma, Huaian; Zhang, Rui; Li, Pengfei; Liu, Lihong; Yue, Yuhong; Zhang, Jianping; Tong, Qing; Wang, Qingtao

2016-09-01

The level of glycated hemoglobin (HbA1c ) has been recognized as an important indicator of long-term glycemic control. However, the HbA1c measurement is not currently included as a diagnostic determinant in China. Current study aims to assess a candidate modified International Federation of Clinical Chemistry reference method for the forthcoming standardization of HbA1c measurements in China. The HbA1c concentration was measured using a modified high-performance liquid chromatography-electrospray ionization-mass spectrometry (HPLC-ESI-MS) method. The modified method replaces the propylcyanide column with a C18 reversed-phase column, which has a lower cost and is more commonly used in China, and uses 0.1% (26.5 mmol/l) formic acid instead of trifluoroacetic acid. Moreover, in order to minimize matrix interference and reduce the running time, a solid-phase extraction was employed. The discrepancies between HbA1c measurements using conventional methods and the HPLC-ESI-MS method were clarified in clinical samples from healthy people and diabetic patients. Corresponding samples were distributed to 89 hospitals in Beijing for external quality assessment. The linearity, reliability, and accuracy of the modified HPLC-ESI-MS method with a shortened running time of 6 min were successfully validated. Out of 89 hospitals evaluated, the relative biases of HbA1c concentrations were < 8% for 74 hospitals and < 5% for 60 hospitals. Compared with other conventional methods, HbA1c concentrations determined by HPLC methods were similar to the values obtained from the current HPLC-ESI-MS method. The HPLC-ESI-MS method represents an improvement over existing methods and provides a simple, stable, and rapid HbA1c measurement with strong signal intensities and reduced ion suppression. © 2015 Wiley Periodicals, Inc.

Serum Uric Acid Levels were Dynamically Coupled with Hemoglobin A1c in the Development of Type 2 Diabetes

NASA Astrophysics Data System (ADS)

Wei, Fengjiang; Chang, Baocheng; Yang, Xilin; Wang, Yaogang; Chen, Liming; Li, Wei-Dong

2016-06-01

The aim of the study was to decipher the relationship between serum uric acid (SUA) and glycated hemoglobin A1c (HbA1c) or fasting plasma glucose (FPG) in both type 2 diabetes mellitus (T2DM) patients and normal subjects. A total of 2,250 unrelated T2DM patients and 4,420 Han Chinese subjects from a physical examination population were recruited for this study. In T2DM patients SUA levels were negatively correlated with HbA1c (rs = -0.109, P = 0.000) and 2 h plasma glucose levels (rs = -0.178, P = 0.000). In the physical examination population, SUA levels were inversely correlated with HbA1c (rs = -0.175, P = 0.000) and FPG (rs = -0.131, P = 0.009) in T2DM patients but positively correlated with HbA1c (rs = 0.040, P = 0.012) and FPG (rs = 0.084, P = 0.000) in normal-glucose subjects. Multivariate analyses showed that HbA1c was significantly negatively associated with HUA both in T2DM patients (OR = 0.872, 95% CI: 0.790~0.963) and in the physical examination T2DM patients (OR = 0.722, 95% CI: 0.539~0.968). Genetic association studies in T2DM patients showed that alleles of two glucose-uric acid transporter genes, ABCG2 and SLC2A9 were significantly associated with SUA levels (P < 0.05). SUA level is inversely correlated with HbA1c in T2DM patients but positively correlated with HbA1c in normal-glucose subjects. The reverse transporting of uric acid and glucose in renal tubules might be accounted for these associations.

Java project on periodontal diseases: effect of vitamin C/calcium threonate/citrus flavonoids supplementation on periodontal pathogens, CRP and HbA1c.

PubMed

Amaliya, Amaliya; Laine, Marja L; Loos, Bruno G; Van der Velden, Ubele

2015-12-01

To assess in a periodontally diseased rural population deprived from regular dental care and having poor dietary conditions, the effect of vitamin C/calcium threonate/citrus flavonoids (VitC/Ca/Fl) supplementation on subgingival microbiota and plasma levels of vitamin C, HbA1c and hsCRP. The study population consisted of 98 subjects who previously participated in a prospective study on the natural history of periodontitis. Participants were instructed to consume one tablet/day containing 200 mg Ester C(®) calcium ascorbate, 25 mg calcium threonate and 100 mg citrus flavonoids for 90 days. Following parameters were evaluated: prevalence/amount of seven traditional periodontal pathogens, cytomegalovirus, Epstein-Barr virus (EBV); and plasma levels of vitamin C, HbA1c and hsCRP. After VitC/Ca/Fl supplementation, 100% of subjects showed normal plasma vitamin C values compared to 55% before. At baseline, 48% of subjects harboured Aggregatibacter actinomycetemcomitans, >97% the other periodontal pathogens and 73% EBV. Supplementation with VitC/Ca/F reduced the subgingival load of all studied bacteria (p-values: 0.014-0.0001) and EBV (p < 0.0001) substantially in all initially positive subjects. Plasma levels of HbA1c and hsCRP dropped in all subjects (p < 0.0001). This uncontrolled study suggested that supplemental VitC/Ca/Fl may be helpful in reducing subgingival numbers of periodontal pathogens and EBV, and promoting systemic health. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparison of twelve single-drug regimens for the treatment of type 2 diabetes mellitus

PubMed Central

Wang, Shao-Lian; Dong, Wen-Bin; Dong, Xiao-Lin; Zhu, Wen-Min; Wang, Fang-Fang; Han, Fang; Yan, Xin

2017-01-01

We performed a network meta-analysis to compare the efficacy of 12 single-drug regimens (Glibenclamide, Glimepiride, Pioglitazone, Rosiglitazone, Repaglinide, Metformin, Sitaglitin, Exenatide, Liraglutide, Acarbose, Benfluorex, and Glipizide) in the treatment of type 2 diabetes mellitus (T2DM). Fifteen relevant randomized controlled trials (RCTs) were included; direct and indirect evidence from these studies was combined, and weighted mean difference (WMD) and surface under the cumulative ranking curves (SUCRAs) were examined to evaluate the monotherapies. Liraglutide was more effective than Glimepiride, Pioglitazone, Sitaglitin, Exenatide, and Glipizide at reducing glycated hemoglobin (HbA1c) levels. In contrast, Acarbose was less effective than Glibenclamide, Glimepiride, Pioglitazone, Rosiglitazone, Repaglinide, Metformin, and Liraglutide at decreasing HbA1c levels. Reductions in fasting plasma glucose (FPG) levels were similar after all treatments. Rosiglitazone was less effective than Glibenclamide and Repaglinide at reducing total cholesterol (TC) levels. High density lipoprotein (HDL), low density lipoprotein (LDL), and triglyceride levels did not differ after treatment with any of the monotherapies. HbA1c and FPG SUCRA values were highest for Liraglutide, while HbA1c and FPG values were lowest for Acarbose, and TC and LDL values were lowest for Rosiglitazone. These results suggest that Liraglutide may be most effective, and Acarbose least effective, at reducing blood glucose levels, while Glibenclamide, Repaglinide, and Metformin may be most effective, and Rosiglitazone least effective, at reducing lipoidemia, in T2DM patients. PMID:29069819

Association of Postmortem Blood Hemoglobin A1c Levels With Diabetic Conditions in Aviation Accident Pilot Fatalities

DTIC Science & Technology

2001-07-01

A1c ( HbA1c ) at selected time intervals during the 52-day period. Postmortem blood specimens from 34 aviation accident pilot fatalities were also...analyzed. Some of these pilots had a known history of diabetes. Results. HbA1c values in blood from volunteers did not significantly change for up to 52...days. The HbA1c concentration in postmortem blood samples from pilots ranged from 3.9-10.5%. Only one pilot with a HbA1c over 6.0% did not have a

Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: a pooled analysis of 96 population-based studies with 331 288 participants

PubMed Central

2015-01-01

Summary Background Diabetes has been defined on the basis of different biomarkers, including fasting plasma glucose (FPG), 2-h plasma glucose in an oral glucose tolerance test (2hOGTT), and HbA1c. We assessed the effect of different diagnostic definitions on both the population prevalence of diabetes and the classification of previously undiagnosed individuals as having diabetes versus not having diabetes in a pooled analysis of data from population-based health examination surveys in different regions. Methods We used data from 96 population-based health examination surveys that had measured at least two of the biomarkers used for defining diabetes. Diabetes was defined using HbA1c (HbA1c ≥6·5% or history of diabetes diagnosis or using insulin or oral hypoglycaemic drugs) compared with either FPG only or FPG-or-2hOGTT definitions (FPG ≥7·0 mmol/L or 2hOGTT ≥11·1 mmol/L or history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated diabetes prevalence, taking into account complex survey design and survey sample weights. We compared the prevalences of diabetes using different definitions graphically and by regression analyses. We calculated sensitivity and specificity of diabetes diagnosis based on HbA1c compared with diagnosis based on glucose among previously undiagnosed individuals (ie, excluding those with history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated sensitivity and specificity in each survey, and then pooled results using a random-effects model. We assessed the sources of heterogeneity of sensitivity by meta-regressions for study characteristics selected a priori. Findings Population prevalence of diabetes based on FPG-or-2hOGTT was correlated with prevalence based on FPG alone (r=0·98), but was higher by 2–6 percentage points at different prevalence levels. Prevalence based on HbA1c was lower than prevalence based on FPG in 42·8% of age–sex–survey groups and higher in another 41·6%; in the other 15·6%, the two definitions provided similar prevalence estimates. The variation across studies in the relation between glucose-based and HbA1c-based prevalences was partly related to participants' age, followed by natural logarithm of per person gross domestic product, the year of survey, mean BMI, and whether the survey population was national, subnational, or from specific communities. Diabetes defined as HbA1c 6·5% or more had a pooled sensitivity of 52·8% (95% CI 51·3–54·3%) and a pooled specificity of 99·74% (99·71–99·78%) compared with FPG 7·0 mmol/L or more for diagnosing previously undiagnosed participants; sensitivity compared with diabetes defined based on FPG-or-2hOGTT was 30·5% (28·7–32·3%). None of the preselected study-level characteristics explained the heterogeneity in the sensitivity of HbA1c versus FPG. Interpretation Different biomarkers and definitions for diabetes can provide different estimates of population prevalence of diabetes, and differentially identify people without previous diagnosis as having diabetes. Using an HbA1c-based definition alone in health surveys will not identify a substantial proportion of previously undiagnosed people who would be considered as having diabetes using a glucose-based test. Funding Wellcome Trust, US National Institutes of Health. PMID:26109024

Diabetes care and outcomes for American Indians and Alaska natives in commercial integrated delivery systems: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) Study.

PubMed

Schmittdiel, Julie A; Steiner, John F; Adams, Alyce S; Dyer, Wendy; Beals, Janette; Henderson, William G; Desai, Jay; Morales, Leo S; Nichols, Gregory A; Lawrence, Jean M; Waitzfelder, Beth; Butler, Melissa G; Pathak, Ram D; Hamman, Richard F; Manson, Spero M

2014-01-01

To compare cardiovascular disease risk factor testing rates and intermediate outcomes of care between American Indian/Alaska Native (AI/AN) patients with diabetes and non-Hispanic Caucasians enrolled in nine commercial integrated delivery systems in the USA. We used modified Poisson regression models to compare the annual testing rates and risk factor control levels for glycated haemoglobin (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP); number of unique diabetes drug classes; insulin use; and oral diabetes drug medication adherence between insured AI/AN and non-Hispanic white adults with diabetes aged ≥18 in 2011. 5831 AI/AN patients (1.8% of the cohort) met inclusion criteria. After adjusting for age, gender, comorbidities, insulin use, and geocoded socioeconomic status, AI/AN patients had similar rates of annual HbA1c, LDL-C, and SBP testing, and LDL-C and SBP control, compared with non-Hispanic Caucasians. However, AI/AN patients were significantly more likely to have HbA1c >9% (>74.9 mmol/mol; RR=1.47, 95% CI 1.38 to 1.58), and significantly less likely to adhere to their oral diabetes medications (RR=0.90, 95% CI 0.88 to 0.93) compared with non-Hispanic Caucasians. AI/AN patients in commercial integrated delivery systems have similar blood pressure and cholesterol testing and control, but significantly lower rates of HbA1c control and diabetes medication adherence, compared with non-Hispanic Caucasians. As more AI/ANs move to urban and suburban settings, clinicians and health plans should focus on addressing disparities in diabetes care and outcomes in this population.

Diabetes care and outcomes for American Indians and Alaska natives in commercial integrated delivery systems: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) Study

PubMed Central

Schmittdiel, Julie A; Steiner, John F; Adams, Alyce S; Dyer, Wendy; Beals, Janette; Henderson, William G; Desai, Jay; Morales, Leo S; Nichols, Gregory A; Lawrence, Jean M; Waitzfelder, Beth; Butler, Melissa G; Pathak, Ram D; Hamman, Richard F; Manson, Spero M

2014-01-01

Objective To compare cardiovascular disease risk factor testing rates and intermediate outcomes of care between American Indian/Alaska Native (AI/AN) patients with diabetes and non-Hispanic Caucasians enrolled in nine commercial integrated delivery systems in the USA. Research design and methods We used modified Poisson regression models to compare the annual testing rates and risk factor control levels for glycated haemoglobin (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP); number of unique diabetes drug classes; insulin use; and oral diabetes drug medication adherence between insured AI/AN and non-Hispanic white adults with diabetes aged ≥18 in 2011. Results 5831 AI/AN patients (1.8% of the cohort) met inclusion criteria. After adjusting for age, gender, comorbidities, insulin use, and geocoded socioeconomic status, AI/AN patients had similar rates of annual HbA1c, LDL-C, and SBP testing, and LDL-C and SBP control, compared with non-Hispanic Caucasians. However, AI/AN patients were significantly more likely to have HbA1c >9% (>74.9 mmol/mol; RR=1.47, 95% CI 1.38 to 1.58), and significantly less likely to adhere to their oral diabetes medications (RR=0.90, 95% CI 0.88 to 0.93) compared with non-Hispanic Caucasians. Conclusions AI/AN patients in commercial integrated delivery systems have similar blood pressure and cholesterol testing and control, but significantly lower rates of HbA1c control and diabetes medication adherence, compared with non-Hispanic Caucasians. As more AI/ANs move to urban and suburban settings, clinicians and health plans should focus on addressing disparities in diabetes care and outcomes in this population. PMID:25452877

Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial.

PubMed

Heller, Simon R; Bergenstal, Richard M; White, William B; Kupfer, Stuart; Bakris, George L; Cushman, William C; Mehta, Cyrus R; Nissen, Steven E; Wilson, Craig A; Zannad, Faiez; Liu, Yuyin; Gourlie, Noah M; Cannon, Christopher P

2017-05-01

To investigate relationships between glycated haemoglobin (HbA1c) and reported hypoglycaemia and risk of major adverse cardiovascular events (MACE). The EXAMINE trial randomized 5380 patients with type 2 diabetes (T2DM) and a recent acute coronary syndrome (ACS) event, in 49 countries, to double-blind treatment with alogliptin or placebo in addition to standard of care. We used Cox proportional hazards models to analyse relationships among MACE, HbA1c levels and hypoglycaemic events. Patients randomized to alogliptin achieved lower HbA1c levels than the placebo group in all baseline HbA1c categories without differences in hypoglycaemia rates. No systematic change was found in MACE rates according to baseline HbA1c (P interaction  = 0.971) or HbA1c category at 1 month. Patients in the combined treatment groups (n = 5380) who experienced serious hypoglycaemia (n = 34) had higher MACE rates than those who did not (35.3% vs 11.4%, adjusted hazard ratio [HR] 2.42, 95% confidence interval [CI] 1.27-4.60; P = .007), although the association was less strong when analysing only events after the hypoglycaemic event (adjusted HR 1.60, 95% CI 0.80, 3.20). There were no relationships between baseline HbA1c levels or HbA1c levels after 1 month of treatment and the risk of MACE. Alogliptin improved glycaemic control without increasing hypoglycaemia. Reported events of hypoglycaemia and serious hypoglycaemia were associated with MACE. These data underscore the safety of alogliptin in improving glycaemic control in T2DM post-ACS. Further study of hypoglycaemia as an independent risk factor for MACE in patients with T2DM and coronary disease is needed. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Interindividual differences in the clinical effectiveness of liraglutide in Type 2 diabetes: a real-world retrospective study conducted in Spain.

PubMed

Gomez-Peralta, F; Lecube, A; Fernández-Mariño, A; Alonso Troncoso, I; Morales, C; Morales-Pérez, F M; Guler, I; Cadarso-Suárez, C

2018-06-26

To study the response of clinical variables (HbA 1c , body weight, lipid profile and blood pressure) over 24 months of liraglutide treatment in a real-world clinical setting, and to describe the evolution of HbA 1c and body weight reduction in response to liraglutide treatment by employing generalized additive mixed models (GAMMs). We included people aged ≥ 18 years with Type 2 diabetes mellitus that initiated liraglutide treatment between November 2011 and May 2015. Demographic and clinical data were retrieved retrospectively over 24 months from electronic medical records with a median duration of observation of 7.0 (IQR 3.0-12.0) months. Individuals that initiated liraglutide therapy were obese (BMI 39.1 kg/m 2 ), with inadequate HbA 1c (68 mmol/mol [8.4%)], blood pressure and lipid levels. Upon liraglutide treatment, HbA 1c , body weight, mean systolic and diastolic blood pressure, and lipid levels decreased gradually. GAMMs demonstrated that longer treatment with liraglutide was a predictor of improved HbA 1c response, whereas higher baseline HbA 1c , longer Type 2 diabetes duration and treatment with insulin were predictors of worse HbA 1c response. Higher baseline weight, longer treatment with liraglutide and the interaction between metformin and time were predictors of improved weight response. In this real-world study, we showed the effectiveness of liraglutide in improving body weight, HbA 1c , mean systolic and diastolic blood pressure, and lipid levels. GAMMs indicated that baseline HbA 1c and weight, time of treatment with liraglutide, diabetes duration and the use of metformin or insulin are predictors of clinical response to liraglutide. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Regional, geographic, and racial/ethnic variation in glycemic control in a national sample of veterans with diabetes.

PubMed

Egede, Leonard E; Gebregziabher, Mulugeta; Hunt, Kelly J; Axon, Robert N; Echols, Carrae; Gilbert, Gregory E; Mauldin, Patrick D

2011-04-01

We performed a retrospective analysis of a national cohort of veterans with diabetes to better understand regional, geographic, and racial/ethnic variation in diabetes control as measured by HbA(1c). A retrospective cohort study was conducted in a national cohort of 690,968 veterans with diabetes receiving prescriptions for insulin or oral hypoglycemic agents in 2002 that were followed over a 5-year period. The main outcome measures were HbA(1c) levels (as continuous and dichotomized at ≥8.0%). Relative to non-Hispanic whites (NHWs), HbA(1c) levels remained 0.25% higher in non-Hispanic blacks (NHBs), 0.31% higher in Hispanics, and 0.14% higher in individuals with other/unknown/missing racial/ethnic group after controlling for demographics, type of medication used, medication adherence, and comorbidities. Small but statistically significant geographic differences were also noted with HbA(1c) being lowest in the South and highest in the Mid-Atlantic. Rural/urban location of residence was not associated with HbA(1c) levels. For the dichotomous outcome poor control, results were similar with race/ethnic group being strongly associated with poor control (i.e., odds ratios of 1.33 [95% CI 1.31-1.35] and 1.57 [1.54-1.61] for NHBs and Hispanics vs. NHWs, respectively), geographic region being weakly associated with poor control, and rural/urban residence being negligibly associated with poor control. In a national longitudinal cohort of veterans with diabetes, we found racial/ethnic disparities in HbA(1c) levels and HbA(1c) control; however, these disparities were largely, but not completely, explained by adjustment for demographic characteristics, medication adherence, type of medication used to treat diabetes, and comorbidities.

The preoperative HbA1c level is an independent prognostic factor for the postoperative survival after resection of non-small cell lung cancer in elderly patients.

PubMed

Motoishi, Makoto; Sawai, Satoru; Hori, Tetsuo; Yamashita, Naoki

2018-05-01

The aim of this study was to investigate the influence of a history of diabetes mellitus (DM) and the glycated hemoglobin (HbA1c) level on the survival in patients who underwent complete resection for non-small cell lung cancer (NSCLC). Of the patients who underwent complete resection for NSCLC between 2007 and 2015, 468 were classified into DM (who were currently taking medication for DM) and no DM groups as well as into high HbA1c (≥ 6.5) and normal HbA1c (< 6.5) groups. The overall survival (OS) did not differ significantly between either pair of groups. Among the elderly patients, the OS did not differ significantly between the DM and no DM groups, but was significantly higher in the normal-HbA1c group than in the high-HbA1c group (5-year survival rate: 84.7 versus 37.2%, respectively, p < 0.01). In the elderly patients, non-adenocarcinoma histology, advanced stage, a high Charlson comorbidity index, and a high preoperative HbA1c level were found to be independent risk factors for the OS. We revealed that a high preoperative HbA1c level was associated with a poor OS in elderly patients who underwent complete resection for NSCLC. This suggests that it is necessary to achieve diabetic control prior to complete resection in NSCLC patients.

Comparison of HbA1c Measurements using 3 Methods in 75 Patients Referred to One Outpatient Department.

PubMed

Roth, Johannes; Müller, Nicolle; Lehmann, Thomas; Böer, Klas; Löbel, Sven; Pum, Joachim; Müller, Ulrich Alfons

2018-01-01

HbA 1c is the most important surrogate parameter to assess the quality of diabetes care and is also used for the diagnosis of diabetes mellitus (DM) since 2010. We investigated the comparability of 3 HbA 1c methods in the city of Jena (Germany). The HbA 1c determination was carried out in 50 healthy subjects and 24 people with DM (age 51.2±16.3 years, HbA 1c 6.8±2.2%) with 3 different hemoglobin A 1c testing methods at 4 locations in one city. Our laboratory (HPLC method) served as a reference for comparing the results. All methods are IFCC standardized and all devices are certified by the interlaboratory test. The mean HbA 1c of people without diabetes was: laboratory A (TOSOH G8, HPLC) 5.7±0.3%; laboratory B (TOSOH G8, HPLC) 5.5±0.3%, laboratory C (VARIANT II) 5.2±0.3%; laboratory D (COBAS INT.) 5.6±0.3%. All differences are significant (p=0.001).The mean HbA 1c of patients with mild to moderate elevated HbA 1c was: Laboratory A 7.5±0.9%; B 7.3±1.0%; C 7.0±0.9%; D 7.5±1.1%. Differences are significant (p=0.001) except between laboratory A and D (p=0.8).The mean HbA 1c of patients with massively increased HbA 1c was: laboratory A 11.5±1.8%; laboratory B 11.4±1.8%; laboratory C 10.8±1.6%; laboratory D 11.5±1.5%. Differences between laboratory A and C, as well as between C and D were significant (p=0.001). The mean IFCC standardized HbA 1c from 75 people differs by up to 0.5% absolute between 4 laboratories. This difference is clinically significant and may lead to misdiagnosis and wrong treatment decisions, while HbA 1c value from one patient were analyzed in different laboratories within a short time. © Georg Thieme Verlag KG Stuttgart · New York.

A nomogram to estimate the proportion of patients at hemoglobin A1c target <7% with noninsulin antidiabetic drugs in type 2 diabetes: a systematic review of 137 randomized controlled trials with 39,845 patients.

PubMed

Esposito, Katherine; Chiodini, Paolo; Ceriello, Antonio; Giugliano, Dario

2014-04-01

We assessed the efficacy of noninsulin antidiabetic medications used in current clinical practice (metformin, sulfonylureas, α-glucosidase inhibitors, thiazolidinediones, glinides, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists) to reach the HbA1c target <7% in people with type 2 diabetes. MEDLINE, EMBASE, and the Cochrane CENTRAL were searched from inception through April 2011 for randomized controlled trials (RCTs) involving noninsulin antidiabetic drugs. RCTs had to report the effect of any diabetes medication on the HbA1c levels, to include at least 30 subjects in every arm of the study, and to last at least 12 weeks. Data were summarized across studies using random-effects meta-regression. We found 137 RCTs with 205 arms and 39,845 patients. The proportion of patients who achieved the HbA1c goal ranged from 25.9% (95% CI 18.5-34.9) with α-glucosidase inhibitors to 48.6% (95% CI, 53.6) with GLP-1 analogs. Baseline HbA1c was the major determinant of the proportion of patients at HbA1c goal. The meta-regression model with mean baseline HbA1c value, concomitant drug use, and class of drugs as covariates explained almost 67% of the between-study variability. A nomogram was developed to estimate the proportion of patients at target for each noninsulin drug class: for a baseline HbA1c level of 7.5%, all noninsulin drugs, except α-glucosidase inhibitors, achieved the HbA1c goal <7% in more than 50% of patients. Starting or intensifying pharmacological therapy at baseline HbA1c 8% or less was associated with more than 50% of patients at HbA1c goal for most noninsulin drugs.

Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus

PubMed Central

Ito, Hiroyuki; Abe, Mariko; Antoku, Shinichi; Omoto, Takashi; Shinozaki, Masahiro; Nishio, Shinya; Mifune, Mizuo; Togane, Michiko

2014-01-01

Background The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus. Methods The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study. Results The glycated hemoglobin (HbA1c) level (8.3%±1.8% to 8.2%±1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA1c level was found in nine (33%) subjects. The change in HbA1c showed a significant negative correlation with baseline HbA1c, and was significantly better in patients with a baseline HbA1c >8.0% than in those with an HbA1c ≤8.0% (−0.9±2.0 versus 0.3±0.6, respectively, P=0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA1c level was improved than in those in whom it was not (2.7±3.6 versus −0.8±3.5, P=0.04). Conclusion B2B was noninferior to PPT with regard to HbA1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT. PMID:24790413

Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus.

PubMed

Ito, Hiroyuki; Abe, Mariko; Antoku, Shinichi; Omoto, Takashi; Shinozaki, Masahiro; Nishio, Shinya; Mifune, Mizuo; Togane, Michiko

2014-01-01

The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus. The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study. The glycated hemoglobin (HbA1c) level (8.3% ± 1.8% to 8.2% ± 1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA1c level was found in nine (33%) subjects. The change in HbA1c showed a significant negative correlation with baseline HbA1c, and was significantly better in patients with a baseline HbA1c >8.0% than in those with an HbA1c ≤ 8.0% (-0.9 ± 2.0 versus 0.3 ± 0.6, respectively, P = 0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA1c level was improved than in those in whom it was not (2.7 ± 3.6 versus -0.8 ± 3.5, P = 0.04). B2B was noninferior to PPT with regard to HbA1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT.

Determining the Threshold for HbA1c as a Predictor for Adverse Outcomes After Total Joint Arthroplasty: A Multicenter, Retrospective Study.

PubMed

Tarabichi, Majd; Shohat, Noam; Kheir, Michael M; Adelani, Muyibat; Brigati, David; Kearns, Sean M; Patel, Pankajkumar; Clohisy, John C; Higuera, Carlos A; Levine, Brett R; Schwarzkopf, Ran; Parvizi, Javad; Jiranek, William A

2017-09-01

Although HbA1c is commonly used for assessing glycemic control before surgery, there is no consensus regarding its role and the appropriate threshold in predicting adverse outcomes. This study was designed to evaluate the potential link between HbA1c and subsequent periprosthetic joint infection (PJI), with the intention of determining the optimal threshold for HbA1c. This is a multicenter retrospective study, which identified 1645 diabetic patients who underwent primary total joint arthroplasty (1004 knees and 641 hips) between 2001 and 2015. All patients had an HbA1c measured within 3 months of surgery. The primary outcome of interest was a PJI at 1 year based on the Musculoskeletal Infection Society criteria. Secondary outcomes included orthopedic (wound and mechanical complications) and nonorthopedic complications (sepsis, thromboembolism, genitourinary, and cardiovascular complications). A regression analysis was performed to determine the independent influence of HbA1c for predicting PJI. Overall 22 cases of PJI occurred at 1 year (1.3%). HbA1c at a threshold of 7.7 was distinct for predicting PJI (area under the curve, 0.65; 95% confidence interval, 0.51-0.78). Using this threshold, PJI rates increased from 0.8% (11 of 1441) to 5.4% (11 of 204). In the stepwise logistic regression analysis, PJI remained the only variable associated with higher HbA1c (odds ratio, 1.5; confidence interval, 1.2-2.0; P = .0001). There was no association between high HbA1c levels and other complications assessed. High HbA1c levels are associated with an increased risk for PJI. A threshold of 7.7% seems to be more indicative of infection than the commonly used 7% and should perhaps be the goal in preoperative patient optimization. Copyright © 2017 Elsevier Inc. All rights reserved.

The influence of glycemic control on the oral health of children and adolescents with diabetes mellitus type 1.

PubMed

Carneiro, Vera Lúcia; Fraiz, Fabian Calixto; Ferreira, Fernanda de Morais; Pintarelli, Tatiana Pegoretti; Oliveira, Ana Cristina Borges; Boguszewski, Margaret Cristina da Silva

2015-12-01

To evaluate the influence of disease control, expressed by the mean values of glycated hemoglobin (HbA1c), in the oral health of children and adolescents with diabetes mellitus type 1 (T1DM). A cross sectional study involving 87 children and adolescents (59 girls), 10 ± 2.6 years old. The participants were divided into three groups: HbA1c ≤ 8%, 8% < HbA1c ≤ 10% and HbA1c > 10%. The duration of the disease, age and average HbA1c were obtained from their medical records. Oral health was evaluated according to the following indexes: Simplified Oral Hygiene Index (OHI-S); Community Periodontal Index (CPI); Decayed, Missing or Filled Teeth Index (DMFT/dmft) for permanent and deciduous teeth; and the stimulated salivary flow rate (SSFR). The median SSFR was 1.1 mL/min in the group with HbA1c ≤ 8%, 0.7 mL/min in the intermediary group and 0.6 mL/min in the HbA1c > 10% group. A significant decrease in salivary flow was observed with an increase in HbA1c (p = 0.007). The DMFT/dmft and CPI indexes were higher in individuals with higher HbA1c values. More caries-free individuals were found in the group with HbA1c ≤ 8% compared to those with HbA1c > 10%. The group with HbA1c > 10% exhibited more caries and bleeding gums than the other groups. HbA1c values in girls were higher than in boys. Children and adolescents with unsatisfactory glycemic control, represented by higher HbA1c concentrations, exhibited a higher frequency of caries and gingivitis, and a reduction in salivary flow.

Optimal energy distribution of carbohydrate intake for Japanese elderly patients with type 2 diabetes: the Japanese Elderly Intervention Trial.

PubMed

Kamada, Chiemi; Yoshimura, Hidenori; Okumura, Ryota; Takahashi, Keiko; Iimuro, Satoshi; Ohashi, Yasuo; Araki, Atsushi; Umegaki, Hiroyuki; Sakurai, Takashi; Yoshimura, Yukio; Ito, Hideki

2012-04-01

In diet therapy for diabetes, optimal energy intake and the energy distribution of macronutrients (protein : fat : carbohydrate [PFC] energy ratio) are important. We aimed to clarify the correlation between the PFC energy ratio and metabolic parameters including glycated hemoglobin A1c (HbA1c) and triglycerides in Japanese elderly patients with type 2 diabetes mellitus aged 65 years or older. Participants were 1173 diabetic patients aged 65 years or older with serum HbA1c level of >/=7.4% enrolled in the Japanese Elderly Diabetes Intervention Trial (J-EDIT). The participants were divided into four groups by the percentage of total energy intake (%E) of carbohydrate (C1: less than 55%E, C2: 55%E or more and less than 60%E, C3: 60%E or more and less than 65%E, and C4: 65%E or more). Relations of %E of carbohydrate to HbA1c and other metabolic parameters, energy intake and nutritional intake were examined. Furthermore, the subjects were divided into four categories by HbA1c levels by quartile method (Q1: less than 7.90%, Q2: 7.90% or more and less than 8.30%, Q3: 8.30% or more and less than 8.80%, Q4: 8.80% or more). Relations of HbA1c to other metabolic parameters, energy intake and nutritional intake were examined. The mean HbA1c levels in the four groups were C1: 8.40%, C2: 8.50%, C3: 8.41% and C4: 8.36% in men, and C1: 8.51%, C2: 8.47%, C3: 8.35% and C4: 8.52% in women, respectively. There were no significant differences and linear trend in HbA1c levels across groups. The mean triglyceride levels were in the range of 122-128 mg/dL in men from C1 to C3, although it was significantly higher in C4 (177 mg/dL). The mean triglyceride levels were in the range of 128-136 mg/dL in women from C1 to C3, although it was significantly higher in Q4 (150 mg/dL). Amounts of protein and fat intakes decreased with an increase of %E of carbohydrate, although amount of carbohydrate intake did not change significantly. As a result, %E of protein and fat, and energy intake decreased in both men and women with an increase in %E of carbohydrate. Among the four quartiles divided by HbA1c levels, there were no significant differences in energy intake and PFC energy ratio. The present study suggests that, within the range studied, the carbohydrate energy ratio has no correlation with HbA1c levels. However, serum triglyceride levels increased and high-density lipoprotein cholesterol levels decreased significantly, with an increase of %E of carbohydrate in men, and the same tendencies were observed in women. Furthermore, in patients with 65%E or more of carbohydrate, serum triglyceride levels exceeded 150 mg/dL, which is the recommended treatment target for diabetic patients. These results suggest that the ideal %E of carbohydrate for Japanese elderly type 2 diabetes is less than 65. The lower limit of %E of carbohydrate could not be determined from the present study. © 2012 Japan Geriatrics Society.

Prognostic Implications of Single-Sample Confirmatory Testing for Undiagnosed Diabetes: A Prospective Cohort Study.

PubMed

Selvin, Elizabeth; Wang, Dan; Matsushita, Kunihiro; Grams, Morgan E; Coresh, Josef

2018-06-19

Current clinical definitions of diabetes require repeated blood work to confirm elevated levels of glucose or hemoglobin A1c (HbA1c) to reduce the possibility of a false-positive diagnosis. Whether 2 different tests from a single blood sample provide adequate confirmation is uncertain. To examine the prognostic performance of a single-sample confirmatory definition of undiagnosed diabetes. Prospective cohort study. The ARIC (Atherosclerosis Risk in Communities) study. 13 346 ARIC participants (12 268 without diagnosed diabetes) with 25 years of follow-up for incident diabetes, cardiovascular outcomes, kidney disease, and mortality. Confirmed undiagnosed diabetes was defined as elevated levels of fasting glucose (≥7.0 mmol/L [≥126 mg/dL]) and HbA1c (≥6.5%) from a single blood sample. Among 12 268 participants without diagnosed diabetes, 978 had elevated levels of fasting glucose or HbA1c at baseline (1990 to 1992). Among these, 39% had both (confirmed undiagnosed diabetes), whereas 61% had only 1 elevated measure (unconfirmed undiagnosed diabetes). The confirmatory definition had moderate sensitivity (54.9%) but high specificity (98.1%) for identification of diabetes cases diagnosed during the first 5 years of follow-up, with specificity increasing to 99.6% by 15 years. The 15-year positive predictive value was 88.7% compared with 71.1% for unconfirmed cases. Confirmed undiagnosed diabetes was significantly associated with cardiovascular and kidney disease and mortality, with stronger associations than unconfirmed diabetes. Lack of repeated measurements of fasting glucose and HbA1c. A single-sample confirmatory definition of diabetes had a high positive predictive value for subsequent diagnosis and was strongly associated with clinical end points. Our results support the clinical utility of using a combination of elevated fasting glucose and HbA1c levels from a single blood sample to identify undiagnosed diabetes in the population. National Institute of Diabetes and Digestive and Kidney Diseases and National Heart, Lung, and Blood Institute.

Comparison of Antidiabetic Regimens in Patients with Type 2 Diabetes Uncontrolled by Combination Therapy of Sulfonylurea and Metformin: Results of the MOHAS Disease Registry in Korea

PubMed Central

Choi, Sung Hee; Oh, Tae Jung

2017-01-01

Background The aim of this study was to investigate the glucose-lowering efficacy of antidiabetic treatments in patients with type 2 diabetes mellitus (T2DM) uncontrolled by sulfonylurea plus metformin. Methods This open-label, multicenter, prospective, observational study was conducted in 144 centers in Korea, from June 2008 to July 2010, and included patients with T2DM who had received sulfonylurea and metformin for at least 3 months and had levels of glycosylated hemoglobin (HbA1c) >7.0% in the last month. Data of clinical and biochemical characteristics were collected at baseline and 6 months after treatment. The treatment option was decided at the physician's discretion. Subjects were classified into the following three groups: intensifying oral hypoglycemic agents (group A), adding basal insulin (group B), or starting intensified insulin therapy (group C). Results Of 2,995 patients enrolled, 2,901 patients were evaluated, and 504 (17.4%), 2,316 (79.8%), and 81 patients (2.8%) were classified into groups A, B, and C, respectively. Subjects in group C showed relatively higher baseline levels of HbA1c and longer duration of diabetes. The mean decrease in HbA1c level was higher in the insulin treated groups (−0.9%±1.3%, −1.6%±1.3%, and −2.4%±2.3% in groups A, B, and C, respectively, P=0.042). The proportion of patients who achieved target HbA1c <7.0% was comparable among the groups; however, intensified insulin therapy seemed to be the most effective in achieving the target HbA1c of 6.5%. Conclusion These findings suggest that insulin-based therapy will be an important option in the improved management of Korean patients with T2DM whose glycemic control is not sufficient with sulfonylurea and metformin. PMID:28537056

HbA1c as a predictor of diabetes after gestational diabetes mellitus.

PubMed

Claesson, Rickard; Ignell, Claes; Shaat, Nael; Berntorp, Kerstin

2017-02-01

We wanted to investigate third-trimester HbA1c as a predictor of diabetes after gestational diabetes mellitus (GDM). Women with GDM were followed up prospectively for five years from pregnancy to detect the development of diabetes. The ability of HbA1c to predict diabetes was evaluated with receiver-operating characteristic (ROC) curves and logistic regression analysis. By five years, 73 of 196 women had been diagnosed with diabetes. An optimal cut-off point for HbA1c of 36mmol/mol (5.4%) could predict diabetes with 45% sensitivity and 92% specificity. For HbA1c ≥39mmol/mol (≥5.7%), sensitivity, specificity, and positive predictive value were 30%, 97%, and 91%, respectively. In logistic regression analysis, adjusting for the diagnostic glucose concentration during pregnancy, HbA1c levels in the upper quartile (≥36mmol/mol) were associated with a 5.5-fold increased risk of diabetes. Third-trimester HbA1c levels in the pre-diabetes range revealed women with post-partum diabetes with high specificity and high positive predictive value. HbA1c testing could be used as a strategy to select high-risk women for lifestyle interventions aimed at prevention of diabetes starting during pregnancy. The results should encourage further validation in other populations using new diagnostic criteria for GDM. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Prevalence and risks of hyperglycaemia and undiagnosed diabetes in patients with acute myocardial infarction.

PubMed

Oswald, G A; Corcoran, S; Yudkin, J S

1984-06-09

Two studies were undertaken to assess the prevalence of undiagnosed diabetes mellitus in patients admitted with acute myocardial infarction (AMI), and the effect of diabetes mellitus and admission hyperglycaemia on outcome. In the retrospective study, admission levels of plasma glucose (APG) were higher (p less than 0.02) in patients dying from cardiogenic shock than in survivors, but they were not related to infarct size. In the prospective study APG was related (p less than 0.01) to concurrent levels of glycosylated haemoglobin (HbA1c), which were in turn related to outcome--the mortality rate was 23% for those with normal HbA1c (less than 7.5%), 33% for those with borderline abnormal HbA1c (7.5-8.5%), and 63% for those with clearly abnormal HbA1c (greater than 8.5%). Cardiogenic shock was commoner in the groups with higher HbA1c levels. In addition, admission hyperglycaemia was associated (p less than 0.01) with the incidence of cardiogenic shock even after correcting for the effects of HbA1c. All of the survivors from the clearly abnormal HbA1c group, but none of those from other groups, were diabetic at follow up, suggesting an overall prevalence of undiagnosed diabetes mellitus of 5.3%. The contribution of undiagnosed diabetes mellitus to total mortality following AMI seems at present to be underestimated.

Comparison of glycated albumin and hemoglobin A1c concentrations in diabetic subjects on peritoneal and hemodialysis.

PubMed

Freedman, Barry I; Shenoy, Rajeev N; Planer, Jonathan A; Clay, Kimberly D; Shihabi, Zak K; Burkart, John M; Cardona, Cesar Y; Andries, Lilian; Peacock, Todd P; Sabio, Hernan; Byers, Joyce R; Russell, Gregory B; Bleyer, Anthony J

2010-01-01

Relative to hemoglobin A(1c) (HbA(1c)), percentage of glycated albumin (GA%) more accurately reflects recent glycemic control in diabetic hemodialysis (HD) patients. To determine the accuracy of glycemic assays in a larger sample including patients on peritoneal dialysis (PD), HbA(1c) and GA% were measured in 519 diabetic subjects: 55 on PD, 415 on HD, and 49 non-nephropathy controls. Mean +/- SD serum glucose levels were higher in HD and PD patients relative to non-nephropathy controls (HD 169.7 +/- 62 mg/dL, PD 168.6 +/- 66 mg/dL, controls 146.1 +/- 66 mg/dL; p = 0.03 HD vs controls, p = 0.13 PD vs controls). GA% was also higher in HD and PD patients (HD 20.6% +/- 8.0%, PD 19.0% +/- 5.7%, controls 15.7% +/- 7.7%; p < 0.02 HD vs controls and PD vs controls). HbA(1c) was paradoxically lower in dialysis patients (HD 6.78% +/- 1.6%, PD 6.87% +/- 1.4%, controls 7.3% +/- 1.4%; p = 0.03 HD vs controls, p = 0.12 PD vs controls). The serum glucose/HbA(1c) ratio differed significantly between dialysis patients and controls (p < 0.0001 HD vs controls, p = 0.002 PD vs controls), while serum glucose/GA% ratio was similar across groups (p = 0.96 HD vs controls, p = 0.64 PD vs controls). In best-fit multivariate models with HbA(1c) or GA% as outcome variable, dialysis status was a significant predictor of HbA(1c) but not GA%. The relationship between HbA(1c) and GA% differs in diabetic patients with end-stage renal disease who perform either PD or HD compared to those without nephropathy. HbA(1c) significantly underestimates glycemic control in peritoneal and hemodialysis patients relative to GA%.

Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study.

PubMed

Dale, Jeremy; Martin, Steven; Gadsby, Roger

2010-07-01

To evaluate the 3-year impact of initiating basal insulin on glycaemic control (HbA1c) and weight gain in patients with poorly controlled type 2 diabetes registered with UK general practices that volunteered to participate in an insulin initiation training programme. Audit utilising data collected from practice record systems, which included data at baseline, 3, 6 months and subsequent six-monthly intervals post-insulin initiation for up to 10 patients per participating practice. Of 115 eligible practices, 55 (47.8%) contributed data on a total of 516 patients. The mean improvement in HbA1c levels in the first 6 months was 1.4% (range -3.8% to 8.2%, median=1.40%). Thereafter, there was no overall change in HbA1c levels, although the change for individual patients ranged from -4.90% to +7.50%. At 36 months, 141 (41%) patients for whom data were provided had achieved the pre-2006/2007 UK Quality and Outcomes Framework (QOF) target of 7.4% or less, including 98 (29%) who had achieved an HbA1c of 7% or less. Patients who achieved target had a lower HbA1c at baseline (mean 9.1% compared to 9.7%; p<0.001); had a lower weight at 36 months (mean 88.0kg compared to 93.5kg; p=0.05); were more likely to be on basal insulin alone (88, 47.1% compared to 46, 34.6%; p<0.05); and were slightly older (mean 64.5 years compared to 61.7 years; p<0.05). Attending an insulin initiation training programme may successfully prepare primary healthcare professionals to initiate insulin therapy as part of everyday practice for patients with poorly controlled type 2 diabetes. The impact on glycaemic control is maintained over a 3-year period. Although intensification of treatment occurred during this period, the findings suggest scope for further intensification of insulin therapy in order to improve on the glycaemic control achieved during the first 6 months post-insulin initiation.

Outcomes of educational interventions in type 2 diabetes: WEKA data-mining analysis.

PubMed

Sigurdardottir, Arun K; Jonsdottir, Helga; Benediktsson, Rafn

2007-07-01

To analyze which factors contribute to improvement in glycemic control in educational interventions in type 2 diabetes reported in randomized controlled trials (RCT) published in 2001-2005. Papers were extracted from Medline and Scopus using educational intervention and adults with type 2 diabetes as keywords. Inclusion criteria were RCT design. Data were analyzed with a data-mining program. Of 464 titles extracted, 21 articles reporting 18 studies met the inclusion criteria. Data mining showed that for initial glycosylated hemoglobin (HbA1c) level < or = 7.9% the diabetes education intervention achieved a small change in HbA1c level, or from +0.1 to -0.7%. For initial HbA1c > or = 8.0%, a significant drop in HbA1c level of 0.8-2.5% was found. Data mining indicated that duration, educational content and intensity of education did not predict changes in HbA1c levels. Initial HbA1c level is the single most important factor affecting improvements in glycemic control in response to patient education. Data mining is an appropriate and sufficiently sensitive method to analyze outcomes of educational interventions. Diversity in conceptualization of interventions and diversity of instruments used for outcome measurements could have hampered actual discovery of effective educational practices. Participation in educational interventions generally seems to benefit people with type 2 diabetes. Use of standardized instruments is encouraged as it gives better opportunities to identify conclusive results with consequent development of clinical guidelines.

Evaluation of Glycated Hemoglobin (HbA1c) for Diagnosing Type 2 Diabetes and Prediabetes among Palestinian Arab Population

PubMed Central

Kharroubi, Akram T.; Darwish, Hisham M.; Abu Al-Halaweh, Ahmad I.; Khammash, Umaiyeh M.

2014-01-01

The purpose of the study is to compare the potential of HbA1c to diagnose diabetes among Palestinian Arabs compared to fasting plasma glucose (FPG). A cross-sectional sample of 1370 Palestinian men (468) and women (902) without known diabetes and above the age of 30 years were recruited. Whole blood was used to estimate HbA1c and plasma for FPG and total lipid profile. Fasting plasma glucose was used as a reference to diagnose diabetes (≥ 126 mg/dL) and prediabetes (100–125 mg/dL). The area under the receiver operating characteristic curve (AUC) for HbA1c was 81.9% to diagnose diabetes and 63.9% for prediabetes. The agreement between HbA1c and diabetes as diagnosed by FPG was moderate (ĸ  =  0.498) and low with prediabetes (ĸ = 0.142). The optimal cut-off value for HbA1c to diagnose diabetes was ≥ 6.3% (45 mmol/mol). The sensitivity, specificity and the discriminant ability were 65.6% (53.1–76.3%), 94.5% (93.1–95.6%), 80.0% (72.8–87.3%), respectively. However, using cut-off value of ≥ 6.5% (48 mmol/mol) improved specificity. At this cut-off value, the sensitivity, specificity and the discriminant ability were 57.4% (44.9–69.0%), 97.1% (96.0–97.9%) and 77.3% (71.0–83.5%). For diagnosing prediabetes with HbA1c between 5.7–6.4% (39–46 mmol/mol), the sensitivity, specificity and the discriminant ability were 62.7% (57.1–67.9%), 56.3% (53.1–59.4%) and 59.5% (56.3–62.5%), respectively. HbA1c at cut-off value of ≥ 6.5% (48 mmol/mol) by itself diagnosed 5.3% and 48.3% as having diabetes and prediabetes compared to 4.5% and 24.2% using FPG, respectively. Mean HbA1c and FPG increase significantly with increasing body mass index. In conclusion, the ROC curves showed HbA1c could be used for diagnosing diabetes when compared to FPG but not for prediabetes in Palestinians Arabs even though only about 50% of the diabetic subjects were identified by the both HbA1c and FPG. PMID:24505401

Relationship between glycated hemoglobin, Intensive Care Unit admission blood sugar and glucose control with ICU mortality in critically ill patients

PubMed Central

Mahmoodpoor, Ata; Hamishehkar, Hadi; Shadvar, Kamran; Beigmohammadi, Mohammadtaghi; Iranpour, Afshin; Sanaie, Sarvin

2016-01-01

Background and Aims: The association between hyperglycemia and mortality is believed to be influenced by the presence of diabetes mellitus (DM). In this study, we evaluated the effect of preexisting hyperglycemia on the association between acute blood glucose management and mortality in critically ill patients. The primary objective of the study was the relationship between HbA1c and mortality in critically ill patients. Secondary objectives of the study were relationship between Intensive Care Unit (ICU) admission blood glucose and glucose control during ICU stay with mortality in critically ill patients. Materials and Methods: Five hundred patients admitted to two ICUs were enrolled. Blood sugar and hemoglobin A1c (HbA1c) concentrations on ICU admission were measured. Age, sex, history of DM, comorbidities, Acute Physiology and Chronic Health Evaluation II score, sequential organ failure assessment score, hypoglycemic episodes, drug history, mortality, and development of acute kidney injury and liver failure were noted for all patients. Results: Without considering the history of diabetes, nonsurvivors had significantly higher HbA1c values compared to survivors (7.25 ± 1.87 vs. 6.05 ± 1.22, respectively, P < 0.001). Blood glucose levels in ICU admission showed a significant correlation with risk of death (P < 0.006, confidence interval [CI]: 1.004–1.02, relative risk [RR]: 1.01). Logistic regression analysis revealed that HbA1c increased the risk of death; with each increase in HbA1c level, the risk of death doubled. However, this relationship was not statistically significant (P: 0.161, CI: 0.933–1.58, RR: 1.2). Conclusions: Acute hyperglycemia significantly affects mortality in the critically ill patients; this relation is also influenced by chronic hyperglycemia. PMID:27076705

Periodontal inflamed surface area and C-reactive protein as predictors of HbA1c: a study in Indonesia.

PubMed

Susanto, Hendri; Nesse, Willem; Dijkstra, Pieter U; Hoedemaker, Evelien; van Reenen, Yvonne Huijser; Agustina, Dewi; Vissink, Arjan; Abbas, Frank

2012-08-01

Periodontitis may exert an infectious and inflammatory burden, evidenced by increased C-reactive protein (CRP). This burden may impair blood glucose control (HbA1c). The aim of our study was to analyze whether periodontitis severity as measured with the periodontal inflamed surface area (PISA) and CRP predict HbA1c levels in a group of healthy Indonesians and a group of Indonesians treated for type 2 diabetes mellitus (DM2). A full-mouth periodontal examination, including probing pocket depth, gingival recession, clinical attachment loss, plaque index and bleeding on probing, was performed in 132 healthy Indonesians and 101 Indonesians treated for DM2. Using these data, PISA was calculated. In addition, HbA1c and CRP were analyzed. A validated questionnaire was used to assess smoking, body mass index (BMI), education and medical conditions. In regression analyses, it was assessed whether periodontitis severity and CRP predict HbA1c, controlling for confounding and effect modification (i.e., age, sex, BMI, pack years, and education). In healthy Indonesians, PISA and CRP predicted HbA1c as did age, sex, and smoking. In Indonesians treated for DM2, PISA did not predict HbA1c. Periodontitis may impair blood glucose regulation in healthy Indonesians in conjunction with elevated CRP levels. The potential effect of periodontitis on glucose control in DM2 patients may be masked by DM2 treatment. periodontitis may impair blood glucose control through exerting an inflammatory and infectious burden evidenced by increased levels of CRP.

Possible discrepancy of HbA1c values and its assessment among patients with chronic renal failure, hemodialysis and other diseases.

PubMed

Inoue, Kaori; Goto, Atsushi; Kishimoto, Miyako; Tsujimoto, Tetsuro; Yamamoto-Honda, Ritsuko; Noto, Hiroshi; Kajio, Hiroshi; Terauchi, Yasuo; Noda, Mitsuhiko

2015-12-01

Glycated hemoglobin (HbA1c) and glycated albumin (GA) are frequently used as glycemic control markers. However, these markers are influenced by alterations in hemoglobin and albumin metabolism. Thus, conditions such as anemia, chronic renal failure, hypersplenism, chronic liver diseases, hyperthyroidism, hypoalbuminemia, and pregnancy need to be considered when interpreting HbA1c or GA values. Using data from patients with normal albumin and hemoglobin metabolism, we previously established a linear regression equation describing the GA value versus the HbA1c value to calculate an extrapolated HbA1c (eHbA1c) value for the accurate evaluation of glycemic control. In this study, we investigated the difference between the measured HbA1c and the eHbA1c values for patients with various conditions. Data sets for a total of 2461 occasions were obtained from 731 patients whose HbA1c and GA values were simultaneously measured. We excluded patients with missing data or changeable HbA1c levels, and patients who had received transfusions or steroids within the previous 3 months. Finally, we included 44 patients with chronic renal failure (CRF), 10 patients who were undergoing hemodialysis (HD), 7 patients with hematological malignancies and a hemoglobin level of less than 10 g/dL (HM), and 12 patients with chronic liver diseases (CLD). In all the groups, the eHbA1c values were significantly higher than the measured HbA1c values. The median difference was 0.75 % (95 % CI 0.40-1.10 %, P for the difference is <0.001) in the CRF group, 0.80 % (95 % CI 0.30-1.65 %, P for the difference is 0.041) in the HD group, 0.90 % (95 % CI 0.90-1.30 %, P for the difference is 0.028) in the HM group, and 0.85 % (95 % CI 0.40-1.50 %, P for the difference is 0.009) in the CLD group. We found that the measured HbA1c values were lower than the eHbA1c values in each of the groups.

Effect of renal function on serum concentration of 1,5-anhydroglucitol in type 2 diabetic patients in chronic kidney disease stages I-III: A comparative study with HbA1c and glycated albumin.

PubMed

Hasslacher, Christoph; Kulozik, Felix

2016-09-01

1,5-Anhydroglucitol (1,5-AG) is a new blood glucose control marker reflecting temporary glucose elevations. However, 1,5-AG is of limited value in patients with advanced renal insufficiency. The aim of the present study was to assess the correlation between 1,5-AG levels and renal function in patients with earlier stages of nephropathy compared with another two markers of diabetes control, namely HbA1c and glycated albumin (GA). The following parameters were measured in 377 patients with type 2 diabetes: HbA1c, serum concentrations of 1,5-AG, GA and creatinine, hemoglobin, urinary albumin/creatinine ratio, and urinary excretion of α1 -microglobulin (A1M). Estimated glomerular filtration rate (eGFR) was calculated according to the Cockgroft-Gault formula. There was a negative correlation between 1,5-AG and renal function (r = -0.18; P < 0.001). Concentrations of 1,5-AG were, on average, 27.2% lower in patients with glomerular hyperfiltration (eGFR >120 mL/min) compared with patients with moderate renal impairment (eGFR 30-59 mL/min; P = 0.016). In contrast, HbA1c, GA levels and urinary A1M excretion did not differ between the two patient groups. The mean age of patients with eGFR 30-59 mL/min was substantially higher than that of patients with glomerular hyperfiltration (P < 0.001). Thus, an age-related change in the renal glucose threshold could be the reason for the observed correlation between 1,5-AG and renal function. In clinical practice, age and renal function must be taken into consideration when interpreting 1,5-AG levels, even in the absence of advanced renal impairment. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control: A Randomized Clinical Trial.

PubMed

Aiello, Lloyd Paul; Ayala, Allison R; Antoszyk, Andrew N; Arnold-Bush, Bambi; Baker, Carl; Bressler, Neil M; Elman, Michael J; Glassman, Adam R; Jampol, Lee M; Melia, Michele; Nielsen, Jared; Wolpert, Howard A

2015-08-01

Optimization of glycemic control is critical to reduce the number of diabetes mellitus-related complications, but long-term success is challenging. Although vision loss is among the greatest fears of individuals with diabetes, comprehensive personalized diabetes education and risk assessments are not consistently used in ophthalmologic settings. To determine whether the point-of-care measurement of hemoglobin A(1c) (HbA(1c)) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA(1c) level. Ophthalmologist office-based randomized, multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care. Adults with type 1 or 2 diabetes enrolled into 2 cohorts: those with a more-frequent-than-annual follow-up (502 control participants and 488 intervention participants) and those with an annual follow-up (368 control participants and 388 intervention participants). Enrollment was from April 2011 through January 2013. Point-of-care measurements of HbA1c, blood pressure, and retinopathy severity; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant's understanding. These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart. Mean change in HbA(1c) level from baseline to 1-year follow-up. Secondary outcomes included body mass index, blood pressure, and responses to diabetes self-management practices and attitudes surveys. In the cohort with more-frequent-than-annual follow-ups, the mean (SD) change in HbA(1c) level at 1 year was -0.1% (1.5%) in the control group and -0.3% (1.4%) in the intervention group (adjusted mean difference, -0.09% [95% CI, -0.29% to 0.12%]; P = .35). In the cohort with annual follow-ups, the mean (SD) change in HbA(1c) level was 0.0% (1.1%) in the control group and -0.1% (1.6%) in the intervention group (mean difference, -0.05% [95% CI, -0.27% to 0.18%]; P = .63). Results were similar for all secondary outcomes. Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes. The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA(1c) level compared with usual care over 1 year. These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in our study. clinicaltrials.gov Identifier:NCT01323348.

Baseline glycemic status and mortality in 241,499 Korean metropolitan subjects: A Kangbuk Samsung Health Study.

PubMed

Rhee, Eun-Jung; Park, Se Eun; Chang, Yoosoo; Ryu, Seungho; Lee, Won-Young

2016-02-01

Diabetes and prediabetes subjects have increased risk for mortality. We analyzed the mortality risk due to all causes, cardiovascular disease (CVD) and cancer in Korean subjects participating in a health-screening program according to baseline glycemic status and HbA1c levels. Among 241,499 participants of a health-screening program between 2005 and 2012, the risk of death from all causes, CVD, and cancer was calculated based on the baseline glycemic status (normoglycemia, prediabetes, and diabetes) and HbA1c levels. Uncontrolled diabetes was defined as HbA1c≥7.0%. Vital status and confirmation of the cause of death were based on the analysis of death certificate records from the National Death Index. During 923,343.1 person-years of follow-up, 877 participants died. The multivariable-adjusted hazard ratios (HR) of subjects with controlled and uncontrolled diabetes to normoglycemic subjects for all-cause mortality were 1.58 (95% CI 1.24-2.03) and 2.26 (95% CI 1.78-2.86), respectively. The HRs of subjects with controlled and uncontrolled diabetes to normoglycemic subjects for mortality due to cancer were 1.75 (95% CI 1.23-2.48) and 1.67 (95% CI 1.13-2.45). However, glycemic status was not significantly associated with the risk of mortality due to CVD. The subjects with HbA1c higher than 6.5% showed more than 2-fold increased risk for all-cause mortality and the subjects with HbA1c lower than 5.2% showed increased HR (1.45, 95% CI 1.06-1.97) compared with those with HbA1c of 5.5% in subjects not taking anti-diabetic medications. Mortality risk from all causes and cancer significantly increased in diabetes subjects regardless of the glucose control status. In subjects not taking anti-diabetic medications, both high and low HbA1c resulted in increased risk for all-cause mortality. Copyright © 2015 Elsevier Inc. All rights reserved.

Longitudinal trends in HbA1c patterns and association with outcomes: A systematic review.

PubMed

Luo, Miyang; Tan, Kristin Hui Xian; Tan, Chuen Seng; Lim, Wei Yen; Tai, E-Shyong; Venkataraman, Kavita

2018-04-17

This study aimed to review studies that identified patterns of longitudinal HbA 1c trends in patients with diabetes and to summarize factors and outcomes associated with distinct trajectory patterns. PubMed and Web of Science were systematically searched for studies examining HbA 1c trends among patients with diabetes from database inception through September 2017. Articles were included if they met the following inclusion criteria: (a) longitudinal study of subjects with diabetes only, (b) use of serial measurements of HbA 1c , and (c) analysis of the trend of HbA 1c using group-based trajectory approaches. Twenty studies were included, 11 on type 1 diabetes and 9 on type 2 diabetes. These studies identified 2 to 6 HbA 1c trajectory patterns. The most commonly identified patterns included stable HbA 1c around 7.0% and at levels between 8.0% and 9.9%, which usually captured the HbA 1c pattern among the majority of subjects in the study population. Unstable patterns identified included increasing HbA 1c trend, decreasing HbA 1c trend, and non-linear patterns. These patterns were associated with differential risk of disease outcomes, over and beyond single-point HbA 1c measures. Age, gender, ethnicity, diabetes duration, disease management frequency, cardiovascular risk factors, insulin treatment, family environment, and psychosocial factors were the most frequently reported factors associated with membership of specific HbA 1c pattern groups. Common patterns of longitudinal HbA 1c trends were identified despite heterogeneity among the studies. A better understanding of what underlies these different patterns may provide opportunities to tailor therapies and care for these patients to reduce adverse outcomes. © 2018 The Authors. Diabetes/Metabolism Research and Reviews Published by John Wiley & Sons Ltd.

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.

PubMed

Aroda, Vanita R; Rosenstock, Julio; Wysham, Carol; Unger, Jeffrey; Bellido, Diego; González-Gálvez, Guillermo; Takami, Akane; Guo, Hailing; Niemoeller, Elisabeth; Souhami, Elisabeth; Bergenstal, Richard M

2016-11-01

This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m 2 ) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA 1c levels at 30 weeks. HbA 1c decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA 1c from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA 1c of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA 1c <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi. Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes. © 2016 by the American Diabetes Association.

MARCH2: comparative assessment of therapeutic effects of acarbose and metformin in newly diagnosed type 2 diabetes patients.

PubMed

Wang, Guang; Liu, Jia; Yang, Ning; Gao, Xia; Fan, Hui; Xu, Yuan; Yang, Wenying

2014-01-01

The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c (HbA1c) reduction in Chinese patients with newly diagnosed type 2 diabetes. We investigated whether the therapeutic efficacy was diversified under different body mass index (BMI) status. All 784 subjects were divided into normal-weight group (BMI<24 kg/m2), overweight group (BMI 24-28 kg/m2) and obese group (BMI≥28 kg/m2). Patients were assigned to 48 weeks of therapy with acarbose or metformin, respectively. The clinical trial registry number was ChiCTR-TRC-08000231. The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5% or less were similar in the three groups after acarbose and metformin treatment. In overweight group, fasting blood glucose (FBG) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [-1.73 (-1.99 to -1.46) vs. -1.37 (-1.61 to -1.12), P<0.05), however the decrease of 2 h post-challenge blood glucose (PBG) after acarbose treatment at 48 weeks was bigger compared to metformin group [-3.34 (-3.83 to-2.84) vs. -2.35 (-2.85 to -1.85), P<0.01]. Both acarbose and metformin treatment resulted in a significant decrease in waist circumference, hip circumference, weight and BMI in the three groups (all P<0.05). Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients. Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status. Thus, acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin, even in obesity patients. ChiCTR.org ChiCTR-TRC-08000231.

Exploring Variation in Glycemic Control Across and Within Eight High-Income Countries: A Cross-sectional Analysis of 64,666 Children and Adolescents With Type 1 Diabetes.

PubMed

Charalampopoulos, Dimitrios; Hermann, Julia M; Svensson, Jannet; Skrivarhaug, Torild; Maahs, David M; Akesson, Karin; Warner, Justin T; Holl, Reinhard W; Birkebæk, Niels H; Drivvoll, Ann K; Miller, Kellee M; Svensson, Ann-Marie; Stephenson, Terence; Hofer, Sabine E; Fredheim, Siri; Kummernes, Siv J; Foster, Nicole; Hanberger, Lena; Amin, Rakesh; Rami-Merhar, Birgit; Johansen, Anders; Dahl-Jørgensen, Knut; Clements, Mark; Hanas, Ragnar

2018-06-01

International studies on childhood type 1 diabetes (T1D) have focused on whole-country mean HbA 1c levels, thereby concealing potential variations within countries. We aimed to explore the variations in HbA 1c across and within eight high-income countries to best inform international benchmarking and policy recommendations. Data were collected between 2013 and 2014 from 64,666 children with T1D who were <18 years of age across 528 centers in Germany, Austria, England, Wales, U.S., Sweden, Denmark, and Norway. We used fixed- and random-effects models adjusted for age, sex, diabetes duration, and minority status to describe differences between center means and to calculate the proportion of total variation in HbA 1c levels that is attributable to between-center differences (intraclass correlation [ICC]). We also explored the association between within-center variation and children's glycemic control. Sweden had the lowest mean HbA 1c (59 mmol/mol [7.6%]) and together with Norway and Denmark showed the lowest between-center variations (ICC ≤4%). Germany and Austria had the next lowest mean HbA 1c (61-62 mmol/mol [7.7-7.8%]) but showed the largest center variations (ICC ∼15%). Centers in England, Wales, and the U.S. showed low-to-moderate variation around high mean values. In pooled analysis, differences between counties remained significant after adjustment for children characteristics and center effects ( P value <0.001). Across all countries, children attending centers with more variable glycemic results had higher HbA 1c levels (5.6 mmol/mol [0.5%] per 5 mmol/mol [0.5%] increase in center SD of HbA 1c values of all children attending a specific center). At similar average levels of HbA 1c , countries display different levels of center variation. The distribution of glycemic achievement within countries should be considered in developing informed policies that drive quality improvement. © 2018 by the American Diabetes Association.

Determinants of hemoglobin A1c level in patients with type 2 diabetes after in-hospital diabetes education: A study based on continuous glucose monitoring.

PubMed

Torimoto, Keiichi; Okada, Yosuke; Sugino, Sachiko; Tanaka, Yoshiya

2017-05-01

We investigated the relationship between blood glucose profile at hospital discharge, evaluated by continuous glucose monitoring (CGM), and hemoglobin A1c (HbA1c) level at 12 weeks after discharge in patients with type 2 diabetes who received inpatient diabetes education. This was a retrospective study. The participants were 54 patients with type 2 diabetes who did not change their medication after discharge. The mean blood glucose (MBG), standard deviation, coefficient of variation, mean postprandial glucose excursion, maximum blood glucose, minimum blood glucose, percentage of time with blood glucose at ≥180 mg/dL (time at ≥180), percentage of time with blood glucose at ≥140 mg/dL, and percentage of time with blood glucose at <70 mg/dL were measured at admission and discharge using CGM. The primary end-point was the relationship between CGM parameters and HbA1c level at 12 weeks after discharge. The HbA1c level at 12 weeks after discharge correlated with MBG level (r = 0.30, P = 0.029). Multivariate analysis showed that MBG level and disease duration were predictors of 12-week HbA1c level. Multivariate logistic regression analysis was carried out considering goal achievement as a HbA1c level <7.0% 12 weeks after discharge. Disease duration and time at ≥180 were associated with goal achievement. The present results suggested that blood glucose profile at discharge using CGM seems useful to predict HbA1c level after discharge in patients with type 2 diabetes who received inpatient diabetes education. Early treatment to improve MBG level, as well as postprandial hyperglycemia, is important to achieve strict glycemic control. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Effectiveness of basal-supported oral therapy (BOT) using insulin glargine in patients with poorly controlled type 2 diabetes.

PubMed

Suzuki, Daisuke; Umezono, Tomoya; Miyauchi, Masaaki; Kimura, Moritsugu; Yamamoto, Naoyuki; Tanaka, Eitaro; Kuriyama, Yusuke; Sato, Hiroki; Miyatake, Han; Kondo, Masumi; Toyoda, Masao; Fukagawa, Masafumi

2012-07-20

To determine the clinical usefulness of basal-supported oral therapy (BOT) using insulin glargine in Japanese patients with type 2 diabetes. We compared HbA1c levels, body weight, and insulin doses before the introduction of BOT and in the final month of the observation period in 122 patients with type 2 diabetes who received BOT with insulin glargine between October 2007 and July 2009. To exclude the possible effects of seasonal changes in glycemic control, 57 of the 122 patients were followed-up for one year and examined for changes in HbA1c levels, body weight, and insulin dose. Examination of all cases (n=122) showed a significant decrease in HbA1c (before BOT: 8.7±1.8, after: 7.1±1.1%), but no significant change in body weight (before: 63.1±16.1, after: 63.8±17.0 kg). The mean observation period was 10.5±6.4 months. Insulin doses were significantly increased during the study. HbA1c levels improved significantly in patients on non-insulin-secreting drugs (biguanide, α-glucosidase inhibitor and thiazolidine derivatives) than those on insulin-secreting drugs (SU agents and glinides). BOT with insulin glargine is a useful strategy that can achieve good glycemic control in clinical practice without causing serious hypoglycemia. The introduction of BOT before exhaustion of pancreatic β cells may increase its effectiveness.

The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial.

PubMed

Gay, Isabel C; Tran, Duong T; Cavender, Adriana C; Weltman, Robin; Chang, Jennifer; Luckenbach, Estelle; Tribble, Gena D

2014-07-01

In the Mexican-American population, the prevalence of Type 2 diabetes mellitus (T2DM) is as high as 50% of the population. This randomized controlled clinical trial was designed to elucidate how treatment of periodontal disease affects HbA1c values in this population. One hundred and fifty-four T2DM patients with periodontal disease were enrolled in the study. The test group was treated with scaling and root planing (SRP); the control group received oral hygiene instructions. At baseline and 4-6 weeks after therapy, a complete periodontal examination was performed. Blood was collected at baseline and 4 months later for HbA1c levels. One hundred and twenty-six individuals completed the study. Baseline mean ± SD HbA1c for the test and control groups were 9.0 ± 2.3% and 8.4 ± 2.0% respectively. Non-significant difference in HbA1c reductions (0.6 ± 2.1% and 0.3 ± 1.7%) was found between test and control groups at 4 months. Comparisons of the periodontal clinical parameters between the test and control groups found significant differences with improved results in the test subjects. No statistically significant differences were found in the changes of HbA1c levels between test and control groups. Non-surgical periodontal therapy improved the magnitude of change in periodontal parameters as compared to the control subjects. ClinicalTrials.gov Identifier: NCT01128374. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Male hypogonadism and metabolic syndrome.

PubMed

Naifar, M; Rekik, N; Messedi, M; Chaabouni, K; Lahiani, A; Turki, M; Abid, M; Ayedi, F; Jamoussi, K

2015-06-01

The role of androgens in cardiovascular disease is still controversial in men. In this study, we investigated metabolic disorders in Tunisian hypogonadal men compared with healthy controls. Forty hypogonadal men and 80 control subjects were enrolled. Patients with a history of pre-existing panhypopituitarism, thyroid dysfunction or inflammatory disease were excluded. Glycaemia, glycated haemoglobin (HbA1c), high-sensitive C-reactive protein (hsCRP), lipid profile, insulin, testosterone and gonadotrophins were measured. Insulin resistance was assessed by homoeostasis model assessment of insulin resistance (Homa IR). Waist circumference, body mass index and blood pressure were significantly higher in patients compared with controls. Glycemia, HbA1c, fasting serum insulin and Homa IR were significantly increased among hypogonadal men. In univariate analysis, testosterone levels were inversely correlated with body mass index, waist circumference, blood pressure, glycaemia, HbA1C, insulin, Homa IR and hsCRP. In multivariate analysis including all significant variables, initial testosterone level was the only independent risk factor for developing dyslipidaemia. With logistic regression, male hypogonadism was an independent risk factor for MS (P < 0.001). We conclude that low testosterone level plays a central role in the development of metabolic syndrome. Further prospective data are required to establish the causative link. © 2014 Blackwell Verlag GmbH.

Changes in HbA1c levels and body mass index after successful decompression surgery in patients with type 2 diabetes mellitus and lumbar spinal stenosis: results of a 2-year follow-up study.

PubMed

Kim, Kyoung-Tae; Cho, Dae-Chul; Sung, Joo-Kyung; Kim, Chi Heon; Kang, Hyun; Kim, Du Hwan

2017-02-01

Lumbar spinal stenosis (LSS) can hinder a patient's physical activity, which in turn can impair glucose tolerance and body weight regulation in patients with type 2 diabetes mellitus (DM-2). Therefore, successful lumbar surgery could facilitate glycemic control and body weight regulation. This study aimed to evaluate the effects of postoperative improvement in physical activity on body mass index (BMI) and hemoglobin A 1c (HbA 1c ) level in patients with LSS and DM-2 over a 2-year follow-up period. Prospective longitudinal observational study. Patients with LSS and DM-2. Visual analogue scale (VAS) scores for back pain and leg pain, Oswestry Disability Index (ODI) scores, Japanese Orthopaedic Association (JOA) scores, JOA Back Pain Evaluation Questionnaire (JOABPEQ) sections, BMI, and blood analysis for HbA 1c were carried out. A total of 119 patients were enrolled for analysis of the effect of successful decompression surgery on changes in HbA 1c levels and BMI. The VAS score, ODI score, JOA score, JOABPEQ, BMI, HbA 1c were reassessed at 6 months, 1 year, and 2 years after surgery. Additionally, correlations between changes in HbA 1c and changes in the ODI, JOA, JOABPEQs, and BMI were analyzed. The overall values of HbA1c before and at 6 months, 1 year, and 2 years after the surgery were 7.08±0.94%, 6.58±0.87%, 6.59±0.79%, and 6.59±0.79%, respectively (p-values; 6 months: .024; 1 year: .021; 2 years: .038). In the not well-controlled sugar (non-WCS) group (preoperative HbA 1c >6.5%), the difference between pre- and postoperative HbA 1c was highly statistically significant (p<.01). The overweight group (preoperative BMI≥25) showed statistically significant BMI reduction in the second year after surgery (p=.034). The postoperative HbA 1c changes are strongly correlated with the improvements of ODI, JOA, and JOABPEQ after surgery. The present study demonstrates that in patients with DM-2 and LSS, successful lumbar surgery may facilitate glycemic control by enabling an increase in the patient's level of physical activity. Additionally, it could help reduce body weight in overweight (BMI>25) patients with DM-2 and LSS. Copyright © 2016 Elsevier Inc. All rights reserved.

Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial.

PubMed

Aronson, R; Reznik, Y; Conget, I; Castañeda, J A; Runzis, S; Lee, S W; Cohen, O

2016-05-01

To compare insulin pump therapy and multiple daily injections (MDI) in patients with type 2 diabetes receiving basal and prandial insulin analogues. After a 2-month dose-optimization period, 331 patients with glycated haemoglobin (HbA1c) levels ≥8.0% and ≤12% were randomized to pump therapy or continued MDI for 6 months [randomization phase (RP)]. The MDI group was subsequently switched to pump therapy during a 6-month continuation phase (CP). The primary endpoint was the between-group difference in change in mean HbA1c from baseline to the end of the RP. The mean HbA1c at baseline was 9% in both groups. At the end of the RP, the reduction in HbA1c was significantly greater with pump therapy than with MDI (-1.1 ± 1.2% vs -0.4 ± 1.1%; p < 0.001). The pump therapy group maintained this improvement to 12 months while the MDI group, which was switched to pump therapy, showed a 0.8% reduction: the final HbA1c level was identical in both arms. In the RP, total daily insulin dose (TDD) was 20.4% lower with pump therapy than with MDI and remained stable in the CP. The MDI-pump group showed a 19% decline in TDD, such that by 12 months TDD was equivalent in both groups. There were no differences in weight gain or ketoacidosis between groups. In the CP, one patient in each group experienced severe hypoglycaemia. Pump therapy has a sustained durable effect on glycaemic control in uncontrolled type 2 diabetes. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12‐month data from the OpT2mise randomized trial

PubMed Central

Reznik, Y.; Conget, I.; Castañeda, J. A.; Runzis, S.; Lee, S. W.; Cohen, O.

2016-01-01

Aims To compare insulin pump therapy and multiple daily injections (MDI) in patients with type 2 diabetes receiving basal and prandial insulin analogues. Methods After a 2‐month dose‐optimization period, 331 patients with glycated haemoglobin (HbA1c) levels ≥8.0% and ≤12% were randomized to pump therapy or continued MDI for 6 months [randomization phase (RP)]. The MDI group was subsequently switched to pump therapy during a 6‐month continuation phase (CP). The primary endpoint was the between‐group difference in change in mean HbA1c from baseline to the end of the RP. Results The mean HbA1c at baseline was 9% in both groups. At the end of the RP, the reduction in HbA1c was significantly greater with pump therapy than with MDI (−1.1 ± 1.2% vs −0.4 ± 1.1%; p < 0.001). The pump therapy group maintained this improvement to 12 months while the MDI group, which was switched to pump therapy, showed a 0.8% reduction: the final HbA1c level was identical in both arms. In the RP, total daily insulin dose (TDD) was 20.4% lower with pump therapy than with MDI and remained stable in the CP. The MDI–pump group showed a 19% decline in TDD, such that by 12 months TDD was equivalent in both groups. There were no differences in weight gain or ketoacidosis between groups. In the CP, one patient in each group experienced severe hypoglycaemia. Conclusions Pump therapy has a sustained durable effect on glycaemic control in uncontrolled type 2 diabetes. PMID:26854123

Diagnostic performance of HbA1c for diabetes in Arab vs. European populations: a systematic review and meta-analysis.

PubMed

Bertran, E A; Berlie, H D; Taylor, A; Divine, G; Jaber, L A

2017-02-01

To examine differences in the performance of HbA 1c for diagnosing diabetes in Arabs compared with Europeans. The PubMed, Embase and Cochrane library databases were searched for records published between 1998 and 2015. Estimates of sensitivity, specificity and log diagnostic odds ratios for an HbA 1c cut-point of 48 mmol/mol (6.5%) were compared between Arabs and Europeans, using a bivariate linear mixed-model approach. For studies reporting multiple cut-points, population-specific summary receiver operating characteristic (SROC) curves were constructed. In addition, sensitivity, specificity and Youden Index were estimated for strata defined by HbA 1c cut-point and population type. Database searches yielded 1912 unique records; 618 full-text articles were reviewed. Fourteen studies met the inclusion criteria; hand-searching yielded three additional eligible studies. Three Arab (N = 2880) and 16 European populations (N = 49 127) were included in the analysis. Summary sensitivity and specificity for a HbA 1c cut-point of 48 mmol/mol (6.5%) in both populations were 42% (33-51%), and 97% (95-98%). There was no difference in area under SROC curves between Arab and European populations (0.844 vs. 0.847; P = 0.867), suggesting no difference in HbA 1c diagnostic accuracy between populations. Multiple cut-point summary estimates stratified by population suggest that Arabs have lower sensitivity and higher specificity at a HbA 1c cut-point of 44 mmol/mol (6.2%) compared with European populations. Estimates also suggest similar test performance at cut-points of 44 mmol/mol (6.2%) and 48 mmol/mol (6.5%) for Arabs. Given the low sensitivity of HbA 1c in the high-risk Arab American population, we recommend a combination of glucose-based and HbA 1c testing to ensure an accurate and timely diagnosis of diabetes. © 2016 Diabetes UK.

The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial.

PubMed

Engebretson, Steven P; Hyman, Leslie G; Michalowicz, Bryan S; Schoenfeld, Elinor R; Gelato, Marie C; Hou, Wei; Seaquist, Elizabeth R; Reddy, Michael S; Lewis, Cora E; Oates, Thomas W; Tripathy, Devjit; Katancik, James A; Orlander, Philip R; Paquette, David W; Hanson, Naomi Q; Tsai, Michael Y

2013-12-18

Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all). Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. clinicaltrials.gov Identifier: NCT00997178.

Do eating behaviors in the general population account for country variance in glycemic control among adolescents with diabetes: the Hvidoere Study Group and the Health Behaviour in School-Aged Children study.

PubMed

Due, Pernille; de Beaufort, Carine; Damsgaard, Mogens Trab; Mortensen, Henrik Bindesbøl; Rasmussen, Mette; Ahluwalia, Naman; Skinner, Timothy; Swift, Peter

2013-12-01

The Hvidoere Study Group (HSG) has demonstrated major differences in glycemic control between pediatric diabetes centers which remain largely unexplained. This study investigates whether these differences are partly attributable to healthy eating norms in the background population. The study involved adolescents from 18 countries from (i) the Health Behaviour in School-Aged Children study (HBSC) and (ii) the HSG. There were 94 387 participants from representative HBSC samples of 11-, 13- and 15-yr-olds and 1483 11- to 15-yr-old adolescents with diabetes from the HSG. The frequency of intake of fruit, vegetables, sweets, sugary soft drinks, and daily breakfast was compared between the two groups. The glycemic control of the adolescents in the HSG cohort was determined by measuring glycated hemoglobin (HbA1c). Across countries in the HSBC survey, there was substantial variation in prevalence of healthy eating behavior and even greater variation between adolescents from the HSG centers. In all countries more adolescents with diabetes reported healthy eating behavior compared to national norms. In individuals healthy eating behavior had a significant effect on the individual level HbA1c. There was no significant correlation between the frequencies of these healthy eating behaviors at (i) the national level and (ii) diabetes center level and the center mean HbA1c. Although individual healthy eating behavior is associated with better glycemic control at the individual level, such eating behavior does not explain the center differences in HbA1c. Similarly, the reported healthy eating norm of the background populations does not explain the variation in glycemic control among centers. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Raman spectroscopy and PCA-SVM as a non-invasive diagnostic tool to identify and classify qualitatively glycated hemoglobin levels in vivo.

PubMed

Villa-Manríquez, J F; Castro-Ramos, J; Gutiérrez-Delgado, F; Lopéz-Pacheco, M A; Villanueva-Luna, A E

2017-08-01

In this study we identify and classify high and low levels of glycated hemoglobin (HbA1c) in healthy volunteers (HV) and diabetic patients (DP). Overall, 86 subjects were evaluated. The Raman spectrum was measured in three anatomical regions of the body: index fingertip, right ear lobe, and forehead. The measurements were performed to compare the difference between the HV and DP (22 well controlled diabetic patients (WCDP) (HbA1c <6.5%), and 49 not controlled diabetic patients (NCDP) (HbA1c ≥6.5%)). Multivariable methods such as principal components analysis (PCA) combined with support vector machine (SVM) were used to develop effective diagnostic algorithms for classification among these groups. The forehead of HV versus WCDP showed the highest sensitivity (100%) and specificity (100%). Sensitivity (100%) and specificity (60%), were highest in the forehead of WCDP, versus NCDP. In HV versus NCDP, the fingertip had the highest sensitivity (100%) and specificity (80%). The efficacy of the diagnostic algorithm by receiver operating characteristic (ROC) curve was confirmed. Overall, our study demonstrated that the combination of Raman spectroscopy and PCA-SVM are feasible non-invasive diagnostic tool in diabetes to classify qualitatively high and low levels of HbA1c in vivo. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Is social support universally adaptive in diabetes? A correlational study in an Arabic-speaking population with type 2 diabetes.

PubMed

Sukkarieh-Haraty, Ola; Howard, Elizabeth

2015-01-01

The purpose of this study was to assess the relationship between diabetes self-care, diabetes-specific emotional distress, and social support and glycemic control (hemoglobin A1C levels: HbA1c) among a sample of Lebanese adults with type 2 diabetes. A descriptive correlational design was adapted with descriptive statistics and multiple logistic regressions for analyses. A convenience sample of 140 adults diagnosed with type 2 diabetes was recruited from 2 diabetes clinics in Greater Beirut. Participants were asked to complete 4 questionnaires in Arabic. Significant associations (P < .05) were found between following a general diet for more than 3.5 days per week and higher social support and HbA1c levels of 7% or more. Social support was positively associated with HbA1c levels such that participants with uncontrolled glycemic levels, as evidenced by higher values for HbA1c, received more support from their social network.

Cost-effectiveness of a New Opportunistic Screening Strategy for Walk-in Fingertip HbA1c Testing at Community Pharmacies in Japan.

PubMed

Shono, Aiko; Kondo, Masahide; Hoshi, Shu-Ling; Okubo, Reiko; Yahagi, Naoya

2018-06-01

A new opportunistic community-based strategy was launched in Japan in April 2014 to detect lifestyle-related diseases, including diabetes, by creating Specimen Measurement Offices (SMOs). SMOs offer walk-in fingertip HbA 1c testing. This article aimed to assess the value-for-money of HbA 1c testing services at SMOs by conducting a cost-effectiveness analysis. We compared two scenarios: 1 ) status quo, defined as HbA 1c testing that is available only through conventional screening, and 2 ) HbA 1c testing available at SMOs as a complement to the status quo scenario. The model consisted of a screening module with a decision tree and a disease progression module with a Markov model. We calculated incremental cost-effectiveness ratios (i.e., cost per quality-adjusted life-years [QALYs]) over the lifetime analytic horizon as the primary end point of the cost-effectiveness analysis. In this model, we assumed the participant cohort to be people 40-74 years of age who sought walk-in fingertip HbA 1c testing at SMOs on the premises of community pharmacies. Costs and outcomes were discounted at a rate of 3%. The cost-effectiveness was analyzed from a societal perspective. The incremental cost per individual for those 40-74 years of age was estimated to be -527 U.S. dollars (USD) (-52,722 Japanese yen [JPY]) for HbA 1c testing at SMOs compared with the status quo. Incremental effectiveness was estimated to be 0.0203 QALYs for HbA 1c testing at SMOs compared with the status quo. Therefore, this cost-effectiveness analysis showed that compared with the status quo, HbA 1c testing at SMOs was more effective and had lower cost for the population studied. We consider our results to be robust because most simulations were under the threshold of USD 50,000 (JPY 5,000,000) per QALYs gained, by sensitivity analysis. These results will be useful to managers of pharmacies or other health institutions and/or policy makers in local government. © 2018 by the American Diabetes Association.

Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis.

PubMed

Yeh, Hsin-Chieh; Brown, Todd T; Maruthur, Nisa; Ranasinghe, Padmini; Berger, Zackary; Suh, Yong D; Wilson, Lisa M; Haberl, Elisabeth B; Brick, Jessica; Bass, Eric B; Golden, Sherita Hill

2012-09-04

Patients with diabetes mellitus need information about the effectiveness of innovations in insulin delivery and glucose monitoring. To review how intensive insulin therapy (multiple daily injections [MDI] vs. rapid-acting analogue-based continuous subcutaneous insulin infusion [CSII]) or method of monitoring (self-monitoring of blood glucose [SMBG] vs. real-time continuous glucose monitoring [rt-CGM]) affects outcomes in types 1 and 2 diabetes mellitus. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through February 2012 without language restrictions. 33 randomized, controlled trials in children or adults that compared CSII with MDI (n=19), rt-CGM with SMBG (n=10), or sensor-augmented insulin pump use with MDI and SMBG (n=4). 2 reviewers independently evaluated studies for eligibility and quality and serially abstracted data. In randomized, controlled trials, MDI and CSII showed similar effects on hemoglobin A1c (HbA1c) levels and severe hypoglycemia in children or adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. In adults with type 1 diabetes mellitus, HbA1c levels decreased more with CSII than with MDI, but 1 study heavily influenced these results. Compared with SMBG, rt-CGM achieved a lower HbA1c level (between-group difference of change, 0.26% [95% CI, 0.33% to 0.19%]) without any difference in severe hypoglycemia. Sensor-augmented insulin pump use decreased HbA1c levels more than MDI and SMBG did in persons with type 1 diabetes mellitus (between-group difference of change, 0.68% [CI, 0.81% to 0.54%]). Little evidence was available on other outcomes. Many studies were small, of short duration, and limited to white persons with type 1 diabetes mellitus. Continuous subcutaneous insulin infusion and MDI have similar effects on glycemic control and hypoglycemia, except CSII has a favorable effect on glycemic control in adults with type 1 diabetes mellitus. For glycemic control, rt-CGM is superior to SMBG and sensor-augmented insulin pumps are superior to MDI and SMBG without increasing the risk for hypoglycemia. Agency for Healthcare Research and Quality.

Long-Term Single and Joint Effects of Excessive Daytime Napping on the HOMA-IR Index and Glycosylated Hemoglobin: A Prospective Cohort Study.

PubMed

Li, Xue; Pang, Xiuyu; Zhang, Qiao; Qu, Qiannuo; Hou, Zhigang; Liu, Zhipeng; Lv, Lin; Na, Guanqiong; Zhang, Wei; Sun, Changhao; Li, Ying

2016-02-01

This prospective cohort study was conducted to assess the duration of daytime napping and its effect combined with night sleep deprivation on the risk of developing high HOMA-IR (homeostasis model assessment of insulin resistance) index and disadvantageous changes in glycosylated hemoglobin (HbA1c) levels.A total of 5845 diabetes-free subjects (2736 women and 3109 men), 30 to 65 years of age, were targeted for this cohort study since 2008. Multiple adjusted Cox regression models were performed to evaluate the single and joint effects of daytime napping on the risk of an elevated HbA1c level and high HOMA-IR index.After an average of 4.5 years of follow-up, >30 minutes of daytime napping was significantly associated with an increased risk of an elevated HbA1c level (>6.5%) in men and women (all P trend < 0.05). Hazard ratios (HRs) for an HbA1c level between 5.7% and 6.4% were also significant in the entire cohort and women, but nonsignificant in men. HRs (95% confidence interval, CIs) for the high HOMA-IR index in the entire cohort, men, and women were 1.33 (1.10-1.62), 1.46 (1.08-1.98), and 1.47 (1.12-1.91), respectively. The combination of sleep deprivation with no naps or >30 minutes napping and the combination of no sleep deprivation with >30 minutes daytime napping were all associated with an HbA1c level >6.5% (HR = 2.08, 95% CI = 1.24-3.51; HR = 4.00, 95% CI = 2.03-7.90; and HR = 2.05, 95% CI = 1.29-3.27, respectively). No sleep deprivation combined with >30 minutes daytime napping correlated with a high risk of an HbA1c level between 5.7% and 6.4% and high HOMA-IR index (HR = 2.12, 95% CI = 1.48-3.02; and HR = 1.35, 95% CI = 1.10-1.65, respectively).Daytime napping >30 minutes was associated with a high risk of an elevated HbA1c level and high HOMA-IR index. No sleep deprivation combined with napping >30 minutes carries a risk of abnormal glucose metabolism. Sleep deprivation combined with brief daytime napping <30 minutes was not associated with a risk for an elevated HbA1c level and high HOMA-IR index.

Long-Term Single and Joint Effects of Excessive Daytime Napping on the HOMA-IR Index and Glycosylated Hemoglobin

PubMed Central

Li, Xue; Pang, Xiuyu; Zhang, Qiao; Qu, Qiannuo; Hou, Zhigang; Liu, Zhipeng; Lv, Lin; Na, Guanqiong; Zhang, Wei; Sun, Changhao; Li, Ying

2016-01-01

Abstract This prospective cohort study was conducted to assess the duration of daytime napping and its effect combined with night sleep deprivation on the risk of developing high HOMA-IR (homeostasis model assessment of insulin resistance) index and disadvantageous changes in glycosylated hemoglobin (HbA1c) levels. A total of 5845 diabetes-free subjects (2736 women and 3109 men), 30 to 65 years of age, were targeted for this cohort study since 2008. Multiple adjusted Cox regression models were performed to evaluate the single and joint effects of daytime napping on the risk of an elevated HbA1c level and high HOMA-IR index. After an average of 4.5 years of follow-up, >30 minutes of daytime napping was significantly associated with an increased risk of an elevated HbA1c level (>6.5%) in men and women (all P trend < 0.05). Hazard ratios (HRs) for an HbA1c level between 5.7% and 6.4% were also significant in the entire cohort and women, but nonsignificant in men. HRs (95% confidence interval, CIs) for the high HOMA-IR index in the entire cohort, men, and women were 1.33 (1.10–1.62), 1.46 (1.08–1.98), and 1.47 (1.12–1.91), respectively. The combination of sleep deprivation with no naps or >30 minutes napping and the combination of no sleep deprivation with >30 minutes daytime napping were all associated with an HbA1c level >6.5% (HR = 2.08, 95% CI = 1.24–3.51; HR = 4.00, 95% CI = 2.03–7.90; and HR = 2.05, 95% CI = 1.29–3.27, respectively). No sleep deprivation combined with >30 minutes daytime napping correlated with a high risk of an HbA1c level between 5.7% and 6.4% and high HOMA-IR index (HR = 2.12, 95% CI = 1.48–3.02; and HR = 1.35, 95% CI = 1.10–1.65, respectively). Daytime napping >30 minutes was associated with a high risk of an elevated HbA1c level and high HOMA-IR index. No sleep deprivation combined with napping >30 minutes carries a risk of abnormal glucose metabolism. Sleep deprivation combined with brief daytime napping <30 minutes was not associated with a risk for an elevated HbA1c level and high HOMA-IR index. PMID:26844520

Hospital admission rates and emergency department use in relation to glycated hemoglobin in people with diabetes mellitus: a linkage study using electronic medical record and administrative data in Ontario

PubMed Central

Birtwhistle, Richard; Green, Michael E.; Frymire, Eliot; Dahrouge, Simone; Whitehead, Marlo; Khan, Shahriar; Greiver, Michelle; Glazier, Richard H.

2017-01-01

Background: The Canadian Primary Care Sentinel Surveillance Network (CPCSSN) collects extensive data on primary care patients but it currently does not gather reliable information on outcomes in other settings. The objectives of this study were to link electronic medical record (EMR) data from Ontario patients in the CPCSSN with administrative data from the Institute for Clinical Evaluative Sciences (ICES), to assess the representativeness of the CPCSSN population, and to identify people with diabetes in the CPCSSN data and describe their emergency department (ED) visits and hospital admissions over a 2-year period (2010-2012) by HbA1c level. Methods: We conducted a cross-sectional study linking 2014 Ontario CPCSSN data with ICES administrative data and a retrospective cohort study using the 2014 data extraction linked with data from the Ontario health care registry, hospital discharge abstracts and a database of emergency department visits. Demographics of CPCSSN patients were compared with those of the Ontario population. Patients with a CPCSSN diagnosis of diabetes were compared by HbA1c category for ED visits, hospital admissions and diagnosis of diabetes-related complications. Results: The linkage rate was 99%. We identified 12 358 patients with diabetes, 2356 of whom were missing data on HbAIc, for a final sample of 10 002. Patients with diabetes had a mean age of 64 years. Those with a higher HbA1c were younger, more likely to be male, had a lower income, had more comorbidities and were more likely to live in rural or suburban areas than patients with a lower HbA1c. Over the study period 31.8% of patients had 1 or more ED visits and 13.7% had a hospital admission for a diabetes-related complication. Patients with HbA1c greater than 8 had significantly more hospital admissions, ED visits and diabetes-related complications than patients with a lower HbA1c . Interpretation: The linkage between EMR and administrative data was successful. In this study population, higher HbA1c values were associated with increased ED visits and hospital admissions, with an increasing gradient as HbA1c increased from less than 7% to greater than 8%. PMID:28701374

Comparability of HbA1c and lipids measured with dried blood spot versus venous samples: a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Levels of haemoglobin A1c (HbA1c) and blood lipids are important determinants of risk in patients with diabetes. Standard analysis methods based upon venous blood samples can be logistically challenging in resource-poor settings where much of the diabetes epidemic is occurring. Dried blood spots (DBS) provide a simple alternative method for sample collection but the comparability of data from analyses based on DBS is not well established. Methods We conducted a systematic review and meta-analysis to define the association of findings for HbA1c and blood lipids for analyses based upon standard methods compared to DBS. The Cochrane, Embase and Medline databases were searched for relevant reports and summary regression lines were estimated. Results 705 abstracts were found by the initial electronic search with 6 further reports identified by manual review of the full papers. 16 studies provided data for one or more outcomes of interest. There was a close agreement between the results for HbA1c assays based on venous and DBS samples (DBS = 0.9858venous + 0.3809), except for assays based upon affinity chromatography. Significant adjustment was required for assays of total cholesterol (DBS = 0.6807venous + 1.151) but results for triglycerides (DBS = 0.9557venous + 0.1427) were directly comparable. Conclusions For HbA1c and selected blood lipids, assays based on DBS samples are clearly associated with assays based on standard venous samples. There are, however, significant uncertainties about the nature of these associations and there is a need for standardisation of the sample collection, transportation, storage and analysis methods before the technique can be considered mainstream. This should be a research priority because better elucidation of metabolic risks in resource poor settings, where venous sampling is infeasible, will be key to addressing the global epidemic of cardiovascular diseases. PMID:25045323

Diabetes Complications at Presentation and One Year by Glycated Haemoglobin at Diagnosis in a Multiethnic and Diverse Socioeconomic Population: Results from the South London Diabetes Study.

PubMed

Azam, Mohsin; Marwood, Lindsey; Ismail, Khalida; Evans, Tyrrell; Sivaprasad, Sobha; Winkley, Kirsty; Amiel, Stephanie Anne

2015-01-01

Background. WHO's recommendation of HbA1c ≥ 48 mmol/mol (6.5%) as diagnostic for type 2 diabetes mellitus (T2DM) was adopted by three UK London boroughs in May 2012. The South London Diabetes (SOUL-D) study has recruited people with newly diagnosed T2DM since 2008. We compared participants diagnosed before May 2012 with HbA1c < 48 mmol/mol to those with diagnostic HbA1c ≥ 48 mmol/mol. Methods. A prospective cohort study of newly diagnosed T2DM participants from 96 primary care practices, comparing demographic and biomedical variables between those with diagnostic HbA1c < 48 mmol/mol or HbA1c ≥ 48 mmol/mol at recruitment and after one year. Results. Of 1488 participants, 22.8% had diagnostic HbA1c < 48 mmol/mol. They were older and more likely to be white (p < 0.05). At recruitment and one year, there were no between-group differences in the prevalence of diabetic complications, except that those diagnosed with HbA1c < 48 mmol/mol had more sensory neuropathy at recruitment (p = 0.039) and, at one year, had new myocardial infarction (p = 0.012) but less microalbuminuria (p = 0.012). Conclusions. Use of HbA1c ≥ 48 mmol/mol as the sole T2DM diagnostic criterion may miss almost a quarter of those previously diagnosed in South London yet HbA1c < 48 mmol/mol may not exclude clinically important diabetes.

Diabetes Complications at Presentation and One Year by Glycated Haemoglobin at Diagnosis in a Multiethnic and Diverse Socioeconomic Population: Results from the South London Diabetes Study

PubMed Central

Azam, Mohsin; Marwood, Lindsey; Ismail, Khalida; Evans, Tyrrell; Sivaprasad, Sobha; Winkley, Kirsty; Amiel, Stephanie Anne

2015-01-01

Background. WHO's recommendation of HbA1c ≥ 48 mmol/mol (6.5%) as diagnostic for type 2 diabetes mellitus (T2DM) was adopted by three UK London boroughs in May 2012. The South London Diabetes (SOUL-D) study has recruited people with newly diagnosed T2DM since 2008. We compared participants diagnosed before May 2012 with HbA1c < 48 mmol/mol to those with diagnostic HbA1c ≥ 48 mmol/mol. Methods. A prospective cohort study of newly diagnosed T2DM participants from 96 primary care practices, comparing demographic and biomedical variables between those with diagnostic HbA1c < 48 mmol/mol or HbA1c ≥ 48 mmol/mol at recruitment and after one year. Results. Of 1488 participants, 22.8% had diagnostic HbA1c < 48 mmol/mol. They were older and more likely to be white (p < 0.05). At recruitment and one year, there were no between-group differences in the prevalence of diabetic complications, except that those diagnosed with HbA1c < 48 mmol/mol had more sensory neuropathy at recruitment (p = 0.039) and, at one year, had new myocardial infarction (p = 0.012) but less microalbuminuria (p = 0.012). Conclusions. Use of HbA1c ≥ 48 mmol/mol as the sole T2DM diagnostic criterion may miss almost a quarter of those previously diagnosed in South London yet HbA1c < 48 mmol/mol may not exclude clinically important diabetes. PMID:26090473

Blood Glucagon Levels Predict the Hemoglobin A1c Response to Saxagliptin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin.

PubMed

Liu, Hao; Hu, Yun; Li, Feng-Fei; Liu, Bing-Li; Su, Xiao-Fei; Ma, Jian-Hua

2016-12-01

Dipeptidyl peptidase-4 (DPP-4) inhibitors are widely used as second-option medications when metformin fails. Variance of the glycated hemoglobin (HbA1c) response to DPP-4 inhibitions in patients with type 2 diabetes mellitus (T2DM) has been observed, but the characteristics which predict the response to DPP-4 inhibitor therapy are unclear. The aim of this study was to investigate the characteristics of α- and β-cell functions which might predict the efficacy of saxagliptin and facilitate personalization of treatment. We studied 60 patients with T2DM who had inadequate glycemic control [HbA1c7.0-13.0% (53-119 mmol/mol)) with metformin alone. The patients were treated with saxagliptin (5 mg, daily) and metformin (1000-2000 mg as former) for 12 weeks. Oral glucose tolerance tests were carried out at baseline and endpoint to evaluate α- and β-cell functions, and blood C-peptide, insulin, glucagon levels were tested. Blood glucose, HbA1c and weight were also observed. Significant reduction of weight, HbA1c and glucagon was observed after 12-week treatment, while C-peptide, insulin and homeostasis model assessment-β increased (P < 0.05). Linear regression and receiver operating characteristic analysis showed that baseline HbA1c and 30 min-glucagon were correlated with the HbA1c response to saxagliptin, while the weight loss was correlated with gender, age and fasting-insulin level. Further analysis showed the 30 min-glucagon of 49.1 pmol/L was the optimal cutoff value to predict the efficacy of saxagliptin. Saxagliptin added to metformin significantly improved glycemic control and α- and β-cell function. Blood glucagon level was a good predicting factor for the HbA1c response to saxagliptin, and it will help appropriate patient selection. Chinese Clinical Trial Register identifier, ChiCTR-PPR-15007045.

Effect of nonsurgical periodontal therapy verses oral hygiene instructions on type 2 diabetes subjects with chronic periodontitis: a randomised clinical trial.

PubMed

Raman, Renukanth Patabi Cheta; Taiyeb-Ali, Tara Bai; Chan, Siew Pheng; Chinna, Karuthan; Vaithilingam, Rathna Devi

2014-06-25

40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 15 subjects from NSPT group and 17 from OHI group completed the study. The difference in plaque index (PI) between NSPT and OHI groups were significant at 2 months recall (p = 0.013). There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters, HbA1c and CRP levels. At 3 months post-therapy, periodontal parameters improved significantly in both groups with sites with probing pocket depth (PPD) < 4 mm reported as 98 ± 1.8% in NSPT group and 92 ± 14.9% in OHI group. Mean PPD and mean probing attachment loss (PAL) within the NSPT group reduced significantly from baseline (2.56 ± 0.57 mm, 3.35 ± 0.83 mm) to final visit (1.94 ± 0.26 mm, 2.92 ± 0.72 mm) (p = 0.003, p < 0.001). For OHI group, improvements in mean PPD and mean PAL were also seen from baseline (2.29 ± 0.69 mm, 2.79 ± 0.96 mm) to final visit (2.09 ± 0.72 mm, 2.62 ± 0.97 mm) (p < 0.001 for both). Similarly, HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction (p = 0.038). Participants who demonstrated ≥ 50% reduction in PPD showed significant reductions of HbA1c and hs-CRP levels (p = 0.004 and p = 0.012). NSPT significantly reduced PI at 2 months post-therapy as compared to OHI. Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels. ClinicalTrials.gov: NCT01951547.

Beyond HbA1c.

PubMed

Bloomgarden, Zachary

2017-12-01

It can scarcely be denied that the supreme goal of all theory is to make the irreducible basic elements as simple and as few as possible without having to surrender the adequate representation of a single datum of experience. The diaTribe Foundation convened a meeting on the topic of glycemic outcomes beyond HbA1c on 21 July 2017, in Bethesda (MD, USA), focusing on potential uses of continuous glucose monitoring (CGM). Understanding patterns of glycemia in people with diabetes has long been a focus of approaches to improving treatment, and over the past few years this has become an available modality for clinical practice. Glucose levels are not the only biologic parameters affecting HbA1c levels; HbA1c changes with anemia or, more subtly, with changes in rates of erythrocyte turnover not reflected in hemoglobin levels outside the normal range. Renal disease often is associated with lower HbA1c than would be predicted based on an individual's glycemic levels. Furthermore, HbA1c levels tend to increase with age and are higher in some ethnic groups; for example, people of African ethnicity have higher HbA1c levels than people of Northern European descent. Indeed, we have argued that even as a measure of mean glycemia HbA1c is inherently imprecise. Overall, for some 20% of people with diabetes, HbA1c levels are substantially higher, or substantially lower, than those that would be predicted from mean blood glucose levels. If one recognizes that HbA1c is, at best, a partial measure of mean glycemic exposure, one must surely accept that HbA1c does not reflect variability within a day, from day to day, and from period to period. Many glucose-lowering medicines, particularly the sulfonylureas and insulin, cause hypoglycemia, with consequent negative effects on quality of life and patient-reported outcomes, as well as association with weight gain and adverse macrovascular outcome; hypoglycemia will, of course, not be captured by HbA1c measurement. Based on these considerations, HbA1c may be more limited than generally recognized as a surrogate marker of optimal diabetes treatment, leading the European Medicines Agency to consider relying less on this measure, with the implication that novel approaches will be required for clinical practice and for clinical trials in developing future medicines. In surveys performed by a market research company (dQ&A Market Research, San Francisco, CA, USA) and reported at the Bethesda meeting, among >3000 people with type 1 (T1D) or type 2 (T2D) diabetes both receiving and not receiving insulin, the majority reported a sense that their diabetes care is not very successful and that too much of their time was spent outside the 70-180 mg/dL (3.9-10.0 mEq/L) range. Although self-monitoring of capillary blood glucose (SMBG) is an important tool for patients to use in understanding glycemic excursions, CGM offers a far superior technology in this regard and can avoid the erroneous conclusions often accompanying the use of the inherently indirect measurement of HbA1c. Duration and severity of hypoglycemia may come to be considered important medication efficacy measures, rather than just being considered safety outcomes. Glucose cut-off levels suggested at the meeting may be: <54 mg/dL (3.0 mEq/L) for severe hypoglycemia, <70 mg/dL (3.9 mEq/L) for low blood glucose levels, >180 mg/dL (10.0 mEq/L) for high blood glucose levels, and >240 mg/dL (13.3 mEq/L) for serious high blood glucose levels. An important part of both SMBG and CGM technologies will be the development of data transmission and storage modalities to better provide feedback to people with diabetes and health care providers in adjusting a variety of treatments, as well as their growing use in insulin dose adjustment algorithms; important in such approaches will be the integration of SMBG with CGM to recognize potential measurement errors and to improve the accuracy and assurance of patients and providers that the CGM results are accurate, a particular concern for readings in the hypoglycemia range, but remaining an issue throughout the clinical glycemia range. However, one must recognize that many commercially available SMBG instruments also fail to exhibit required accuracy, and that the indirect relationship between HbA1c and blood glucose suggests that HbA1c is at best limited in its portrayal of glycemic exposure. All these modalities play a role, but the use of CGM appears crucial to the development of better approaches to clinical treatment with multiple views allowing understanding of patterns of glycemic exposure. We look forward to further improvements in this methodology. © 2017 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Arsenic Exposure, Diabetes Prevalence, and Diabetes Control in the Strong Heart Study

PubMed Central

Gribble, Matthew O.; Howard, Barbara V.; Umans, Jason G.; Shara, Nawar M.; Francesconi, Kevin A.; Goessler, Walter; Crainiceanu, Ciprian M.; Silbergeld, Ellen K.; Guallar, Eliseo; Navas-Acien, Ana

2012-01-01

This study evaluated the association of arsenic exposure, as measured in urine, with diabetes prevalence, glycated hemoglobin, and insulin resistance in American Indian adults from Arizona, Oklahoma, and North and South Dakota (1989–1991). We studied 3,925 men and women 45–74 years of age with available urine arsenic measures. Diabetes was defined as a fasting glucose level of 126 mg/dL or higher, a 2-hour glucose level of 200 mg/dL or higher, a hemoglobin A1c (HbA1c) of 6.5% or higher, or diabetes treatment. Median urine arsenic concentration was 14.1 µg/L (interquartile range, 7.9–24.2). Diabetes prevalence was 49.4%. After adjustment for sociodemographic factors, diabetes risk factors, and urine creatinine, the prevalence ratio of diabetes comparing the 75th versus 25th percentiles of total arsenic concentrations was 1.14 (95% confidence interval: 1.08, 1.21). The association between arsenic and diabetes was restricted to participants with poor diabetes control (HbA1c ≥8%). Arsenic was positively associated with HbA1c levels in participants with diabetes. Arsenic was not associated with HbA1c or with insulin resistance (assessed by homeostatic model assessment to quantify insulin resistance) in participants without diabetes. Urine arsenic was associated with diabetes control in a population from rural communities in the United States with a high burden of diabetes. Prospective studies that evaluate the direction of the relation between poor diabetes control and arsenic exposure are needed. PMID:23097256

HbA1c Predicts Time to Diagnosis of Type 1 Diabetes in Children at Risk.

PubMed

Helminen, Olli; Aspholm, Susanna; Pokka, Tytti; Hautakangas, Milla-Riikka; Haatanen, Nora; Lempainen, Johanna; Ilonen, Jorma; Simell, Olli; Knip, Mikael; Veijola, Riitta

2015-05-01

Prediction of type 1 diabetes is based on the detection of multiple islet autoantibodies in subjects who are at increased genetic risk. Prediction of the timing of diagnosis is challenging, however. We assessed the utility of HbA1c levels in predicting the clinical disease in genetically predisposed children with multiple autoantibodies. Cord blood samples from 168,055 newborn infants were screened for class II HLA genotypes in Finland, and 14,876 children with increased genetic risk for type 1 diabetes were invited to participate in regular follow-ups, including screening for diabetes-associated autoantibodies. When two or more autoantibodies were detected, HbA1c levels were analyzed at each visit. During follow-up, multiple (two or more) autoantibodies developed in 466 children; type 1 diabetes was diagnosed in 201 of these children (43%, progressors), while 265 children remained disease free (nonprogressors) by December 2011. A 10% increase in HbA1c levels in samples obtained 3-12 months apart predicted the diagnosis of clinical disease (hazard ratio [HR] 5.7 [95% CI 4.1-7.9]) after a median time of 1.1 years (interquartile range [IQR] 0.6-3.1 years) from the observed rise of HbA1c. If the HbA1c level was ≥5.9% (41 mmol/mol) in two consecutive samples, the median time to diagnosis was 0.9 years (IQR 0.3-1.5, HR 11.9 [95% CI 8.8-16.0]). In conclusion, HbA1c is a useful biochemical marker when predicting the time to diagnosis of type 1 diabetes in children with multiple autoantibodies. © 2015 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.

Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes.

PubMed

Husted, Gitte R; Thorsteinsson, Birger; Esbensen, Bente Appel; Gluud, Christian; Winkel, Per; Hommel, Eva; Zoffmann, Vibeke

2014-08-12

Providing care for adolescents with type 1 diabetes is complex, demanding, and often unsuccessful. Guided self-determination (GSD) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes. To improve care, GSD was revised for adolescents, their parents, and interdisciplinary healthcare providers (HCP) to create GSD-Youth (GSD-Y). We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual, focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes. Seventy-one adolescents (mean age: 15 years, mean duration of diabetes: 5.7 years, mean HbA1c: 77 mmol/mol (9.1%), upon entering the study) from two pediatric departments were randomized into a GSD-Y group (n = 37, GSD-Y was provided during individual outpatient sessions) versus a treatment-as-usual group (n = 34). The primary outcome was the HbA1c measurement. The secondary outcomes were life skills development (assessed by self-reported psychometric scales), self-monitored blood glucose levels, and hypo- and hyperglycemic episodes. The analysis followed an intention-to-treat basis. Fifty-seven adolescents (80%) completed the trial, and 53 (75%) completed a six-month post-treatment follow-up. No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP (P = 0.85). GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value (P = 0.001). Compared with the control group, the trial completion was prolonged in the GSD-Y group (P <0.001), requiring more visits (P = 0.05) with a higher rate of non-attendance (P = 0.01). GSD-Y parents participated in fewer of the adolescents' visits (P = 0.05) compared with control parents. Compared with treatment-as-usual, GSD-Y did not improve HbA1c levels, but it did decrease adolescents' amotivation for diabetes self-management. ISRCTN 54243636, registered on 10 January 2010. Life skills for adolescents with type 1 diabetes and their parents.

The Association of Normal Range Glycated Hemoglobin with Restrictive Lung Pattern in the General Population

PubMed Central

Oh, Il Hwan; Park, Jung Hwan; Lee, Chang Hwa; Park, Joon-Sung

2015-01-01

Glycated hemoglobin (HbA1c) is an important diagnostic indicator of diabetes mellitus, and some authors have argued that it is related to impaired lung function in the diabetic population. However, there was rare study for association between lung function and HbA1c in the non-diabetic population. We investigated whether HbA1c below the diagnostic threshold is related to deficits in lung function. We analyzed biochemical and spirometry data from a nation-wide, population-based, case-control study (the KNHANES IV and V). Eligible as cases were all native Koreans aged 40 years or more with no medical illness. A total of 3670 participants were divided into 4 groups according to HbA1c (%) as follows: Group I (n = 842), ≥ 4.0 and ≤ 5.3; Group II (n = 833), > 5.3 and ≤ 5.5; Group III (n = 898), > 5.5 and ≤ 5.7; and Group IV (n = 1097), > 5.7 and ≤ 6.4. Group I had the greatest forced vital capacity (FVC, 96.3 ± 0.5% pred, P < 0.0001), forced expiratory volume per second (FEV1, 93.8 ± 0.5% pred, P < 0.0001) and FEV1/FVC (0.792 ± 0.003, P < 0.0001) compared with the other groups. Linear regression showed that HbA1c was closely related to FVC (β = -6.972154, P < 0.0001) and FEV1 (β = -5.591589, P < 0.0001), but not to FEV1/FVC. Logistic regression analysis revealed a significant association between HbA1c and a restrictive spirometric pattern (FVC < 80% pred., FEV1/FVC ≥ 0.70; OR = 3.772, 95% CI = 1.234-11.53), indicating that elevated HbA1c is closely associated with lung impairment in the non-diabetic population. In the healthy population, relatively high HbA1c level is associated with decrements of FVC and FEV1 and may be a reliable predictor of poor lung function, especially the restrictive pattern. PMID:25658743

Pre-pregnancy care and pregnancy outcomes in type 1 diabetes mellitus: a comparison of continuous subcutaneous insulin infusion and multiple daily injection therapy.

PubMed

Neff, K J; Forde, R; Gavin, C; Byrne, M M; Firth, R G R; Daly, S; McAuliffe, F M; Foley, M; Coffey, M; Coulter-Smith, S; Kinsley, B T

2014-09-01

Pre-pregnancy care improves pregnancy outcomes in type 1 diabetes mellitus (T1DM). Continuous subcutaneous insulin infusion (CSII) therapy and multiple daily injection (MDI) therapy can both be used to achieve glycaemic targets, but few data are available to compare their efficacy in pre-pregnancy care. To compare MDI and CSII in pre-pregnancy care in T1DM. Retrospective database review of women with T1DM attending the Dublin Diabetes in Pregnancy Centre. 464 women with T1DM (40 treated with CSII) were included. Women attending for pre-pregnancy care had lower HbA1c levels at booking to antenatal services [52 ± 10 mmol/mol (6.9 ± 0.9 %) vs. 62 ± 16 mmol/mol (7.8 ± 1.5 %), p < 0.001], and booked at an earlier gestation (6 ± 2 vs. 8 ± 6 weeks, p < 0.001). In those who attended for pre-pregnancy care, the CSII group had lower HbA1c levels at booking than those using MDI [48 ± 8 mmol/mol (6.5 ± 0.7 %) vs. 53 ± 10 mmol/mol (7.0 ± 0.9 %), p = 0.03]. Gestational age at delivery and birth weight did not differ between groups. Caesarean section rates were associated with CSII use (p < 0.001), duration of diabetes (p = 0.002), and parity (p = 0.006). Nulliparous women using CSII with a longer history of diabetes were more likely to deliver by Caesarean section. There was no perinatal mortality. Pre-pregnancy care delivered by a specialist multi-disciplinary team effectively reduces HbA1c levels peri-conception. CSII use results in lower HbA1c levels in pre-pregnancy care in selected individuals and should be considered in women with T1DM planning pregnancy.

Effects of dapagliflozin on insulin-requirement, glucose excretion and ß-hydroxybutyrate levels are not related to baseline HbA1c in youth with type 1 diabetes.

PubMed

Biester, Torben; Aschemeier, Baerbel; Fath, Maryam; Frey, Marcel; Scheerer, Markus F; Kordonouri, Olga; Danne, Thomas

2017-11-01

Youth with type 1 diabetes (T1D) infrequently achieve HbA1c targets. Therefore, this placebo-controlled, randomized, crossover study was set up to assess the safety, effect and pharmacokinetics of a single dose of 10 mg dapagliflozin (DAPA) as add-on to insulin in relationship to HbA1c in youth. A total of 33 youths (14 males, median age 16 years, diabetes duration 8 years) were included and stratified into 3 baseline HbA1c categories (<7.5%, 7.5%-9.0% or >9.0; n = 11 each). During the study period of 24 hours, intravenous insulin administration and glucose-infusion kept blood glucose levels at 160 to 220 mg/dL. DAPA reduced mean insulin dose by 13.6% ( P  < .0001 by ANOVA) and increased urinary glucose excretion by 610% (143.4 vs 22.4 g/24 h; P  < .0001), both irrespective of baseline HbA1c. Six independent episodes in 6 patients with plasma ß-hydroxybutyrate levels between ≥0.6 and <1.0 mmol/L were observed after liquid meal challenges, 5 episodes in the DAPA group and 1 in the placebo group. This study provides a proof-of-concept, irrespective of preexisting HbA1c levels, for adjunct SGLT2-inhibitor therapy in the paediatric age group by lowering insulin dose and increasing glucose excretion. © 2017 John Wiley & Sons Ltd.

Differential effects of blood insulin and HbA1c on cerebral amyloid burden and neurodegeneration in nondiabetic cognitively normal older adults.

PubMed

Byun, Min Soo; Kim, Hyun Jung; Yi, Dahyun; Choi, Hyo Jung; Baek, Hyewon; Lee, Jun Ho; Choe, Young Min; Sohn, Bo Kyung; Lee, Jun-Young; Lee, Younghwa; Ko, Hyunwoong; Kim, Yu Kyeong; Lee, Yun-Sang; Sohn, Chul-Ho; Woo, Jong Inn; Lee, Dong Young

2017-11-01

We tested the hypothesis that lower insulin or higher glycated hemoglobin (HbA1c) levels in blood are associated with increased cerebral beta amyloid (Aβ) deposition and neurodegeneration in nondiabetic cognitively normal (CN) older adults. A total of 205 nondiabetic CN older adults underwent comprehensive clinical assessment, [ 11 C]Pittsburgh compound B (PiB)-positron emission tomography (PET), [ 18 F]fluorodeoxyglucose-PET, magnetic resonance imaging, and blood sampling for fasting insulin and HbA1c measurement. Lower blood insulin was significantly associated with increased Aβ positivity rates and decreased cerebral glucose metabolism in the AD-signature region. In contrast, higher HbA1c levels were not associated with Aβ positivity rates but were significantly associated with higher rates of having neurodegeneration in the AD-signature regions. Our results suggest different roles of insulin and HbA1c in AD pathogenesis, in that decreased blood insulin below optimal levels may contribute to increasing cerebral Aβ deposition and neurodegeneration whereas impaired glycemic control may aggravate neurodegeneration through a nonamyloid mechanism in nondiabetic CN older adults. Copyright © 2017 Elsevier Inc. All rights reserved.

Glycated hemoglobin independently predicts stroke recurrence within one year after acute first-ever non-cardioembolic strokes onset in A Chinese cohort study.

PubMed

Wu, Shuolin; Shi, Yuzhi; Wang, Chunxue; Jia, Qian; Zhang, Ning; Zhao, Xingquan; Liu, Gaifen; Wang, Yilong; Liu, Liping; Wang, Yongjun

2013-01-01

Hyperglycemia is related to stroke. Glycated hemoglobin (HbA1c) can reflect pre-stroke glycaemia status. However, the information on the direct association between HbA1c and recurrence after non-cardioembolic acute ischemic strokes is rare and there is no consistent conclusion. The ACROSS-China database comprised of 2186 consecutive first-ever acute ischemic stroke patients with baseline HbA1c values. After excluding patients who died from non-stroke recurrence and patients lost to follow up, 1817 and 1540 were eligible for 3-month and 1-year analyses, respectively. Multivariate Cox regression was performed to evaluate the associations between HbA1c and 3-month and 1-year stroke recurrence. The HbA1c values at admission were divided into 4 levels by quartiles: Q1 (<5.5%); Q2 (5.5 to <6.1%); Q3 (6.1% to <7.2%); and Q4 (≥ 7.2%). The cumulative recurrence rates were 8.3% and 11.0% for 3 months and 1 year, respectively. In multivariate analyses, when compared with Q1, the adjusted hazard ratios (AHRs) were 2.83 (95% confidence interval (CI) 1.28-6.26) in Q3 and 3.71(95% CI 1.68-8.21) in Q4 for 3-month stroke recurrence; 3.30 (95% CI 1.31-8.34) in Q3 and 3.35 (95% CI 1.36-8.21) in Q4 for 1-year stroke recurrence. Adding fasting plasma glucose in the multivariate analyses did not modify the association: AHRs were 2.75 (95% CI 1.24-6.11) in Q3 and 3.67 (95% CI 1.59-8.53) in Q4 for 3-month analysis; AHRs were 3.08 (95% CI 1.10-8.64) in Q3 and 3.31(95% CI 1.35-8.14) in Q4 for 1-year analysis. A higher "normal" HbA1c level reflecting pre-stroke glycaemia status independently predicts stroke recurrence within one year after non-cardioembolic acute ischemic stroke onset. HbA1c is recommended as a routine test in acute ischemic stroke patients.

Glycated Hemoglobin Independently Predicts Stroke Recurrence within One Year after Acute First-Ever Non-Cardioembolic Strokes Onset in A Chinese Cohort Study

PubMed Central

Wu, Shuolin; Shi, Yuzhi; Wang, Chunxue; Jia, Qian; Zhang, Ning; Zhao, Xingquan; Liu, Gaifen; Wang, Yilong; Liu, Liping; Wang, Yongjun

2013-01-01

Objective Hyperglycemia is related to stroke. Glycated hemoglobin (HbA1c) can reflect pre-stroke glycaemia status. However, the information on the direct association between HbA1c and recurrence after non-cardioembolic acute ischemic strokes is rare and there is no consistent conclusion. Methods The ACROSS-China database comprised of 2186 consecutive first-ever acute ischemic stroke patients with baseline HbA1c values. After excluding patients who died from non-stroke recurrence and patients lost to follow up, 1817 and 1540 were eligible for 3-month and 1-year analyses, respectively. Multivariate Cox regression was performed to evaluate the associations between HbA1c and 3-month and 1-year stroke recurrence. Results The HbA1c values at admission were divided into 4 levels by quartiles: Q1 (<5.5%); Q2 (5.5 to <6.1%); Q3 (6.1% to <7.2%); and Q4 (≥7.2%). The cumulative recurrence rates were 8.3% and 11.0% for 3 months and 1 year, respectively. In multivariate analyses, when compared with Q1, the adjusted hazard ratios (AHRs) were 2.83 (95% confidence interval (CI) 1.28-6.26) in Q3 and 3.71(95% CI 1.68-8.21) in Q4 for 3-month stroke recurrence; 3.30 (95% CI 1.31-8.34) in Q3 and 3.35 (95% CI 1.36-8.21) in Q4 for 1-year stroke recurrence. Adding fasting plasma glucose in the multivariate analyses did not modify the association: AHRs were 2.75 (95% CI 1.24-6.11) in Q3 and 3.67 (95% CI 1.59-8.53) in Q4 for 3-month analysis; AHRs were 3.08 (95% CI 1.10-8.64) in Q3 and 3.31(95% CI 1.35-8.14) in Q4 for 1-year analysis. Conclusions A higher “normal” HbA1c level reflecting pre-stroke glycaemia status independently predicts stroke recurrence within one year after non-cardioembolic acute ischemic stroke onset. HbA1c is recommended as a routine test in acute ischemic stroke patients. PMID:24236195

One year follow-up after a randomized controlled trial of a 130 g/day low-carbohydrate diet in patients with type 2 diabetes mellitus and poor glycemic control

PubMed Central

Kanazawa, Akio; Hatae, Chie; Makita, Sumiko; Komiya, Koji; Shimizu, Tomoaki; Ikeda, Fuki; Tamura, Yoshifumi; Ogihara, Takeshi; Mita, Tomoya; Goto, Hiromasa; Uchida, Toyoyoshi; Miyatsuka, Takeshi; Ohmura, Chie; Watanabe, Takehito; Kobayashi, Kiyoe; Miura, Yoshiko; Iwaoka, Manami; Hirashima, Nao; Watada, Hirotaka

2017-01-01

Background & aims Recently, we conducted a prospective randomized controlled trial (RCT) showing that a 6-month 130g/day low-carbohydrate diet (LCD) reduced HbA1c and BMI more than a calorie restricted diet (CRD). [1] To assess whether the benefits of the LCD persisted after the intensive intervention, we compared HbA1c and BMI between the LCD and CRD groups at 1 year after the end of the 6-month RCT. Methods Following the end of the 6-month RCT, patients were allowed to manage their own diets with periodic outpatient visits. One year later, we analyzed clinical and nutrition data. Results Of the 66 participants in the original study, 27 in the CRD group and 22 in the LCD group completed this trial. One year after the end of the original RCT, the carbohydrate intake was comparable between the groups (215 [189–243]/day in the CRD group and 214 (176–262) g/day in the LCD group). Compared with the baseline data, HbA1c and BMI were decreased in both groups (CRD: HbA1c -0.4 [-0.9 to 0.3] % and BMI -0.63 [-1.20 to 0.18] kg/m2; LCD: HbA1c -0.35 [-1.0 to 0.35] % and BMI -0.77 [-1.15 to -0.12] kg/m2). There were no significant differences in HbA1c and BMI between the groups. Conclusions One year after the diet therapy intervention, the beneficial effect of the LCD on reduction of HbA1c and BMI did not persist in comparison with CRD. However, combining the data of both groups, significant improvements in HbA1c and BMI from baseline were observed. Although the superiority of the LCD disappeared 1 year after the intensive intervention, these data suggest that well-constructed nutrition therapy programs, both CRD and LCD, were equally effective in improving HbA1c for at least 1 year. Trial registration University Hospital Medical Information Network (UMIN) ID000010663 PMID:29206237

Preoperative octreotide therapy and surgery in acromegaly: associations between glucose homeostasis and treatment response.

PubMed

Helseth, R; Carlsen, S M; Bollerslev, J; Svartberg, J; Øksnes, M; Skeie, S; Fougner, S L

2016-02-01

In acromegaly, high GH/IGF-1 levels associate with abnormal glucose metabolism. Somatostatin analogs (SSAs) reduce GH and IGF-1 but inhibit insulin secretion. We studied glucose homeostasis in de novo patients with acromegaly and changes in glucose metabolism after treatment with SSA and surgery. In this post hoc analysis from a randomized controlled trial, 55 de novo patients with acromegaly, not using antidiabetic medication, were included. Before surgery, 26 patients received SSAs for 6 months. HbA1c, fasting glucose, and oral glucose tolerance test were performed at baseline, after SSA pretreatment and at 3 months postoperative. Area under curve of glucose (AUC-G) was calculated. Glucose homeostasis was compared to baseline levels of GH and IGF-1, change after SSA pretreatment, and remission both after SSA pretreatment and 3 months postoperative. In de novo patients, IGF-1/GH levels did not associate with baseline glucose parameters. After SSA pretreatment, changes in GH/IGF-1 correlated positively to change in HbA1c levels (both p < 0.03). HbA1c, fasting glucose, and AUC-G increased significantly during SSA pretreatment in patients not achieving hormonal control (all p < 0.05) but did not change significantly in patients with normalized hormone levels. At 3 months postoperative, HbA1c, fasting glucose, and AUC-G were significantly reduced in both cured and not cured patients (all p < 0.05). To conclude, in de novo patients with acromegaly, disease activity did not correlate with glucose homeostasis. Surgical treatment of acromegaly improved glucose metabolism in both cured and not cured patients, while SSA pretreatment led to deterioration in glucose homeostasis in patients not achieving biochemical control.

An Audit of Clinical Practice in a Single Centre in Kuwait: Management of Children on Continuous Subcutaneous Insulin Infusion and Cardiovascular Risk Factors Screening.

PubMed

Omar, Dina; Alsanae, Hala; Al Khawari, Mona; Abdulrasoul, Majedah; Rahme, Zahraa; Al Refaei, Faisal; Behbehani, Kazem; Shaltout, Azza

2017-01-01

To audit the current clinical practice of continuous subcutaneous insulin infusion (CSII) for the treatment of type 1 diabetes mellitus (T1D) in children and adolescents attending a single centre in Kuwait. A one year retrospective audit was performed in children and adolescents with T1D on CSII, who attended the paediatric diabetes clinic, Dasman Diabetes Institute during 2012. The primary outcome measure was glycaemic control as evidenced by glycated haemoglobin (HbA1c) level and the secondary outcome measures were the frequency of monitoring of the risk for microvascular complications and occurrence of acute complications and adverse events. 58 children and adolescents (mean age ± SD: 12.6 ± 4.1 years) were included. Mean HbA1c at baseline was 8.8% (72.7 mmol/mol) and 8.9% (73.8 mmol/mol) at the end of a 12 months observation period. Children with poor control (HbA1c >9.5% (80 mmol/mol) had a significant 1.4% reduction in HbA1c compared with the overall reduction of 0.1% (p=0.7). Rate of screening for cardiovascular risk factors and for long term complications were well documented. However, there was underreporting of acute complications such as severe hypoglycaemia and diabetic ketoacidosis. Only 1.7% of patients discontinued the pump. There was no significant change in HbA1c values at the end of 12 months follow up. However, HbA1c values in poorly controlled children improved. CSII requires care by skilled health professionals as well as education and selection of motivated parents and children.

Effects of zinc and multimineral vitamin supplementation on glycemic and lipid control in adult diabetes.

PubMed

Gunasekara, Priyanka; Hettiarachchi, Manjula; Liyanage, Chandrani; Lekamwasam, Sarath

2011-01-26

To evaluate the effects of zinc with or without other antioxidants on blood glucose, lipid profile, and serum creatinine in adult diabetics on long-term follow-up. Patients (n = 96) were randomly allocated to three groups: group A (n = 29) was supplemented with oral zinc sulfate (22 mg/day) and multivitamin/mineral (zinc+MVM) preparation; group B (n = 31) was given the same preparation without zinc (MVM); and group C (n = 36) was given a matching placebo for a period of 4 months in a single-blinded study. Blood samples were taken at baseline and after 4 months of supplementation to assess blood glucose (fasting and postprandial) and glycosylated hemoglobin (Hb(A1C)%) and serum levels of zinc, creatinine, and lipids. The zinc+MVM group had a mean change of fasting blood sugar -0.33 mmol/L (standard error of the mean 0.21 mmol/L) and was significant (P = 0.05) when compared with the other two groups (mean change in the MVM group +0.19 (0.31) mmol/L and +0.43 (0.23) mmol/L in the control group, respectively). The Hb(A1C)% level reduced significantly, irrespective of the baseline level, in zinc+MVM-supplemented individuals. In the other two groups, the change of Hb(A1C)% level was not significant. Serum lipid levels reduced significantly in the zinc+MVM and MVM groups. Zinc+MVM supplementation showed beneficial effects in the metabolic control of adult diabetics in addition to elevating their serum zinc level. Zinc supplementation improved glycemic control measured by Hb(A1C)% and fasting and postprandial glucose. Furthermore, zinc supplementation lowered serum cholesterol and cholesterol/high-density lipoprotein ratio.

Do high blood glucose peaks contribute to higher HbA1c? Results from repeated continuous glucose measurements in children.

PubMed

Ulf, Samuelsson; Ragnar, Hanas; Arne, Whiss Per; Johnny, Ludvigsson

2008-08-01

HbA1c levels are influenced by the glycemic control of previous 2-3 months. Sometimes patients have surprisingly low HbA1c in spite of many correctly measured high blood glucose values, which is difficult to explain. As glucose sensors give an objective picture based on glucose readings several times per minute over 24 hours, we used the area under the curve (AUC) of such subcutaneous glucose profiles to evaluate their relationship with HbA1c. Thirty-two patients were randomized into two study arms, one open and the other blinded. Both arms had 8 pump users and 8 patients with multiple daily injections (MDI). After three months the two arms crossed over. Both study arms wore a continuous glucose monitoring system (CGMS) for 3 days every 2 weeks. HbA1c was determined before and after each 3-month study period. There was no relationship between HbA1c and s.c. glucose AUC or between HbA1c and the number of peaks >15.0 mmol/L when all CGMS profiles during the 6 months were taken together. Children on MDI showed a positive relationship between HbA1c and AUC (P<0.01) as well as the number of peaks (P<0.01). Children with a negative relationship between HbA1c and AUC generally had fewer fluctuations in blood glucose values, whereas children with a positive relationship had wide fluctuations. between s.c. glucose AUC and HbA1c, the results indicate that wide blood glucose fluctuations may be related to high HbA1c values. Therefore, complications and therapeutic interventions should aim at reducing such fluctuations. Although there was no relationship between s.c. glucose AUC and HbA1c, the results indicate that wide blood glucose fluctuations may be related to high HbA1c values. Therefore, complications and therapeutic interventions should aim at reducing such fluctuations.

Comparative analysis of the effects of alogliptin and vildagliptin on glucose metabolism in type 2 diabetes mellitus.

PubMed

Tanaka, Kenichi; Okada, Yosuke; Mori, Hiroko; Miyazaki, Megumi; Kuno, Fumi; Sonoda, Satomi; Sugai, Kei; Hajime, Maiko; Kurozumi, Akira; Narisawa, Manabu; Torimoto, Keiichi; Arao, Tadashi; Mine, Shinichiro; Tanaka, Yoshiya

2017-02-27

The aim of this 24-week, prospective randomized open-label study was to compare the effects of alogliptin and vildagliptin on glucose control, renal function, and lipid metabolism. In Study 1, DPP-4 inhibitor-naive type 2 diabetes (T2DM) were randomly assigned to alogliptin 25 mg/day or vildagliptin 50 mg twice daily. In Study 2, T2DM on treatment with 50 mg/day sitagliptin were switched to either 25 mg/day alogliptin or 50 mg twice daily vildagliptin. The primary endpoint was change in glycosylated hemoglobin (HbA1c) level at 24 weeks, while the secondary endpoints were changes in urinary albumin excretion and low-density lipoprotein cholesterol (LDL-C) levels at 24 weeks. In Study 1, HbA1c levels changed at 24-week by -0.5±0.7% in the alogliptin group (p=0.002, relative to baseline) and -0.7±0.9% in the vildagliptin group (p=0.001, relative to baseline), and the extent of these changes were comparable between the two groups (p=0.219). The decrease in log urinary albumin excretion was more significant in the vildagliptin group (p=0.008). In Study 2, HbA1c levels at 24-week changed by 0.2±0.7% in the switch-to-alogliptin group (p=0.007) and 0.0±0.6% in the switch-to-vildagliptin group (p=0.188), indicating a significant difference between the groups (p=0.003). In both studies, the changes in LDL-C levels were comparable between the two groups. The two drugs had comparable glucose-lowering effects in DPP-4 inhibitor-naive patients but the effect was more pronounced for vildagliptin in patients switched from sitagliptin. The results may point to subtle yet important differences between the two DPP-4 inhibitors. This trial was registered with UMIN (no. #000019022).

Ambulatory glucose profile analysis of the juvenile diabetes research foundation continuous glucose monitoring dataset-Applications to the pediatric diabetes population.

PubMed

Forlenza, Gregory P; Pyle, Laura L; Maahs, David M; Dunn, Timothy C

2017-11-01

Increased continuous glucose monitor (CGM) use presents both the benefit and burden of increased data for clinicians to rapidly analyze. The ambulatory glucose profile (AGP) is an evolving a universal software report for CGM data analysis. We utilized the Juvenile Diabetes Research Foundation-CGM dataset to evaluate the AGP across a broad spectrum of patients to show how AGP can be used clinically to assist with CGM-related decision making. We hypothesized that AGP metrics would be different across age and HbA1c strata. AGPs were generated from the JDRF-CGM trial dataset for all periods during which there were ≥10 days of CGM coverage in the 2 weeks adjacent to an HbA1c measurement yielding 1101 AGPs for 393 unique subjects. AGPs were stratified by age group (8-14, 15-24, and ≥25 years) and HbA1c (within or above target for age) and compared for between group differences in AGP metrics via two-factor ANOVA. Glycemic differences between time periods were analyzed via segmented regression analysis. Glucose exposure (average and estimated A1c) and variability (standard deviation and interquartile range) were different between the low and high HbA1c levels. Within a given HbA1c level all age groups were significantly different from each other with older patients having lower averages with less variability than younger patients. AGP analysis of the JDRF-CGM data highlights significant differences in glycemic profiles between pediatric and adult age groups and between well and less well-controlled patient populations. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Data analytics identify glycated haemoglobin co-markers for type 2 diabetes mellitus diagnosis.

PubMed

Jelinek, Herbert F; Stranieri, Andrew; Yatsko, Andrew; Venkatraman, Sitalakshmi

2016-08-01

Glycated haemoglobin (HbA1c) is being more commonly used as an alternative test for the identification of type 2 diabetes mellitus (T2DM) or to add to fasting blood glucose level and oral glucose tolerance test results, because it is easily obtained using point-of-care technology and represents long-term blood sugar levels. HbA1c cut-off values of 6.5% or above have been recommended for clinical use based on the presence of diabetic comorbidities from population studies. However, outcomes of large trials with a HbA1c of 6.5% as a cut-off have been inconsistent for a diagnosis of T2DM. This suggests that a HbA1c cut-off of 6.5% as a single marker may not be sensitive enough or be too simple and miss individuals at risk or with already overt, undiagnosed diabetes. In this study, data mining algorithms have been applied on a large clinical dataset to identify an optimal cut-off value for HbA1c and to identify whether additional biomarkers can be used together with HbA1c to enhance diagnostic accuracy of T2DM. T2DM classification accuracy increased if 8-hydroxy-2-deoxyguanosine (8-OhdG), an oxidative stress marker, was included in the algorithm from 78.71% for HbA1c at 6.5% to 86.64%. A similar result was obtained when interleukin-6 (IL-6) was included (accuracy=85.63%) but with a lower optimal HbA1c range between 5.73 and 6.22%. The application of data analytics to medical records from the Diabetes Screening programme demonstrates that data analytics, combined with large clinical datasets can be used to identify clinically appropriate cut-off values and identify novel biomarkers that when included improve the accuracy of T2DM diagnosis even when HbA1c levels are below or equal to the current cut-off of 6.5%. Copyright © 2016 Elsevier Ltd. All rights reserved.

Prevalence and phenotype of diabetes and prediabetes using fasting glucose vs HbA1c in a Caribbean population.

PubMed

Unwin, Nigel; Howitt, Christina; Rose, Angela Mc; Samuels, T Alafia; Hennis, Anselm Jm; Hambleton, Ian R

2017-12-01

Both fasting plasma glucose (FPG) and HbA1c are recommended for the diagnosis of diabetes and prediabetes by the American Diabetes Association (ADA), and for diabetes by the World Health Organization. The ADA guidance is influential on clinical practice in many developing countries, including in the Caribbean and Latin America. We aimed to compare the prevalence and characteristics of individuals identified as having diabetes and prediabetes by FPG and HbA1c in a predominantly African ancestry Caribbean population. A representative population-based sample of 1234 adults (≥25 years of age) resident in Barbados was recruited. Standard methods with appropriate quality control were used to collect data on height, weight, blood pressure, fasting lipids and history of diagnosed diabetes, and to measure fasting glucose and HbA1c. Those with previously diagnosed diabetes (n = 192) were excluded from the analyses. Diabetes was defined as: FPG ≥7.0 mmol/L or HbA1c ≥6.5%; prediabetes as: FPG ≥5.6 to <7mmol/L or HbA1c ≥5.7 to <6.5%. Complete data were available on 939 participants without previously diagnosed diabetes. The prevalence of undiagnosed diabetes was higher, but not significantly so, by HbA1c (4.9%, 95% CI 3.5, 6.8) vs FPG (3.5%, 2.4, 5.1). Overall 79 individuals had diabetes by either measure, but only 21 on both. The prevalence of prediabetes was higher by HbA1c compared to FPG: 41.7% (37.9, 45.6) vs 15.0% (12.8, 17.5). Overall 558 individuals had prediabetes by either measure, but only 107 on both. HbA1c, but not FPG, was significantly higher in women than men; and FPG, but not HbA1c, was significantly associated with raised triglycerides and low HDL cholesterol. The agreement between FPG and HbA1c defined hyperglycaemia is poor. In addition, there are some differences in the phenotype of those identified, and HbA1c gives a much higher prevalence of prediabetes. The routine use of HbA1c for screening and diagnosis in this population would have major implications for clinical and public health policies and resources. Given the lack of robust evidence, particularly for prediabetes, on whether intervention in the individuals identified would improve outcomes, this approach to screening and diagnosis cannot be currently recommended for this population.

Prevalence and phenotype of diabetes and prediabetes using fasting glucose vs HbA1c in a Caribbean population

PubMed Central

Unwin, Nigel; Howitt, Christina; Rose, Angela MC; Samuels, T Alafia; Hennis, Anselm JM; Hambleton, Ian R

2017-01-01

Background Both fasting plasma glucose (FPG) and HbA1c are recommended for the diagnosis of diabetes and prediabetes by the American Diabetes Association (ADA), and for diabetes by the World Health Organization. The ADA guidance is influential on clinical practice in many developing countries, including in the Caribbean and Latin America. We aimed to compare the prevalence and characteristics of individuals identified as having diabetes and prediabetes by FPG and HbA1c in a predominantly African ancestry Caribbean population. Methods A representative population–based sample of 1234 adults (≥25 years of age) resident in Barbados was recruited. Standard methods with appropriate quality control were used to collect data on height, weight, blood pressure, fasting lipids and history of diagnosed diabetes, and to measure fasting glucose and HbA1c. Those with previously diagnosed diabetes (n = 192) were excluded from the analyses. Diabetes was defined as: FPG ≥7.0 mmol/L or HbA1c ≥6.5%; prediabetes as: FPG ≥5.6 to <7mmol/L or HbA1c ≥5.7 to <6.5%. Results Complete data were available on 939 participants without previously diagnosed diabetes. The prevalence of undiagnosed diabetes was higher, but not significantly so, by HbA1c (4.9%, 95% CI 3.5, 6.8) vs FPG (3.5%, 2.4, 5.1). Overall 79 individuals had diabetes by either measure, but only 21 on both. The prevalence of prediabetes was higher by HbA1c compared to FPG: 41.7% (37.9, 45.6) vs 15.0% (12.8, 17.5). Overall 558 individuals had prediabetes by either measure, but only 107 on both. HbA1c, but not FPG, was significantly higher in women than men; and FPG, but not HbA1c, was significantly associated with raised triglycerides and low HDL cholesterol. Conclusion The agreement between FPG and HbA1c defined hyperglycaemia is poor. In addition, there are some differences in the phenotype of those identified, and HbA1c gives a much higher prevalence of prediabetes. The routine use of HbA1c for screening and diagnosis in this population would have major implications for clinical and public health policies and resources. Given the lack of robust evidence, particularly for prediabetes, on whether intervention in the individuals identified would improve outcomes, this approach to screening and diagnosis cannot be currently recommended for this population. PMID:28959440

The Effect of Diabetes Self-Management Education on Hba1c Level and Fasting Blood Sugar in Type 2 Diabetes Mellitus Patients in Primary Health Care in Binjai City of North Sumatera, Indonesia.

PubMed

Rusdiana; Savira, Maya; Amelia, Rina

2018-04-15

The study aimed to evaluate the effect of short-term diabetes self-management education (DSME) on Hba1and Fasting Blood Sugar in type 2 diabetes mellitus patients attending the Primary Health Care (PHC) in Binjai city of North Sumatera, Indonesia. A quasi-experimental (pretest-posttest) study was conducted in 4 PHCs, involving 80 patients with type 2 diabetes mellitus. The patients in received a 3-months intervention, including an 8 week education on self- management of diabetes mellitus and subsequent 4 weeks of practice of the self- management guidelines.The patients received standard advice on diet management. There was a significant reduction in Hba1c levels. The statistical analysis using t-test found that there was a significant difference of Hba1c value between pre and post education among type 2 diabetes mellitus patients (p < 0.005). Diabetes self-management education in PHC of Binjai city can reduce the Hba1c level in type 2 diabetes mellitus patients.

Can an electronic glycaemic notebook associated with an insulin calculator improve HbA1c in diabetic patients on a multiple insulin injections regimen? A 26-week observational real-life study.

PubMed

Oriot, Philippe; Ponchon, Michel; Hermans, Michel P

2016-02-01

Automated insulin calculators (AICs) with carbohydrate counting (CHC) have been shown to be effective in improving glycated haemoglobin (HbA1c) levels. By contrast, use of AICs without CHC, with predetermined prandial insulin doses modified according to a correction factor and modulated as a function of glycaemia, has not yet been investigated. This comparative, retrospective, observational and non-randomized study took place over a 6-month period of routine clinical practice. It evaluated the use of Free-style InsuLinx® and Free-style Neo® Abbott Diabetes Care (AIC) in easy mode (no CHC). All patients performed a basal-prandial insulin dosing schedule, and were not educated as to how to determine carbohydrate intake. Changes in HbA1c and capillary blood glucose levels, insulin therapy, frequency of blood glucose tests and body weight were analyzed 6 months prior to inclusion (T-6), at the time of inclusion (T0) and 6 months later (T+6). From T-6 to T0 (period A), patients used a standard blood glucose meter and adjusted their insulin doses themselves, and from T0 to T+6 (period B), each patient was provided with an AIC on easy mode function. Of the 230 patients, 221 were retained at the end of the study (126 type 1 diabetes mellitus (T1DM) and 95 type 2 diabetes mellitus (T2DM)). At T-6, average (±standard error of mean) HbA1c level was 8.3 ± 0.1%; T1DM: 8.5 ± 0.1% and T2DM: 8.0 ± 0.1%, respectively. At T0, the average HbA1c level was 8.4 ± 0.1% (p = 0.02); T1DM: 8.5 ± 0.1% (ns) and T2DM: 8.2 ± 0.1% (p = 0.004). At T+6, with AIC in easy mode, average HbA1c level decreased significantly to 7.7 ± 0.1% (p < 0.0001); T1DM: 8.0 ± 0.1% (p < 0.0001) and T2DM: 7.5 ± 0.1% (p < 0.0001). At T+6, in all diabetics, blood glucose monitoring frequency increased by 0.4/day (p < 0.0001). Insulin correction amounted to 14% of changes in predetermined prandial insulin doses. Routine clinical use of an AIC without CHC improved self-management of blood glucose and on average, decreased HbA1c levels by 0.52% in T1DM and 0.80% in T2DM after 6 months.

Higher health literacy is associated with better glycemic control in adults with type 1 diabetes: a cohort study among 1399 Danes.

PubMed

Olesen, Kasper; F Reynheim, Anne Louise; Joensen, Lene; Ridderstråle, Martin; Kayser, Lars; Maindal, Helle T; Osborne, Richard H; Skinner, Timothy; Willaing, Ingrid

2017-01-01

Self-management of diabetes is influenced by a range of factors including the ability to access, understand, appraise, and use of health information in everyday life, which can collectively be called health literacy. We investigated associations between nine domains of health literacy and HbA1c level in people with type 1 diabetes. A cross-sectional study was conducted with 1399 people with type 1 diabetes attending a Danish specialist diabetes clinic. Health literacy was assessed using the nine-domain Health Literacy Questionnaire. The association between health literacy and HbA1c was analyzed using linear regression with adjustment for age, sex, educational attainment and diabetes duration. Of the 1399 participants, 50% were women, mean age was 54 years, and mean HbA1c was 61 mmol/mol (7.8%). Higher health literacy scores were associated with lower HbA1c levels across eight of nine health literacy domains. This association remained significant after adjusting for educational attainment. Among the domains, 'Actively managing my health' had the strongest impact on HbA1c. This was in turn predicted by 'Appraising health information', 'Having sufficient information to manage health', and 'Social support for health'. Higher health literacy levels are associated with lower HbA1c regardless of educational background. This study highlights the importance of healthcare provision to respond to the health literacy levels of people with diabetes and to the possible need to provide program designed to enhance health literacy.

Haemoglobin A1c as a screening tool for type 2 diabetes and prediabetes in populations of Swedish and Middle-East ancestry.

PubMed

Hellgren, Margareta; Hjörleifsdottir Steiner, Kristin; Bennet, Louise

2017-08-01

To explore and compare sensitivity and specificity for HbA1c ≥48mmol/mol as a predictor for type 2 diabetes mellitus (T2DM) in two populations with different ethnicity and to examine the predictive value of two levels of HbA1c (≥42mmol/mol, ≥39mmol/mol) for prediabetes in these populations. Four cohorts were examined with an oral glucose tolerance test. (1) The MEDIM Study (n=1991 individuals of Swedish and Iraqi ancestry); (2) The Skaraborg Project (n=1327 individuals of Swedish ancestry); (3) The 4-D study (n=424 individuals of Swedish, Iraqi and Turkish ancestry); (4) The Flemingsberg study (n=212 participants of Turkish ancestry). HbA1c ≥48mmol/mol had a sensitivity for T2DM of 31% and 25% respectively in individuals of Middle-East and Swedish ancestry. The positive and negative predictive value was high in both populations (70.3, 96.4 and 96.2, 97.6 respectively). Using HbA1c ≥42mmol/mol and ≥39mmol/mol as a predictor for prediabetes gave a sensitivity of 17% and 36% in individuals of Middle-East and 15% and 34% in individuals of Swedish ancestry. Even if HbA1c ≥48mmol/mol is a valuable diagnostic tool, it is a blunt and insensitive tool for screening and would exclude most people with T2DM, independent of ancestry and age. HbA1c is an inefficient way to detect individuals with prediabetes. Copyright © 2017 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Race-ethnic differences in the association of genetic loci with HbA1c levels and mortality in U.S. adults: the third National Health and Nutrition Examination Survey (NHANES III).

PubMed

Grimsby, Jonna L; Porneala, Bianca C; Vassy, Jason L; Yang, Quanhe; Florez, José C; Dupuis, Josée; Liu, Tiebin; Yesupriya, Ajay; Chang, Man-Huei; Ned, Renee M; Dowling, Nicole F; Khoury, Muin J; Meigs, James B

2012-04-27

Hemoglobin A1c (HbA1c) levels diagnose diabetes, predict mortality and are associated with ten single nucleotide polymorphisms (SNPs) in white individuals. Genetic associations in other race groups are not known. We tested the hypotheses that there is race-ethnic variation in 1) HbA1c-associated risk allele frequencies (RAFs) for SNPs near SPTA1, HFE, ANK1, HK1, ATP11A, FN3K, TMPRSS6, G6PC2, GCK, MTNR1B; 2) association of SNPs with HbA1c and 3) association of SNPs with mortality. We studied 3,041 non-diabetic individuals in the NHANES (National Health and Nutrition Examination Survey) III. We stratified the analysis by race/ethnicity (NHW: non-Hispanic white; NHB: non-Hispanic black; MA: Mexican American) to calculate RAF, calculated a genotype score by adding risk SNPs, and tested associations with SNPs and the genotype score using an additive genetic model, with type 1 error = 0.05. RAFs varied widely and at six loci race-ethnic differences in RAF were significant (p < 0.0002), with NHB usually the most divergent. For instance, at ATP11A, the SNP RAF was 54% in NHB, 18% in MA and 14% in NHW (p < .0001). The mean genotype score differed by race-ethnicity (NHW: 10.4, NHB: 11.0, MA: 10.7, p < .0001), and was associated with increase in HbA1c in NHW (β = 0.012 HbA1c increase per risk allele, p = 0.04) and MA (β = 0.021, p = 0.005) but not NHB (β = 0.007, p = 0.39). The genotype score was not associated with mortality in any group (NHW: OR (per risk allele increase in mortality) = 1.07, p = 0.09; NHB: OR = 1.04, p = 0.39; MA: OR = 1.03, p = 0.71). At many HbA1c loci in NHANES III there is substantial RAF race-ethnic heterogeneity. The combined impact of common HbA1c-associated variants on HbA1c levels varied by race-ethnicity, but did not influence mortality.

A Test in Context: Hemoglobin A1c and Cardiovascular Disease.

PubMed

Gore, M Odette; McGuire, Darren K

2016-12-06

Measurement of glycated hemoglobin (HbA 1c ), the most widely accepted indicator of long-term glycemic exposure, is central for the diagnosis and management of diabetes mellitus. Levels of HbA 1c track epidemiologically with diabetic complications, and glycemic control, as reflected by HbA 1c reduction, results in decreased risk of microvascular complications, including diabetic kidney disease, neuropathy, and retinopathy. The relationship between HbA 1c reduction and cardiovascular disease prevention in patients with diabetes is more complex, with data from large randomized trials published over the past decade providing clear evidence that lowering of HbA 1c per se is an inadequate marker for a therapeutic regimen's impact on cardiovascular outcomes and patient survival. Recent revisions in professional society guidelines moved away from uniform recommendations and toward a more nuanced, patient-centered approach to HbA 1c therapeutic targets. The context and key evidence underpinning these recent changes are discussed in this paper, alongside a brief overview of HbA 1c contemporary assays and their limitations. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Associations between local descriptive norms for overweight/obesity and insufficient fruit intake, individual-level diet, and 10-year change in body mass index and glycosylated haemoglobin in an Australian cohort.

PubMed

Carroll, Suzanne J; Niyonsenga, Theo; Coffee, Neil T; Taylor, Anne W; Daniel, Mark

2018-05-18

Descriptive norms (what other people do) relate to individual-level dietary behaviour and health outcome including overweight and obesity. Descriptive norms vary across residential areas but the impact of spatial variation in norms on individual-level diet and health is poorly understood. This study assessed spatial associations between local descriptive norms for overweight/obesity and insufficient fruit intake (spatially-specific local prevalence), and individual-level dietary intakes (fruit, vegetable and sugary drinks) and 10-year change in body mass index (BMI) and glycosylated haemoglobin (HbA 1c ). HbA 1c and BMI were clinically measured three times over 10 years for a population-based adult cohort (n = 4056) in Adelaide, South Australia. Local descriptive norms for both overweight/obesity and insufficient fruit intake specific to each cohort participant were calculated as the prevalence of these factors, constructed from geocoded population surveillance data aggregated for 1600 m road-network buffers centred on cohort participants' residential addresses. Latent growth models estimated the effect of local descriptive norms on dietary behaviours and change in HbA 1c and BMI, accounting for spatial clustering and covariates (individual-level age, sex, smoking status, employment and education, and area-level median household income). Local descriptive overweight/obesity norms were associated with individual-level fruit intake (inversely) and sugary drink consumption (positively), and worsening HbA 1c and BMI. Spatially-specific local norms for insufficient fruit intake were associated with individual-level fruit intake (inversely) and sugary drink consumption (positively) and worsening HbA 1c but not change in BMI. Individual-level fruit and vegetable intakes were not associated with change in HbA 1c or BMI. Sugary drink consumption was also not associated with change in HbA 1c but rather with increasing BMI. Adverse local descriptive norms for overweight/obesity and insufficient fruit intake are associated with unhealthful dietary intakes and worsening HbA 1c and BMI. As such, spatial variation in lifestyle-related norms is an important consideration relevant to the design of population health interventions. Adverse local norms influence health behaviours and outcomes and stand to inhibit the effectiveness of traditional intervention efforts not spatially tailored to local population characteristics. Spatially targeted social de-normalisation strategies for regions with high levels of unhealthful norms may hold promise in concert with individual, environmental and policy intervention approaches.

Therapeutic management of orally treated type 2 diabetic patients, by French general practitioners in 2010: the DIAttitude Study.

PubMed

Halimi, S; Balkau, B; Attali, C; Detournay, B; Amelineau, E; Blickle, J-F

2012-03-01

To describe the behaviour of French general practitioners (GP) regarding intensification of hypoglycaemic agents in orally treated type 2 diabetic (T2D) patients, according to their HbA(1c) level. General practitioners were recruited from a panel of office-based general practitioners. T2D patients who had been orally treated for at least 6 months were included in the study; their characteristics were recorded, and their HbA(1c) values and hypoglycaemic treatments over the previous 24 months extracted from electronic records The major reasons for intensification (or no intensification) of hypoglycaemic agents were recorded at the inclusion visit. A total of 236 general practitioners recruited 2109 T2D patients: 1732 had at least one HbA(1c) value recorded in the previous 6 months, and 52%, 33% and 14% had been treated, with oral hypoglycaemic agents in monotherapy, bitherapy or tri-or quadritherapy, respectively. Of these patients, 702 (41%) remained uncontrolled (47%, 39% and 20% respectively) and according to the current French guidelines needed treatment intensification. Only 46 (7%) had their treatment intensified at inclusion. Of those without intensified treatment, 60% were treated with monotherapy; the main reason given by the general practitioners for not intensifying treatment was a satisfactory HbA(1c) level (53%), although 32% had an HbA(1c)>7%. Other reasons were: lifestyle advice had greater priority (20%); decision was postponed until the next visit (11%); HbA(1c) had decreased since last visit (7%; not confirmed by available data in 58% of cases); a medical priority other than diabetes (6%) and other reasons related to the patient (3%). For T2D patients managed by French general practitioners, guidelines are not consistently followed: HbA(1c) should be monitored more frequently and treatment adjusted according to HbA(1c) levels. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Association of glycated hemoglobin with carotid intimal medial thickness in Asian Indians with normal glucose tolerance.

PubMed

Venkataraman, Vijayachandrika; Amutha, Anandakumar; Anbalagan, Viknesh Prabu; Deepa, Mohan; Anjana, Ranjit Mohan; Unnikrishnan, Ranjit; Vamsi, Mamilla; Mohan, Viswananthan

2012-01-01

To assess the association of glycated hemoglobin (HbA1c) levels with carotid intimal medial thickness (CIMT) in Asian Indians with normal glucose tolerance (NGT). Subjects with NGT were recruited from the Chennai Urban Rural Epidemiology Study carried out on a representative population of Chennai, South India. All subjects had fasting plasma glucose <100 mg/dl (5.6 mmol/l) and 2-h post load plasma glucose <140 mg/dl (7.8 mmol/l). HbA1c was measured using the Biorad Variant machine. CIMT was measured on the right common carotid artery using high-resolution B-mode ultrasonography. The study group included 1383 NGT subjects, of whom 760 (54.9%) were women. The mean CIMT value in the 1st quartile of HbA1c (<5.2%) was 0.65 and it increased significantly to 0.73 in the last quartile of HbA1c (>5.8) (p<0.001). Regression analysis showed that HbA1c had a strong association with CIMT after adjusting for age, gender, waist circumference, systolic and diastolic blood pressure, LDL cholesterol, serum triglycerides, HOMA-IR and smoking (ß - 0.046, p=0.047). Even among subjects with NGT, there is a significant increase in CIMT with increasing levels of HbA1c, showing the value of using HbA1c for diagnosis of glucose intolerance. Copyright © 2012 Elsevier Inc. All rights reserved.

Efficacy and Acceptability of Glycemic Control of Glucagon-Like Peptide-1 Receptor Agonists among Type 2 Diabetes: A Systematic Review and Network Meta-Analysis.

PubMed

Li, Zhixia; Zhang, Yuan; Quan, Xiaochi; Yang, Zhirong; Zeng, Xiantao; Ji, Linong; Sun, Feng; Zhan, Siyan

2016-01-01

To synthesize current evidence of the impact of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on hypoglycemia, treatment discontinuation and glycemic level in patients with type 2 diabetes. Systematic review and network meta-analysis. Literature search (Medline, Embase, the Cochrane library), website of clinical trial, bibliographies of published systematic reviews. Randomized controlled trials with available data comparing GLP-1 RAs with placebo or traditional anti-diabetic drugs in patients with type 2 diabetes. Traditional pairwise meta-analyses within DerSimonian-Laird random effects model and network meta-analysis within a Bayesian framework were performed to calculate odds ratios for the incidence of hypoglycemia, treatment discontinuation, HbA1c<7.0% and HbA1c<6.5%. Ranking probabilities for all treatments were estimated to obtain a treatment hierarchy using the surface under the cumulative ranking curve (SUCRA) and mean ranks. 78 trials with 13 treatments were included. Overall, all GLP-1 RAs except for albiglutide increased the risk of hypoglycemia when compared to placebo. Reduction in the incidence of hypoglycemia was found for all GLP-1 RAs versus insulin (except for dulaglutide) and sulphonylureas. For the incidence of treatment discontinuation, increase was found for exenatide, liraglutide, lixisenatide and taspoglutide versus placebo, insulin and sitagliptin. For glycemic level, decrease was found for all GLP-1 RAs versus placebo. Dulaglutide, exenatide long-acting release (exe_lar), liraglutide and taspoglutide had significant lowering effect when compared with sitagliptin (HbA1c<7.0%) and insulin (HbA1c<6.5%). Finally, according to SUCRAs, placebo, thiazolidinediones and albiglutide had the best decrease effect on hypoglycemia; sulphanylureas, sitagliptin and insulin decrease the incidence of treatment discontinuation most; exe_lar and dulaglutide had the highest impact on glycemic level among 13 treatments. Among 13 treatments, GLP-1 RAs had a significant reduction with glycemic level but a slight increase effect on hypoglycemia and treatment discontinuation. While albiglutide had the best decrease effect on hypoglycemia and treatment discontinuation among all GLP-1 RAs. However, further evidence is necessary for more conclusive inferences on mechanisms underlying the rise in hypoglycemia.

Hemoglobin A1c and short-term outcomes in patients with acute myocardial infarction undergoing primary angioplasty: an observational multicenter study.

PubMed

Tian, Li; Zhu, Jun; Liu, Lisheng; Liang, Yan; Li, Jiandong; Yang, Yanmin

2013-01-01

Several studies to date have examined whether admission levels of hemoglobin A1c (HbA1c) correlate with short-term and long-term outcomes in patients with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI). However, the results have been ambiguous. We speculated that admission levels of HbA1c correlate with short-term outcomes of patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. In this observational multicenter study, 608 patients with STEMI who underwent primary PCI between June 2001 and July 2004 were enrolled. Blood samples were collected upon admission to hospital for HbA1c measurement. Follow-up was carried out at 7 and 30 days after hospital admission. According to the new American Diabetes Association criteria, patients were stratified into three groups: I, HbA1c 5.6% or less (n=262); II, HbA1c 5.7-6.4% (n=182); and III, HbA1c at least 6.5% (n=164). The primary outcomes were all-cause mortality and major adverse cardiac events at follow-up. The 7-day mortality was similar (P=0.179) between groups I (1.9%), II (2.2%), and III (0.0%); the 30-day mortality was also similar (P=0.241) between groups I (3.8%), II (2.2%), and III (1.2%). MACE at the 7- day and 30-day follow-up were not significantly different between the three groups either (P>0.05). Rates of target vessel revascularization and rehospitalization, and MACE-free survival curves, at the 30-day follow-up were also similar among the three groups. After adjusting the baseline characteristics, HbA1c was not an independent predictor of short-term outcomes (hazards ratio: 0.431; 95% confidence interval: 0.175-1.061, P=0.067). Admission levels of HbA1c are not an independent prognostic marker for short-term outcomes in STEMI patients treated with primary PCI.

Glycated hemoglobin correlates with arterial stiffness and endothelial dysfunction in patients with resistant hypertension and uncontrolled diabetes mellitus.

PubMed

Moreno, Beatriz; de Faria, Ana Paula; Ritter, Alessandra Mileni Versuti; Yugar, Lara Buonalumi Tacito; Ferreira-Melo, Silvia Elaine; Amorim, Rivadavio; Modolo, Rodrigo; Fattori, André; Yugar-Toledo, Juan Carlos; Coca, Antonio; Moreno, Heitor

2018-05-01

This study aimed to evaluate the effects of glycated hemoglobin (HbA 1c ) on flow-mediated dilation, intima-media thickness, pulse wave velocity, and left ventricular mass index in patients with resistant hypertension (RHTN) comparing RHTN-controlled diabetes mellitus and RHTN-uncontrolled type 2 diabetes mellitus. Two groups were formed: HbA 1c <7.0% (RHTN-controlled diabetes mellitus: n = 98) and HbA 1c ≥7.0% (RHTN-uncontrolled diabetes mellitus: n = 122). Intima-media thickness and flow-mediated dilation were measured by high-resolution ultrasound, left ventricular mass index by echocardiography, and arterial stiffness by carotid-femoral pulse wave velocity. No differences in blood pressure levels were found between the groups but body mass index was higher in patients with RHTN-uncontrolled diabetes mellitus. Endothelial dysfunction and arterial stiffness were worse in patients with RHTN-uncontrolled diabetes mellitus. Intima-media thickness and left ventricular mass index measurements were similar between the groups. After adjustments, multiple linear regression analyses showed that HbA 1c was an independent predictor of flow-mediated dilation and pulse wave velocity in all patients with RHTN. In conclusion, HbA 1c may predict the grade of arterial stiffness and endothelial dysfunction in patients with RHTN, and superimposed uncontrolled diabetes mellitus implicates further impairment of vascular function. ©2018 Wiley Periodicals, Inc.

Glycaemic indices and non-traditional biochemical cardiovascular disease markers in a diabetic population in Nigeria.

PubMed

Ogbera, Okeoghene Anthonia; Okeoghene, Ogbera Anthonia; Azenabor, Alfred

2011-08-01

To determine the frequency of hyperfibrinogenaemia, elevated C-reactive protein, hyperuricaemia and elevated lipoprotein A in a clinic population of patients with type 2 Diabetes mellitus (DM) compared with healthy controls; and determine the interrelationship between fasting plasma glucose levels and indices of long-term glycaemic control (fructosamine and glycosylated haemoglobin) in DM. Cross-sectional, analytical study. The study was conducted at the Lagos State University Teaching Hospital, Ikeja, from April to June 2009. A total of 200 patients with type 2 DM and 100 age and gender matched healthy controls were recruited for the study. Glycaemic control was assessed using fasting blood glucose, fructosamine and glycosylated haemoglobin levels. The non-traditional risk factors studied included C-reactive protein (CRP), Lipoprotein a (Lpa), serum uric acid (SUA), microalbuminuria and fibrinogen. Mann-whitney, chi-square and Pearson's correlation tests were used for analysis as applicable. Hyperfibrinoginaemia, elevated CRP, LPa, microalbuminuria and hyperuricaemia were present in 3.5%, 65%, 12%, 6% and 57% respectively in type 2 DM. The mean levels of these CV risk factors were significantly higher in subjects with type 2 DM than that of the control subject. There was a positive and significant correlation between HbA1c and FBS (r=0.46, p=0.0001) and HbA1c and fructosamine (r=0.49, p=0.0001). All studied CVS risk factors were related to indices of glycaemic control which were found to be interrelated. Fasting blood glucose significantly correlated with both HbA1c and fructosamine but HbA1c showed better correlation to FPG than fructosamine (r=0.51 vs. 0.32). Glycosylated haemoglobin and fasting plasma glucose but not fructosamine are significantly associated with microalbuminuria, fibrinogen SUA and CRP in type 2 DM. HbA1c was found to be better than fructosamine in monitoring overall long-term glycaemic control.

Glycated haemoglobin (HbA1c), diabetes and trajectories of change in episodic memory performance.

PubMed

Pappas, Colleen; Andel, Ross; Infurna, Frank J; Seetharaman, Shyam

2017-02-01

As the ageing population grows, it is important to identify strategies to moderate cognitive ageing. We examined glycated haemoglobin (HbA1c) and diabetes in relation to level and change in episodic memory in older adults with and without diabetes. Data from 4419 older adults with (n=950) and without (n=3469) diabetes participating in a nationally representative longitudinal panel study (the Health and Retirement Study) were examined. Average baseline age was 72.66 years and 58% were women. HbA1c was measured in 2006 and episodic memory was measured using immediate and delayed list recall over 4 biennial waves between 2006 and 2012. Growth curve models were used to assess trajectories of episodic memory change. In growth curve models adjusted for age, sex, education, race, depressive symptoms and waist circumference, higher HbA1c levels and having diabetes were associated with poorer baseline episodic memory (p=0.036 and <0.001, respectively) and greater episodic memory decline (p=0.006 and 0.004, respectively). The effect of HbA1c on episodic memory decline was smaller than the effect of age. The results were stronger for women than men and were not modified by age or race. When the main analyses were estimated for those with and without diabetes separately, HbA1c was significantly linked to change in episodic memory only among those with diabetes. Higher HbA1c and diabetes were both associated with declines in episodic memory, with this relationship further exacerbated by having diabetes and elevated HbA1c. HbA1c appeared more important for episodic memory performance among women than men. 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/.

HbA1c Identifies Subjects With Prediabetes and Subclinical Left Ventricular Diastolic Dysfunction.

PubMed

Di Pino, Antonino; Mangiafico, Sarah; Urbano, Francesca; Scicali, Roberto; Scandura, Salvatore; D'Agate, Veronica; Piro, Salvatore; Tamburino, Corrado; Purrello, Francesco; Rabuazzo, Agata Maria

2017-10-01

Prediabetes is associated with subclinical cardiac changes associated with heart failure development. We investigated diastolic function and its association with markers of glycation and inflammation related to cardiovascular disease in patients with prediabetes. We focused on individuals with prediabetes identified only by glycated hemoglobin A1c [HbA1c; 5.7% to 6.4% and normal fasting glucose (NFG) and normal glucose tolerance (NGT) after an oral glucose tolerance test (OGTT)]. Cross-sectional study. Departments of Clinical and Experimental Medicine and Cardiology, University of Catania, Catania, Italy. HbA1c, OGTT, Doppler echocardiography, soluble receptor for advanced glycation end products (sRAGEs), and endogenous secretory RAGE (esRAGE) were evaluated. We recruited 167 subjects with NFG/NGT who were stratified according to HbA1c level: controls (HbA1c <5.7%) and HbA1c prediabetes (HbA1c 5.7% to 6.4%). Patients with HbA1c prediabetes (n = 106) showed a lower peak mitral inflow in early diastole (E wave) to late diastolic atrial filling velocity (A wave) ratio (E/A ratio) than controls (n = 61) (1.10 ± 0.24 vs 1.18 ± 0.23; P < 0.05). They showed a higher left atrium volume (LAV) (28.4 ± 5 vs 22.1 ± 3; P < 0.05) and sphericity index (SI) (0.6 ± 0.06 vs 0.5 ± 0.05; P < 0.05). After multiple regression analyses, HbA1c, sRAGE, and esRAGE were the major determinants of E/A ratio, LAV, and SI. Subjects with HbA1c prediabetes exhibited subclinical cardiac alterations associated with sRAGE, esRAGE, and HbA1c. These subjects would not have been classified as having prediabetes on the basis of fasting glycemia or post-OGTT values. Copyright © 2017 Endocrine Society

The impact of ambient temperature on HbA1c in Taiwanese type 2 diabetic patients: The most vulnerable subgroup.

PubMed

Tien, Kai-Jen; Yang, Chwen-Yi; Weng, Shih-Feng; Liu, Su-Yen; Hsieh, Ming-Chia; Chou, Chien-Wen

2016-05-01

The relationship between temperature variability and HbA1c has been reported in Caucasians, but not for Asians of Taiwanese origin. This study investigated the impact of temperature on HbA1c in various groups of Taiwanese with type 2 diabetes in Taiwan. For this longitudinal follow-up study which started in 2006, we recruited a total of 4399 patients with type 2 diabetes who had been regularly followed up at Chi Mei Medical Center and obtained local temperature data for 2006 to 2011 from Taiwan's Central Weather Bureau. We used a generalized estimated equation (GEE) to analyze the HbA1c level and its change over time with temperature and temperature changes, respectively. We found a negative correlation between HbA1c and temperature (R = -0.475, p = 0.001). For every 1°C decrement in temperature, there was an increase in the risk of having a HbA1c level >7% [p < 0.001, adjusted odds ratio (OR): 1.01]. There was a significantly higher risk of HbA1c > 7% among those in the lowest quartile of temperatures than the highest quartile (p = 0.0038, adjusted OR: 1.13). Patients with diabetic patients were at higher risk of HbA1C > 7% in the winter and spring than those in the summer (adjusted OR: 1.13, p = 0.0027; adjusted OR: 1.14, p = 0.0022). After adjusting for various confounders, we found people who were younger than 65 years old, people who had diabetes for longer than 6 years, and people who had a body mass index (BMI) < 24 to be more susceptible to temperature changes (p = 0.0022, β: 0.0095; p < 0.0001, β: 0.0125; p < 0.0001, β: 0.016, respectively). Our study suggests cold weather may adversely affect HbA1c levels in Taiwanese people with type 2 diabetes, especially in people under 65 years old, people with diabetes for longer than 6 years, and those with a BMI < 24. Copyright © 2015. Published by Elsevier B.V.

Emotional abilities and HbA1c levels in patients with type 1 diabetes.

PubMed

Ruiz-Aranda, Desireé; Zysberg, Leehu; García-Linares, Ernesto; Castellano-Guerrero, Ana María; Martínez-Brocca, María Asunción; Gutiérrez-Colosía, Mencía R

2018-07-01

In recent years a growing body of research is focused on the relationships between emotions and health. When it comes to diabetes, findings suggest that distress might play a key role in the acquisition and maintenance of health habits associated with diabetic management. This report describes two studies examining the roles of emotional abilities in diabetic management from two different conceptual points of view using two culturally different samples. In study 1, we examined the relationship between emotional intelligence and HbA1c levels in a sample of eighty-five patients with type 1 diabetes mellitus (DM1) in Israel. In study 2, we examined the relationship between specific emotional regulation strategies and HbA1c in sixty-seven adolescents with DM1, while examining the mediating role of distress in this association. The results showed a negative association between emotional intelligence and HbA1c levels, even after controlling for potential intervening factors. We found that the relationship between difficulties in emotion regulation and HbA1c seemed to be mediated by diabetes-related distress. These findings may aid in the design of psychological models for future research as well as interventions aimed at improving emotional abilities in people with DM1. Copyright © 2018 Elsevier Ltd. All rights reserved.

Serum Levels of Inflammatory Markers in Depressed Elderly Patients with Diabetes and Mild Cognitive Impairment

PubMed Central

Gorska-Ciebiada, Malgorzata; Saryusz-Wolska, Malgorzata; Borkowska, Anna; Ciebiada, Maciej; Loba, Jerzy

2015-01-01

Objective The aim of the study was to determine the serum levels of CRP, IL-6 and TNF-α in elderly diabetic patients with depressive syndrome alone or with coexisting mild cognitive impairment (MCI). Methods 276 diabetics elders were screened for depressive symptoms (using Geriatric Depression Scale: GDS-30) and MCI (using the Montreal Cognitive Assessment: MoCA score). Data of HbA1c, blood lipids and inflammatory markers levels were collected. Results In all groups of patients levels of CRP, IL-6 and TNF-α were significantly higher as compared to controls. The highest level of inflammatory markers was detected in group with depressive mood and coexisting MCI, however IL-6 level didn’t significantly differ as compared to MCI group. We founded correlations between all inflammatory markers in group of patients with depressive mood and in group of subjects with depressive symptoms and coexisting MCI. GDS-30 score was correlated with levels of inflammatory markers in group with depressive mood, and with levels of CRP and TNF-α in group with depressive mood and coexisting MCI. In the group with depressive mood and coexisting MCI we founded that MoCA score was negatively correlated with CRP and TNF-α levels; and HbA1c level was positively correlated with all inflammatory markers. The univariate logistic regression models revealed that variables which increased the likelihood of having been diagnosed with MCI in depressed patients were: higher levels of HbA1c, CRP, IL-6 and TNF-α, previous CVD or stroke, increased number of co-morbidities and microvascular complications, older age, less years of formal education. The multivariable model showed that previous CVD, higher HbA1c and IL-6 levels are significant factors. Conclusions We demonstrated that the presence of depressive syndrome is associated with higher levels of inflammatory markers in elderly patients with diabetes. The presence of MCI in these depressed subjects has additive effect on levels of inflammatory mediators. PMID:25793613

Management of endocrine disease. Effects of telecare intervention on glycemic control in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Huang, Zhenru; Tao, Hong; Meng, Qingdong; Jing, Long

2015-03-01

To review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control. A review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed. An analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by -0.54 (95% CI, -0.75 to -0.34; P<0.05), mean FPG levels by -9.00 mg/dl (95% CI, -17.36 to -0.64; P=0.03), and mean PPG levels reduced by -52.86 mg/dl (95% CI, -77.13 to -28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity. Patients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%. © 2015 European Society of Endocrinology.

Exenatide's effect in reducing weight and glycosylated hemoglobin level in an Arab population with type 2 diabetes.

PubMed

Bashier, Alaaeldin M; Abdelgadir, Elamin I; Khalifa, Azza A; Rashid, Fouzia; Abuelkeir, Sona M; Bachet, Fawzi E

2014-11-01

To determine whether exenatide is effective in reducing weight and glycosylated hemoglobin level (HbA1c), and to investigate its efficacy in improving lipid profile, blood pressure, and creatinine levels in the Arab population. This study was conducted at the Endocrine Unit, Dubai Hospital, Dubai, United Arab Emirates. We retrospectively collected data from patients with type 2 diabetes started on exenatide between November 2011 and February 2012. Data included demographics, clinical, laboratory results, and medications used. A general linear model adjusted by baseline characteristics (weight, HbA1C, age, use of statins, and duration of diabetes) was used to assess changes between baseline and end of trial in HbA1C, weight, low density lipoprotein cholesterol, total cholesterol, triglycerides, creatinine, and blood pressure. After 6 months of treatment with exenatide, the HbA1c decreased by 0.47% (95% confidence level [CI]: -0.01 - 0.95) (p=0.055). Weight reduction was highly significant; 5.6 kg (95% CI: 3.34 - 7.85) (p<0.001). Those reductions remained significant after adjustment for confounding factors. This study showed that weight reduction was highly significant with exenatide. The borderline significance in HbA1c reduction can be attributed to the small sample size. 

Modelling the Relative Contribution of Fasting and Post-Prandial Plasma Glucose to HbA1c in Healthy and Type 2 Diabetic Subjects

ERIC Educational Resources Information Center

Ollerton, Richard L.; Luzio, Steven D.; Owens, David R.

2004-01-01

Glycated haemoglobin (HbA1c) is regarded as the gold standard of glucose homeostasis assessment in diabetes. There has been much discussion in recent medical literature of experimental results concerning the relative contribution of fasting and post-prandial glucose levels to the value of HbA1c. A mathematical model of haemoglobin glycation is…

Performance evaluation of the Arkray Adams HA-8160 HbA1c analyser.

PubMed

Thevarajah, T Malathi; Nani, Nordin; Chew, Y Y

2008-12-01

HbA1c measurement is currently routinely used to predict long term outcome of diabetes, thus playing a fundamental role in the management of diabetes. The relationship between HbA1c value and long term diabetic complications has been established by a randomised control Diabetes Control and Complications Trial (DCCT) which used high performance liquid chromatography (HPLC) as a reference method for HbA1c assay. To ensure that HbA1c results from a variety HbA1c assay methods are similar to the DCCT values, the American Diabetes Association (ADA) recommended that all laboratories should use methods certified by the National Glycohemoglobin Standardization Programme (NGSP) with interassay coefficient variation (CV) of < 5% (ideally < 3%). The International Federation of Clinical Chemistry (IFCC) working group on HbA1c standardisation has set a CV < 2.5% as a criteria for its reference laboratories. To evaluate the performance of Arkray Adams HA-8160 HbA1c analyser which uses a cation exchange HPLC method and its correlation to HbA1c assay on Cobas Integra 800 which is an immunoturbidimetric method. For the imprecision study, patient samples and control material of two levels were analysed on HA-8160 analyser 20 times in a single run (within-run imprecision) and twice a day on five consecutive days (between-run imprecision). For the recovery study, two samples each with high and low values were selected and mixed in ratios of 1:3, 1:1 and 3:1, and were analysed by HA-8160. Sixty samples were analysed by both Cobas Integra 800 and HA-8160 for method comparison study. Ten uraemic samples and ten thalassaemic samples were assayed on Cobas Integra 800 and HA 8160 for interference study. Within-run CVs were 0.6% and 0.7% for medium and high value samples respectively, 0.6% and 0.7% for low and high level controls respectively. Between-run CVs were 0.5% and 0.4% for medium and high value samples respectively, 0.5% and 0.6% for low and high level controls respectively. The mean recovery was 100.1%. A good correlation between the 2 methods (Adams = 1.00 Cobas - 0.11, r = 0.98) was observed. The Akray Adams HA-8160 HbA1c analyser performed within the target CV of < 2.5% and showed a good correlation with the Cobas Integra 800.

Hemoglobin A1c Accurately Predicts Continuous Glucose Monitoring-Derived Average Glucose in Youth and Young Adults With Cystic Fibrosis.

PubMed

Chan, Christine L; Hope, Emma; Thurston, Jessica; Vigers, Timothy; Pyle, Laura; Zeitler, Philip S; Nadeau, Kristen J

2018-04-19

In cystic fibrosis (CF), HbA 1c is thought to underestimate glycemia. However, few studies have directly assessed the relationship between HbA 1c and average glucose in CF. We determined the relationships among glycemic markers-HbA 1c , fructosamine (FA), glycated albumin (%GA), and 1,5-anhydroglucitol (1,5-AG)-and continuous glucose monitoring (CGM) in CF, hypothesizing that alternate markers would better predict average sensor glucose (ASG) than HbA 1c . CF participants and a group of healthy control subjects (HC), ages 6-25 years, wore CGM for up to 7 days. Pearson correlations assessed the relationships between CGM variables and HbA 1c , FA, %GA, and 1,5-AG. The regression line between HbA 1c and ASG was compared in CF versus HC. Linear regressions determined whether alternate markers predicted ASG after adjustment for HbA 1c . CF ( n = 93) and HC ( n = 29) groups wore CGM for 5.2 ± 1 days. CF participants were 14 ± 3 years of age and 47% were male, with a BMI z score -0.1 ± 0.8 and no different from HCs in age, sex, or BMI. Mean HbA 1c in CF was 5.7 ± 0.8% (39 ± 9 mmol/mol) vs. HC 5.1 ± 0.2% (32 ± 2 mmol/mol) ( P < 0.0001). All glycemic markers correlated with ASG ( P ≤ 0.01): HbA 1c ( r = 0.86), FA ( r = 0.69), %GA ( r = 0.83), and 1,5-AG ( r = -0.26). The regression line between ASG and HbA 1c did not differ in CF versus HC ( P = 0.44). After adjustment for HbA 1c , %GA continued to predict ASG ( P = 0.0009) in CF. HbA 1c does not underestimate ASG in CF as previously assumed. No alternate glycemic marker correlated more strongly with ASG than HbA 1c . %GA shows strong correlation with ASG and added to the prediction of ASG beyond HbA 1c . However, we are not advocating use of HbA 1c for diabetes screening in CF based on these results. Further study will determine whether glycemic measures other than ASG differ among different types of diabetes for a given HbA 1c . © 2018 by the American Diabetes Association.

HbA1c and Risks of All-Cause and Cause-Specific Death in Subjects without Known Diabetes: A Dose-Response Meta-Analysis of Prospective Cohort Studies

PubMed Central

Zhong, Guo-Chao; Ye, Ming-Xin; Cheng, Jia-Hao; Zhao, Yong; Gong, Jian-Ping

2016-01-01

Whether HbA1c levels are associated with mortality in subjects without known diabetes remains controversial. Moreover, the shape of the dose–response relationship on this topic is unclear. Therefore, a dose–response meta-analysis was conducted. PubMed and EMBASE were searched. Summary hazard ratios (HRs) were calculated using a random-effects model. Twelve studies were included. The summary HR per 1% increase in HbA1c level was 1.03 [95% confidence interval (CI) = 1.01–1.04] for all-cause mortality, 1.05 [95% CI = 1.02–1.07) for cardiovascular disease (CVD) mortality, and 1.02 (95% CI = 0.99–1.07) for cancer mortality. After excluding subjects with undiagnosed diabetes, the aforementioned associations remained significant for CVD mortality only. After further excluding subjects with prediabetes, all aforementioned associations presented non-significance. Evidence of a non-linear association between HbA1c and mortality from all causes, CVD and cancer was found (all Pnon-linearity < 0.05). The dose–response curves were relatively flat for HbA1c less than around 5.7%, and rose steeply thereafter. In conclusion, higher HbA1c level is associated with increased mortality from all causes and CVD among subjects without known diabetes. However, this association is driven by those with undiagnosed diabetes or prediabetes. The results regarding cancer mortality should be treated with caution due to limited studies. PMID:27045572

Correlation between Glycated Hemoglobin and Triglyceride Level in Type 2 Diabetes Mellitus.

PubMed

Naqvi, Syeda; Naveed, Shabnam; Ali, Zeeshan; Ahmad, Syed Masroor; Asadullah Khan, Raad; Raj, Honey; Shariff, Shoaib; Rupareliya, Chintan; Zahra, Fatima; Khan, Saba

2017-06-13

Dyslipidemia is quite prevalent in non-insulin dependent diabetes mellitus. Maintaining tight glycemic along with lipid control plays an essential role in preventing micro- and macro-vascular complications associated with diabetes. The main purpose of the study was to highlight the relationship between glycosylated hemoglobin (HbA1c) and triglyceride levels. This may in turn help in predicting the triglyceride status of type 2 diabetics and therefore identifying patients at increased risk from cardiovascular events. Hypertriglyceridemia is one of the common risk factors for coronary artery disease in type 2 diabetes mellitus (DM). Careful monitoring of the blood glucose level can be used to predict lipid status and can prevent most of the complications associated with the disease. This is a cross-sectional study using data collected from the outpatient diabetic clinic of Jinnah Postgraduate Medical Centre (JPMC) Karachi, Pakistan. Patients of age 18 years and above were recruited from the clinic. A total of consenting 509 patients of type 2 diabetes mellitus were enrolled over a period of 11 months.  For statistical analysis, SPSS Statistics for Windows, Version 17.0 ( IBM Corp, Armonk, New York) was used and Chi-square and Pearson's correlation coefficient was used to find the association between triglyceride and HbA1c. The HbA1c was dichotomized into four groups on the basis of cut-off. Chi-square was used for association between HbA1c with various cut-off values and high triglyceride levels. Odds-ratio and its 95% confidence interval were calculated to estimate the level of risk between high triglyceride levels and HbA1c groups. The p-value < 0.05 was considered statistically significant for all the tests applied for significance. The association of high triglyceride was evaluated in four different groups of HbA1c, with a cut-off seven, eight, nine and 10 respectively. With HbA1c cut-off value of 7%, 74% patients had high triglycerides and showed a significant association with high triglyceride levels at p < 0.001 and odds ratio was 2.038 (95% confidence interval: 1.397 - 2.972). Logistic regression models were adjusted for demographic factors (age, race, gender), lifestyle factors (smoking, body mass index, lifestyle) and health status factors (blood pressure, physician-rated health status). After adjusting for relevant covariates, glycated hemoglobin was positively correlated with high triglyceride. Hence, HbA1c can be an indicator of triglyceride level and can be one of the predictors of cardiovascular risk factors in type 2 diabetes mellitus.

A prospective clinical pilot-trial comparing the effect of an optimized mixed diet versus a flexible low-glycemic index diet on nutrient intake and HbA(1c) levels in children with type 1 diabetes.

PubMed

Marquard, Jan; Stahl, Anna; Lerch, Christian; Wolters, Mareen; Grotzke-Leweling, Maike; Mayatepek, Ertan; Meissner, Thomas

2011-01-01

Low-glycemic index (GI) diet vs. high-GI diet improves glycemic control, but it is not clear whether a low-GI diet is superior to an optimized mixed diet (OMD). This was a 12-week parallel-group pilot-trial including 17 children with type 1 diabetes. A separate dietary education into the allocated diet (OMD vs. low-GI) was performed. Nutrition was recorded by means of a three-day dietary record. The primary objective was to determine the macro- and micronutrient composition of the different diets, the secondary objective was to determine the short-term effect on HbA(1c) levels. In the low-GI group carbohydrate intake decreased, fat intake increased by trend. In the OMD group fat and energy intake decreased. No changes of HbA(1c) levels between the groups were observed. OMD could have positive effects in overweight and obese diabetic children, since a reduction in fat and energy intake can be achieved. The findings of this pilot-trial suggest that OMD could be superior to a low-GI diet.

Prevalence of Insulin Pump Therapy and Its Association with Measures of Glycemic Control: Results from the Canadian Study of Longevity in Type 1 Diabetes.

PubMed

Boulet, Geneviève; Halpern, Elise M; Lovblom, Leif E; Weisman, Alanna; Bai, Johnny-Wei; Eldelekli, Devrim; Keenan, Hillary A; Brent, Michael H; Paul, Narinder; Bril, Vera; Cherney, David Z I; Perkins, Bruce A

2016-05-01

We aimed to determine cross-sectional insulin pump prevalence and factors associated with measures of glycemic control as a secondary analysis in a long-standing type 1 diabetes mellitus (T1DM) national cohort. Canadian participants with ≥50 years of T1DM (n = 305) were administered a comprehensive mail-based questionnaire including acquisition of contemporaneous laboratory results. Factors associated with pump use, glycosylated hemoglobin (HbA1c), and hypoglycemia were analyzed by regression. The 305 participants had a median age of 65 [interquartile range, 59, 71] years, median diabetes duration of 54 [51, 59] years, and mean HbA1c level of 7.5 ± 1.1%. Prevalence of pump use was 44% (133/305), with median duration of use 8 [4, 13] years. Compared with the non-pump subgroup, the pump subgroup had numerically lower but similar HbA1c levels (7.4 ± 0.9% vs. 7.6 ± 1.2%; P = 0.22) and reported greater numbers of minor hypoglycemia events (6.5 vs. 5.1 events/patient·month; P = 0.004) and fewer severe hypoglycemia events (0.5 vs. 1.3 events/patient·year; P = 0.02) in the past year. More frequent daily glucose tests and more frequent minor hypoglycemia events-but not pump therapy or its prescription parameters-were independently associated with lower HbA1c level in multivariable regression. However, use of insulin pump and habitual use of continuous glucose monitoring (≥1 week/month) were each independently associated with lower risk of severe hypoglycemia (risk ratio = 0.50 [P < 0.0001] and 0.30 [P = 0.001], respectively). Insulin pump and continuous glucose monitoring technologies were associated with lower risk of severe hypoglycemia, while frequent daily glucose testing was associated with lower HbA1c level. These findings imply that basic self-management skill and technology play complementary roles in glycemic control among older adults with long-standing T1DM.

Vitamin D deficiency among the elderly: insights from Qatar.

PubMed

Alhamad, Hanadi Khamis; Nadukkandiyil, Navas; El-Menyar, Ayman; Abdel Wahab, Luay; Sankaranarayanan, Anoop; Al Sulaiti, Essa Mubarak

2014-06-01

Vitamin D (VitD) deficiency is associated with comorbidities in the elderly. The present study investigates the prevalence of VitD deficiency among the elderly in Qatar. A retrospective study conducted between April 2010 and April 2012 that involved chart reviews. All elderly patients of age ≥65 years in geriatrics facilities including Rumailah hospital, skilled nursing facility and home healthcare services in Qatar were included in the study. Patient characteristics and outcomes were analyzed and compared according to the severity of VitD deficiency. Correlation of VitD with comorbidities was analyzed. Mean follow-up period was 6 months. A total of 889 patients were enrolled; the majority (66%) were females and the mean age was 75 ± 8.7 years. Patient comorbidities included hypertension (76.5%), diabetes mellitus (63%), dyslipidemia, (47.5%), dementia (26%) coronary artery disease (24%) and cerebrovascular accident (24%). The mean baseline serum VitD level was 24.4 ± 13.5 ng/ml; 72% of patients had VitD deficiency: mild (31%), moderate (30%) and severe (11%). Patients with severe VitD deficiency had significantly higher HbA1c levels compared with patients with optimal VitD (P = 0.03). High density lipoprotein (HDL-C) levels were significantly lower in severe VitD deficiency patients compared with optimal VitD patients (P = 0.04). There was a positive correlation between HDL-C and VitD level (r = 0.17, P = 0.001), whereas HbA1c levels showed negative correlation with VitD (r = -0.15, P = 0.009). A high prevalence of VitD deficiency (72%) was observed among the elderly in Qatar. Lower VitD was associated with higher HbA1c and lower HDL-C levels. Further studies are warranted to evaluate whether VitD supplementation controls diabetes mellitus (DM) and low HDL-C levels among the elderly.

Efficacy of vildagliptin versus sulfonylureas as add-on therapy to metformin: comparison of results from randomised controlled and observational studies.

PubMed

Ahrén, Bo; Mathieu, Chantal; Bader, Giovanni; Schweizer, Anja; Foley, James E

2014-07-01

Randomised control trials (RCTs) do not always reflect real-life outcomes for glucose-lowering drugs. In this work we compared RCT and real-life data on the efficacy of the dipeptidyl peptidase-IV (DPP-4) inhibitor vildagliptin or sulfonylureas when added to metformin. Data were pooled from five RCTs examining vildagliptin (n = 2,788) and sulfonylureas (glimepiride [n = 1,259] or gliclazide [n = 433]), added to metformin. For real-life conditions, data were extracted from an observational study examining vildagliptin (n = 7,002) or sulfonylureas (n = 3,702), added to metformin monotherapy. Linear regression analyses were performed between the baseline HbA1c and the change in HbA1c (Δ HbA1c) after 24 weeks. Baseline HbA1c correlated to Δ HbA1c (r (2) = 0.36, slope = -0.54 [95% CI -0.55, -0.53; p < 0.0001]) for both treatments. With sulfonylureas, the slope of the correlation was steeper in the observational study than in RCTs (interaction coefficient = -0.327, p < 0.001), whereas for vildagliptin, the slope was virtually identical in the observational study and the RCTs (interaction coefficient = 0.024, p = 0.175). For any given baseline HbA1c, Δ HbA1c with sulfonylureas was smaller in real life than in RCTs, whereas Δ HbA1c with vildagliptin was the same. When comparing RCT to real-life data, the decrease in HbA1c from baseline with sulfonylurea treatment is smaller in real life than in RCTs, whereas the reduction with vildagliptin is essentially the same, suggesting that the full power of treatment is retained in real life for vildagliptin but not for sulfonylureas, possibly due to fear of hypoglycaemia.

Glycated hemoglobin: A powerful tool not used enough in primary care.

PubMed

Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Carlos

2018-03-01

Glycated haemoglobin (HbA1c) is one of the most useful and relevant laboratory tests currently available. The aim of the actual research was to study the variability and appropriateness in the request of HbA1c in primary care, and differences between regions, to assess if there would be an opportunity to improve the request. A cross-sectional study was conducted enrolling clinical Spanish laboratories. The number of HbA1c requested in 2014 by all general practitioners was reported by each participant. Test-utilization rate was expressed as tests per 1000 inhabitants. The index of variability was calculated, as the top decile divided by the bottom decile. HbA1c per 1000 inhabitants was compared between the different regions. To investigate whether HbA1c was appropriately requested to manage patients with diabetes, the real request was compared to the theoretically ideal number, according to prevalence of known diabetes mellitus in Spain and guideline recommendations. A total of 110 laboratories participated in the study, corresponding to a catchment area of 27 798 262 inhabitants (59.8% of the Spanish population) from 15 different autonomous communities (AACCs). 2 655 547 HbA1c were requested, a median of 93.9 (interquartile range (IQR): 33.4) per 1000 inhabitants. The variability index was 1.97. The HbA1c/1000 inhabitants was significantly different among the AACCs, ranging from 73.4 to 126.3. A total of 4 336 529 additional HbA1c would have been necessary to manage patients with diabetes according to guidelines, and 3 861 769 for diagnosis in asymptomatic patients. There was a high variability and significant differences between Spanish AACCs. Also a significant under-request of HbA1c was observed in Primary Care in Spain. © 2017 Wiley Periodicals, Inc.

Optimal Hemoglobin A1c Levels for Screening of Diabetes and Prediabetes in the Japanese Population.

PubMed

Shimodaira, Masanori; Okaniwa, Shinji; Hanyu, Norinao; Nakayama, Tomohiro

2015-01-01

The aim of this study was to evaluate the utility of hemoglobin A1c (HbA1c) to identify individuals with diabetes and prediabetes in the Japanese population. A total of 1372 individuals without known diabetes were selected for this study. A 75 g oral glucose tolerance test (OGTT) was used to diagnose diabetes and prediabetes. The ability of HbA1c to detect diabetes and prediabetes was investigated using receiver operating characteristic (ROC) analysis. The kappa (κ) coefficient was used to test the agreement between HbA1c categorization and OGTT-based diagnosis. ROC analysis demonstrated that HbA1c was a good test to identify diabetes and prediabetes, with areas under the curve of 0.918 and 0.714, respectively. Optimal HbA1c cutoffs for diagnosing diabetes and prediabetes were 6.0% (sensitivity 83.7%, specificity 87.6%) and 5.7% (sensitivity 60.6%, specificity 72.1%), respectively, although the cutoff for prediabetes showed low accuracy (67.6%) and a high false-negative rate (39.4%). Agreement between HbA1c categorization and OGTT-based diagnosis was low in diabetes (κ = 0.399) and prediabetes (κ = 0.324). In Japanese subjects, the HbA1c cutoff of 6.0% had appropriate sensitivity and specificity for diabetes screening, whereas the cutoff of 5.7% had modest sensitivity and specificity in identifying prediabetes. Thus, HbA1c may be inadequate as a screening tool for prediabetes.

Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the pre-randomization run-in phase of the TODAY study

PubMed Central

Laffel, Lori; Chang, Nancy; Grey, Margaret; Hale, Dan; Higgins, Laurie; Hirst, Kathryn; Izquierdo, Roberto; Larkin, Mary; Macha, Christina; Pham, Trang; Wauters, Aimee; Weinstock, Ruth S.

2011-01-01

Background TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) is a federally-funded multi-center randomized clinical trial comparing three treatments of youth-onset type 2 diabetes. Objective To describe the experience of youth participating in a 2–6 month run-in period in preparation for randomization into TODAY. Subjects An ethnically diverse sample of 927 youth, 65.4% female, aged 13.7±2.0 years old, with type 2 diabetes for a median of 2 months (0.7–7.8 months, 25th-75th percentiles). Methods A run-in period was conducted to achieve HbA1c <8% with metformin monotherapy and diabetes education, and to evaluate adherence to pill taking, visit attendance, and other procedures. Results At entry, mean BMI and z-BMI were 35.6±7.7 and 2.3±0.4, respectively, mean HbA1c was 7.7±2.2%, only 42.5% were on a hypoglycemic treatment, and 35.6% had HbA1c ≥8%. Co-morbid conditions were common; 18.8% had hypertension, 24.2% had elevated cholesterol, and 6.5% had abnormal liver enzymes. After a median 71 days of run-in, 90.9% had HbA1c <8%, 77.9% had HbA1c <7%, and 46.4% had HbA1c <6%. Of the 772 youth achieving the target HbA1c <8%, 704 (91.2%) were randomized; non-adherence to metformin treatment was the main cause for non-randomization. Youth proceeding to randomization decreased weight by 0.68 kg and HbA1c by 1.45% compared to a weight gain of 0.71 kg and HbA1c decrease of 0.74% in the non-randomized youth (p=0.01 in both cases). Change in z-BMI was not significantly different between the two groups, however. Conclusions Most youth with recent onset type 2 diabetes can achieve target HbA1c <8.0% with short-term metformin monotherapy and standard diabetes education. PMID:22369102

Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the prerandomization run-in phase of the TODAY study.

PubMed

Laffel, Lori; Chang, Nancy; Grey, Margaret; Hale, Dan; Higgins, Laurie; Hirst, Kathryn; Izquierdo, Roberto; Larkin, Mary; Macha, Christina; Pham, Trang; Wauters, Aimee; Weinstock, Ruth S

2012-08-01

TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) is a federally funded multicenter randomized clinical trial comparing three treatments of youth onset type 2 diabetes. To describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY. An ethnically diverse sample of 927 youth, 65.4% females, aged 13.7 ± 2.0 yr old, with type 2 diabetes for a median of 2 months (0.7-7.8 months, 25th-75th percentiles). A run-in period was conducted to achieve HbA1c <8% with metformin monotherapy and diabetes education, and to evaluate adherence to pill taking, visit attendance, and other procedures. At entry, mean body mass index (BMI) and z-BMI were 35.6 ± 7.7 and 2.3 ± 0.4, respectively, mean HbA1c was 7.7 ± 2.2%, only 42.5% were on a hypoglycemic treatment, and 35.6% had HbA1c ≥8%. Comorbid conditions were common; 18.8% had hypertension, 24.2% had elevated cholesterol, and 6.5% had abnormal liver enzymes. After a median 71 d of run-in, 90.9% had HbA1c <8%, 77.9% had HbA1c <7%, and 46.4% had HbA1c <6%. Of the 772 youth achieving the target HbA1c <8%, 704 (91.2%) were randomized; non-adherence to metformin treatment was the main cause for non-randomization. Youth proceeding to randomization decreased weight by 0.68 kg and HbA1c by 1.45% compared to a weight gain of 0.71 kg and HbA1c decrease of 0.74% in the non-randomized youth (p = 0.01 in both cases). However, change in z-BMI was not significantly different between the two groups. Most youth with recent onset type 2 diabetes can achieve target HbA1c <8.0% with short-term metformin monotherapy and standard diabetes education (ClinicalTrials.gov identifier: NCT00081328). © 2012 John Wiley & Sons A/S.

Unanticipated error in HbA(1c) measurement on the HLC-723 G7 analyzer.

PubMed

van den Ouweland, Johannes M W; de Keijzer, Marinus H; van Daal, Henny

2010-04-01

Investigation of falsely elevated HbA(1c) measurements on the HLC-723 G7 analyser. Comparison of HbA(1c) in blood samples that were diluted either in hemolysis reagent or water. HbA(1c) results became falsely elevated when samples were diluted in hemolysis reagent, but not in water. QC-procedures failed to detect this error as calibrator and QC samples were manually diluted in water, according to manufacturer's instructions, whereas patient samples were automatically diluted using hemolysing reagent. After replacement of the instruments' sample-loop and rotor seal comparable HbA(1c) results were obtained, irrespective of dilution with hemolysing reagent or water. This case illustrates the importance of treating calibrator and QC materials similar to routine patient samples in order to prevent unnoticed drift in patient HbA(1c) results. Copyright 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Effect of the systemic inflammatory response, as provoked by elective orthopaedic surgery, on HbA1c.

PubMed

Chadburn, Andrew J; Garman, Elizabeth; Abbas, Raad; Modupe, Anu; Ford, Clare; Thomas, Osmond L; Chugh, Sanjiv; Deshpande, Shreeram; Gama, Rousseau

2017-07-01

Background In acutely ill patients with new onset hyperglycaemia, plasma glucose cannot reliably distinguish between stress hyperglycaemia and undiagnosed diabetes mellitus. We, therefore, investigated the diagnostic reliability of glycated haemoglobin (HbA1c) in acute illness by prospectively evaluating the effect of the systemic inflammatory response, as provoked by elective orthopaedic surgery, on HbA 1c . Methods HbA 1c and serum C-reactive protein concentrations were compared before and two days after elective knee or hip surgery in 30 patients without diabetes. C-reactive protein was used to assess the systemic inflammatory response. Results The mean (standard deviation) serum C-reactive protein increased following surgery (4.8 [7.5] vs. 179.7 [61.9] mg/L; P<0.0001). HbA 1c was similar before and after surgery (39.2 [5.4] vs. 38.1 [5.1] mmol/moL, respectively; P = 0.4363). Conclusions HbA 1c is unaffected within two days of a systemic inflammatory response as provoked by elective orthopaedic surgery. This suggests that HbA 1c may be able to differentiate newly presenting type 2 diabetes mellitus from stress hyperglycaemia in acutely ill patients with new onset hyperglycaemia.

HbA1c Outcomes in Patients Treated With Canagliflozin Versus Sitagliptin in US Health Plans.

PubMed

Thayer, Sarah; Aguilar, Richard; Korrer, Stephanie; Chow, Wing

2017-10-01

Clinical trial evidence supports greater glycemic control with canagliflozin than with sitagliptin. The objective of this study was to provide real-world evidence comparing outcomes in routine clinical practice among patients initiating each medication. With the use of a health care administrative database, patients initiating canagliflozin were compared with patients initiating sitagliptin (first prescription fill as index date). Baseline (6 months before index date) demographic and clinical (eg, comorbidities and diabetes-related complications) characteristics were compared, and propensity score matching was used to control for baseline differences between cohorts. Outcomes included change in glycosylated hemoglobin (HbA 1c ) and persistence with medication over a 9-month period after index date. Before matching, the canagliflozin cohort (N = 3993) was younger than the sitagliptin cohort (N = 12,153) and was composed of fewer women and Medicare Advantage enrollees, with lower mean baseline comorbidity scores (all p < 0.001). Before matching, the canagliflozin cohort (valid n = 1482) had a significantly (p < 0.001) higher baseline HbA 1c (8.60) than the sitagliptin cohort (valid n = 3697; HbA 1c , 8.32). After matching (n = 1472 per cohort), patients were well balanced on baseline characteristics, and HbA 1c values were not significantly different (p = 0.634) between the cohorts. Patients initiating canagliflozin had greater reductions in HbA 1c than patients in the sitagliptin cohort (-0.93% versus -0.57%, respectively; p = 0.004), with similar mean (median) time from index date to follow-up HbA 1c of 185.4 (199.0) and 184.3 (190.5) days, respectively (p = 0.802). Only 29.8% of canagliflozin patients discontinued during follow-up compared with 41.5% of sitagliptin patients (p < 0.001); the average days of persistence on index therapy was longer for canagliflozin patients (152 days) than for sitagliptin patients (139 days; p < 0.001). In this observational study, patients initiating canagliflozin had greater reduction in HbA 1c and longer persistence with medication than did patients who initiated sitagliptin, over a 9-month period. Better understanding of antihyperglycemic treatment, HbA 1c results, and differences among patients in demographic/clinical characteristics as well as persistence with treatment will inform optimal diabetes treatment choice in routine practice. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Glucokinase MODY and implications for treatment goals of common forms of diabetes.

PubMed

Ajjan, Ramzi A; Owen, Katharine R

2014-12-01

Treatment goals in diabetes concentrate on reducing the risk of vascular complications, largely through setting targets for glycated haemoglobin (HbA1c). These targets are based on epidemiological studies of complication development, but so far have not adequately addressed the adverse effects associated with lowering HbA1c towards the normal range. Glucokinase (GCK) mutations cause a monogenic form of hyperglycaemia (GCK-MODY) characterised by fasting hyperglycaemia with low postprandial glucose excursions and a marginally elevated HbA1c. Minimal levels of vascular complications (comparable with nondiabetic individuals) are observed in GCK-MODY, leading to the hypothesis that GCK-MODY may represent a useful paradigm for assessing treatment goals in all forms of diabetes. In this review, we discuss the evidence behind this concept, suggest ways of translating this hypothesis into clinical practice and address some of the caveats of such an approach.

Pediatric diabetes consortium type 1 diabetes new onset (NeOn) study: Factors associated with HbA1c levels one year after diagnosis

USDA-ARS?s Scientific Manuscript database

To identify determinants of hemoglobin A1c (HbA1c) levels 1 yr after the diagnosis of type 1 diabetes (T1D) in participants in the Pediatric Diabetes Consortium (PDC) T1D New Onset (NeOn) Study. Diabetes-specific as well as socioeconomic factors during the first year following diagnosis were analyze...

Change in Sedentary Time, Physical Activity, Bodyweight, and HbA1c in High-Risk Adults.

PubMed

McCarthy, Matthew; Edwardson, Charlotte L; Davies, Melanie J; Henson, Joseph; Gray, Laura; Khunti, Kamlesh; Yates, Thomas

2017-06-01

In recent years, there has been a migration toward the use of glycated hemoglobin (HbA1c) in determining glycemic control. This study aimed to quantify the associations between changes in body weight, sedentary time, and moderate to vigorous physical activity (MVPA) time with HbA1c levels for a 3-yr period among adults at high risk of type 2 diabetes. This study reports baseline and 3-yr follow-up data from the Walking Away from Type 2 Diabetes study. ActiGraph GT3X accelerometers captured sedentary time and MVPA. Linear regression examined the independent associations of changes in sedentary time, MVPA, and body weight with HbA1c between baseline and 3-yr follow-up. The sample composed of 489 participants (mean age = 64.2 ± 7.3 yr, body mass index = 31.7 ± 5.1, 63.4% male) with valid baseline and follow-up accelerometer, body weight, and HbA1c data. After adjustment for known confounders, an increase in MVPA time (per 30 min·d) was associated with a decrease in HbA1c percentage (β = -0.11 [-0.18 to -0.05], P = 0.001), and an increase in body weight (per 6 kg) was associated with an increase in HbA1c percentage (β = 0.08 [0.04-0.12], P < 0.001). The presence of dysglycemia at baseline (HbA1c ≥ 6.0%) strengthened these associations (P < 0.001 for interactions). Change in sedentary time was not significantly associated with change in HbA1c after adjustment for change in MVPA time. Increases in MVPA and body weight were associated with a reduction and increase in HbA1c, respectively, particularly in those with dysglycemia. Quantifying the effect that health behavior changes have on HbA1c can be used to inform prevention programs.

Real-world Clinical Outcomes Among Patients With Type 2 Diabetes Receiving Canagliflozin at a Specialty Diabetes Clinic: Subgroup Analysis by Baseline HbA1c and Age.

PubMed

Johnson, June Felice; Parsa, Rahul; Bailey, Robert A

2017-06-01

Canagliflozin, a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM), has demonstrated effectiveness in patients with T2DM receiving care at a specialty diabetes clinic. We report the outcomes in these patients in subgroups classified by baseline hemoglobin A 1c (HbA 1c ) and age. This subgroup analysis was based on a review of data from the electronic health records of adults with T2DM who were prescribed canagliflozin at a specialty diabetes clinic and who returned for ≥1 follow-up office visit. Mean changes from baseline to the first and second follow-up office visits in HbA 1c , body weight, and systolic and diastolic blood pressure (BP) were calculated in each subgroup classified by baseline HbA 1c (≥7.0%, ≥8.0%, and >9.0%) and age (<65 and ≥65 years). Of the 462 patients included in the study, 430, 305, and 169 patients had baseline HbA 1c ≥7.0%, ≥8.0%, and >9.0%, respectively; 396 and 66 patients were aged <65 and ≥65 years, respectively. With canagliflozin use, patients across subgroups classified by baseline HbA 1c and age experienced clinically and statistically significant reductions from baseline in HbA 1c , body weight, and systolic BP that were sustained over 2 office visits; diastolic BP was also reduced across baseline HbA 1c and age subgroups. Greater reductions in HbA 1c were seen among the canagliflozin-treated patients with higher baseline HbA 1c and among younger versus older patients. These findings from clinical practice demonstrate real-world effectiveness of canagliflozin in lowering HbA 1c , body weight, and systolic BP among patients with T2DM, regardless of baseline HbA 1c levels or age. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

A study of the differences in the request of glycated hemoglobin in primary care in Spain: A global, significant, and potentially dangerous under-request.

PubMed

Salinas, Maria; López-Garrigós, Maite; Uris, Joaquín; Leiva-Salinas, Carlos

2014-08-01

The study was performed to compare the variability and appropriateness in the request of glycated hemoglobin (HbA1c) in primary care in Spain. 76 Spanish laboratories from diverse regions across Spain filled out the number of HbA1c tests requested by general practitioners (GPs) during the year 2012. Every patient seen at the different primary care centers was included in the study. Each participating laboratory was required to provide organizational data. The number of HbA1c requests per 1000 inhabitants was calculated and compared between regions. To investigate whether HbA1c was appropriately requested to manage and to diagnose Diabetes Mellitus (DM), the number of necessary HbA1c was calculated, according to the disease prevalence in Spain (6.9%) and the guidelines regarding DM management and diagnosis. 17679195 patients were included in the study. A total of 1544551 HbA1c tests were ordered. No significant difference in the number of HbA1c requests per 1000 inhabitants was seen according to hospital setting (rural, urban or rural-urban). No significant differences were noticed between 3 Spanish regions, except the Valencian Community that presented higher values. Regarding the request appropriateness, 3280183 additional tests would have been necessary to manage diabetic patients and to diagnose new patients with the disease. There was a high variability regarding the request of HbA1c; the test was under-requested in all the participating health departments. This emphasizes the need to accomplish interventions to improve an appropriate use. Copyright © 2014. Published by Elsevier Inc.

HbA1c below 7% as the goal of glucose control fails to maximize the cardiovascular benefits: a meta-analysis.

PubMed

Wang, Pin; Huang, Rong; Lu, Sen; Xia, Wenqing; Sun, Haixia; Sun, Jie; Cai, Rongrong; Wang, Shaohua

2015-09-22

Whether lowering glycosylated haemoglobin (HbA1c) level below 7.0% improves macro-vascular outcomes in diabetes remains unclear. Here, we aimed to assess the effect of relatively tight glucose control resulting in a follow-up HbA1c level of less or more than 7.0% on cardiovascular outcomes in diabetic patients. We systematically searched Medline, Web of science and Cochrane Library for prospective randomized controlled trials published between Jan 1, 1996 and July 1, 2015 that recorded cardiovascular outcome trials of glucose-lowering drugs or strategies in patients with type 2 diabetes mellitus. Data from 15 studies involving 88,266 diabetic patients with 4142 events of non-fatal myocardial infarction, 6997 of major cardiovascular events, 3517 of heart failure, 6849 of all-cause mortality, 2084 of non-fatal stroke, 3816 of cardiovascular death were included. A 7% reduction of major cardiovascular events was observed only when relatively tight glucose control resulted in a follow-up HbA1c level above 7.0% (OR 0.93, 95% CI 0.88-0.98; I(2) = 33%), however, the patients can benefit from reduction incidence of non-fatal myocardial infarction only when the follow-up HbA1c value below 7.0% (OR 0.85, 95% CI 0.74-0.96). Apart from the HbA1c value above 7.0% (OR 1.22, 95% CI 1.06-1.40), the application of thiazolidinediones (OR 1.39, 95% CI 1.14-1.69) also increased the risk of heart failure, while the gliptins shows neutral effects to heart failure (OR 1.14, 95% CI 0.97-1.34). Relatively tight glucose control has some cardiovascular benefits. HbA1c below 7.0% as the goal to maximize the cardiovascular benefits remains suspended.

Association of glycosylated hemoglobin (HbA1c) levels with Iinsulin resistance in obese children.

PubMed

Onal, Zehra Esra; Atasayan, Vildan; Gürbüz, Tamay; Hepkaya, Evrim; Nuhoğlu, Cağatay

2014-09-01

We investigated the relationship between insulin resistance reflected by homeostasis model assessment (HOMA-IR) index and serum HbA1c levels of obese children. This study included 70 obese and 60 normal weight healthy children between the ages of 3 and 15. Anthropometric measures and biochemical tests (fasting glucose, fasting insulin, HbA1c) were performed on all subjects. Plasma glucose levels were measured by the glucose oxidase method. Plasma insulin concentrations were measured by radioimmunoassay (RIA). HOMA-IR index was used to estimate insulin resistance. A cut-off HOMA-IR level of ≥2.5 was accepted. The HbA1c analysis was performed using high-pressure liquid chromatography. The statistical analysis was performed using SPSS 5. Student's unpaired t-test and the Mann-Whitney U test were used to determine statistical significance. Gender distribution did not reveal significant difference among the obese (F: 48.6%, M: 51.4%) and the non-obese (F: 46.7%, M: 53.3%) groups. The mean age value was significantly higher in the obese group (10.09 ± 3.09) (p > 0.005) than the non-obese group (8.31 ± 3.14) (p < 0.05). The mean value of body mass index (BMI) was 25.55 ± 4.3 in the obese group and 16.63 ± 2.3 in the non-obese group. The mean HOMA-IR values of obese group (2.84 ± 1.77) was significantly higher than the non-obese group (1.50 ± 0.95) (p < 0.005). Insulin resistance was significantly higher in the obese group. Subjects with HOMA-IR ≥2.5 levels in the obese group had significantly higher HbA1c values than those with HOMA-IR <2.5 levels. High HbA1c levels in obese children can be used as a screening tool to detect insulin sensitivity and resistance at an early stage.

Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: a pooled analysis of 96 population-based studies with 331,288 participants.

PubMed

2015-08-01

Diabetes has been defined on the basis of different biomarkers, including fasting plasma glucose (FPG), 2-h plasma glucose in an oral glucose tolerance test (2hOGTT), and HbA1c. We assessed the effect of different diagnostic definitions on both the population prevalence of diabetes and the classification of previously undiagnosed individuals as having diabetes versus not having diabetes in a pooled analysis of data from population-based health examination surveys in different regions. We used data from 96 population-based health examination surveys that had measured at least two of the biomarkers used for defining diabetes. Diabetes was defined using HbA1c (HbA1c ≥6·5% or history of diabetes diagnosis or using insulin or oral hypoglycaemic drugs) compared with either FPG only or FPG-or-2hOGTT definitions (FPG ≥7·0 mmol/L or 2hOGTT ≥11·1 mmol/L or history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated diabetes prevalence, taking into account complex survey design and survey sample weights. We compared the prevalences of diabetes using different definitions graphically and by regression analyses. We calculated sensitivity and specificity of diabetes diagnosis based on HbA1c compared with diagnosis based on glucose among previously undiagnosed individuals (ie, excluding those with history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated sensitivity and specificity in each survey, and then pooled results using a random-effects model. We assessed the sources of heterogeneity of sensitivity by meta-regressions for study characteristics selected a priori. Population prevalence of diabetes based on FPG-or-2hOGTT was correlated with prevalence based on FPG alone (r=0·98), but was higher by 2-6 percentage points at different prevalence levels. Prevalence based on HbA1c was lower than prevalence based on FPG in 42·8% of age-sex-survey groups and higher in another 41·6%; in the other 15·6%, the two definitions provided similar prevalence estimates. The variation across studies in the relation between glucose-based and HbA1c-based prevalences was partly related to participants' age, followed by natural logarithm of per person gross domestic product, the year of survey, mean BMI, and whether the survey population was national, subnational, or from specific communities. Diabetes defined as HbA1c 6·5% or more had a pooled sensitivity of 52·8% (95% CI 51·3-54·3%) and a pooled specificity of 99·74% (99·71-99·78%) compared with FPG 7·0 mmol/L or more for diagnosing previously undiagnosed participants; sensitivity compared with diabetes defined based on FPG-or-2hOGTT was 30·5% (28·7-32·3%). None of the preselected study-level characteristics explained the heterogeneity in the sensitivity of HbA1c versus FPG. Different biomarkers and definitions for diabetes can provide different estimates of population prevalence of diabetes, and differentially identify people without previous diagnosis as having diabetes. Using an HbA1c-based definition alone in health surveys will not identify a substantial proportion of previously undiagnosed people who would be considered as having diabetes using a glucose-based test. Wellcome Trust, US National Institutes of Health. Copyright © 2015 NCD Risk Factor Collaboration. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Higher glucose levels associated with lower memory and reduced hippocampal microstructure.

PubMed

Kerti, Lucia; Witte, A Veronica; Winkler, Angela; Grittner, Ulrike; Rujescu, Dan; Flöel, Agnes

2013-11-12

For this cross-sectional study, we aimed to elucidate whether higher glycosylated hemoglobin (HbA1c) and glucose levels exert a negative impact on memory performance and hippocampal volume and microstructure in a cohort of healthy, older, nondiabetic individuals without dementia. In 141 individuals (72 women, mean age 63.1 years ± 6.9 SD), memory was tested using the Rey Auditory Verbal Learning Test. Peripheral levels of fasting HbA1c, glucose, and insulin and 3-tesla MRI scans were acquired to assess hippocampal volume and microstructure, as indicated by gray matter barrier density. Linear regression and simple mediation models were calculated to examine associations among memory, glucose metabolism, and hippocampal parameters. Lower HbA1c and glucose levels were significantly associated with better scores in delayed recall, learning ability, and memory consolidation. In multiple regression models, HbA1c remained strongly associated with memory performance. Moreover, mediation analyses indicated that beneficial effects of lower HbA1c on memory are in part mediated by hippocampal volume and microstructure. Our results indicate that even in the absence of manifest type 2 diabetes mellitus or impaired glucose tolerance, chronically higher blood glucose levels exert a negative influence on cognition, possibly mediated by structural changes in learning-relevant brain areas. Therefore, strategies aimed at lowering glucose levels even in the normal range may beneficially influence cognition in the older population, a hypothesis to be examined in future interventional trials.

The effectiveness of theory- and model-based lifestyle interventions on HbA1c among patients with type 2 diabetes: a systematic review and meta-analysis.

PubMed

Doshmangir, P; Jahangiry, L; Farhangi, M A; Doshmangir, L; Faraji, L

2018-02-01

The prevalence of type 2 diabetes is rising rapidly around the world. A number of systematic reviews have provided evidence for the effectiveness of lifestyle interventions on diabetic patients. The effectiveness of theory- and model-based education-lifestyle interventions for diabetic patients are unclear. The systematic review and meta-analysis aimed to evaluate and quantify the impact of theory-based lifestyle interventions on type 2 diabetes. A literature search of authentic electronic resources including PubMed, Scopus, and Cochrane collaboration was performed to identify published papers between January 2002 and July 2016. The PICOs (participants, intervention, comparison, and outcomes) elements were used for the selection of studies to meet the inclusion and exclusion criteria. Mean differences and standard deviations of hemoglobin A1c (HbA1c [mmol/mol]) level in baseline and follow-up measures of studies in intervention and control groups were considered for data synthesis. A random-effects model was used for estimating pooled effect sizes. To investigate the source of heterogeneity, predefined subgroup analyses were performed using trial duration, baseline HbA1c (mmol/mol) level, and the age of participants. Meta-regression was performed to examine the contribution of trial duration, baseline HbA1c (mmol/mol) level, the age of participants, and mean differences of HbA1c (mmol/mol) level. The significant level was considered P < 0.05. Eighteen studies with 2384 participants met the inclusion criteria. The pooled main outcomes by random-effects model showed significant improvements in HbA1c (mmol/mol) -5.35% (95% confidence interval = -6.3, -4.40; P < 0.001) with the evidence of heterogeneity across studies. The findings of this meta-analysis suggest that theory- and model-based lifestyle interventions have positive effects on HbA1c (mmol/mol) indices in patients with type 2 diabetes. Health education theories have been applied as a useful tool for lifestyle change among people with type 2 diabetes. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Affective symptoms and change in diabetes self-efficacy and glycaemic control

PubMed Central

Robertson, S. M.; Amspoker, A. B.; Cully, J. A.; Ross, E. L.; Naik, A. D.

2013-01-01

Aims To examine the role of baseline depression, anxiety and stress symptoms on post-intervention diabetes self-efficacy and glycaemic control (HbA1c). Methods The current study analysed data from patients (n = 85) with treated but uncontrolled Type 2 diabetes who participated in a comparative effectiveness study of two diabetes self-management interventions. Hierarchical linear regression was used to examine the relationships between baseline affective symptoms and post-intervention diabetes self-efficacy and the moderating effects of baseline affective symptoms on the relationship between changes in diabetes self-efficacy and post-intervention HbA1c. Results Baseline depression was inversely associated with post-intervention diabetes self-efficacy (P = 0.0001) after adjusting for baseline characteristics including diabetes self-efficacy. In contrast, normal–mild levels of stress were associated with higher post-intervention diabetes self-efficacy (P = 0.04). Anxiety and stress symptoms significantly and independently moderated the relationship between changes in diabetes self-efficacy and post-intervention HbA1c (P = 0.02 and P = 0.03, respectively). Further evaluation of these interactions demonstrated that changes in diabetes self-efficacy were associated with lower post-intervention HbA1c, but only among those with higher baseline affective symptoms. Conclusions We found a moderating effect across affective symptoms on the relationship between diabetes self-efficacy changes and post-intervention HbA1c in the context of a self-management intervention. Results suggest that patients with poorly controlled diabetes who have higher levels of depression, anxiety and stress symptoms may derive greater benefits from self-management interventions known to improve diabetes self-efficacy. PMID:23350920

HbA1c monitoring interval in patients on treatment for stable type 2 diabetes. A ten-year retrospective, open cohort study.

PubMed

Ohde, Sachiko; Deshpande, Gautam A; Yokomichi, Hiroshi; Takahashi, Osamu; Fukui, Tsuguya; Yamagata, Zentaro

2018-01-01

[Aims] This study aims to suggest an informative interval for HbA1c in DM patients with stable glycemic control, based on test characteristics of the HbA1C assay using the signal-to-noise ratio method. [Methods] This was a retrospective, open cohort study. Data were collected between January 2005 to December 2014 at a tertiary-level community hospital in Japan. All adult patients aged under 75 years, with stable glycemic control on a first pharmaceutical regimen for Type II diabetes, and at least two HbA1c measurements after they achieved glycemic stability, were included in the analysis. We defined stable glycemic control as HbA1c <7.0% (52 mmol/mol) and requiring no change in the medication regimen after three consecutive measurements. We adapted a signal-to-noise method for distinguishing true change from measurement error by constructing a linear random effects model to calculate signal and noise for HbA1c. The screening interval for HbA1c was defined as informative when the signal-to-noise ratio exceeded 1. [Results] Among 1066 adults with diabetes, 639 patients (18.5%) were identified as achieving stable glycemic control (511 male (67.3%)), with a mean HbA1c (SD) of 6.4 (0.4)% (46 mmol/mol). Patients with stable glycemic control increase their HbA1c 0.27% (3 mmol/mol) every year while HbA1c has 0.32% (3.5 mmol/mol) noise, as testing characteristics. Signal exceeds noise after 1.2 years (95%CI: 0.9-1.6). [Conclusion] Once patients achieve stable glycemic control at their HbA1c goal, an informative interval for HbA1c monitoring is once every year. Current guidelines, which suggest testing every six months, may contribute to substantial over-testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Comparison of acarbose and metformin therapy in newly diagnosed type 2 diabetic patients with overweight and/or obesity.

PubMed

Sun, Weiping; Zeng, Chunping; Liao, Lizhen; Chen, Juan; Wang, Ying

2016-08-01

To compare the efficacy of acarbose and metformin in overweight and/or obese patients with newly diagnosed type 2 diabetes mellitus (T2DM). A total of 108 drug-naïve patients with newly diagnosed T2DM, whose hemoglobin A1c (HbA1c) was between 7% and 10% and body mass index was greater than 24 kg/m(2), were enrolled in the First People's Hospital and Municipal Central Hospital of Xiangtan City, Xiangtan, China, from 1 February 2010 to 1 August 2011. Patients were randomly assigned to acarbose (100 mg three times a day) and metformin (1.5 g/day) groups for a predictive follow-up period of 24 weeks. Plasma glucose, insulin, and glucagons at 0, 0.5, and 2 hours after a standardized meal, and HbA1c were measured at baseline and 24 weeks. Baseline characteristics of the acarbose and metformin groups were similar. Glucose control improved significantly in both groups at 24 weeks. The percentage of patients achieving HbA1C <6.5% was comparable for acarbose and metformin therapy at 24 weeks. Body weight reduction from baseline to 24 weeks was 3.3 kg in the acarbose group and 2.7 kg in the metformin group, whereas the change in HbA1c and body weight was similar in both groups. The early-phase insulin secretion index improved only in the acarbose group at 24 weeks. After 24 weeks of therapy, fasting glucagon and 0.5 hour postprandial glucagon levels decreased markedly in the acarbose group compared to the metformin group. Twenty-four weeks of therapy with acarbose and metformin induced similar reductions in HbA1c and body weight, but acarbose showed superior efficacy in improving islet α-cell function compared with metformin in overweight/obese patients with newly diagnosed T2DM. However, more large-sample, multicenter, randomized controlled trials are needed to evaluate the efficacy, safety, cost-effectiveness, and glycemic variability of the two drugs.

Total Antioxidant Status in Type 2 Diabetic Patients in Palestine.

PubMed

Kharroubi, Akram T; Darwish, Hisham M; Akkawi, Mutaz A; Ashareef, Abdelkareem A; Almasri, Zaher A; Bader, Khaldoun A; Khammash, Umaiyeh M

2015-01-01

The objective of this study was to compare the level of total antioxidant status (TAS) in type 2 diabetic and normal Palestinian subjects as well as the major factors influencing TAS levels. A sample of convenience composed of 212 type 2 diabetic and 208 normal subjects above the age of 40 were recruited. Only 9.8% of the subjects had normal body mass index (BMI) levels (<25), 29% were overweight (≥25 to <30), and 61.2% were obese (≥30). The mean levels of TAS were significantly higher in diabetic compared to control subjects (2.18 versus 1.84 mM Trolox, P = 0.001) and in hypertensive subjects compared to subjects with normal blood pressure (BP). Mean TAS levels were higher in obese compared to nonobese subjects (2.12 versus 1.85 mM Trolox, P = 0.001). Mean TAS levels were similarly higher in subjects with high fasting plasma glucose (FPG) compared to normal FPG (2.19 versus 1.90 mM Trolox) and high HbA1c (≥6.5%) compared to HbA1c < 6.5% (2.14 versus 1.91 mM Trolox). Multivariate analysis revealed that only diabetic status (P = 0.032) and the level of education (P = 0.036) were significantly associated with TAS. In conclusion diabetic patients had 18.5% increase in TAS levels compared to control subjects.

Gender-based differences in glycaemic control and hypoglycaemia prevalence in patients with type 2 diabetes: results from patient-level pooled data of six randomized controlled trials.

PubMed

Kautzky-Willer, A; Kosi, L; Lin, J; Mihaljevic, R

2015-06-01

To determine the impact of gender on glycaemic control and hypoglycaemia in insulin-naïve patients with type 2 diabetes (T2DM). Data were pooled from six randomized clinical trials of insulin glargine or NPH insulin in insulin-naïve, inadequately controlled patients. Female [n = 1251; mean glycated haemoglobin (HbA1c) level 8.99%, age 56.91 years, diabetes duration 9.84 years] and male patients (n = 1349; mean HbA1c 8.9%, age 57.47 years, diabetes duration 10.13 years) were started on and treated with insulin glargine or NPH insulin for 24-36 weeks. HbA1c and fasting blood glucose levels, percent achieving HbA1c target of <7% and insulin dose change were recorded. For both men and women, HbA1c levels were significantly reduced over time (p < 0.001); a significantly greater HbA1c reduction was observed in men than in women (-1.36 vs. -1.22; p = 0.002). Significantly fewer women achieved target HbA1c of <7% (p < 0.001). At the study end, women had a significantly higher insulin dose/kg than men (0.47 vs. 0.42 U/kg; p < 0.001). The incidence rates of severe and severe nocturnal hypoglycaemia were significantly higher in women (3.28% vs. 1.85%; p < 0.05 and 2.24% vs. 0.59%; p < 0.001, respectively). Women were more likely to experience severe hypoglycaemia [odds ratio (OR) 1.80; 95% confidence interval (CI) 1.08, 3.00; p = 0.02] and severe nocturnal hypoglycaemia (OR: 3.80; 95% CI 1.72, 8.42; p = 0.001). These observations confirm studies that found a smaller improvement in HbA1c and greater hypoglycaemia in women during insulin treatment. Physicians should be aware of the need to determine and closely monitor dosing, particularly in women, to optimize the balance between glycaemic control and hypoglycaemia risk. © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Glycemic control in familial vs. sporadic type 1 diabetes patients over 5 years.

PubMed

Reddy, Sujana; Reinert, Steven E; Gopalakrishnan, Geetha; Plante, Wendy; Boney, Charlotte M; Quintos, Jose Bernardo

2014-01-01

Studies have shown that familial type 1 diabetes patients (FTID) have less severe metabolic derangement at presentation compared to sporadic patients (ST1D), but data on long-term metabolic control are lacking. (1) FT1D will have less severe presentation and better HbA1c over 5 years compared to ST1D; (2) HbA1c in the offspring will correlate with parent HbA1c in parent-offspring group; and (3) HbA1c of the second affected sibling (SP2) will correlate with the first affected sibling (SP1) in sib-pairs. Cohort of 33 parent-offspring and 19 sib-pairs; controls included 33 sporadic subjects matched by age, sex, ethnicity, puberty, and insulin regimen. Paired t-test and Pearson's correlation were used for statistical analysis. At diagnosis, mean age in FT1D vs. matched ST1D (7.7±4.9 vs. 7.6±4.5 years), mean HbA1c (9.6% vs. 10.7%), HCO3 (21 vs. 18 meq/L), glucose (428 vs. 463 mg/dL) and pH (7.35 vs. 7.36; p=ns) were not different. At 5 years, HbA1c (8.9% vs. 8.8%; p=0.81), clinic visits (12 vs. 12.5, p=0.68) and emergency room visits (0.48 vs. 0.24, p=0.10) were not different. In affected siblings, only HCO3 was different (SP1:18 vs. SP2: 24 meq/L; p<0.01). HbA1c for SP2 correlated positively with SP1 (r=0.67, p<0.01). Offspring HbA1c correlated positively with affected parents (9.3% vs. 8.6%, r=0.57, p=0.18) but was not significant. Metabolic control at diagnosis and at 5 years was similar in FT1D and ST1D. In sib-pairs, the second affected sibling had milder clinical presentation compared to the first affected sibling.

Study of Auditory, Visual Reaction Time and Glycemic Control (HBA1C) in Chronic Type II Diabetes Mellitus.

PubMed

M, Muhil; Sembian, Umapathy; Babitha; N, Ethiya; K, Muthuselvi

2014-09-01

Diabetes mellitus is a disease of insulin deficiencyleads to micro and macro vascular disorder. Neuropathy is one of the major complication of chronic uncontrolled Diabetes affecting the Reaction time. To study the correlation between the glycosylated HbA1C and Auditory, visual Reaction time in chronic Type II diabetes (40-60y) of on oral hypoglycemic drugs of>10 y duration in two groups (n-100 in each group , both Males & females) and compared within the study groups and also with the age matched control group (100). HbA1C-Glycosylated HbA1C was measured by Particle enhanced immunoturbidimetric test method. Auditory and visual reaction time (ART, VRT) were measured by PC 1000 Reaction timer for control & study groups i.e. Group-I - Chronic Type II DM for >10 y with HbA1c < 7.0, and Group II - chronic Type-IIDM for >10 y with HbA1c > 7.0 ie impaired glycemic control. Exclusion Criteria- Subjects with Auditory and visual disturbances, alcoholism and smoking. Statistical Analysis - One-way ANOVA. Using SPSS 21 software. Both the groups had prolonged ART and VRT than controls. Among the study group, G-II (DM with HbA1C >7) had increased Auditory & Visual Reaction time than Group I which is statistically significant p-value <0.05. Impairment of sensory motor function of peripheral nervous system is more in chronic diabetic with less glycemic control ie., HbA1C>7 who have shown increased Auditory and Visual Reaction time than chronic DM with HbA1C<7.Severity of Peripheral neuropathy in Type II Diabetics could be due to elevated HbA1C.

Glycemic control paradox: Poor glycemic control associated with higher one-year and eight-year risks of all-cause hospitalization but lower one-year risk of hypoglycemia in patients with type 2 diabetes.

PubMed

Li, Tsai-Chung; Kardia, Sharon L R; Li, Chia-Ing; Chen, Ching-Chu; Liu, Chiu-Shong; Yang, Sing-Yu; Muo, Chin-Shin; Peyser, Patricia A; Lin, Cheng-Chieh

2015-09-01

The relationship between glycemic control and adverse outcomes found in a population with diabetes has seldom been evaluated in patients with type 2 diabetes. We explored the association between hemoglobin A1c (HbA1c) and hospitalization risks within one-year and eight-year follow-up periods. We conducted a retrospective cohort study on 57,061 patients with type 2 diabetes from National Diabetes Case Management Program during 2002-2004 in Taiwan. HbA1c at baseline and in-hospital mortality, all-cause and cause-specific hospitalization over one year and eight years were analyzed. After multivariate adjustment, one-year risk was higher for cases with HbA1c level <6%, 9-10%, ≥10% versus 6-7% for all-cause hospitalization (hazard ratio [HR]: 1.11, 95% confidence interval [CI]: 1.03-1.20; 1.08, 1.01-1.16, and 1.19, 1.12-1.26, respectively) and for ≥10% for diabetes-related hospitalization (1.68, 1.46-1.92). Yet each 1-step increment in HbA1c category (<6.0, 6.0-6.9, 7.0-7.9, 8.0-8.9, 9.0-9.9 and ≥10.0%) showed linkage with lower risk of hypoglycemia hospitalization (0.81, 95% CI: 0.74-0.88). For eight-year risk, subjects with HbA1c level <6%, and ≥10% were more likely to have in-hospitality mortality (1.16, 1.03-1.31, and 1.23, 1.11-1.35, respectively). Each 1-step increment in HbA1c category showed an association with higher risks of all-cause and diabetes-related hospitalization (1.04, 1.03-1.05, and 1.15, 1.14-1.17, respectively). Higher HbA1c level correlated with lower one-year risk due to hypoglycemia hospitalization but increased one-year and eight-year risks due to all-cause and diabetes-specific hospitalization among Chinese people with type 2 diabetes in Taiwan. Future study must ascertain how to meet HbA1c targets and improve outcome without risk to this population. Copyright © 2015 Elsevier Inc. All rights reserved.

Use of HbA(1C) testing to diagnose pre-diabetes in high risk African American children: a comparison with fasting glucose and HOMA-IR.

PubMed

Sharma, Sushma; Fleming, Sharon E

2012-01-01

This study aimed to compare the discriminating power of HbA(1C) with other pre-diabetes diagnostic tests specifically in high-risk African American children. A cross-sectional analysis was performed on a sample of 172 children (70 boys and 102 girls) aged 9-11 years with BMI's above the 85th percentile. Fasting glucose, insulin and HbA(1C) were analyzed from the plasma samples. Of the 172 participants included in this analysis, 21 (12.2%) had HbA(1C) concentrations above the cutoff of 5.7 used to identify pre-diabetes. None (0%) of these 21 participants, however, were observed to have a glucose concentration above the pre-diabetes cutoff of 110 mg/dl, and only 13 of 21 participants had HOMA-IR above the pre-diabetes cutoff of 2.5. When compared to the previously identified glucose cutoff of 110 mg/dl and HOMA-IR cutoff of 2.5 for pre-diabetes, HbA(1C) showed high specificity (88 and 93%, respectively) but very low sensitivity (0 and 21%, respectively). Glucose, insulin and HOMA-IR were significantly interrelated, but HbA(1C) was not significantly correlated with these biochemical prediabetes assessment variables, nor with anthropometric (BMIz, WC) risk factors. Our results suggest that HbA(1C) had poor discrimination power to identify prediabetes in overweight and obese 9- to 11-year-old African American children. Future studies are recommended to compare the feasibility, sensitivity and predictive power of different screening tests currently recommended to avoid inadequacy when screening for prediabetes and diabetes. Copyright © 2012 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Investigation of effect on glycosylated hemoglobin, blood pressure, and body mass index of diabetes intensive education program in patients with type 2 diabetes mellitus.

PubMed

Beyazit, Emel; Mollaoğlu, Mukadder

2011-07-01

This study investigated the effects of a diabetes intensive education program (DIEP) on glycosylated hemoglobin (HbA(1)c), body mass index (BMI), and arterial blood pressure (BP). An 8-week randomized-controlled trial was conducted in Cumhuriyet University Hospital. Diabetes patients were randomized to control group (CG; n = 25) and intervention group (IG; n = 25) who received DIEP, including the factors affecting metabolic control and implementation of diabetes guidelines. Primary outcomes included HbA(1)c, BP, and BMI. After the 8 weeks, there was a significant decrease in HbA(1)c mean values for the intervention group. Also, BP significantly decreased from 143/87 to 130/80 mmHg in the IG as compared with an increase from 137/82 to 137/86 mmHg in the CG. In addition, the results demonstrated that DIEP improved the number of patients at goal for BP (130/80 mmHg). Baseline BMI did not change significantly in either group during the course of the study. These findings show that the DIEP may be effective in decreasing HbA(1)c levels and improving adherence to BP control.

Sodium-glucose co-transporter-2 inhibitors, the latest residents on the block: Impact on glycaemic control at a general practice level in England.

PubMed

Heald, Adrian H; Fryer, Anthony A; Anderson, Simon G; Livingston, Mark; Lunt, Mark; Davies, Mark; Moreno, Gabriela Y C; Gadsby, Roger; Young, Robert J; Stedman, Mike

2018-03-08

To determine, using published general practice-level data, how differences in Type 2 diabetes mellitus (T2DM) prescribing patterns relate to glycaemic target achievement levels. Multiple linear regression modelling was used to link practice characteristics and defined daily dose (DDD) of different classes of medication in 2015/2016 and changes between that year and the year 2014/2015 in medication to proportion of patients achieving target glycaemic control (glycated haemoglobin A1c [HbA1c] ≤58 mmol/mol [7.5%]) and proportion of patients at high glycaemic risk (HbA1c >86 mmol/mol [10.0%]) for practices in the National Diabetes Audit with >100 people with T2DM on their register. Overall, HbA1c outcomes were not different between the years studied. Although, in percentage terms, most practices increased their use of sodium-glucose co-transporter-2 (SGLT2) inhibitors (96%), dipeptidyl peptidase-4 (DPP-4) inhibitors (76%) and glucagon-like peptide 1 (GLP-1) analogues (53%), there was wide variation in the use of older and newer therapies. For example, 12% of practices used >200% of the national average for some newer agents. In cross-sectional analysis, greater prescribing of metformin and analogue insulin were associated with a higher proportion of patients achieving HbA1c ≤58 mmol/mol; the use of SGLT2 inhibitors and metformin was associated with a reduced proportion of patients with HbA1c >86 mol/mol; otherwise associations for sulphonylureas, GLP-1 analogues, SGLT2 inhibitors and DPP-4 inhibitors were neutral or negative. In year-on-year analysis there was ongoing deterioration in glycaemic control, which was offset to some extent by increased use of SGLT2 inhibitors and GLP-1 analogues, which were associated with a greater proportion of patients achieving HbA1c levels ≤58 mmol/mol and a smaller proportion of patients with HbA1c levels >86 mmol/mol. SGLT2 inhibitor prescribing was associated with significantly greater improvements than those found for GLP-1 analogues. Greater use of newer agents was associated with improvement in glycaemic outcomes but was not sufficient to compensate for the prevailing decline. This may reflect wide variability in the prescribing of newer agents. We found that SGLT inhibitors may be superior to other oral agents in relation to HbA1c outcome. Serious consideration should be given to their use. © 2018 John Wiley & Sons Ltd.

Do pre-existing diabetes social support or depressive symptoms influence the effectiveness of a diabetes management intervention?

PubMed

Rosland, Ann-Marie; Kieffer, Edith; Spencer, Michael; Sinco, Brandy; Palmisano, Gloria; Valerio, Melissa; Nicklett, Emily; Heisler, Michele

2015-11-01

Examine influences of diabetes-specific social support (D-SS) and depressive symptoms on glycemic control over time, among adults randomized to a diabetes self-management education and support (DSME/S) intervention or usual care. Data were from 108 African-American and Latino participants in a 6-month intervention trial. Multivariable linear regression models assessed associations between baseline D-SS from family and friends and depressive symptoms with changes in HbA1c. We then examined whether baseline D-SS or depression moderated intervention-associated effects on HbA1c. Higher baseline D-SS was associated with larger improvements in HbA1c (adjusted ΔHbA1c -0.39% for each +1-point D-SS, p=0.02), independent of intervention-associated HbA1c decreases. Baseline depressive symptoms had no significant association with subsequent HbA1c change. Neither D-SS nor depression moderated intervention-associated effects on HbA1c. Diabetes self-management education and support programs have potential to improve glycemic control for participants starting with varying levels of social support and depressive symptoms. Participants starting with more support for diabetes management from family and friends improved HbA1c significantly more over 6 months than those with less support, independent of additional significant DSME/S intervention-associated HbA1c improvements. Social support from family and friends may improve glycemic control in ways additive to DSME/S. Published by Elsevier Ireland Ltd.

Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial.

PubMed

Hong, A Ram; Lee, Jeun; Ku, Eu Jeong; Hwangbo, Yul; Kim, Kyoung Min; Moon, Jae Hoon; Choi, Sung Hee; Jang, Hak Chul; Lim, Soo

2015-07-01

The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50 mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA(1c) after 24 weeks. The secondary endpoints were patients achieving HbA(1c)≤7.0% (53 mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA(1c) at baseline was 8.6% (70 mmol/mol) in both groups. At week 24, the adjusted mean HbA(1c) levels decreased by -1.19% (-13.09 mmol/mol) with vildagliptin add-on and -0.46% (-5.06 mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA(1c)≤7.0% (53 mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137). Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Current Status of HbA1c Biosensors

PubMed Central

Lin, Hua; Yi, Jun

2017-01-01

Glycated hemoglobin (HbA1c) is formed via non-enzymatic glycosylation reactions at the α–amino group of βVal1 residues in the tetrameric Hb, and it can reflect the ambient glycemic level over the past two to three months. A variety of HbA1c detection methods, including chromatography, immunoassay, enzymatic measurement, electrochemical sensor and capillary electrophoresis have been developed and used in research laboratories and in clinics as well. In this review, we summarize the current status of HbA1c biosensors based on the recognition of the sugar moiety on the protein and also their applications in the whole blood sample measurements. PMID:28777351

Validation and determination of a reference interval for canine HbA1c using an immunoturbidimetric assay.

PubMed

Goemans, Anne F; Spence, Susanna J; Ramsey, Ian K

2017-06-01

Hemoglobin A1c (HbA1c) provides a reliable measure of glycemic control over 2-3 months in human diabetes mellitus. In dogs, presence of HbA1c has been demonstrated, but there are no validated commercial assays. The purpose of the study was to validate a commercially available automated immunoturbidimetric assay for canine HbA1c and determine an RI in a hospital population. The specificity of the assay was assessed by inducing glycosylation in vitro using isolated canine hemoglobin, repeatability by measuring canine samples 5 times in succession, long term inter-assay imprecision by measuring supplied control materials, stability using samples stored at 4°C over 5 days and -20°C over 8 weeks, linearity by mixing samples of known HbA1c in differing proportions, and the effect of anticoagulants with paired samples. An RI was determined using EDTA-anticoagulated blood samples from 60 nondiabetic hospitalized animals of various ages and breeds. Hemoglobin A1c was also measured in 10 diabetic dogs. The concentration of HbA1c increased proportionally with glucose concentration in vitro. For repeat measurements, the CV was 4.08% (range 1.16-6.10%). Samples were stable for 5 days at 4°C. The assay was linear within the assessed range. Heparin- and EDTA-anticoagulated blood provided comparable results. The RI for HbA1c was 9-18.5 mmol/mol. There was no apparent effect of age or breed on HbA1c. In diabetic dogs, HbA1c ranged from 14 to 48 mmol/mol. The assay provides a reliable method for canine HbA1c measurement with good analytic performance. © 2017 American Society for Veterinary Clinical Pathology.

CGM-measured glucose values have a strong correlation with C-peptide, HbA1c and IDAAC, but do poorly in predicting C-peptide levels in the two years following onset of diabetes.

PubMed

Buckingham, Bruce; Cheng, Peiyao; Beck, Roy W; Kollman, Craig; Ruedy, Katrina J; Weinzimer, Stuart A; Slover, Robert; Bremer, Andrew A; Fuqua, John; Tamborlane, William

2015-06-01

The aim of this work was to assess the association between continuous glucose monitoring (CGM) data, HbA1c, insulin-dose-adjusted HbA1c (IDAA1c) and C-peptide responses during the first 2 years following diagnosis of type 1 diabetes. A secondary analysis was conducted of data collected from a randomised trial assessing the effect of intensive management initiated within 1 week of diagnosis of type 1 diabetes, in which mixed-meal tolerance tests were performed at baseline and at eight additional time points through 24 months. CGM data were collected at each visit. Among 67 study participants (mean age [± SD] 13.3 ± 5.7 years), HbA1c was inversely correlated with C-peptide at each time point (p < 0.001), as were changes in each measure between time points (p < 0.001). However, C-peptide at one visit did not predict the change in HbA1c at the next visit and vice versa. Higher C-peptide levels correlated with increased proportion of CGM glucose values between 3.9 and 7.8 mmol/l and lower CV (p = 0.001 and p = 0.02, respectively) but not with CGM glucose levels <3.9 mmol/l. Virtually all participants with IDAA1c < 9 retained substantial insulin secretion but when evaluated together with CGM, time in the range of 3.9-7.8 mmol/l and CV did not provide additional value in predicting C-peptide levels. In the first 2 years after diagnosis of type 1 diabetes, higher C-peptide levels are associated with increased sensor glucose levels in the target range and with lower glucose variability but not hypoglycaemia. CGM metrics do not provide added value over the IDAA1c in predicting C-peptide levels.

Development of a diabetes treatment simulation model: with application to assessing alternative treatment intensification strategies on survival and diabetes-related complications.

PubMed

Chen, J; Alemao, E; Yin, D; Cook, J

2008-06-01

The objective of this analysis is to project the long-term impacts on life expectancy and occurrence over 5, 10, and 40 years of microvascular and macrovascular complications of diabetes when using different haemoglobin A1c (HbA1c) thresholds for intensifying treatment of type 2 diabetes. A flexible, discrete-event simulation model has been developed to evaluate alternative treatment strategies based on the United Kingdom Prospective Diabetes Study Outcomes Model. In the present analysis, the model is used to investigate the impact of alternative HbA1c thresholds for treatment intensification ranging from 7.0 to 9.0%. For each intensification strategy, the model is run using 80 simulated patients for each of 1224 patient profiles from the Real-Life Effectiveness and Care Patterns of Diabetes Management study (for a total of 97,920 simulated patients) to project the number of patients who will experience diabetes-related complications over time. The use of lower HbA1c thresholds for intensifying treatment is associated with improved long-term outcomes. When the HbA1c threshold for intensifying therapy from oral treatment to basal insulin (T1) is 7.0% and the threshold for intensifying basal insulin to multiple-dose insulin (T2) is 7.0%, simulated patients spend 54% of their time with HbA1c >7.0%, but 95% of their time with HbA1c >7.0% if T1 and T2 are set to 9.0%. More aggressive or proactive treatment postures are projected to reduce clinical events, including diabetes-related deaths and diabetes-related complications, particularly myocardial infarctions (MIs). When T1 and T2 are set to 7.0%, there are 592 fewer diabetes-related deaths in the first 5 years of the simulation and 3740 fewer deaths over 40 years compared with the results when T1 and T2 are set to 9.0%. These decreases in deaths were also associated with a 0.35 year gain in projected life expectancy. Compared with an aggressive strategy with both T1 and T2 being 7%, 644 more patients are projected to experience at least one episode of MI in the first 5 years if treatment intensification is delayed until HbA1c reaches 9.0%. This number increases over time, reaching 2906 additional patients experiencing at least one MI over a 40-year time period. We report results from a discrete-event simulation model to explore the impact of alternative treatment strategies for patients with type 2 diabetes. Strategies that intensify therapy (in response to rising HbA1c levels) at lower HbA1c thresholds (e.g. 7.0%) are associated with enhanced projected long-term health outcomes.

MARCH2: Comparative Assessment of Therapeutic Effects of Acarbose and Metformin in Newly Diagnosed Type 2 Diabetes Patients

PubMed Central

Yang, Ning; Gao, Xia; Fan, Hui; Xu, Yuan; Yang, Wenying

2014-01-01

Background The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c (HbA1c) reduction in Chinese patients with newly diagnosed type 2 diabetes. We investigated whether the therapeutic efficacy was diversified under different body mass index (BMI) status. Methods All 784 subjects were divided into normal-weight group (BMI<24 kg/m2), overweight group (BMI 24–28 kg/m2) and obese group (BMI≥28 kg/m2). Patients were assigned to 48 weeks of therapy with acarbose or metformin, respectively. The clinical trial registry number was ChiCTR-TRC-08000231. Results The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5% or less were similar in the three groups after acarbose and metformin treatment. In overweight group, fasting blood glucose (FBG) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [−1.73 (−1.99 to −1.46) vs. −1.37 (−1.61 to −1.12), P<0.05), however the decrease of 2 h post-challenge blood glucose (PBG) after acarbose treatment at 48 weeks was bigger compared to metformin group [−3.34 (−3.83 to−2.84) vs. −2.35 (−2.85 to −1.85), P<0.01 ]. Both acarbose and metformin treatment resulted in a significant decrease in waist circumference, hip circumference, weight and BMI in the three groups (all P<0.05). Conclusion Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients. Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status. Thus, acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin, even in obesity patients. Trial Registration ChiCTR.org ChiCTR-TRC-08000231 PMID:25148570

The Effect of Diabetes Self-Management Education on Hba1c Level and Fasting Blood Sugar in Type 2 Diabetes Mellitus Patients in Primary Health Care in Binjai City of North Sumatera, Indonesia

PubMed Central

Rusdiana; Savira, Maya; Amelia, Rina

2018-01-01

AIM: The study aimed to evaluate the effect of short-term diabetes self-management education (DSME) on Hba1and Fasting Blood Sugar in type 2 diabetes mellitus patients attending the Primary Health Care (PHC) in Binjai city of North Sumatera, Indonesia. SUBJECTS AND METHODS: A quasi-experimental (pretest-posttest) study was conducted in 4 PHCs, involving 80 patients with type 2 diabetes mellitus. The patients in received a 3-months intervention, including an 8 week education on self- management of diabetes mellitus and subsequent 4 weeks of practice of the self- management guidelines.The patients received standard advice on diet management. RESULTS: There was a significant reduction in Hba1c levels. The statistical analysis using t-test found that there was a significant difference of Hba1c value between pre and post education among type 2 diabetes mellitus patients (p < 0.005). CONCLUSIONS: Diabetes self-management education in PHC of Binjai city can reduce the Hba1c level in type 2 diabetes mellitus patients. PMID:29731946

The Effect of Self-Care Education on Emotional Intelligence and HbA1c level in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial.

PubMed

Tavakol Moghadam, Salma; Najafi, Seyed Saeed; Yektatalab, Shahrzad

2018-01-01

The role of Emotional Intelligence (EI) in glycemic control in type 2 Diabetes Mellitus (DM) has not been fully understood. The present study aimed to investigate the effect of self-care education on EI and hemoglobin glycosylated (HbA1c) in patients with type 2 diabetes. In this randomized controlled clinical trial, 48 patients with type 2 DM referred to Shahid Motahari Diabetes Center in 2015 were divided into an intervention and a control group using block randomization. The study data were collected using Bar-On questionnaire and blood testing immediately and two months after the intervention. The educational content was presented to the intervention group through 1-1:30-hour sessions held once a week for 8 continuous weeks. The control group, however, only received the clinic's routine cares. The results showed a significant difference in the mean level of HbA1c in the intervention group before and two months after the intervention (P=0.003). However, this difference was not significant in the control group. Moreover, the mean of EI was higher in the intervention group compared to the control group (P=0.08). Self-care education improved the HbA1c level and EI among the patients with type 2 DM. Therefore, it is recommended that health care providers, specially nurses, should train the diabetic patients for self-care, which can lead to better glycemic control. Trial Registration Number: IRCT201408188505N7.

The Effect of Self-Care Education on Emotional Intelligence and HbA1c level in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

PubMed Central

Tavakol Moghadam, Salma; Najafi, Seyed Saeed; Yektatalab, Shahrzad

2018-01-01

ABSTRACT Background: The role of Emotional Intelligence (EI) in glycemic control in type 2 Diabetes Mellitus (DM) has not been fully understood. The present study aimed to investigate the effect of self-care education on EI and hemoglobin glycosylated (HbA1c) in patients with type 2 diabetes. Methods: In this randomized controlled clinical trial, 48 patients with type 2 DM referred to Shahid Motahari Diabetes Center in 2015 were divided into an intervention and a control group using block randomization. The study data were collected using Bar-On questionnaire and blood testing immediately and two months after the intervention. The educational content was presented to the intervention group through 1-1:30-hour sessions held once a week for 8 continuous weeks. The control group, however, only received the clinic’s routine cares. Results: The results showed a significant difference in the mean level of HbA1c in the intervention group before and two months after the intervention (P=0.003). However, this difference was not significant in the control group. Moreover, the mean of EI was higher in the intervention group compared to the control group (P=0.08). Conclusion: Self-care education improved the HbA1c level and EI among the patients with type 2 DM. Therefore, it is recommended that health care providers, specially nurses, should train the diabetic patients for self-care, which can lead to better glycemic control. Trial Registration Number: IRCT201408188505N7 PMID:29344534

A Randomized Controlled Trial of Vildagliptin Versus Alogliptin: Effective Switch From Sitagliptin in Patients With Type 2 Diabetes.

PubMed

Shigematsu, Erina; Yamakawa, Tadashi; Oba, Mari S; Suzuki, Jun; Nagakura, Jo; Kadonosono, Kazuaki; Terauchi, Yasuo

2017-07-01

We investigated the effects of vildagliptin or alogliptin on blood glucose and hemoglobin A1c (HbA1c) in patients with type 2 diabetes inadequately controlled by sitagliptin. In a single-center open-label trial, 35 patients with inadequate glycemic control on sitagliptin therapy (50 mg once daily) were randomly switched to treatment with vildagliptin (50 mg twice daily) or alogliptin (25 mg once daily). After 12 weeks, patients who failed to achieve the target HbA1c level of < 7.0% with vildagliptin or alogliptin treatment were switched to high-dose sitagliptin (100 mg once daily) and the effect on glycemic control was assessed. Vildagliptin did not significantly alter the mean plasma glucose level (175.5 ± 54.4 mg/dL vs. 179.1 ± 73.4 mg/dL) or HbA1c (8.01% vs. 8.02%) after 12 weeks. With alogliptin, mean plasma glucose increased from 175.4 ± 50.9 mg/dL to 195.3 ± 55.0 mg/dL after 12 weeks and HbA1c increased significantly from 8.0% to 8.3% (P < 0.05). At 12 weeks after switching from vildagliptin to high-dose sitagliptin (100 mg daily), HbA1c was increased to 8.3%, but it was significantly (P < 0.05) reduced to the baseline level of 8.0% after switching from alogliptin. The reduction of HbA1c was significantly greater in the vildagliptin group than the alogliptin group (P = 0.008), but the response rate (achieving the target HbA1c < 7.0%) did not differ significantly between the two groups. The glucose-lowering effects of these three dipeptidyl peptidase-4 (DPP-4) inhibitors (vildagliptin, alogliptin, and sitagliptin) were different, and the effects of vildagliptin and sitagliptin were stronger than that of alogliptin.

Does the treatment of type 2 diabetes mellitus with the DPP-4 inhibitor vildagliptin reduce HbA1c to a greater extent in Japanese patients than in Caucasian patients?

PubMed

Foley, James E; Bhosekar, Vaishali; Kawamori, Ryuzo

2016-01-01

Previous work suggests that Japanese patients with type 2 diabetes mellitus (T2DM) may respond more favorably to a DPP-4 (dipeptidyl peptidase-4) inhibitor than Caucasians. We aimed to compare the efficacy of the DPP-4 inhibitor vildagliptin (50 mg twice daily [bid]) between Japanese and Caucasian populations. This analysis pooled data from 19 studies of drug-naïve patients with T2DM who were treated for 12 weeks with vildagliptin 50 mg bid as monotherapy. The pool comprised Japanese patients (n=338) who had been treated in Japan and Caucasian patients (n=1,275) who were treated elsewhere. Change from baseline (Δ) in glycated hemoglobin (HbA1c) at 12 weeks (in millimoles per mole) versus baseline HbA1c (both in percentage National Glycohemoglobin Standardization Program units [NGSP%] and millimoles per mole) for each population was reported. Universal HbA1c in millimoles per mole was calculated from either the Japanese Diabetes Society or the NGSP% HbA1c standards. At baseline, mean values for Japanese and Caucasian patients, respectively, were as follows: age, 59 years and 56 years; % male, 69% and 57%. The average HbA1c was reduced from 7.90% to 6.96% (Japanese Diabetes Society) and from 8.57% to 7.50% (United States National Glycohemoglobin Standardization Program), while HbA1c was reduced from 63 mmol/mol to 53 mmol/mol and from 70 mmol/mol to 58 mmol/mol in Japanese and Caucasians, respectively. ΔHbA1c increased with increasing baseline in both populations. The slopes were the same (0.41, r (2)=0.36; and 0.41, r (2)=0.15), and the intercepts were 15.4 mmol/mol and 17.2 mmol/mol, respectively. In Japanese patients, mean ΔHbA1c was greater by 1.7 mmol/mol (0.2% NGSP HbA1c) at any given baseline HbA1c than in Caucasians (P=0.01). The present pooled analysis suggests that Japanese patients respond better to vildagliptin treatment compared with Caucasians. However, when glycemic control was corrected by using the same glycemic standard, the difference in HbA1c reduction between these populations was not clinically meaningful.

A nomogram to estimate the HbA1c response to different DPP-4 inhibitors in type 2 diabetes: a systematic review and meta-analysis of 98 trials with 24 163 patients

PubMed Central

Esposito, Katherine; Chiodini, Paolo; Maiorino, Maria Ida; Capuano, Annalisa; Cozzolino, Domenico; Petrizzo, Michela; Bellastella, Giuseppe; Giugliano, Dario

2015-01-01

Objectives To develop a nomogram for estimating the glycated haemoglobin (HbA1c) response to different dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes. Design A systematic review and meta-analysis of randomised controlled trials (RCTs) of DPP-4 inhibitors (vildagliptin, sitagliptin, saxagliptin, linagliptin and alogliptin) on HbA1c were conducted. Electronic searches were carried out up to December 2013. Trials were included if they were carried out on participants with type 2 diabetes, lasted at least 12 weeks, included at least 30 participants and had a final assessment of HbA1c. A random effect model was used to pool data. A nomogram was used to represent results of the metaregression model. Participants Adults with type 2 diabetes. Interventions Any DPP-4 inhibitor (vildagliptin, sitagliptin, saxagliptin, linagliptin or alogliptin). Outcome measures The HbA1c response to each DPP-4 inhibitor within 1 year of therapy. Results We screened 928 citations and reviewed 98 articles reporting 98 RCTs with 100 arms in 24 163 participants. There were 26 arms with vildagliptin, 37 with sitagliptin, 13 with saxagliptin, 13 with linagliptin and 11 with alogliptin. For all 100 arms, the mean baseline HbA1c value was 8.05% (64 mmol/mol); the decrease of HbA1c from baseline was −0.77% (95% CI −0.82 to −0.72%), with high heterogeneity (I2=96%). Multivariable metaregression model that included baseline HbA1c, type of DPP-4 inhibitor and fasting glucose explained 58% of variance between studies, with no significant interaction between them. Other factors, including age, previous diabetes drugs and duration of treatment added low predictive power (<1%). The nomogram estimates the absolute HbA1c reduction from baseline using the type of DPP-4 inhibitor, baseline values of HbA1c and fasting glucose. Conclusions Baseline HbA1c level and fasting glucose explain most of the variance in HbA1c change in response to DPP-4 inhibitors: each increase of 1.0% units HbA1c provides a 0.4–0.5% units greater fall. PMID:25687897

Associations between gestational diabetes mellitus and elevated HbA1c early postpartum in a multi-ethnic population.

PubMed

Waage, Christin; Jenum, Anne Karen; Mdala, Ibrahimu; Berg, Jens Petter; Richardsen, Kåre; Birkeland, Kåre

2017-04-01

To investigate the prevalence of elevated HbA 1c 14 weeks postpartum in different ethnic groups and in women with and without gestational diabetes mellitus (GDM) in the index pregnancy and to explore demographic and biological factors from early pregnancy associated with elevated HbA 1c (HbA 1c ≥5.7% (≥39mmol/mol)) postpartum. From a cohort study in Oslo, Norway, we included 570 pregnant women, examined in gestational week 15, 28, and 14 weeks postpartum. The association between elevated HbA 1c and demographic and biological factors were assessed by logistic regression analyses. The prevalence of elevated HbA 1c postpartum was 23% in the total population, 15% among Western Europeans and 28% among women with ethnic minority background (p<0.01). In ethnic minorities elevated HbA 1c was found in 39% of women with recent GDM diagnosed by the World Health Organization 2013 criteria and in 21% of women without GDM (p<0.01), compared to 22% and 13% in Western Europeans (p=0.11). We found independent associations between elevated HbA 1c and ethnic minority background (OR 2.0, 95% CI 1.27, 3.18), and GDM (OR 2.04, 95% CI 1.35, 3.10) (p<0.01). The prevalence of elevated HbA 1c postpartum was 23%, and significantly higher among women with ethnic minority background irrespective of GDM. Copyright © 2016 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Red cell distribution width is associated with hemoglobin A1C elevation, but not glucose elevation.

PubMed

Bao, Xue; Wan, Min; Gu, Yeqing; Song, Yanqi; Zhang, Qing; Liu, Li; Meng, Ge; Wu, Hongmei; Xia, Yang; Shi, HongBin; Su, Qian; Fang, Liyun; Yang, Huijun; Yu, Fei; Sun, Shaomei; Wang, Xing; Zhou, Ming; Jia, Qiyu; Song, Kun; Wang, Guolin; Yu, Ming; Niu, Kaijun

2017-10-01

To investigate the association between red cell distribution width (RDW) and elevation of glucose/glycated hemoglobin (HbA1c). An analysis was conducted using data from a prospective cohort study of adults. People without prediabetes or diabetes (n=7,795) were followed for a mean of 2.90years (range: 1-7years, 95% confidence interval: 2.86-2.94years). Glucose elevation is defined as fasting glucose levels exceeding 5.6mmol/l, or 2-hour glucose values in the oral glucose tolerance test exceeding 7.8mmol/l. HbA1c elevation is defined as a HbA1c value exceeding a normal limit of 39mmol/mol (5.7%). Adjusted Cox proportional hazards regression models were used to assess the association between RDW quartiles and elevation of HbA1c/glucose. The multiple-adjusted hazard ratios (95% confidence interval) of HbA1c elevation for increased quartiles of RDW were 1.00 (reference), 1.08 (0.89, 1.30), 1.28 (1.07, 1.54), and 1.54 (1.29, 1.85) (P for trend<0.0001). However, no significant association was observed between RDW and blood glucose (fasting and postprandial). Elevated RDW is independently related to future HbA1c elevation, but not to glucose elevation. This suggests that RDW may associate with HbA1c through a non-glycemic way, which should be taken into consideration when using HbA1c as a diagnostic criterion of prediabetes or diabetes. Copyright © 2017 Elsevier Inc. All rights reserved.

Local descriptive body weight and dietary norms, food availability, and 10-year change in glycosylated haemoglobin in an Australian population-based biomedical cohort.

PubMed

Carroll, Suzanne J; Paquet, Catherine; Howard, Natasha J; Coffee, Neil T; Adams, Robert J; Taylor, Anne W; Niyonsenga, Theo; Daniel, Mark

2017-02-02

Individual-level health outcomes are shaped by environmental risk conditions. Norms figure prominently in socio-behavioural theories yet spatial variations in health-related norms have rarely been investigated as environmental risk conditions. This study assessed: 1) the contributions of local descriptive norms for overweight/obesity and dietary behaviour to 10-year change in glycosylated haemoglobin (HbA 1c ), accounting for food resource availability; and 2) whether associations between local descriptive norms and HbA 1c were moderated by food resource availability. HbA 1c , representing cardiometabolic risk, was measured three times over 10 years for a population-based biomedical cohort of adults in Adelaide, South Australia. Residential environmental exposures were defined using 1600 m participant-centred road-network buffers. Local descriptive norms for overweight/obesity and insufficient fruit intake (proportion of residents with BMI ≥ 25 kg/m 2 [n = 1890] or fruit intake of <2 serves/day [n = 1945], respectively) were aggregated from responses to a separate geocoded population survey. Fast-food and healthful food resource availability (counts) were extracted from a retail database. Separate sets of multilevel models included different predictors, one local descriptive norm and either fast-food or healthful food resource availability, with area-level education and individual-level covariates (age, sex, employment status, education, marital status, and smoking status). Interactions between local descriptive norms and food resource availability were tested. HbA 1c concentration rose over time. Local descriptive norms for overweight/obesity and insufficient fruit intake predicted greater rates of increase in HbA 1c . Neither fast-food nor healthful food resource availability were associated with change in HbA 1c . Greater healthful food resource availability reduced the rate of increase in HbA 1c concentration attributed to the overweight/obesity norm. Local descriptive health-related norms, not food resource availability, predicted 10-year change in HbA 1c . Null findings for food resource availability may reflect a sufficiency or minimum threshold level of resources such that availability poses no barrier to obtaining healthful or unhealthful foods for this region. However, the influence of local descriptive norms varied according to food resource availability in effects on HbA 1c . Local descriptive health-related norms have received little attention thus far but are important influences on individual cardiometabolic risk. Further research is needed to explore how local descriptive norms contribute to chronic disease risk and outcomes.

Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system.

PubMed

Teodoro-Morrison, Tracy; Janssen, Marcel J W; Mols, Jasper; Hendrickx, Ben H E; Velmans, Mathieu H; Lotz, Johannes; Lackner, Karl; Lennartz, Lieselotte; Armbruster, David; Maine, Gregory; Yip, Paul M

2015-01-01

The utility of HbA1c for the diagnosis of type 2 diabetes requires an accurate, precise and robust test measurement system. Currently, immunoassay and HPLC are the most popular methods for HbA1c quantification, noting however the limitations associated with some platforms, such as imprecision or interference from common hemoglobin variants. Abbott Diagnostics has introduced a fully automated direct enzymatic method for the quantification of HbA1c from whole blood on the ARCHITECT chemistry system. Here we completed a method evaluation of the ARCHITECT HbA1c enzymatic assay for imprecision, accuracy, method comparison, interference from hemoglobin variants and specimen stability. This was completed at three independent clinical laboratories in North America and Europe. The total imprecision ranged from 0.5% to 2.2% CV with low and high level control materials. Around the diagnostic cut-off of 48 mmol/mol, the total imprecision was 0.6% CV. Mean bias using reference samples from IFCC and CAP ranged from -1.1 to 1.0 mmol/mol. The enzymatic assay also showed excellent agreement with HPLC methods, with slopes of 1.01 and correlation coefficients ranging from 0.984 to 0.996 compared to Menarini Adams HA-8160, Bio-Rad Variant II and Variant II Turbo instruments. Finally, no significant effect was observed for erythrocyte sedimentation or interference from common hemoglobin variants in patient samples containing heterozygous HbS, HbC, HbD, HbE, and up to 10% HbF. The ARCHITECT enzymatic assay for HbA1c is a robust and fully automated method that meets the performance requirements to support the diagnosis of type 2 diabetes.

Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial.

PubMed

Kristensen, Søren L; Preiss, David; Jhund, Pardeep S; Squire, Iain; Cardoso, José Silva; Merkely, Bela; Martinez, Felipe; Starling, Randall C; Desai, Akshay S; Lefkowitz, Martin P; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Solomon, Scott D; Swedberg, Karl; Zile, Michael R; McMurray, John J V; Packer, Milton

2016-01-01

The prevalence of pre-diabetes mellitus and its consequences in patients with heart failure and reduced ejection fraction are not known. We investigated these in the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. We examined clinical outcomes in 8399 patients with heart failure and reduced ejection fraction according to history of diabetes mellitus and glycemic status (baseline hemoglobin A1c [HbA1c]: < 6.0% [< 42 mmol/mol], 6.0%-6.4% [42-47 mmol/mol; pre-diabetes mellitus], and ≥ 6.5% [≥ 48 mmol/mol; diabetes mellitus]), in Cox regression models adjusted for known predictors of poor outcome. Patients with a history of diabetes mellitus (n = 2907 [35%]) had a higher risk of the primary composite outcome of heart failure hospitalization or cardiovascular mortality compared with those without a history of diabetes mellitus: adjusted hazard ratio, 1.38; 95% confidence interval, 1.25 to 1.52; P < 0.001. HbA1c measurement showed that an additional 1106 (13% of total) patients had undiagnosed diabetes mellitus and 2103 (25%) had pre-diabetes mellitus. The hazard ratio for patients with undiagnosed diabetes mellitus (HbA1c, > 6.5%) and known diabetes mellitus compared with those with HbA1c < 6.0% was 1.39 (1.17-1.64); P < 0.001 and 1.64 (1.43-1.87); P < 0.001, respectively. Patients with pre-diabetes mellitus were also at higher risk (hazard ratio, 1.27 [1.10-1.47]; P < 0.001) compared with those with HbA1c < 6.0%. The benefit of LCZ696 (sacubitril/valsartan) compared with enalapril was consistent across the range of HbA1c in the trial. In patients with heart failure and reduced ejection fraction, dysglycemia is common and pre-diabetes mellitus is associated with a higher risk of adverse cardiovascular outcomes (compared with patients with no diabetes mellitus and HbA1c < 6.0%). LCZ696 was beneficial compared with enalapril, irrespective of glycemic status. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255. © 2016 The Authors.

Risk Related to Pre–Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction

PubMed Central

Kristensen, Søren L.; Preiss, David; Jhund, Pardeep S.; Squire, Iain; Cardoso, José Silva; Merkely, Bela; Martinez, Felipe; Starling, Randall C.; Desai, Akshay S.; Lefkowitz, Martin P.; Rizkala, Adel R.; Rouleau, Jean L.; Shi, Victor C.; Solomon, Scott D.; Swedberg, Karl; Zile, Michael R.; Packer, Milton

2016-01-01

Background— The prevalence of pre–diabetes mellitus and its consequences in patients with heart failure and reduced ejection fraction are not known. We investigated these in the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. Methods and Results— We examined clinical outcomes in 8399 patients with heart failure and reduced ejection fraction according to history of diabetes mellitus and glycemic status (baseline hemoglobin A1c [HbA1c]: <6.0% [<42 mmol/mol], 6.0%–6.4% [42–47 mmol/mol; pre–diabetes mellitus], and ≥6.5% [≥48 mmol/mol; diabetes mellitus]), in Cox regression models adjusted for known predictors of poor outcome. Patients with a history of diabetes mellitus (n=2907 [35%]) had a higher risk of the primary composite outcome of heart failure hospitalization or cardiovascular mortality compared with those without a history of diabetes mellitus: adjusted hazard ratio, 1.38; 95% confidence interval, 1.25 to 1.52; P<0.001. HbA1c measurement showed that an additional 1106 (13% of total) patients had undiagnosed diabetes mellitus and 2103 (25%) had pre–diabetes mellitus. The hazard ratio for patients with undiagnosed diabetes mellitus (HbA1c, >6.5%) and known diabetes mellitus compared with those with HbA1c<6.0% was 1.39 (1.17–1.64); P<0.001 and 1.64 (1.43–1.87); P<0.001, respectively. Patients with pre–diabetes mellitus were also at higher risk (hazard ratio, 1.27 [1.10–1.47]; P<0.001) compared with those with HbA1c<6.0%. The benefit of LCZ696 (sacubitril/valsartan) compared with enalapril was consistent across the range of HbA1c in the trial. Conclusions— In patients with heart failure and reduced ejection fraction, dysglycemia is common and pre–diabetes mellitus is associated with a higher risk of adverse cardiovascular outcomes (compared with patients with no diabetes mellitus and HbA1c <6.0%). LCZ696 was beneficial compared with enalapril, irrespective of glycemic status. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255. PMID:26754626

The incidence of severe hypoglycaemia in pregnant women with type 1 diabetes mellitus can be reduced with unchanged HbA1c levels and pregnancy outcomes in a routine care setting.

PubMed

Ringholm, Lene; Secher, A L; Pedersen-Bjergaard, U; Thorsteinsson, B; Andersen, H U; Damm, P; Mathiesen, E R

2013-08-01

To investigate whether the incidence of severe hypoglycaemia in pregnant women with type 1 diabetes can be reduced without deteriorating HbA1c levels or pregnancy outcomes in a routine care setting. Two cohorts (2004-2006; n=108 and 2009-2011; n=104) were compared. In between the cohorts a focused intervention including education of caregivers and patients in preventing hypoglycaemia was implemented. Women were included at median 8 (range 5-13) weeks. Severe hypoglycaemia (requiring assistance from others) was prospectively reported in structured interviews. In the first vs. second cohort, severe hypoglycaemia during pregnancy occurred in 45% vs. 23%, p=0.0006, corresponding to incidences of 2.5 vs. 1.6 events/patient-year, p=0.04. Unconsciousness and/or convulsions occurred at 24% vs. 8% of events. Glucagon and/or glucose injections were given at 15% vs. 5% of events. At inclusion HbA1c was comparable between the cohorts while in the second cohort fewer women reported impaired hypoglycaemia awareness (56% vs. 36%, p=0.0006), insulin dose in women on multiple daily injections was lower (0.77 IU/kg (0.4-1.7) vs. 0.65 (0.2-1.4), p=0.0006) and more women were on insulin analogues (rapid-acting 44% vs. 97%, p<0.0001; long-acting 6% vs. 76%, p<0.0001) and insulin pumps (5% vs. 23%, p<0.0001). Pregnancy outcomes were similar in the two cohorts. A 36% reduction in the incidence of severe hypoglycaemia in pregnancy with unchanged HbA1c levels and pregnancy outcomes was observed after implementation of focused intervention against severe hypoglycaemia in a routine care setting. Improved insulin treatment, increased health professional education and fewer women with impaired hypoglycaemia awareness may contribute. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Race-ethnic differences in the association of genetic loci with HbA1c levels and mortality in U.S. adults: the third National Health and Nutrition Examination Survey (NHANES III)

PubMed Central

2012-01-01

Background Hemoglobin A1c (HbA1c) levels diagnose diabetes, predict mortality and are associated with ten single nucleotide polymorphisms (SNPs) in white individuals. Genetic associations in other race groups are not known. We tested the hypotheses that there is race-ethnic variation in 1) HbA1c-associated risk allele frequencies (RAFs) for SNPs near SPTA1, HFE, ANK1, HK1, ATP11A, FN3K, TMPRSS6, G6PC2, GCK, MTNR1B; 2) association of SNPs with HbA1c and 3) association of SNPs with mortality. Methods We studied 3,041 non-diabetic individuals in the NHANES (National Health and Nutrition Examination Survey) III. We stratified the analysis by race/ethnicity (NHW: non-Hispanic white; NHB: non-Hispanic black; MA: Mexican American) to calculate RAF, calculated a genotype score by adding risk SNPs, and tested associations with SNPs and the genotype score using an additive genetic model, with type 1 error = 0.05. Results RAFs varied widely and at six loci race-ethnic differences in RAF were significant (p < 0.0002), with NHB usually the most divergent. For instance, at ATP11A, the SNP RAF was 54% in NHB, 18% in MA and 14% in NHW (p < .0001). The mean genotype score differed by race-ethnicity (NHW: 10.4, NHB: 11.0, MA: 10.7, p < .0001), and was associated with increase in HbA1c in NHW (β = 0.012 HbA1c increase per risk allele, p = 0.04) and MA (β = 0.021, p = 0.005) but not NHB (β = 0.007, p = 0.39). The genotype score was not associated with mortality in any group (NHW: OR (per risk allele increase in mortality) = 1.07, p = 0.09; NHB: OR = 1.04, p = 0.39; MA: OR = 1.03, p = 0.71). Conclusion At many HbA1c loci in NHANES III there is substantial RAF race-ethnic heterogeneity. The combined impact of common HbA1c-associated variants on HbA1c levels varied by race-ethnicity, but did not influence mortality. PMID:22540250

The cutoffs and performance of glycated hemoglobin for diagnosing diabetes and prediabetes in a young and middle-aged population and in an elderly population.

PubMed

Yan, Shuang-Tong; Xiao, Hai-Ying; Tian, Hui; Li, Chun-Lin; Fang, Fu-Sheng; Li, Xiao-Ying; Cheng, Xiao-Ling; Li, Nan; Miao, Xin-Yu; Yang, Yan; Wang, Liang-Chen; Zou, Xiao-Man; Ma, Fang-Ling; He, Yao; Sai, Xiao-Yong

2015-08-01

The aims were to compare the appropriate cutoffs of glycated hemoglobin (HbA1c) in a population of varying ages and to evaluate the performance of HbA1c for diagnosing diabetes and prediabetes. A total of 1064 participants in the young and middle-aged group and 1671 in the elderly group were included and underwent HbA1c testing and an oral glucose tolerance test (OGTT). Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) were calculated to evaluate the optimal HbA1c cutoffs. Kappa coefficients were used to test for agreement between HbA1c categorization and OGTT-based diagnoses. The optimal HbA1c cutoffs for diagnosing diabetes were 5.7% (39 mmol/mol) in the young and middle-aged group with a sensitivity of 66.7%, specificity of 86.7%, and AUC of 0.821 (95% CI: 0.686, 0.955) and 5.9% (41 mmol/mol) in the elderly group with a sensitivity of 80.4%, specificity of 73.3%, and AUC of 0.831 (0.801, 0.861). The optimal cutoffs for diagnosing prediabetes were 5.6% (38 mmol/mol) and 5.7% (39 mmol/mol) in the young and middle-aged group and in the elderly group, respectively. Agreement between the OGTT-based diagnosis of diabetes or prediabetes and the optimal HbA1c cutoff was low (all kappa coefficients <0.4). The combination of HbA1c and fasting plasma glucose increased diagnostic sensitivities or specificities. In conclusion, age-specific HbA1c cutoffs for diagnosing diabetes or prediabetes were appropriate. Furthermore, the performance of HbA1c for diagnosing diabetes and prediabetes was poor. HbA1c should be used in combination with traditional glucose criteria when detecting and diagnosing diabetes or prediabetes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Are late-night eating habits and sleep duration associated with glycemic control in adult type 1 diabetes patients treated with insulin pumps?

PubMed

Matejko, Bartlomiej; Kiec-Wilk, Beata; Szopa, Magdalena; Trznadel Morawska, Iwona; Malecki, Maciej T; Klupa, Tomasz

2015-07-01

Little is known about the impact of sleep duration and late-night snacking on glycemic control in patients with type 1 diabetes using insulin pumps. The aim of the present study was to examine whether late-night eating habits and short sleep duration are associated with glycemic control in continuous subcutaneous insulin infusion-treated type 1 diabetic patients. We included 148 consecutive adult type 1 diabetic subjects using an insulin pump (100 women and 48 men). Participants completed a questionnaire regarding sleep duration (classified as short if ≤6 h) and late-night snacking. Other sources of information included medical records and data from blood glucose meters. Glycemic control was assessed by glycated hemoglobin (HbA1c) levels and mean self-monitoring of blood glucose (SMBG) readings. The mean age of patients was 26 years, mean type 1 diabetes duration was 13.4 years and mean HbA1c level was 7.2%. In a univariate regression analysis, sleep duration was a predictor of both HbA1c (β = 0.51, P = 0.01) and SMBG levels (β = 11.4, P = 0.02). Additionally, an association was found between frequent late-night snacking and higher SMBG readings (often snacking β = 18.1, P = 0.05), but not with increased HbA1c levels. In the multivariate linear regression, independent predictors for HbA1c and SMBG were sleep duration and patient age. In a univariate logistic regression, sleep duration and frequency of late-night snacking were not predictors of whether HbA1c target levels were achieved. Short sleep duration, but not late-night snacking, seems to be associated with poorer glycemic control in type 1 diabetic patients treated with continuous subcutaneous insulin infusion.

Local descriptive norms for overweight/obesity and physical inactivity, features of the built environment, and 10-year change in glycosylated haemoglobin in an Australian population-based biomedical cohort.

PubMed

Carroll, Suzanne J; Paquet, Catherine; Howard, Natasha J; Coffee, Neil T; Taylor, Anne W; Niyonsenga, Theo; Daniel, Mark

2016-10-01

Descriptive norms vary between places. Spatial variation in health-related descriptive norms may predict individual-level health outcomes. Such relationships have rarely been investigated. This study assessed 10-year change in glycosylated haemoglobin (HbA1c) in relation to local descriptive norms for overweight/obesity (n = 1890) and physical inactivity (n = 1906) in models accounting for features of the built environment. HbA1c was measured three times over 10 years for a population-based biomedical cohort of adults in Adelaide, South Australia. Environmental exposures were expressed for cohort participants using 1600 m road-network buffers centred on participants' residential address. Local descriptive norms (prevalence of overweight/obesity [body mass index ≥25 kg/m(2)] and of physical inactivity [<150 min/week]) were aggregated from responses to a separate geocoded population survey. Built environment measures were public open space (POS) availability (proportion of buffer area) and walkability. Separate sets of multilevel models analysed different predictors of 10-year change in HbA1c. Each model featured one local descriptive norm and one built environment variable with area-level education and individual-level covariates (age, sex, employment status, education, marital status, and smoking status). Interactions between local descriptive norms and built environment measures were assessed. HbA1c increased over time. POS availability and local descriptive norms for overweight/obesity and physical inactivity were each associated with greater rates of HbA1c increase. Greater walkability was associated with a reduced rate of HbA1c increase, and reduced the influence of the overweight/obesity norm on the rate of increase in HbA1c. Local descriptive health-related norms and features of the built environment predict 10-year change in HbA1c. The impact of local descriptive norms can vary according to built environment features. Little researched thus far, local descriptive norms may play an important role in the evolution of HbA1c and thus cardiometabolic risk, over time. Further empirical research on local descriptive norms is necessary to understand how residential environments shape chronic disease risk. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

PubMed

Olry de Labry Lima, Antonio; Bermúdez Tamayo, Clara; Pastor Moreno, Guadalupe; Bolívar Muñoz, Julia; Ruiz Pérez, Isabel; Johri, Mira; Quesada Jiménez, Fermín; Cruz Vela, Pilar; de Los Ríos Álvarez, Ana M; Prados Quel, Miguel Ángel; Moratalla López, Enrique; Domínguez Martín, Susana; Lopez de Hierro, José Andrés; Ricci Cabello, Ignacio

To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients. Copyright © 2016 SESPAS. All rights reserved.

The role of family nutritional support in Japanese patients with type 2 diabetes mellitus.

PubMed

Watanabe, Koin; Kurose, Takeshi; Kitatani, Naomi; Yabe, Daisuke; Hishizawa, Masahiro; Hyo, Takanori; Seino, Yutaka

2010-01-01

We investigated the role of family support in glycemic control by nutritional self-care behavior of Japanese patients with type 2 diabetes. One hundred twelve Japanese out-patients with type 2 diabetes were recruited for the study at Kansai Electric Power Hospital. Interviews were conducted and HbA1c and triglyceride levels were measured. HbA1c levels were significantly related to family nutritional support. Patients under 60 years old with family nutritional support showed significantly lower HbA1c than patients without family support (p<0.05). Female patients with family support showed significantly lower HbA1c than those without family support (p<0.05). In addition, male patients with family support showed significantly lower triglyceride levels than those without family support (p<0.05). In male patients, those who were supported by cooking or buying light meals showed significantly lower HbA1c than those who were supported by advice or encouragement (p<0.05). The frequency of support (every day, 2-3 days, 1 week) showed similar outcomes in glycemic control. Patients who appreciate the support and follow the advice showed lower HbA1c (6.88 +/- 0.22%) than (7.43 +/- 0.23%) patients who appreciate the advice but sometimes feel emotional barriers. Family nutritional support is useful in improving metabolic outcome of diabetic patients. Self-care practice in disease management should be carefully adjusted to the family setting of type 2 diabetic patients. Emotional barriers to family support may affect the metabolic consequences, especially in the Japanese elderly.

A Distribution-based Method for Assessing The Differences between Clinical Trial Target Populations and Patient Populations in Electronic Health Records

PubMed Central

Li, Y.; Ryan, P.; Zhang, Y.; Liu, F.; Gao, J.; Bigger, J.T.; Hripcsak, G.

2014-01-01

Summary Objective To improve the transparency of clinical trial generalizability and to illustrate the method using Type 2 diabetes as an example. Methods Our data included 1,761 diabetes clinical trials and the electronic health records (EHR) of 26,120 patients with Type 2 diabetes who visited Columbia University Medical Center of New-York Presbyterian Hospital. The two populations were compared using the Generalizability Index for Study Traits (GIST) on the earliest diagnosis age and the mean hemoglobin A1c (HbA1c) values. Results Greater than 70% of Type 2 diabetes studies allow patients with HbA1c measures between 7 and 10.5, but less than 40% of studies allow HbA1c<7 and fewer than 45% of studies allow HbA1c>10.5. In the real-world population, only 38% of patients had HbA1c between 7 and 10.5, with 12% having values above the range and 52% having HbA1c<7. The GIST for HbA1c was 0.51. Most studies adopted broad age value ranges, with the most common restrictions excluding patients >80 or <18 years. Most of the real-world population fell within this range, but 2% of patients were <18 at time of first diagnosis and 8% were >80. The GIST for age was 0.75. Conclusions We contribute a scalable method to profile and compare aggregated clinical trial target populations with EHR patient populations. We demonstrate that Type 2 diabetes studies are more generalizable with regard to age than they are with regard to HbA1c. We found that the generalizability of age increased from Phase 1 to Phase 3 while the generalizability of HbA1c decreased during those same phases. This method can generalize to other medical conditions and other continuous or binary variables. We envision the potential use of EHR data for examining the generalizability of clinical trials and for defining population-representative clinical trial eligibility criteria. PMID:25024761

Diabetes care provision and glycaemic control in Northern Ireland: a UK regional audit.

PubMed

Cardwell, C R; Patterson, C C; Allen, M; Carson, D J

2005-05-01

To assess the care received, compared to national guidelines, and to investigate factors associated with glycaemic control in children and adolescents with type 1 diabetes attending clinics in Northern Ireland. An audit of the care provided to all patients attending 11 paediatric diabetes clinics commenced in 2002. A research nurse interviewed 914 patients completing a questionnaire recording characteristics, social circumstances, and aspects of diabetes management, including the monitoring of complications and access to members of the diabetes team. Glycaemic control was measured by glycosylated haemoglobin (HbA1c), determined at a DCCT aligned central laboratory. The average HbA1c concentration was 8.8% (SD 1.5%), with 20% of patients achieving recommended HbA1c levels of less than 7.5%. In the year prior to the audit, 76% of patients were reviewed by a diabetes specialist nurse and 42% were tested for microalbuminuria. After adjustment for confounding factors, better glycaemic control was identified, particularly in patients who had attended exactly four diabetes clinics in the previous year, were members of the patient association Diabetes UK, and lived with both natural parents. In Northern Ireland only a minority of patients achieved recommended HbA1c levels. Furthermore, children and adolescents with diabetes were reviewed by fewer specialists and were less intensively monitored for microvascular complications than recommended. There was evidence of better control in children who were members of Diabetes UK, suggesting that parental attitude and involvement could lead to benefits.

Introducing a simplified approach to insulin therapy in type 2 diabetes: a comparison of two single-dose regimens of insulin glulisine plus insulin glargine and oral antidiabetic drugs.

PubMed

Lankisch, M R; Ferlinz, K C; Leahy, J L; Scherbaum, W A

2008-12-01

To investigate whether the addition of a single bolus of insulin glulisine (glulisine), administered at either breakfast or main mealtime, in combination with basal insulin glargine (glargine) and oral antidiabetic drugs (OADs), provides equivalent glycaemic control in patients with type 2 diabetes, irrespective of the time of glulisine injection. A national, multicentre, randomized, open-label, parallel-group study of 393 patients with type 2 diabetes who were suboptimally controlled [haemoglobin A(1c) (HbA(1c)) > 6.5-9.0% and fasting blood glucose (BG) 7.0% at baseline and who reached HbA(1c)

Effects of a structured education program on glycemic control in type 1 diabetes.

PubMed

Pacheco, Ana Paula F; Sande-Lee, Simone van de; Sandoval, Rita de Cássia B; Batista, Sônia; Marques, Jefferson L B

2017-12-01

Diabetes mellitus is associated with significant morbidity and mortality, and education is known to play a key role in managing this disease. This study addresses the effects of a structured education program (SEP) on self-care in subjects with type 1 diabetes mellitus (T1DM). The aim was to evaluate the effect of a SEP on glycemic control, knowledge, and skills associated with diabetes care in subjects with T1DM. A total of 47 adults with T1DM were followed up for 20 months (32 participated in the SEP and 15 served as a control group). The SEP consisted of workshops, individualized care, 24-hour distant support, and a questionnaire assessing knowledge of diabetes care. Glycosylated hemoglobin (HbA1c) levels were measured before and after the SEP implementation. Compared with pre-SEP levels, the mean HbA1c levels decreased by approximately 20% (21 mmol/mol) at 1 year, with a further 11% reduction (10 mmol/mol) observed 8 months later (p < 0.001). Knowledge about diabetes care increased by 37% between the pre-SEP and post-SEP questionnaires (p < 0.005). Relevant improvements occurred after SEP activities. The sustained decrease in HbA1c levels and the overall increase in knowledge and confidence regarding diabetes care reinforce the importance, necessity, and positive outcomes of a SEP intervention in T1DM.

Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial.

PubMed

Di Bartolo, Paolo; Nicolucci, Antonio; Cherubini, Valentino; Iafusco, Diario; Scardapane, Marco; Rossi, Maria Chiara

2017-04-01

To compare iBGStar™ + DMApp (experimental meter + telemedicine system) (iBGStar) with a traditional glucose meter (Control) in type 1 diabetes adolescents/young adults. i-NewTrend was a multicenter, open-label, randomized trial involving subjects aged 14-24 years, on basal-bolus insulin, HbA1c ≥ 8.0%, and poorly compliant with SMBG (i.e., <30% of the recommended frequency). Primary end points were change in HbA1c and achievement of compliance with SMBG (≥30% of the recommended frequency) after 6 months. Quality of life was also evaluated. A post-trial observational phase was conducted, where both groups used the experimental device. Of 182 randomized patients (51.1% male; age 17.7 ± 3.0 years; diabetes duration 8.8 ± 4.7 years; HbA1c levels 10.0% ± 1.4), 92 were allocated to iBGStar and 90 to Control; 6.5% in iBGStar and 8.9% in Control dropped-out. After 6 months, HbA1c changes (±SE) were -0.44% ± 0.13 in iBGStar and -0.32% ± 0.13 in Control (p = 0.51). In the post-trial phase, HbA1c changes from 6 months (±SE) were -0.07% ± 0.14 in iBGStar and -0.31% ± 0.14 in Control (p = 0.24). Compliance end point was reached by 53.6% in iBGStar and 55.0% in Control (p = 0.86). Mean daily SMBG measurements increased from 1.1 to 2.3 in both groups without worsening quality of life. Compliant subjects showed a greater reduction in HbA1c levels (-0.60% ± 0.23 in iBGStar; -0.41% ± 0.21 in Control; p = 0.31). Within iBGStar group, telemedicine users (38.0%) reduced HbA1c by -0.58 ± 0.18. iBGStar was not superior to the traditional meter. Irrespective of the strategy, increasing from 1 to 2 SMBG tests/day was associated with HbA1c reduction in both groups, without pharmacologic interventions. Identifying new technologies effective and acceptable to patients is an option to improve adherence to diabetes care. The trial was registered at ClinicalTrials.gov (registration number NCT02073188).

Associations of Glycemic Control With Cardiovascular Outcomes Among US Hemodialysis Patients With Diabetes Mellitus.

PubMed

Rhee, Jinnie J; Zheng, Yuanchao; Montez-Rath, Maria E; Chang, Tara I; Winkelmayer, Wolfgang C

2017-06-07

There is a lack of data on the relationship between glycemic control and cardiovascular end points in hemodialysis patients with diabetes mellitus. We included adult Medicare-insured patients with diabetes mellitus who initiated in-center hemodialysis treatment from 2006 to 2008 and survived for >90 days. Quarterly mean time-averaged glycated hemoglobin (HbA 1c ) values were categorized into <48 mmol/mol (<6.5%) (reference), 48 to <58 mmol/mol (6.5% to <7.5%), 58 to <69 mmol/mol (7.5% to <8.5%), and ≥69 mmol/mol (≥8.5%). Medicare claims were used to identify outcomes of cardiovascular mortality, nonfatal myocardial infarction (MI), fatal or nonfatal MI, stroke, and peripheral arterial disease. We used Cox models as a function of time-varying exposure to estimate multivariable adjusted hazard ratios and 95%CI for the associations between HbA 1c and time to study outcomes in a cohort of 16 387 eligible patients. Patients with HbA 1c 58 to <69 mmol/mol (7.5% to <8.5%) and ≥69 mmol/mol (≥8.5%) had 16% (CI, 2%, 32%) and 18% (CI, 1%, 37%) higher rates of cardiovascular mortality ( P -trend=0.01) and 16% (CI, 1%, 33%) and 15% (CI, 1%, 32%) higher rates of nonfatal MI ( P -trend=0.05), respectively, compared with those in the reference group. Patients with HbA 1c ≥69 mmol/mol (≥8.5%) had a 20% (CI, 2%, 41%) higher rate of fatal or nonfatal MI ( P -trend=0.02), compared with those in the reference group. HbA 1c was not associated with stroke, peripheral arterial disease, or all-cause mortality. Higher HbA 1c levels were significantly associated with higher rates of cardiovascular mortality and MI but not with stroke, peripheral arterial disease, or all-cause mortality in this large cohort of hemodialysis patients with diabetes mellitus. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Modelling incremental benefits on complications rates when targeting lower HbA1c levels in people with Type 2 diabetes and cardiovascular disease.

PubMed

Mostafa, S A; Coleman, R L; Agbaje, O F; Gray, A M; Holman, R R; Bethel, M A

2018-01-01

Glucose-lowering interventions in Type 2 diabetes mellitus have demonstrated reductions in microvascular complications and modest reductions in macrovascular complications. However, the degree to which targeting different HbA 1c reductions might reduce risk is unclear. Participant-level data for Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) participants with established cardiovascular disease were used in a Type 2 diabetes-specific simulation model to quantify the likely impact of different HbA 1c decrements on complication rates. Ten-year micro- and macrovascular rates were estimated with HbA 1c levels fixed at 86, 75, 64, 53 and 42 mmol/mol (10%, 9%, 8%, 7% and 6%) while holding other risk factors constant at their baseline levels. Cumulative relative risk reductions for each outcome were derived for each HbA 1c decrement. Of 5717 participants studied, 72.0% were men and 74.2% White European, with a mean (sd) age of 66.2 (7.9) years, systolic blood pressure 134 (16.9) mmHg, LDL-cholesterol 2.3 (0.9) mmol/l, HDL-cholesterol 1.13 (0.3) mmol/l and median Type 2 diabetes duration 9.6 (5.1-15.6) years. Ten-year cumulative relative risk reductions for modelled HbA 1c values of 75, 64, 53 and 42 mmol/mol, relative to 86 mmol/mol, were 4.6%, 9.3%, 15.1% and 20.2% for myocardial infarction; 6.0%, 12.8%, 19.6% and 25.8% for stroke; 14.4%, 26.6%, 37.1% and 46.4% for diabetes-related ulcer; 21.5%, 39.0%, 52.3% and 63.1% for amputation; and 13.6%, 25.4%, 36.0% and 44.7 for single-eye blindness. These simulated complication rates might help inform the degree to which complications might be reduced by targeting particular HbA 1c reductions in Type 2 diabetes. © 2017 Diabetes UK.

The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education.

PubMed

Bowen, Michael E; Cavanaugh, Kerri L; Wolff, Kathleen; Davis, Dianne; Gregory, Rebecca P; Shintani, Ayumi; Eden, Svetlana; Wallston, Ken; Elasy, Tom; Rothman, Russell L

2016-08-01

To compare the effectiveness of different approaches to nutrition education in diabetes self-management education and support (DSME/S). We randomized 150 adults with type 2 diabetes to either certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education. The primary outcome was change in HbA1C over 6 months. At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34]. Change in HbA1C from baseline between the control and intervention groups was not significant at 6 months (carbohydrate counting, P=0.36; modified plate method, P=0.08). In a pre-specified subgroup analysis of patients with a baseline HbA1C 7-10%, change in HbA1C from baseline improved in the carbohydrate counting [-0.86% (-1.47, -0.26), P=0.006] and plate method groups [-0.76% (-1.33, -0.19), P=0.01] compared to controls. CDE-delivered DSME/S focused on carbohydrate counting or the modified plate method improved glycemic control in patients with an initial HbA1C between 7 and 10%. Both carbohydrate counting and the modified plate method improve glycemic control as part of DSME/S. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes.

PubMed

Saslow, Laura R; Kim, Sarah; Daubenmier, Jennifer J; Moskowitz, Judith T; Phinney, Stephen D; Goldman, Veronica; Murphy, Elizabeth J; Cox, Rachel M; Moran, Patricia; Hecht, Fredrick M

2014-01-01

We compared the effects of two diets on glycated hemoglobin (HbA1c) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes (HbA1c>6%). We randomized participants to either a medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet (MCCR) consistent with guidelines from the American Diabetes Association (n = 18) or a very low carbohydrate, high fat, non calorie-restricted diet whose goal was to induce nutritional ketosis (LCK, n = 16). We excluded participants receiving insulin; 74% were taking oral diabetes medications. Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance. At 3 months, mean HbA1c level was unchanged from baseline in the MCCR diet group, while it decreased 0.6% in the LCK group; there was a significant between group difference in HbA1c change favoring the LCK group (-0.6%, 95% CI, -1.1% to -0.03%, p = 0.04). Forty-four percent of the LCK group discontinued one or more diabetes medications, compared to 11% of the MCCR group (p = 0.03); 31% discontinued sulfonylureas in the LCK group, compared to 5% in the MCCR group (p = 0.05). The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group (p = 0.09). Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications. This clinical trial was registered with ClinicalTrials.gov, number NCT01713764.

A Randomized Pilot Trial of a Moderate Carbohydrate Diet Compared to a Very Low Carbohydrate Diet in Overweight or Obese Individuals with Type 2 Diabetes Mellitus or Prediabetes

PubMed Central

Saslow, Laura R.; Kim, Sarah; Daubenmier, Jennifer J.; Moskowitz, Judith T.; Phinney, Stephen D.; Goldman, Veronica; Murphy, Elizabeth J.; Cox, Rachel M.; Moran, Patricia; Hecht, Fredrick M.

2014-01-01

We compared the effects of two diets on glycated hemoglobin (HbA1c) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes (HbA1c>6%). We randomized participants to either a medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet (MCCR) consistent with guidelines from the American Diabetes Association (n = 18) or a very low carbohydrate, high fat, non calorie-restricted diet whose goal was to induce nutritional ketosis (LCK, n = 16). We excluded participants receiving insulin; 74% were taking oral diabetes medications. Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance. At 3 months, mean HbA1c level was unchanged from baseline in the MCCR diet group, while it decreased 0.6% in the LCK group; there was a significant between group difference in HbA1c change favoring the LCK group (−0.6%, 95% CI, −1.1% to −0.03%, p = 0.04). Forty-four percent of the LCK group discontinued one or more diabetes medications, compared to 11% of the MCCR group (p = 0.03); 31% discontinued sulfonylureas in the LCK group, compared to 5% in the MCCR group (p = 0.05). The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group (p = 0.09). Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications. This clinical trial was registered with ClinicalTrials.gov, number NCT01713764. PMID:24717684

Safety and Efficacy of D-Tagatose in Glycemic Control in Subjects with Type 2 Diabetes.

PubMed

Ensor, Mark; Banfield, Amy B; Smith, Rebecca R; Williams, Jarrod; Lodder, Robert A

The primary objectives of this study were to evaluate the treatment effect of D-tagatose on glycemic control, determined by a statistically significant decrease in hemoglobin A1c (HbA1c), and safety profile of D-tagatose compared to placebo. The secondary objectives were to evaluate the treatment effects on fasting blood glucose, insulin, lipid profiles, changes in BMI, and the proportion of subjects achieving HbA1c targets of <7%. Type 2 diabetic patients not taking any blood glucose lowering medications were administered either 15 g of D-tagatose dissolved in 125-250 ml of water three times a day or placebo with meals. Reduction in HbA1c was statistically significant compared to placebo at all post-baseline time points in the ITT population. Additionally, secondary endpoints were achieved in the ITT population with regard to LDL, total cholesterol, fasting blood glucose, and proportion of subjects achieving HbA1c targets of <7%. D-tagatose was unable to lower triglycerides or raise HDL compared to placebo. A subgroup LOCF analysis on the ITT US population showed a greater and statistically significant LS mean reduction in HbA1c in the D-tagatose group at all post-baseline visits. Based on these results it is concluded that in the ITT population D-tagatose is an effective single agent at treating many of the therapy targets of type 2 diabetes including lowering fasting blood glucose and HbA1c, and lowering of LDL and total cholesterol.

Safety and Efficacy of D-Tagatose in Glycemic Control in Subjects with Type 2 Diabetes

PubMed Central

Ensor, Mark; Banfield, Amy B.; Smith, Rebecca R.; Williams, Jarrod; Lodder, Robert A.

2015-01-01

The primary objectives of this study were to evaluate the treatment effect of D-tagatose on glycemic control, determined by a statistically significant decrease in hemoglobin A1c (HbA1c), and safety profile of D-tagatose compared to placebo. The secondary objectives were to evaluate the treatment effects on fasting blood glucose, insulin, lipid profiles, changes in BMI, and the proportion of subjects achieving HbA1c targets of <7%. Type 2 diabetic patients not taking any blood glucose lowering medications were administered either 15 g of D-tagatose dissolved in 125–250 ml of water three times a day or placebo with meals. Reduction in HbA1c was statistically significant compared to placebo at all post-baseline time points in the ITT population. Additionally, secondary endpoints were achieved in the ITT population with regard to LDL, total cholesterol, fasting blood glucose, and proportion of subjects achieving HbA1c targets of <7%. D-tagatose was unable to lower triglycerides or raise HDL compared to placebo. A subgroup LOCF analysis on the ITT US population showed a greater and statistically significant LS mean reduction in HbA1c in the D-tagatose group at all post-baseline visits. Based on these results it is concluded that in the ITT population D-tagatose is an effective single agent at treating many of the therapy targets of type 2 diabetes including lowering fasting blood glucose and HbA1c, and lowering of LDL and total cholesterol. PMID:27054147

Attainment of Canadian Diabetes Association recommended targets in patients with type 2 diabetes

PubMed Central

McCrate, Farah; Godwin, Marshall; Murphy, Laura

2010-01-01

OBJECTIVE To examine the degree to which targets for diabetes (blood pressure [BP], glycated hemoglobin [HbA1c], and low-density lipoprotein cholesterol [LDL-C]) are achieved in family practices and how these results compare with family physicians’ perceptions of how well targets are being achieved. DESIGN Chart audit and physician survey. SETTING Newfoundland and Labrador. PARTICIPANTS Patients with type 2 diabetes and their family physicians. INTERVENTIONS The charts of 20 patients with type 2 diabetes were randomly chosen from each of 8 family physician practices in St John’s, Nfld, and data were abstracted. All family physicians in the province were surveyed using a modified Dillman method. MAIN OUTCOME MEASURES The most recent HbA1c, LDL-C, and BP measurements listed in each audited chart; surveyed family physicians’ knowledge of the recommended targets for HbA1c, LDL-C, and BP and their estimates of what percentage of their patients were at those recommended targets. RESULTS The chart audit revealed that 20.6% of patients were at the recommended target for BP, 48.1% were at the recommended target for HbA1c, and 17.5% were at the recommended target for LDL-C. When targets were examined collectively, only 2.5% of patients were achieving targets in all 3 areas. The survey found that most family physicians were aware of the recommended targets for BP, LDL-C, and HbA1c. However, their estimates of the percentages of patients in their practices achieving these targets appeared high (59.3% for BP, 58.2% for HbA1c, and 48.4% for LDL-C) compared with the results of the chart audit. CONCLUSION The findings of the chart audit are consistent with other published reports, which have illustrated that a large majority of patients with diabetes fall short of reaching recommended targets for BP, blood glucose, and lipid levels. Although family physicians are knowledgeable about recommended targets, there is a gap between knowledge and clinical outcomes. The reasons for this are likely multifactorial. Further investigation is needed to better understand this phenomenon as well as to understand the foundation for physicians’ optimistic estimates of how many of their patients with diabates were reaching target values. PMID:20090056

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12-week trial.

PubMed

Tian, Jiaxing; Lian, Fengmei; Yang, Libo; Tong, Xiaolin

2018-02-01

The Chinese herbal medicine Jinlida can significantly enhance the hypoglycemic action of metformin. However, the population showing the best responses to Jinlida has not been clarified. The aim of the present study was to compare the efficacy of Jinlida in type 2 diabetes mellitus (T2DM) after stratification. Data were analyzed from a 12-week randomized placebo-controlled double-blind multicenter study with 192 T2DM patients (186 completed the study). The efficacy evaluation included HbA1c, fasting plasma glucose (FPG), and 2-h postprandial glucose (2hPG) levels stratified by baseline HbA1c, sex, age, body mass index (BMI), and duration of T2DM diagnosis. Homeostasis model assessment of insulin resistance (HOMA-IR) and homeostatic model assessment of β-cell function (HOMA-β) were also evaluated stratified by baseline insulin levels. In the Jinlida group, HbA1c was significantly reduced (P < 0.05). Greater reductions were observed in patients with baseline HbA1c >8.5%, in males and in those aged >60 years, with a BMI ≤24 kg/m 2 , or with a duration of T2DM diagnosis >5 years (P < 0.05). Compared with baseline, Jinlida significantly alleviated insulin resistance (P < 0.05) in patients with baseline insulin levels >20 mU/L. Jinlida also significantly improved β-cell function in patients with baseline insulin levels ≤20 mU/L (P < 0.05). Jinlida significantly improved glycemic control, with greater improvements in patients with poor glycemic control and male, elderly, of normal weight, or with a long disease course. Furthermore, Jinlida alleviated insulin resistance with hyperinsulinemia and promoted insulin secretion with hypoinsulinemia. These results need to be further confirmed in clinical trials. © 2017 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Effect of Ramadan fasting on diabetes mellitus: a population-based study in Qatar.

PubMed

Bener, Abdulbari; Yousafzai, Mohammad T

2014-08-01

Over one billion Muslims fast worldwide during the month of Ramadan. Fasting during Ramadan is a radical change in lifestyle for the period of a lunar month, and it might affect the biochemical parameters among diabetic patients. This study aimed to investigate the effect of Ramadan fasting on the blood levels of glucose, glycated hemoglobin (HbA1c), and lipid profile among diabetic patients observing fast during the Ramadan. An observational study recruiting 1301 Muslim diabetic patients above 18 years age was conducted in diabetic outpatient clinic of Hamad General Hospital, Hamad Medical Corporation, and Primary Health Care Center, Qatar, from July 2012 to September 2013. Data on sociodemographic characteristics (age, sex, nationality, marital status, education level, and occupation) and lifestyle habits (smoking and physical activity), blood pressures, and anthropometric measurements were obtained by a face-to-face interview and measurement using a structured questionnaire. Blood samples were collected for testing glucose, glycosylated hemoglobin (HbA1C), lipid profile, urea, and creatinine (by the licensed research assistants). Slightly less than half of the participants were overweight (BMI: 25-29.9). Significantly higher proportion of female participants were obese as compared with male participants (P<0.001). Among both male participants and female participants, the average level of blood glucose, HbA1c, total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, albumin, bilirubin, uric acid, and systolic and diastolic blood pressures were significantly lower during the Ramadan as compared with before Ramadan (P<0.001 each). Results revealed that fasting during Ramadan is significantly associated with decrease in blood lipid profile, blood pressures, glucose, and HbA1C level among diabetic patients. Muslim diabetic patients after the consultation of their primary physician can fast during the month of Ramadan and it might be beneficial for their health.

Effect of Probiotic Fermented Milk (Kefir) on Glycemic Control and Lipid Profile In Type 2 Diabetic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial

PubMed Central

OSTADRAHIMI, Alireza; TAGHIZADEH, Akbar; MOBASSERI, Majid; FARRIN, Nazila; PAYAHOO, Laleh; BEYRAMALIPOOR GHESHLAGHI, Zahra; VAHEDJABBARI, Morteza

2015-01-01

Background: Diabetes is a global health problem in the world. Probiotic food has anti-diabetic property. The aim of this trial was to determine the effect of probiotic fermented milk (kefir) on glucose and lipid profile control in patients with type 2 diabetes mellitus. Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years.Patients were randomly and equally (n=30) assigned to consume either probiotic fermented milk (kefir) or conventional fermented milk (dough) for 8 weeks. Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei, Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk.Blood samples tested for fasting blood glucose, HbA1C, triglyceride (TG), total cholesterol, HDL-C and LDL-C at the baseline and end of the study. Results: The comparison of fasting blood glucose between two groups after intervention was statistically significant (P=0.01). After intervention, reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant (P=0.001), also the HbA1C level significantly decreased in probiotic group in comparison with control group (P=0.02) adjusting for serum levels of glucose, baseline values of HbA1c and energy intake according to ANCOVA model. Serum triglyceride, total cholesterol, LDL-cholesterol and HDL- cholesterol levels were not shown significant differences between and within the groups after intervention. Conclusion: Probiotic fermented milk can be useful as a complementary or adjuvant therapy in the treatment of diabetes. PMID:25905057

Baseline HbA1c to Identify High-Risk Gestational Diabetes: Utility in Early vs Standard Gestational Diabetes.

PubMed

Sweeting, Arianne N; Ross, Glynis P; Hyett, Jon; Molyneaux, Lynda; Tan, Kris; Constantino, Maria; Harding, Anna Jane; Wong, Jencia

2017-01-01

The increasing prevalence of gestational diabetes mellitus (GDM) necessitates risk stratification directing limited antenatal resources to those at greatest risk. Recent evidence demonstrates that an early pregnancy glycated hemoglobin (HbA1c ≥5.9% (41 mmol/mol) predicts adverse pregnancy outcomes. To determine the optimal HbA1c threshold for adverse pregnancy outcomes in GDM in a treated multiethnic cohort and whether this differs in women diagnosed <24 vs ≥24 weeks' gestation (early vs standard GDM). This was a retrospective cohort study undertaken at the Royal Prince Alfred Hospital Diabetes Antenatal Clinic, Australia, between 1991 and 2011. Pregnant women (N = 3098) underwent an HbA1c (single-laboratory) measurement at the time of GDM diagnosis. Maternal clinical and pregnancy outcome data were collected prospectively. The association between baseline HbA1c and adverse pregnancy outcomes in early vs standard GDM. HbA1c was measured at a median of 17.6 ± 3.3 weeks' gestation in early GDM (n = 844) and 29.4 ± 2.6 weeks' gestation in standard GDM (n = 2254). In standard GDM, HbA1c >5.9% (41 mmol/mol) was associated with the greatest risk of large-for-gestational-age (odds ratio [95% confidence interval] = 2.7 [1.5-4.9]), macrosomia (3.5 [1.4-8.6]), cesarean section (3.6 [2.1-6.2]), and hypertensive disorders (2.6 [1.1-5.8]). In early GDM, similar HbA1c associations were seen; however, lower HbA1c correlated with the greatest risk of small-for-gestational-age (P trend = 0.004) and prevalence of neonatal hypoglycemia. Baseline HbA1c >5.9% (41 mmol/mol) identifies an increased risk of large-for-gestational-age, macrosomia, cesarean section, and hypertensive disorders in standard GDM. Although similar associations are seen in early GDM, higher HbA1c levels do not adequately capture risk-limiting utility as a triage tool in this cohort. Copyright © 2017 by the Endocrine Society

Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin.

PubMed

Blonde, Lawrence; Raccah, Denis; Lew, Elisheva; Meyers, Juliana; Nikonova, Elena; Ajmera, Mayank; Davis, Keith L; Bertolini, Monica; Guerci, Bruno

2018-06-01

Treatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting. Adults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007-2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the 'index date'); patients were required to have HbA1c > 7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period. Data for 6054 patients were analyzed (2-OAD, n = 4442; GLP-1 RA, n = 361; basal insulin, n = 1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were -1.2% for GLP-1 RA, -1.6% for OADs, and -1.8% for basal insulin. HbA1c < 7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]). Despite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c < 7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further. Sanofi U.S., Inc.

The Influence of Diabetes, Glycemic Control, and Diabetes-Related Comorbidities on Pulmonary Tuberculosis

PubMed Central

Chiang, Chen Yuan; Bai, Kuan Jen; Lin, Hsien Ho; Chien, Shun Tien; Lee, Jen Jyh; Enarson, Donald A.; Lee, Ting-I; Yu, Ming-Chih

2015-01-01

Background To assess the influence of diabetes mellitus (DM), glycemic control, and diabetes-related comorbidities on manifestations and outcome of treatment of pulmonary tuberculosis (TB). Methodology/Principal Findings Culture positive pulmonary TB patients notified to health authorities in three hospitals in Taiwan from 2005–2010 were investigated. Glycemic control was assessed by glycated haemoglobin A1C (HbA1C) and diabetic patients were categorized into 3 groups: HbA1C<7%, HbA1C 7–9%, HbA1C>9%. 1,473 (705 with DM and 768 without DM) patients were enrolled. Of the 705 diabetic patients, 82 (11.6%) had pretreatment HbA1C<7%, 152 (21.6%) 7%–9%, 276 (39.2%) >9%, and 195 (27.7%) had no information of HbA1C. The proportions of patients with any symptom, cough, hemoptysis, tiredness and weight loss were all highest in diabetic patients with HbA1C>9%. In multivariate analysis adjusted for age, sex, smoking, and drug resistance, diabetic patients with HbA1C>9% (adjOR 3.55, 95% CI 2.40–5.25) and HbA1C 7–9% (adjOR 1.62, 95% CI 1.07–2.44) were significantly more likely to be smear positive as compared with non-diabetic patients, but not those with HbA1C<7% (adjOR 1.16, 95% CI 0.70–1.92). The influence of DM on outcome of TB treatment was not proportionately related to HbA1C, but mainly mediated through diabetes-related comorbidities. Patients with diabetes-related comorbidities had an increased risk of unfavorable outcome (adjOR 3.38, 95% CI 2.19–5.22, p<0.001) and one year mortality (adjOR 2.80, 95% CI 1.89–4.16). However, diabetes was not associated with amplification of resistance to isoniazid (p = 0.363) or to rifampicin (p = 0.344). Conclusions/Significance Poor glycemic control is associated with poor TB treatment outcome and improved glycemic control may reduce the influence of diabetes on TB. PMID:25822974

Hemoglobin A1c variability as an independent correlate of cardiovascular disease in patients with type 2 diabetes: a cross-sectional analysis of the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study

PubMed Central

2013-01-01

Background Previous reports have clearly indicated a significant relationship between hemoglobin (Hb) A1c change from one visit to the next and microvascular complications, especially nephropathy (albuminuria and albuminuric chronic kidney disease, CKD). In contrast, data on macrovascular disease are less clear. This study was aimed at examining the association of HbA1c variability with cardiovascular disease (CVD) in the large cohort of subjects with type 2 diabetes from the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study. Methods Serial (3–5) HbA1c values obtained during the 2-year period preceding recruitment, including that obtained at the enrolment, were available from 8,290 subjects from 9 centers (out of 15,773 patients from 19 centers). Average HbA1c and HbA1c variability were calculated as the intra-individual mean (HbA1c-MEAN) and standard deviation (HbA1c-SD), respectively, of 4.52±0.76 values. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events. Diabetic retinopathy (DR) was assessed by dilated fundoscopy. CKD was defined based on albuminuria, as measured by immunonephelometry or immunoturbidimetry, and estimated glomerular filtration rate, as calculated from serum creatinine. Results HbA1c-MEAN, but not HbA1c-SD, was significantly higher (P<0.0001) in subjects with history of any CVD (n. 2,133, 25.7%) than in those without CVD (n. 6,157, 74.3%). Median and interquartile range were 7.78 (7.04-8.56) and 7.49 (6.81-8.31), respectively, for HbA1c-MEAN, and 0.47 (0.29-0.75) and 0.46 (0.28-0.73), respectively, for HbA1c-SD. Logistic regression analyses showed that HbA1c-MEAN, but not HbA1c-SD (and independent of it), was a significant correlate of any CVD. Similar findings were observed in subjects with versus those without any coronary or cerebrovascular event or myocardial infarction. Conversely, none of these measures were associated with stroke, whereas both correlated with any lower limb vascular event and HbA1c-SD alone with ulceration/gangrene. All these associations were independent of known CVD risk factors and microvascular complications (DR and CKD). Conclusions In patients with type 2 diabetes, HbA1c variability has not a major impact on macrovascular complications, at variance with average HbA1c, an opposite finding as compared with microvascular disease, and particularly nephropathy. Trial registration ClinicalTrials.Gov NCT00715481 PMID:23829205

Multiple educational programs improves glycemic control, quality of life with diminishing the impact of diabetes in poorly controlled type 1 diabetics.

PubMed

Vyas, Chintan; Dalal, Lopa; Talaviya, Praful; Saboo, Banshi

2017-12-01

The aim of present study was to assess the outcomes of multiple educational programs on glycemic control, quality of life and impact of diabetes in poorly controlled Type 1 Diabetic patients. A 12 months diabetes education programs were conducted every week for first one month then followed by every 3 months with follow up on improvement of HbA1c and QOL in T1D patients (n=54). Clinical characteristics were recorded at baseline visit. The QOL was evaluated by 15 set DQOL questionnaires in 40 consecutive patients at baseline, 3, 6 and 12 months after education programs. The HbA1c level (%) was evaluated at same time point. Decrease in DQOL score was reported as improvement in QOL. The rate of patients response to educational programs was noted 74.07% (n=40) at end of the study (12 months). The prevalence of T1D was reported higher in men than in women. The overall DQOL score and HbA1c% level was significantly (P<0.05) decreased at 3, 6 and 12 months after educational programs. Patients exhibited greater satisfaction and diminished impact of diabetes after educational programs was observed after 3 months and it was continue up to end of study. The frequencies of self-monitoring of blood glucose were increased. Numbers of hypoglycemic and DKA events were decreased after educational programs when compared to baseline. Results of study revealed that the appropriate education and counseling diminish impact of diabetes, improve QOL and help to achieve desired glycemic (HbA1c) level in poorly control T1D patients. Copyright © 2017. Published by Elsevier Ltd.

Validity of Postmortem Glycated Hemoglobin to Determine Status of Diabetes Mellitus in Corneal Donors.

PubMed

Soper, Mark C; Marcovina, Santica M; Hoover, Caroline K; Calhoun, Peter M; McCoy, Kristen E; Stoeger, Christopher G; Schmidt, Gregory A; Arafah, Baha M; Price, Marianne O; Szczotka-Flynn, Loretta B; Lass, Jonathan H

2017-08-01

To examine the stability of postmortem glycated hemoglobin (HbA1c) measurement and its relationship to premortem glycemia. Postmortem blood samples were obtained from 32 donors (8 known diabetic) and shipped on ice to a central laboratory to examine the stability of HbA1c measurements during the first 9 postmortem days. Thirty-nine other suspected diabetic donors underwent comparison of premortem and postmortem HbA1c measurements. Postmortem HbA1c measurements remained stable after 9 postmortem days (all measurements within ±0.2% from baseline with a mean difference of 0.02% ± 0.10%). Of the premortem measurements obtained within 90 days before death, 79% were within ±1.0% of the postmortem measurements compared with 40% for measurements more than 90 days apart. Three of the postmortem HbA1c measurements exceeded 6.5% (considered a threshold for diabetes diagnosis), although the medical histories did not indicate any previous diabetes diagnosis. Postmortem HbA1c testing is feasible with current eye bank procedures and is reflective of glycemic control of donors during 90 days before death. HbA1c testing could potentially be a useful adjunct to review of the medical history and records for donor assessment for endothelial keratoplasty suitability and long-term graft success.

Comparative study of HbA1c and fasting plasma glucose vs the oral glucose tolerance test for diagnosis of diabetes in people with tuberculosis.

PubMed

Aftab, H; Ambreen, A; Jamil, M; Garred, P; Petersen, J H; Nielsen, S D; Bygbjerg, I C; Christensen, D L

2017-06-01

To compare HbA 1c and fasting plasma glucose assessment, with the 2-h oral glucose tolerance test as reference, in screening for diabetes in people with turberculosis. Individuals (N=268) with newly diagnosed smear-positive tuberculosis were screened for diabetes at a tertiary hospital in Lahore, Pakistan. Diabetes diagnosis was based on WHO criteria: thresholds were ≥48 mmol/mol (≥6.5%) for HbA 1c and ≥7.0mmol/l for fasting plasma glucose. The proportion of participants diagnosed with diabetes was 4.9% (n =13) by oral glucose tolerance test, while 11.9% (n =32) and 14.6% (n =39) were diagnosed with diabetes using HbA 1c and fasting plasma glucose criteria, respectively. The area under the receiver-operating characteristic curve was 0.79 (95% CI 0.64 to 0.94) for HbA 1c and 0.61 (95% CI 0.50 to 0.73) for fasting plasma glucose, with a borderline significant difference between the two tests (P=0.07). HbA 1c and fasting plasma glucose performed equally in terms of diagnosing new diabetes cases in individuals with tuberculosis, but the proportion of participants falsely classified as positive was higher for fasting plasma glucose. This may be explained by acute blood glucose fluctuations when using fasting plasma glucose. HbA 1c may be a more reliable test in individuals with transient hyperglycaemia. © 2017 Diabetes UK.

Performance of HbA1c as an Early Diagnostic Indicator of Type 1 Diabetes in Children and Youth

PubMed Central

Vehik, Kendra; Cuthbertson, David; Boulware, David; Beam, Craig A.; Rodriguez, Henry; Legault, Laurent; Hyytinen, Mila; Rewers, Marian J.; Schatz, Desmond A.; Krischer, Jeffrey P.

2012-01-01

OBJECTIVE The aim of this study was to evaluate HbA1c as an alternative criterion for impaired glucose tolerance (IGT) or type 1 diabetes (T1D) in high-risk subjects <21 years of age. RESEARCH DESIGN AND METHODS Subjects <21 years of age who participated in the prospective DPT-1, TEDDY, TRIGR, and Type 1 Diabetes TrialNet Natural History (TrialNet) studies and had an HbA1c within 90 days of an OGTT with a 2-h plasma glucose (2-hPG) measure were included. An OGTT of 140–199 mg/dL defined IGT, and an OGTT with 2-hPG ≥200 mg/dL or fasting plasma glucose ≥126 mg/dL defined diabetes. HbA1c ≥5.7% defined IGT, and HbA1c ≥ 6.5% defined diabetes. Receiver-operating characteristic curve analysis was used to assess diagnostic accuracy of HbA1c compared with OGTT. RESULTS There were 587 subjects from DPT-1, 884 from TrialNet, 91 from TEDDY, and 420 from TRIGR. As an indicator for IGT, HbA1c sensitivity was very low across the studies (8–42%), and specificity was variable (64–95%). With HbA1c ≥6.5% threshold used for T1D diagnosis, the sensitivity was very low and specificity was high (sensitivity and specificity: DPT-1 24 and 98%, TrialNet 28 and 99%, TEDDY 34 and 98%, and TRIGR 33 and 99%, respectively). The positive predictive value of HbA1c ≥6.5% for the development of T1D was variable (50–94%) across the four studies. CONCLUSIONS HbA1c ≥6.5% is a specific but not sensitive early indicator for T1D in high-risk subjects <21 years of age diagnosed by OGTT or asymptomatic hyperglycemia. Redefining the HbA1c threshold is recommended if used as an alternative criterion in diagnosing T1D. PMID:22699293

Performance of HbA1c as an early diagnostic indicator of type 1 diabetes in children and youth.

PubMed

Vehik, Kendra; Cuthbertson, David; Boulware, David; Beam, Craig A; Rodriguez, Henry; Legault, Laurent; Hyytinen, Mila; Rewers, Marian J; Schatz, Desmond A; Krischer, Jeffrey P

2012-09-01

The aim of this study was to evaluate HbA(1c) as an alternative criterion for impaired glucose tolerance (IGT) or type 1 diabetes (T1D) in high-risk subjects <21 years of age. Subjects <21 years of age who participated in the prospective DPT-1, TEDDY, TRIGR, and Type 1 Diabetes TrialNet Natural History (TrialNet) studies and had an HbA(1c) within 90 days of an OGTT with a 2-h plasma glucose (2-hPG) measure were included. An OGTT of 140-199 mg/dL defined IGT, and an OGTT with 2-hPG ≥200 mg/dL or fasting plasma glucose ≥126 mg/dL defined diabetes. HbA(1c) ≥5.7% defined IGT, and HbA(1c) ≥ 6.5% defined diabetes. Receiver-operating characteristic curve analysis was used to assess diagnostic accuracy of HbA(1c) compared with OGTT. There were 587 subjects from DPT-1, 884 from TrialNet, 91 from TEDDY, and 420 from TRIGR. As an indicator for IGT, HbA(1c) sensitivity was very low across the studies (8-42%), and specificity was variable (64-95%). With HbA(1c) ≥6.5% threshold used for T1D diagnosis, the sensitivity was very low and specificity was high (sensitivity and specificity: DPT-1 24 and 98%, TrialNet 28 and 99%, TEDDY 34 and 98%, and TRIGR 33 and 99%, respectively). The positive predictive value of HbA(1c) ≥6.5% for the development of T1D was variable (50-94%) across the four studies. HbA(1c) ≥6.5% is a specific but not sensitive early indicator for T1D in high-risk subjects <21 years of age diagnosed by OGTT or asymptomatic hyperglycemia. Redefining the HbA(1c) threshold is recommended if used as an alternative criterion in diagnosing T1D.

HbA1c, diabetes and cognitive decline: the English Longitudinal Study of Ageing.

PubMed

Zheng, Fanfan; Yan, Li; Yang, Zhenchun; Zhong, Baoliang; Xie, Wuxiang

2018-04-01

The aim of the study was to evaluate longitudinal associations between HbA 1c levels, diabetes status and subsequent cognitive decline over a 10 year follow-up period. Data from wave 2 (2004-2005) to wave 7 (2014-2015) of the English Longitudinal Study of Ageing (ELSA) were analysed. Cognitive function was assessed at baseline (wave 2) and reassessed every 2 years at waves 3-7. Linear mixed models were used to evaluate longitudinal associations. The study comprised 5189 participants (55.1% women, mean age 65.6 ± 9.4 years) with baseline HbA 1c levels ranging from 15.9 to 126.3 mmol/mol (3.6-13.7%). The mean follow-up duration was 8.1 ± 2.8 years and the mean number of cognitive assessments was 4.9 ± 1.5. A 1 mmol/mol increment in HbA 1c was significantly associated with an increased rate of decline in global cognitive z scores (-0.0009 SD/year, 95% CI -0.0014, -0.0003), memory z scores (-0.0005 SD/year, 95% CI -0.0009, -0.0001) and executive function z scores (-0.0008 SD/year, 95% CI -0.0013, -0.0004) after adjustment for baseline age, sex, total cholesterol, HDL-cholesterol, triacylglycerol, high-sensitivity C-reactive protein, BMI, education, marital status, depressive symptoms, current smoking, alcohol consumption, hypertension, CHD, stroke, chronic lung disease and cancer. Compared with participants with normoglycaemia, the multivariable-adjusted rate of global cognitive decline associated with prediabetes and diabetes was increased by -0.012 SD/year (95% CI -0.022, -0.002) and -0.031 SD/year (95% CI -0.046, -0.015), respectively (p for trend <0.001). Similarly, memory, executive function and orientation z scores showed an increased rate of cognitive decline with diabetes. Significant longitudinal associations between HbA 1c levels, diabetes status and long-term cognitive decline were observed in this study. Future studies are required to determine the effects of maintaining optimal glucose control on the rate of cognitive decline in people with diabetes.

Association between impaired fasting glycaemia in pediatric obesity and type 2 diabetes in young adulthood.

PubMed

Hagman, E; Danielsson, P; Brandt, L; Ekbom, A; Marcus, C

2016-08-22

In adults, impaired fasting glycemia (IFG) increases the risk for type 2 diabetes mellitus (T2DM). This study aimed to investigate to which extent children with obesity develop T2DM during early adulthood, and to determine whether IFG and elevated hemoglobin A1c (HbA1c) in obese children are risk markers for early development of T2DM. In this prospective cohort study, 1620 subjects from the Swedish Childhood Obesity Treatment Registry - BORIS who were ⩾18 years at follow-up and 8046 individuals in a population-based comparison group, matched on gender age and living area, were included. IFG was defined according to both ADA (cut-off 5.6 mmol l(-1)) and WHO (6.1 mmol l(-1)). Elevated HbA1c was defined according to ADA (cut-off 39 mmol l(-1)). Main outcome was T2DM medication, as a proxy for T2DM. Data on medications were retrieved from a national registry. The childhood obesity cohort were 24 times more likely to receive T2DM medications in early adulthood compared with the comparison group (95% confidence interval (CI): 12.52-46). WHO-defined IFG predicted future use of T2DM medication with an adjusted hazard ratio (HR) of 3.73 (95% CI: 1.87-7.45) compared with those who had fasting glucose levels <5.6 mmol l(-1). A fasting glucose level of 5.6-6.0 mmol l(-1), that is, the IFG-interval added by American Diabetes Association (ADA), did not increase the use of T2DM medication more than pediatric obesity itself, adjusted HR=1.72 (0.84-3.52). Elevated levels of HbA1c resulted in an adjusted HR=3.12 (1.50-6.52). More severe degree of obesity also increased the future T2DM risk. IFG according to WHO and elevated HbA1c (39-48 mmol l(-1)), but not the additional fasting glucose interval added by ADA (5.6-6.0 mmol l(-1)), can be considered as prediabetes in the obese pediatric population in Sweden.

Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study.

PubMed

Hirose, Takahisa; Suzuki, Manabu; Tsumiyama, Isao

2015-12-01

To assess the efficacy and safety of vildagliptin as add-on therapy in Japanese patients with type 2 diabetes mellitus (T2DM), inadequately controlled on stable long-acting, intermediate-acting, or pre-mixed insulin, with or without concomitant metformin. In this 12-week placebo-controlled study, patients were randomized to receive either vildagliptin 50 mg twice daily (bid) or placebo treatment in a 1:1 ratio. The primary endpoint was change in glycated hemoglobin A1c (HbA1c) from baseline to 12-week endpoint. Secondary endpoints included proportion of patients achieving pre-defined HbA1c targets of ≤6.5%, <7.0%, and HbA1c <7.0% in patients with baseline HbA1c ≤8.0% and change in fasting plasma glucose (FPG) after 12 weeks of treatment. Regular monitoring was performed to record any treatment-emergent adverse events (AEs) and serious adverse events or hypoglycemic episodes. Of the 156 patients randomized, 96.8% completed the study (vildagliptin, n = 76; placebo, n = 75). Patient demographics and clinical characteristics were comparable between the groups at baseline. Addition of vildagliptin resulted in statistically significant reductions in HbA1c after 12 weeks (-1.01 ± 0.06%), with a between-treatment difference of -0.91 ± 0.09% (p < 0.001). FPG levels reduced from baseline to 12 weeks in the vildagliptin group (-1.2 ± 0.2 mmol/L), with a between-treatment difference of -1.2 ± 0.3 mmol/L which was significant (p < 0.001). The proportion of patients achieving HbA1c targets was higher with vildagliptin treatment for all pre-defined responder rate categories. The overall incidence of AEs was comparable between groups (vildagliptin, 46.2% vs. placebo, 43.6%). The overall incidence of hypoglycemic events was low and all events were self-treatable without using drug therapy. No severe hypoglycemic events were reported. Treatment with vildagliptin 50 mg bid as add-on to insulin with or without metformin resulted in statistically significant reductions in HbA1c in Japanese patients with T2DM. Overall, vildagliptin was well tolerated with a safety profile similar to that of placebo in this patient population. ClinicalTrials.gov Identifier, NCT02002221 FUNDING: Novartis Pharma K.K.

An analysis of cognitive functioning of children and youth with type 1 diabetes (T1DM) in the context of glycemic control.

PubMed

Stanisławska-Kubiak, M; Mojs, E; Wójciak, R W; Piasecki, B; Matecka, M; Sokalski, J; Kopczyński, P; Fichna, P

2018-06-01

The aim of the study was to evaluate the cognitive functioning of children and youth with type 1 diabetes (T1DM). The study included 68 children with type 1 diabetes, aged 6-17 years, divided into 3 groups according to the level of glycated hemoglobin (HbA1c): group 1: HbA1c ≤ 6.0-7.5%; group 2: HbA1c 7.6-8.5%; group 3: HbA1c over 8.6%. Wechsler's intelligence scale (WISC-R), the Trail of 10 words and Brickenkamp's and Zillmer's d2 Test of Attention were used to assess cognitive functioning. The research demonstrated a significant influence of low, medium or high glycaemic control on lowering the general level of functioning in verbal intelligence, and in WISC-R subtests: information, vocabulary, comprehension, number sequencing and block design. Children with type 1 diabetes mellitus can experience difficulties in cognitive functioning, as a consequence of high HbA1c. Additional research, involving a larger group of patients and a wider age range when the disease was diagnosed, will enable further findings on the occurrence of cognitive impairment in T1DM.

HbA1c in the diagnosis of diabetes and abnormal glucose tolerance in patients with Graves' hyperthyroidism.

PubMed

Yang, Liyong; Shen, Ximei; Yan, Sunjie; Yuan, Xin; Lu, Juanjuan; Wei, Wenfeng

2013-07-01

To assess the suitability of HbA1c as a criterion for the diagnosis of diabetes in patients with Graves' disease. This study enrolled 310 patients with untreated newly diagnosed Graves' disease, 208 patients with euthyroid goiter and 329 age-matched (control) subjects without thyroid disease from Fuzhou, China. The performance of HbA1c against the OGTT for diagnosing diabetes was determined. The Framingham risk score was used to assess general cardiovascular disease (CVD) risk. The percentage of patients with abnormal glucose metabolism as classified by HbA1c levels was lower than by OGTT criteria in patients with Graves' disease-33.2% vs. 41.3% for pre-diabetes and 4.5% vs. 11.3% for diabetes, respectively. The sensitivity of HbA1c for diagnosing diabetes in patients with Graves' disease was lower than in patients with euthyroid goiter and subjects without thyroid disease (34.9%, 63.2% and 60.6% respectively), while the specificity was similar (99.3%, 98.6%, 97.4%). Approximately 7.4% of patients with Graves' disease diagnosed with diabetes according to OGTT criteria were misdiagnosed as not having the disease by HbA1c, much higher than that for the other two groups. Patients with Graves' disease with diabetes not diagnosed with the disease by HbA1c showed a high risk for CVD. The low sensitivity of the HbA1c criterion underestimated the percentage of diabetes in patients with Graves' disease. Patients with diabetes who were misdiagnosed as not having the disease by HbA1c were at high risk for CVD. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Risk of suicidal ideation in diabetes varies by diabetes regimen, diabetes duration, and HbA1c level.

PubMed

Lee, Hoo-Yeon; Hahm, Myung-Il; Lee, Sang Gyu

2014-04-01

To investigate patient subgroups based on the clinical characteristics of diabetes to evaluate risk factors for suicidal ideation using a large population-based sample in South Korea. Data from the Fifth Korea National Health and Nutrition Examination Survey, a cross-sectional, nationally representative survey, were analyzed. The participants were 9159 subjects aged ≥40years. We defined patients with diabetes based on self-reported physician-diagnosed diabetes. We evaluated clinical risk factors for suicidal ideation according to diabetes regimen, diabetes duration, and glycated hemoglobin (HbA1c) level compared with no diabetes. Given the complex sample design and unequal weights, we analyzed weighted percentages and used survey logistic regression. Diabetes per se was not associated with suicidal ideation. However, suicidal ideation was significantly more prevalent among patients who had injected insulin, had a duration of diabetes ≥5years and had HbA1c levels ≥6.5 compared with those without diabetes. Depressive symptoms were the most prominent predictor of suicidal ideation. Insulin therapy, diabetes of long duration, and unsatisfactory glycemic control were identified as risk factors for suicidal ideation; thus, patients with these characteristics warrant special attention. Our findings suggest the need to integrate efforts to manage emotional distress into diabetes care. Copyright © 2014 Elsevier Inc. All rights reserved.

Reduced risk of hypoglycemia with once-daily glargine versus twice-daily NPH and number needed to harm with NPH to demonstrate the risk of one additional hypoglycemic event in type 2 diabetes: Evidence from a long-term controlled trial

PubMed Central

Rosenstock, Julio; Fonseca, Vivian; Schinzel, Stefan; Dain, Marie-Paule; Mullins, Peter; Riddle, Matthew

2016-01-01

Aims This analysis evaluated HbA1c-adjusted hypoglycemia risk with glargine versus neutral protamine Hagedorn (NPH) over a 5-year study in patients with Type 2 diabetes mellitus (T2DM). Clinical significance was assessed using number needed to harm (NNH) to demonstrate the risk of one additional patient experiencing at least one hypoglycemic event. Methods Individual patient-level data for symptomatic documented hypoglycemia and HbA1c values from a 5-year randomized study comparing once-daily glargine (n = 513) with twice-daily NPH (n = 504) were analyzed. Symptomatic hypoglycemia was categorized according to concurrent self-monitoring blood glucose levels and need for assistance. Hypoglycemic events per patient-year as a function of HbA1c were fitted by negative binomial regression using treatment and HbA1c at endpoint as independent variables. An estimate of NNH was derived from logistic regression models. Results The cumulative number of symptomatic hypoglycemia events was consistently lower with glargine compared with NPH over 5 years. Compared with twice-daily NPH, once-daily glargine treatment resulted in significantly lower adjusted odds ratios (OR) for all daytime hypoglycemia (OR 0.74; p = 0.030) and any severe event (OR 0.64; p = 0.035), representing a 26% and 36% reduction in the odds of daytime and severe hypoglycemia, respectively. Our model predicts that, if 25 patients were treated with NPH instead of glargine, then one additional patient would experience at least one severe hypoglycemic event. Conclusions This analysis of long-term insulin treatment confirms findings from short-term studies and demonstrates that glargine provides sustained, clinically meaningful reductions in risk of hypoglycemia compared with NPH in patients with T2DM. PMID:24856612

Impact of perioperative hypoglycaemia in subjects with diabetes undergoing colorectal surgery.

PubMed

Goh, Si Ning Serene; Yeoh, Ester; Tan, Kok Yang

2017-02-01

This study explores the association between perioperative hypoglycaemia and surgical outcomes in subjects with diabetes, undergoing colorectal surgery. A retrospective review of 149 subjects with Type 2 Diabetes Mellitus (DM) who underwent colorectal surgery between 2010 and 2015 was performed. Perioperative glucose levels, glycated haemoglobin (HbA1c) measurements within 3 months of surgery and surgical complications based on Clavien-Dindo classification were analysed. The mean age was 67 years (67 ± 11.2). Perioperative hypoglycaemia was found in 7.4% of subjects. The mean HbA1c of subjects with Clavien 2 and above surgical complications were higher than patients with Clavien 1 or no complications, Hba1c 7.6% (7.6 ± 2.5%) and 7.0% (7.0 ± 1.1%, p = 0.008), respectively. Similar findings in subjects with Clavien 3 and above complications, HbA1c of 8.2% (8.2 ± 3.9%) as compared to those with Clavien 2 and below complications, 7.2% (7.2 ± 1.5%, p = 0.001). Adjusted multivariate analysis showed that hypoglycaemia was significantly associated with Clavien 2 and above surgical complications, OR of 19.0 (CI 2.23-162, p = 0.007). Preoperative hypoglycaemia was associated with Clavien 2 and above surgical complications, OR 10.7 (CI 1.22-94.1, p = 0.032). Suboptimal glycaemic control (Hba1c >8.0%) was significantly associated with Clavien 2 and above complications, OR 2.48 (CI 1.04-5.91, p = 0.04), but not with Clavien 3 and above complications, OR 1.50 (CI 0.450-4.98, p = 0.511). Perioperative hypoglycaemia is associated with adverse surgical outcomes in diabetic patients undergoing colorectal surgery. Prevention of hypoglycaemia may improve surgical outcomes. HbA1c is an independent predictor for adverse surgical outcomes.

Do Pre-Existing Diabetes Social Support or Depressive Symptoms Influence the Effectiveness of a Diabetes Management Intervention?

PubMed Central

Rosland, Ann-Marie; Kieffer, Edith; Spencer, Michael; Sinco, Brandy; Palmisano, Gloria; Valerio, Melissa; Nicklett, Emily; Heisler, Michele

2015-01-01

Objective Examine influences of diabetes-specific social support (D-SS) and depressive symptoms on glycemic control over time, among adults randomized to a diabetes self-management education and support (DSME/S) intervention or usual care. Methods Data were from 108 African-American and Latino participants in a six-month intervention trial. Multivariable linear regression models assessed associations between baseline D-SS from family and friends and depressive symptoms with changes in HbA1c. We then examined whether baseline D-SS or depression moderated intervention-associated effects on HbA1c. Results Higher baseline D-SS was associated with larger improvements in HbA1c (adjusted ΔHbA1c -0.39% for each +1-point D-SS, p=0.02), independent of intervention-associated HbA1c decreases. Baseline depressive symptoms had no significant association with subsequent HbA1c change. Neither D-SS nor depression moderated intervention-associated effects on HbA1c. Conclusions and Practice Implications Diabetes self-management education and support programs have potential to improve glycemic control for participants starting with varying levels of social support and depressive symptoms. Participants starting with more support for diabetes management from family and friends improved HbA1c significantly more over six months than those with less support, independent of additional significant DSME/S intervention-associated HbA1c improvements. Social support from family and friends may improve glycemic control in ways additive to DSME/S. PMID:26234800

HbA1c Measured in Stored Erythrocytes Is Positively Linearly Associated with Mortality in Individuals with Diabetes Mellitus

PubMed Central

Sluik, Diewertje; Boeing, Heiner; Montonen, Jukka; Kaaks, Rudolf; Lukanova, Annekatrin; Sandbaek, Annelli; Overvad, Kim; Arriola, Larraitz; Ardanaz, Eva; Saieva, Calogero; Grioni, Sara; Tumino, Rosario; Sacerdote, Carlotta; Mattiello, Amalia; Spijkerman, Annemieke M. W.; van der A, Daphne L.; Beulens, Joline W. J.; van Dieren, Susan; Nilsson, Peter M.; Groop, Leif C.; Franks, Paul W.; Rolandsson, Olov; Bueno-de-Mesquita, Bas; Nöthlings, Ute

2012-01-01

Introduction Observational studies have shown that glycated haemoglobin (HbA1c) is related to mortality, but the shape of the association is less clear. Furthermore, disease duration and medication may modify this association. This observational study explored the association between HbA1c measured in stored erythrocytes and mortality. Secondly, it was assessed whether disease duration and medication use influenced the estimates or were independently associated with mortality. Methods Within the European Prospective Investigation into Cancer and Nutrition a cohort was analysed of 4,345 individuals with a confirmed diagnosis of diabetes at enrolment. HbA1c was measured in blood samples stored up to 19 years. Multivariable Cox proportional hazard regression models for all-cause mortality investigated HbA1c in quartiles as well as per 1% increment, diabetes medication in seven categories of insulin and oral hypoglycaemic agents, and disease duration in quartiles. Results After a median follow-up of 9.3 years, 460 participants died. Higher HbA1c was associated with higher mortality: Hazard Ratio for 1%-increase was 1.11 (95% CI 1.06, 1.17). This association was linear (P-nonlinearity =0.15) and persistent across categories of medication use, disease duration, and co-morbidities. Compared with metformin, other medication types were not associated with mortality. Longer disease duration was associated with mortality, but not after adjustment for HbA1c and medication. Conclusion This prospective study showed that persons with lower HbA1c had better survival than those with higher HbA1c. The association was linear and independent of disease duration, type of medication use, and presence of co-morbidities. Any improvement of HbA1c appears to be associated with reduced mortality risk. PMID:22719972

A real-world analysis of glycemic control among patients with type 2 diabetes treated with canagliflozin versus dapagliflozin.

PubMed

Blonde, Lawrence; Patel, Charmi; Bookhart, Brahim; Pfeifer, Michael; Chen, Yen-Wen; Wu, Bingcao

2018-06-01

This US retrospective cohort study compared the real-world effectiveness of canagliflozin 300 mg versus dapagliflozin 10 mg on HbA1c reduction in patients with type 2 diabetes mellitus (T2DM). Patients initiated on canagliflozin 300 mg or dapagliflozin 10 mg were identified from de-identified claims data in the Optum Clinformatics database (1 January 2014-30 September 2016). Propensity score matching was used to create balanced cohorts. The primary outcome was the proportion of patients with HbA1c <8.0% (HEDIS target); secondary outcomes included the proportion of patients with HbA1c <7.0% (ADA target) and >9.0% (HEDIS poor control), absolute change in HbA1c, and treatment patterns. At 6 months post-index (intent-to-treat population), a significantly higher proportion of patients in the canagliflozin 300 mg versus dapagliflozin 10 mg cohort achieved HbA1c <8.0% (70.8% vs. 59.1%; OR [95% CI]: 1.60 [1.26, 2.04]; p = .0001) and HbA1c <7.0% (36.7% vs. 25.1%; OR [95% CI]: 1.75 [1.34, 2.27]; p < .0001). A similar proportion of patients had HbA1c >9.0%. Mean HbA1c reduction was -1.17% with canagliflozin 300 mg and -0.91% with dapagliflozin 10 mg (difference of -0.26%; p = .0049). HbA1c results from a sensitivity analysis in the on-treatment population were consistent with the primary analysis. Patients in the canagliflozin 300 mg versus dapagliflozin 10 mg cohort were less likely to discontinue treatment (OR [95% CI]: 0.75 [0.57, 0.99]; p = .0400) or switch medication (OR [95% CI]: 0.72 [0.54, 0.96]; p = .0229). In this real-world study, patients with T2DM initiated on canagliflozin 300 mg had better HbA1c goal attainment and larger HbA1c reduction than patients initiated on dapagliflozin 10 mg.

The Impact of Electronic Health Records and Teamwork on Diabetes Care Quality

PubMed Central

Graetz, Ilana; Huang, Jie; Brand, Richard; Shortell, Stephen M.; Rundall, Thomas G.; Bellows, Jim; Hsu, John; Jaffe, Marc; Reed, Mary E.

2016-01-01

Objective Evidence of the impact Electronic Health Records (EHR) on clinical outcomes remains mixed. The impact EHRs likely depends on the organizational context in which they are used. We focus on one aspect of the organizational context: cohesion of primary care teams. We examined whether team cohesion among primary care team members changed the association of EHR use and changes in clinical outcomes for patients with diabetes. Study Design We combined provider-reported primary care team cohesion with lab values for patients with diabetes collected during the staggered EHR implementation (2005–2009). We used multivariate regression models with patient-level fixed effects to assess whether team cohesion levels changed the association between outpatient EHR use and clinical outcomes for patients with diabetes. Subjects 80,611 patients with diabetes mellitus. Measures Changes in hemoglobin A1c (HbA1c) and low-density lipoprotein cholesterol (LDL-C) Results For HbA1c, EHR use was associated with an average decrease of 0.11% for patients with higher cohesion primary care teams compared with a decrease of 0.08% for patients with lower cohesion teams (difference 0.02% in HbA1c, 95%CI: 0.01–0.03). For LDL-C, EHR use was associated with a decrease of 2.15 mg/dL for patients with higher cohesion primary teams compared with a decrease of 1.42 mg/dL for patients with lower cohesion teams (difference 0.73 mg/dL, 95%CI: 0.41–1.11 mg/dL). Conclusions Patients cared for by higher cohesion primary care teams experienced modest but statistically significantly greater EHR-related health outcome improvements, compared with patients cared for by providers practicing in lower cohesion teams. PMID:26671699

Lipoprotein(a) predicts the development of diabetic retinopathy in people with type 2 diabetes mellitus.

PubMed

Yun, Jae-Seung; Lim, Tae-Seok; Cha, Seon-Ah; Ahn, Yu-Bae; Song, Ki-Ho; Choi, Jin A; Kwon, Jinwoo; Jee, Donghyun; Cho, Yang Kyung; Park, Yong-Moon; Ko, Seung-Hyun

2016-01-01

Lipoprotein(a) [Lp(a)] has mainly been considered to be a predictor of the incidence of cardiovascular disease. In addition, previous studies have shown potential linkage between Lp(a) and diabetic microvascular complications. We investigated the incidence and risk factors for the development of diabetic retinopathy (DR) in patients with type 2 diabetes. A total of 787 patients with type 2 diabetes without DR were consecutively enrolled and followed up prospectively. Retinopathy evaluation was annually performed by ophthalmologists. The main outcome was new onset of DR. The median follow-up time was 11.1 years. Patients in the DR group had a longer duration of diabetes (P < .001), higher baseline HbA1c (P < .001), higher albuminuria level (P = .033), and higher level of Lp(a) (P = .005). After adjusting for sex, age, diabetes duration, presence of hypertension, renal function, LDL cholesterol, mean HbA1c, and medications, the development of DR was significantly associated with the serum Lp(a) level (HR 1.57, 95% confidence interval [1.11-2.24]; P = .012, comparing the 4th vs 1st quartile of Lp(a)). The patient group with the highest quartile range of Lp(a) and mean HbA1c levels ≥7.0% had an HR of 5.09 (95% confidence interval [2.63-9.84]; P < .001) for developing DR compared with patients with lower levels of both factors. In this prospective cohort study, we demonstrated that the DR was independently associated with the serum Lp(a) level in patients with type 2 diabetes. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Do patients with diabetes and low socioeconomic status receive less care and have worse outcomes? A national study.

PubMed

Jotkowitz, Alan B; Rabinowitz, Gad; Raskin Segal, Anat; Weitzman, Ron; Epstein, Leon; Porath, Avi

2006-08-01

The objective of the study was to assess the influence of socioeconomic status (SES) on the care of patients with diabetes. Quality indicators for patients who were taking medication for diabetes were established. Overall compliance with the quality indicators, as well as prevalence of diabetes by age, were obtained from a national database. Patients with national tax exemptions (used as a marker for low SES) were compared to those without. Of 4,110,852 citizens aged 18-74, 210,988 (5.1%) were receiving medication for diabetes. The prevalence of diabetes reached 19.9% in people aged 65-74. 495,392 citizens had an exemption, and they had a higher prevalence of diabetes that those who did not (15.4% vs. 3.7%). Patients with an exemption had a higher rate of having a yearly HbA1c done, a yearly LDL level done, a yearly eye exam, a yearly urinary protein exam, of being treated with insulin for an elevated HbA1c than those without an exemption. In patients with an exemption there was a lower percentage with an HbA1c less than 7%, a higher percentage with an HbA1c greater than 9%, and a lower percentage with an LDL less than 130. Multivariate analysis showed that exemption status was a predictor of better performance on process measures (LDL test done, OR-1.03, 95% CI 1.01-1.06, HbA1c test done, OR 1.03, 95% CI- 1.01-1.05) and of worse outcomes (high LDL, OR 0.92, 95% CI, 0.90-0.95 and high HbA1c, OR, 0.85, 95% CI, 0.83-0.87). In a country with universal healthcare, patients from a lower SES had an increased prevalence of diabetes and had greater adherence to preventive healthcare measures However, they were less successful in meeting target treatment goals.

Ursodeoxycholic acid potentiates dipeptidyl peptidase-4 inhibitor sitagliptin by enhancing glucagon-like peptide-1 secretion in patients with type 2 diabetes and chronic liver disease: a pilot randomized controlled and add-on study

PubMed Central

Ota, Tsuguhito; Kato, Ken-ichiro; Takeshita, Yumie; Misu, Hirofumi; Kaneko, Shuichi

2018-01-01

Objective We evaluated the effects of ursodeoxycholic acid (UDCA) on glucagon-like peptide-1 (GLP-1) secretion and glucose tolerance in patients with type 2 diabetes with chronic liver disease. Research design and methods Japanese patients with type 2 diabetes (glycated hemoglobin (HbA1c) levels ≥7.0%) and chronic liver disease were included in this study. Sixteen patients (HbA1c level, 7.2%±0.6%(55.2 mmol/mol)) were randomized to receive 900 mg UDCA for 12 weeks followed by 50 mg sitagliptin add-on therapy for 12 weeks (UDCA-first group; n=8) or 50 mg sitagliptin for 12 weeks followed by 900 mg UDCA add-on therapy for 12 weeks (sitagliptin-first group; n=8). All patients underwent a liquid high-fat meal test before and after 12 or 24 weeks of treatment. Results The baseline characteristics were similar between the UDCA-first and sitagliptin-first groups. There was a decrease in body weight (72.5±8.4 to 70.6±8.6 kg; P=0.04) and the HbA1c level (7.0%±0.3% to 6.4%±0.5%(53.0 to 46.4 mmol/mol); P=0.01) in the UDCA-first group. The HbA1c level decreased further after sitagliptin administration (6.4%±0.5% to 6.0%±0.4%(46.4 to 42.1 mmol/mol); P<0.01). Although there were no initial changes in the weight and HbA1c level in the sitagliptin-first group, the HbA1c level decreased after UDCA addition (7.1%±1.1% to 6.6%±0.9%(54.1 to 48.6 mmol/mol); P=0.04). UDCA alone increased the area under the curve0–30 for GLP-1 response (115.4±47.2 to 221.9±48.9 pmol·min/L; P<0.01), but not the glucose-dependent insulinotropic polypeptide response, in the UDCA-first group. Conclusions UDCA treatment resulted in a greater reduction in HbA1c levels, and an increased early phase GLP-1 secretion. Trial registration number NCT01337440. PMID:29607050

Prediction of Adolescents’ Glycemic Control 1 Year After Diabetes-Specific Family Conflict

PubMed Central

Hilliard, Marisa E.; Guilfoyle, Shanna M.; Dolan, Lawrence M.; Hood, Korey K.

2015-01-01

Objective To test adherence to blood glucose monitoring (BGM) as a mediator between diabetes-specific family conflict and glycemic control (hemoglobin A1c [HbA1c] levels) for 1 year. Design Three waves of prospective data spanning 1 year. Setting Diabetes clinic in a large tertiary care children’s hospital in the Midwestern United States. Participants One hundred forty-five dyads composed of an adolescent (aged 13–18 years) with type 1 diabetes mellitus and a parent. Main Exposures Adolescent- and parent-rated diabetes-specific family conflict and mean daily BGM frequency obtained through meter downloads. Main Outcome Measure Levels of HbA1c, abstracted from the medical record. Results In separate general linear models, higher adolescent-rated family conflict scores at baseline predicted less frequent BGM at 6 months (β=−0.08 [P=.01]) and higher HbA1c levels at 12 months (β=0.08 [P=.02]). In the multivariate model including baseline conflict and BGM as predictors of HbA1c levels, BGM was a significant predictor (β=−0.24 [P=.007]) and conflict was no longer significant (β=0.05 [P=.11]), supporting the mediation hypothesis. Post hoc probing showed that BGM explained 24% of the variance in the conflict-HbA1c link. The mediation between parent-reported conflict andHbA1c levels via BGM adherence was partially supported (conflict predicting HbA1c in the zero-order equation, β=−0.24 [P=.004]; multivariate equation, β=0.06 [P=.02]), and BGM frequency explained 16% of the conflict-HbA1c link. Conclusions Diabetes-specific family conflict in adolescence predicts deteriorations in BGM and subsequent glycemic control for at least 1 year. Results support ongoing intervention research designed to reduce family conflict and thus prevent a trajectory of declining adherence and glycemic control across adolescence. PMID:21727273

The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.

PubMed

Goldfine, Allison B; Fonseca, Vivian; Jablonski, Kathleen A; Pyle, Laura; Staten, Myrlene A; Shoelson, Steven E

2010-03-16

Salsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies. To compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes. Parallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678) 3 private practices and 14 universities in the United States. Persons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (< or = 225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks. After a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy. Change in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes. Higher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were -0.36% (P = 0.02) at 3.0 g/d, -0.34% (P = 0.02) at 3.5 g/d, and -0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated. The number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time. Salsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

The Effects of Salsalate on Glycemic Control in Patients With Type 2 Diabetes

PubMed Central

Goldfine, Allison B.; Fonseca, Vivian; Jablonski, Kathleen A.; Pyle, Laura; Staten, Myrlene A.; Shoelson, Steven E.

2011-01-01

Background Salsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies. Objective To compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes. Design Parallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678) Setting 3 private practices and 14 universities in the United States. Patients Persons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (≤225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks. Intervention After a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy. Measurements Change in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes. Results Higher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were −0.36% (P = 0.02) at 3.0 g/d, −0.34% (P = 0.02) at 3.5 g/d, and −0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated. Limitation The number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time. Conclusion Salsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation. Primary Funding Source National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. PMID:20231565

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.

Pharmacist-led, primary care-based disease management improves hemoglobin A1c in high-risk patients with diabetes.

PubMed

Rothman, Russell; Malone, Robb; Bryant, Betsy; Horlen, Cheryl; Pignone, Michael

2003-01-01

We developed and evaluated a comprehensive pharmacist-led, primary care-based diabetes disease management program for patients with Type 2 diabetes and poor glucose control at our academic general internal medicine practice. The primary goal of this program was to improve glucose control, as measured by hemoglobin A1c (HbA1c). Clinic-based pharmacists offered support to patients with diabetes through direct teaching about diabetes, frequent phone follow-up, medication algorithms, and use of a database that tracked patient outcomes and actively identified opportunities to improve care. From September 1999, to May 2000, 159 subjects were enrolled, and complete follow-up data were available for 138 (87%) patients. Baseline HbA1c averaged 10.8%, and after an average of 6 months of intervention, the mean reduction in HbA1c was 1.9 percentage points (95% confidence interval, 1.5-2.3). In predictive regression modeling, baseline HbA1c and new onset diabetes were associated with significant improvements in HbA1c. Age, race, gender, educational level, and provider status were not significant predictors of improvement. In conclusion, a pharmacist-based diabetes care program integrated into primary care practice significantly reduced HbA1c among patients with diabetes and poor glucose control.

The impact of carbohydrate intake and its sources on hemoglobin A1c levels in Japanese patients with type 2 diabetes not taking anti-diabetic medication

PubMed Central

Haimoto, Hajime; Watanabe, Shiho; Komeda, Masashi; Wakai, Kenji

2018-01-01

Background Although postprandial glucose levels largely depend on carbohydrate intake, the impact of carbohydrate and its sources on hemoglobin A1c (HbA1c) levels has not been demonstrated in patients with type 2 diabetes (T2DM) probably because, in previous studies, more than 50% of patients were taking anti-diabetic medication, and the researchers used energy percent of carbohydrate as an indicator of carbohydrate intake. Patients and methods We recruited 125 Japanese men (mean age 58±12 years) and 104 women (mean age 62±10 years) with T2DM who were not taking anti-diabetic medication and dietary therapy. We used 3-day dietary records to assess total carbohydrate intake and its sources, computed Spearman’s correlation coefficients, and conducted multiple regression analyses for associations of carbohydrate sources with HbA1c by sex. Results Mean HbA1c and total carbohydrate intake were 8.2%±1.9% and 272.0±84.6 g/day in men and 7.6%±1.3% and 226.7±61.5 g/day in women, respectively. We observed positive correlation of total carbohydrate intake (g/day) with HbA1c in men (rs=0.384) and women (rs=0.251), but no correlation for % carbohydrate in either sex. Regarding carbohydrate sources, we found positive correlations of carbohydrate from noodles (rs=0.231) and drinks (rs=0.325), but not from rice, with HbA1c in men. In women, carbohydrate from rice had a positive correlation (rs=0.317), but there were no correlations for carbohydrate from noodles and drinks. The association of total carbohydrate intake (g/day) and carbohydrate from soft drinks with HbA1c in men remained significant even after adjustment for total energy by multiple regression analyses. Conclusion Our findings warrant interventional studies for moderate low-carbohydrate diets that focus on carbohydrate sources and sex differences in order to efficiently decrease HbA1c in patients with T2DM. PMID:29563823

Use of HbA1c to diagnose type 2 diabetes mellitus among high risk Sri Lankan adults.

PubMed

Herath, H M M; Weerarathna, T P; Dahanayake, M U; Weerasinghe, N P

Even though, glycosylated hemoglobin (HbA1c) was found to be effective in predicting diabetes especially in Caucasians there is limited evidence of its diagnostic utility in high risk Sri Lankan adults. This study aimed to determine the optimal HbA1c cut-off points for detecting diabetes in a high risk population in Sri Lanka. This community based study consisted of 254 previously healthy adults with history of diabetes in one or more first-degree relatives. Fasting plasma glucose (FPG) , glucose tolerance test (GTT) and HbA1c were measured in all and GTT was used as a reference to diagnose diabetes. Receiver operating characteristic curve was created to find the optimum HbA1c cut-off value to predict diabetes. Prevalence of diabetes was 12.2% (n=31) with FPG and 16.1% (n=41) with GTT. Prevalence rose to 27.6% (P<0.01) when HbA1c with cut-off of ≥6.5% was used as the diagnostic test. The ROC curves showed the HbA1c threshold of 6.3% provided the optimum balance between sensitivity (80.5%) and specificity (79%). In compared to GTT, FPG had only a modest sensitivity (65%) in diagnosing diabetes in this high risk population. Our study showed that optimum HbA1C cut-off for detecting diabetes was 6.3% and it had better sensitivity, but lower specificity than FPG. This study further showed that the prevalence of diabetes would become double if HbA1c is used over FPG to screen this high risk population. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

PubMed

Sajatovic, Martha; Gunzler, Douglas D; Kanuch, Stephanie W; Cassidy, Kristin A; Tatsuoka, Curtis; McCormick, Richard; Blixen, Carol E; Perzynski, Adam T; Einstadter, Douglas; Thomas, Charles L; Lawless, Mary E; Martin, Siobhan; Falck-Ytter, Corinna; Seeholzer, Eileen L; McKibben, Christine L; Bauer, Mark S; Dawson, Neal V

2017-09-01

A 60-week randomized controlled trial assessed the effects of targeted training in illness management (TTIM) versus treatment as usual among 200 individuals with serious mental illness and diabetes mellitus. The study used the Clinical Global Impression (CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Brief Psychiatric Rating Scale (BPRS) to assess psychiatric symptoms; the Global Assessment of Functioning (GAF) and the Sheehan Disability Scale (SDS) to assess functioning; the 36-Item Short-Form Health Survey (SF-36) to assess general health, and serum glycosylated hemoglobin (HbA1c) to assess diabetes control. Participants' mean±SD age was 52.7±9.5 years, and 54% were African American. They were diagnosed as having depression (48%), schizophrenia (25%), and bipolar disorder (28%). At baseline, depression severity was substantial but psychosis severity was modest. At 60 weeks, there was greater improvement among TTIM participants versus treatment-as-usual recipients on the CGI (p<.001), the MADRS (p=.016), and the GAF (p=.003). Diabetes knowledge was significantly improved among TTIM participants but not in the treatment-as-usual group. In post hoc analyses among participants whose HbA1c levels at baseline met recommendations set by the American Diabetes Association for persons with high comorbidity (53%), TTIM participants had minimal change in HbA1c over the 60-week follow-up, whereas HbA1c levels worsened in the treatment-as-usual group. TTIM was associated with improved psychiatric symptoms, functioning, and diabetes knowledge compared with treatment as usual. Among participants with better diabetes control at baseline, TTIM participants had better diabetes control at 60 weeks compared with recipients of treatment as usual.

Hemoglobin A1c Point-of-Care Assays; a New World with a Lot of Consequences!

PubMed Central

Lenters-Westra, Erna; Slingerland, Robbert J.

2009-01-01

Background Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly. PMID:20144277

The Impact of HbA1c Testing on Total Annual Healthcare Expenditures Among Newly Diagnosed Patients with Diabetes.

PubMed

Bhounsule, Prajakta; Peterson, Andrew M

2015-09-01

In 2010, diabetes was the seventh leading cause of death in the United States. Diabetes also imposes a huge financial burden on the US economy. In 2009, the American Diabetes Association International Expert Committee recommended the use of the glycated hemoglobin (HbA1c) test as a uniform diagnostic measure to identify patients with diabetes. Although HbA1c is a convenient diagnostic test, it is also more expensive than older tests and could, therefore, have an impact on patients' healthcare expenditures. To determine if HbA1c testing has an impact on total annual healthcare expenditures among newly diagnosed patients with diabetes and to analyze the factors that are associated with the total healthcare expenditures among diabetic patients before and after HbA1c was implemented as a standard diagnostic factor. This was an observational, retrospective, cross-sectional study. The Medical Expenditure Panel Survey-Household Component 2009 and 2011 databases were used to form the study cohort of patients with diabetes. The total mean healthcare expenditures among patients with diabetes formed the dependent variable. A proxy variable representing a diagnosis of diabetes with and without the use of HbA1c testing in 2009 and in 2011, respectively, formed the main independent variable along with demographic factors, comorbidities, and healthcare services utilization in both years. A generalized linear regression was conducted to determine the association of HbA1c testing with total diabetes-related healthcare expenditures. The mean total healthcare expenditure decreased in 2011 compared with 2009. The HbA1c test did not show an association with the total healthcare expenditures versus earlier diabetes-related diagnostic factors. The total expenditures were associated with private insurance, the incidence of a previous heart attack, prescription drug refills, inpatient hospital stays, home care, hospital discharges, and visits to outpatient providers and physicians in both years. The HbA1c diagnostic factor did not yield any association with diabetes healthcare expenditures. Although the total healthcare expenditures were reduced in 2011 compared with 2009, it cannot be established that the reduction in costs is solely attributed to the implementation of the HbA1c diagnostic criteria. Further research on healthcare expenditures for diabetic patients diagnosed with and without the use of HbA1c testing is warranted to establish any possible association.

Increased glycemic variability and decrease of the postprandial glucose contribution to HbA1c in obese subjects across the glycemic continuum from normal glycemia to first time diagnosed diabetes.

PubMed

Fysekidis, Marinos; Cosson, Emmanuel; Banu, Isabela; Duteil, Régine; Cyrille, Chantal; Valensi, Paul

2014-12-01

The contribution of postprandial glycemia (PPG) to hyperglycemia has been shown to decrease as HbA1c increased in type 2 diabetic patients. This study aimed at examining, in a series of overweight/obese patients without known glycemic disorder, the contribution of PPG to a "relative" hyperglycemia (glucose values≥5.5 mmol/L) and the presence of glycemic variability according to HbA1c levels. Seventy overweight/obese inpatients (body mass index 35.2±6.8 kg/m2) without known glycemic disorder were included. Participants were classified according to an oral glucose tolerance test (according to the American Diabetes Association criteria) as patients with normoglycemia (n=33), with intermediate hyperglycemia (n=24) or diabetes (n=13). They were separated into HbA1c quartiles (Q1 to Q4). A 24 hour continuous glucose monitoring was used under a 1800 kcal diet and minimal physical activity. We assessed PPG contribution (3 hour period after each meal) to the "relative" 24 hour hyperglycemia (glucose values ≥5.5 mmol/L); the remaining time was considered as the fasting/post-absorptive period. HbA1c range was from 5.1% to 7.4% (32 to 57 mmol/mmol). From the lowest to the highest HbA1c quartile, the area under the curve (AUC) for the "relative" hyperglycemia presented a 17-fold increase for the fasting/post-absorptive (p<0.001) period and a 7-fold increase postprandially (p<0.001). The percent of PPG contribution to the "relative" hyperglycemia was calculated with the following formula [100×(postprandial 3 hour AUC-3 h AUC for a constant 5.5 mmol/L glycemia)/(total 24 h AUC-24 h AUC for constant 5. 5 mmol/L glycemia)] and decreased from Q1 to Q4 of HbA1c (81.2%, 66%, 65.8%, 57%; p<0.001). Increasing HbA1c quartiles were associated with higher daily mean blood glucose level (p<0.001) and higher levels of daily glucose variability indices, including mean amplitude of glycemic excursions (p<0.01). In overweight/obese patients, HbA1c was associated with lower PPG contribution to "relative" hyperglycemia and greater glycemic variability. The present findings support the importance of postprandial period in glycemic exposure even before the appearance of diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial.

PubMed

Tinahones, F J; Gross, J L; Onaca, A; Cleall, S; Rodríguez, A

2014-10-01

To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. A multinational, randomized, open-label trial that compared insulin lispro low mixture (LM25; n = 236) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily (IGL; n = 240) over 24 weeks in patients with HbA1c 7.5-10.5% and fasting plasma glucose ≤ 6.7 mmol/l. The primary objective was to assess non-inferiority [per-protocol (PP) population], and then superiority [intention-to-treat (ITT) population], of LM25 versus IGL according to change in HbA1c after 24 weeks (non-inferiority margin 0.4%, two-sided significance level 0.05). Estimated change [least squares (LS) mean (95% CI)] in HbA1c after 24 weeks: -1.30 (-1.44, -1.16)% with LM25 and -1.08 (-1.22, -0.94)% with IGL. Non-inferiority was shown [LS mean (95% CI) HbA1c treatment difference -0.21 (-0.38, -0.04) (PP population)]; gated superiority assessment showed a statistically significant advantage for LM25 (p = 0.010; ITT population). Mean blood glucose, glycaemic variability, overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study. In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone, intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes. © 2014 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.

HbA1c for diagnosis and prognosis of gestational diabetes mellitus.

PubMed

Kwon, Soon Sung; Kwon, Ja-Young; Park, Yong-Won; Kim, Young-Han; Lim, Jong-Baeck

2015-10-01

HbA1c is a widely used marker in diagnosing type 2 diabetes mellitus (DM), but its clinical utility in diagnosing gestational diabetes mellitus (GDM) is not established. Here, we evaluated the clinical usefulness of HbA1c in diagnosing GDM and predicting the risk of future type 2 DM development among GDM patients. This retrospective, cross-sectional study included 321 subjects who underwent 100-g oral glucose tolerance tests (OGTT) during pregnancy. HbA1c and other variables were analyzed to evaluate their diagnostic performance for GDM. To evaluate the clinical usefulness of HbA1c in predicting future type 2 DM development, we classified GDM subjects who had more than 3 months of follow-up data into two subgroups: those who developed postpartum type 2 DM (PDM) and those who did not. HbA1c was significantly higher in the GDM group than in the normal control group. With the 100-g OGTT as reference, HbA1c showed 91.3% sensitivity and 62% specificity at a cut-off value of 5.05% (32 mmol/mol) for GDM diagnosis. At a cut-off value of 5.25% (34 mmol/mol), sensitivity was 73.6% and specificity was 77.2%. HbA1c levels during pregnancy were higher in those with PDM than in those without PDM (5.91 [41 mmol/mol] vs. 5.44% [36 mmol/mol], p<0.001). The prognostic value of HbA1c for PDM was evaluated by ROC curve analysis, with sensitivity of 78.6% and specificity of 72.5% at a cut-off value of 5.55% (37 mmol/mol). HbA1c showed high sensitivity with relatively low specificity for diagnosis of GDM in pregnant women and was a potential predictor of PDM. HbA1c may be able to be used as a simple and less invasive alternative screening test for OGTT in GDM patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Mobile phone intervention to improve diabetes care in rural areas of Pakistan: a randomized controlled trial.

PubMed

Shahid, Muhammad; Mahar, Saeed Ahmed; Shaikh, Shiraz; Shaikh, Zuhaib-u-ddin

2015-03-01

To determine the effect of mobile phone intervention on HbA1c in type-2 Diabetes Mellitus (DM) patients living in rural areas of Pakistan. Randomized controlled trial. Department of Endocrinology, Liaquat National Hospital, Karachi, from December 2013 to June 2014. A total of 440 patients in intervention and control groups were enrolled. All patients between 18 - 70 years of age, residing in rural areas of Pakistan, HbA1c ³ 8.0% and having personal functional mobile phone were included. The intervention group patients were called directly on mobile phone after every 15 days for a period of 4 months. They were asked about the self-monitoring blood glucose, intake of medications, physical activity, healthy eating and were physically examined after 4 months. However, the control group was examined initially and after 4 months physically in the clinic and there were no mobile phone contacts with these patients. Patients in intervention group showed improvement (p < 0.001) in following diet plan from 17.3% at baseline to 43.6% at endline, however, the control group showed insignificant increase (p=0.522) from 13.6% at baseline to 15.9% at endline. Intervention group (RR = 2.71, 95% CI = 1.18 - 6.40) showed significant positive association with normalization of HbA1c levels. The relationship was adjusted for age, gender, socio-economic status, ethnicity, education, hypertension, medication, BMI, diet, LDL levels and physical activity. Dietary restriction and low LDL levels also showed significant associations with reduced HbA1c levels on multivariate analysis. Mobile phone technology in rural areas of Pakistan was helpful in lowering HbA1c levels in intervention group through direct communication with the diabetic patients. Lowering LDL and following diabetic diet plan can reduce HbA1c in these patients and help in preventing future complications.

Type II diabetes and personality; a study to explore other psychosomatic aspects of diabetes.

PubMed

Esmaeilinasab, Maryam; Ebrahimi, Mehdi; Mokarrar, Mohsen Heidari; Rahmati, Leila; Mahjouri, Mohammad Yoosef; Arzaghi, Seyed Masoud

2016-01-01

As one of the most common chronic diseases, diabetes and its control are affected by the patients' psychological and spiritual attributes. The present study investigates the relationship between glycemic control in patients with type II diabetes and personality traits, defense mechanisms and spirituality. The present cross-sectional study was conducted on 400 Iranian patients with type II diabetes, 64% were men. Participants completed the NEO Personality Inventory, the Defense Style Questionnaire (DSQ) and the Spiritual Assessment Inventory (SAI) and then underwent a blood sampling for the assessment of HbA1C levels. Of the five personality traits, extraversion ( r =  -0.13 and P <  0.01) and conscientiousness ( r =  -0.13 and P <  0.01) had significant negative relationships with HbA1C HbA1C levels, while neuroticism had a significant positive relationship with HbA1C levels ( r =  0.12 and P <  0.05). Of the defense styles assessed, the neurotic style was found to have a significant negative relationship with HbA1C levels ( r =  -0.1 and P <  0.05). Also, of the spirituality elements, impression management had significant relationship with glycemic control ( r =  0.17 and P <  0.001). According to data, Extraversion and conscientiousness can help control blood sugar while anxiety and negative emotions have detrimental effects on glycemic control. As a result considering psychological counselling beside medical interventions can help to better treatment.

Impact of hypoglycemic events and HbA1c level on sulfonylurea discontinuation and down-titration.

PubMed

Laires, Pedro A; Tang, Jackson; Fan, Chun Po Steve; Li, Zhiyi; Qiu, Ying; Iglay, Kristy

2017-04-01

A retrospective cohort study using GE Centricity electronic medical records assessed the association between post-index hypoglycemia and HbA1c with discontinuation and down-titration of sulfonylureas among patients with Type 2 diabetes mellitus. Adult patients with an index prescription for a sulfonylurea and ≥12 months' continuous records pre- and post-index were eligible. Sulfonylurea discontinuation and down-titration was assessed 1-year post-index. Discontinuation occurred if the date of a prescription was >90 days from the preceding prescription plus days of supply. Down-titration occurred when a subsequent prescription was lower than the index dose. Cox regression assessed the association between post-index hypoglycemia and HbA1c with time to sulfonylurea discontinuation and down-titration, as well as other factors. 28,371 participants were included in the study; 13,459 (47.4%) were discontinuers, 717 (2.5%) were down-titraters, and 14,195 (50.0%) were continuers. 0.6% of continuers experienced hypoglycemia 1-year post-index, compared with 3.1% of down-titraters and 0.8% of discontinuers (p < 0.0001). Patients with post-index hypoglycemia had a significantly higher rate of discontinuation (hazard ratio [HR] = 1.82, 95% CI: 1.47-2.23) and down-titration (HR = 4.25, 95% CI: 1.92-8.03). Patients with higher post-index HbA1c and use of 2 nd generation sulfonylureas had an increased rate of discontinuation (HR = 1.05, 95% CI: 1.04-1.06; HR = 1.19, 95% CI: 1.14-1.24, respectively). Approximately half of participants who initiated sulfonylureas discontinued or down-titrated therapy within one year. Both post-index hypoglycemia and higher HbA1c were significant risk factors for sulfonylurea treatment change.

Comparative prognostic performance of definitions of prediabetes: a prospective cohort analysis of the Atherosclerosis Risk in Communities (ARIC) study.

PubMed

Warren, Bethany; Pankow, James S; Matsushita, Kunihiro; Punjabi, Naresh M; Daya, Natalie R; Grams, Morgan; Woodward, Mark; Selvin, Elizabeth

2017-01-01

No consensus on definitions of prediabetes exists among international organisations. Analysis of associations with different definitions and clinical complications can inform the comparative value of different prediabetes definitions. We compared the risk of future outcomes across different prediabetes definitions based on fasting glucose concentration, HbA 1c , and 2 h glucose concentration during over two decades of follow-up in the community-based Atherosclerosis Risk in Communities (ARIC) study. We aimed to analyse the associations of definitions with outcomes to provide a comparison of different definitions. We did a prospective cohort study of participants in the ARIC study who did not have diagnosed diabetes and who attended visit 2 (1990-92; n=10 844) and who attended visit 4 (1996-98; n=7194). ARIC participants were enrolled from four communities across the USA. Fasting glucose concentration and HbA 1c were measured at visit 2 and fasting glucose concentration and 2 h glucose concentration were measured at visit 4. We compared prediabetes definitions based on fasting glucose concentration (American Diabetes Association [ADA] fasting glucose concentration cutoff 5·6-6·9 mmol/L and WHO fasting glucose concentration cutoff 6·1-6·9 mmol/L), HbA 1c (ADA HbA 1c cutoff 5·7-6·4% [39-46 mmol/mol] and International Expert Committee [IEC] HbA 1c cutoff 6·0-6·4% [42-46 mmol/mol]), and 2 h glucose concentration (ADA and WHO 2 h glucose concentration cutoff 7·8-11·0 mmol/L). Prediabetes defined using the ADA fasting glucose concentration cutoff (prevalence 4112 [38%] of 10 844 people; 95% CI 37·0-38·8) was the most sensitive for major clinical outcomes, whereas using the ADA HbA 1c cutoff (2027 [19%] of 10 884 people; 18·0-19·4) and IEC HbA 1c cutoff (970 [9%] of 10 844 people; 8·4-9·5), and the WHO fasting glucose concentration cutoff (1213 [11%] of 10 844 people; 10·6-11·8) were more specific. After demographic adjustment, HbA 1c -based definitions of prediabetes had higher hazard ratios and better risk discrimination for chronic kidney disease, cardiovascular disease, peripheral arterial disease, and all-cause mortality than did fasting glucose concentration-based definitions (all p<0·05). The C-statistic for incident chronic kidney disease was 0·636 for ADA fasting glucose concentration clinical categories and 0·640 for ADA HbA 1c clinical categories (difference -0·005, 95% CI -0·008 to -0·001). The C-statistics were 0·662 for ADA fasting glucose clinical concentration categories and 0·672 for ADA HbA 1c clinical categories for atherosclerotic cardiovascular disease, 0·701 for ADA fasting glucose concentration clinical categories and 0·722 for ADA HbA 1c clinical categories for peripheral arterial disease, and 0·683 for ADA fasting glucose concentration clinical categories and 0·688 for ADA HbA 1c clinical categories for all-cause mortality. Prediabetes defined using the ADA HbA 1c cutoff showed a significant overall improvement in the net reclassification index for cardiovascular outcomes and death compared with prediabetes defined with glucose-based definitions. ADA fasting glucose concentration clinical categories, WHO fasting glucose concentration clinical categories, and ADA and WHO 2 h glucose concentrations clinical categories were not significantly different in terms of risk discrimination for chronic kidney disease, cardiovascular outcomes, or mortality outcomes. Our results suggest that prediabetes definitions using HbA 1c were more specific and provided modest improvements in risk discrimination for clinical complications. The definition of prediabetes using the ADA fasting glucose concentration cutoff was more sensitive overall. US National Institutes of Health. Copyright © 2017 Elsevier Ltd. All rights reserved.

HbA1c and the Prediction of Type 2 Diabetes in Children and Adults

PubMed Central

Vijayakumar, Pavithra; Nelson, Robert G.; Hanson, Robert L.; Knowler, William C.

2017-01-01

OBJECTIVE Long-term data validating glycated hemoglobin (HbA1c) in assessing the risk of type 2 diabetes in children are limited. HbA1c, fasting plasma glucose (FPG), and 2-h postload plasma glucose (2hPG) concentrations were measured in a longitudinal study of American Indians to determine their utility in predicting incident diabetes, all of which is thought to be type 2 in this population. RESEARCH DESIGN AND METHODS Incident diabetes (FPG ≥126 mg/dL [7.0 mmol/L], 2hPG ≥200 mg/dL [11.1 mmol/L], HbA1c ≥6.5% [8 mmol/mol], or clinical diagnosis) was determined in 2,095 children without diabetes ages 10–19 years monitored through age 39, and in 2,005 adults ages 20–39 monitored through age 59. Areas under the receiver operating characteristic (ROC) curve for HbA1c, FPG, and 2hPG in predicting diabetes within 10 years were compared. RESULTS During long-term follow-up of children and adolescents who did not initially have diabetes, the incidence rate of subsequent diabetes was fourfold (in boys) as high and more than sevenfold (in girls) as high in those with HbA1c ≥5.7% as in those with HbA1c ≤5.3%—greater rate ratios than experienced by adults in the same HbA1c categories. Analyses of ROCs revealed no significant differences between HbA1c, FPG, and 2hPG in sensitivity and specificity for identifying children and adolescents who later developed diabetes. CONCLUSIONS HbA1c is a useful predictor of diabetes risk in children and can be used to identify prediabetes in children with other type 2 diabetes risk factors with the same predictive value as FPG and 2hPG. PMID:27810987

HbA1c and the Prediction of Type 2 Diabetes in Children and Adults.

PubMed

Vijayakumar, Pavithra; Nelson, Robert G; Hanson, Robert L; Knowler, William C; Sinha, Madhumita

2017-01-01

Long-term data validating glycated hemoglobin (HbA 1c ) in assessing the risk of type 2 diabetes in children are limited. HbA 1c , fasting plasma glucose (FPG), and 2-h postload plasma glucose (2hPG) concentrations were measured in a longitudinal study of American Indians to determine their utility in predicting incident diabetes, all of which is thought to be type 2 in this population. Incident diabetes (FPG ≥126 mg/dL [7.0 mmol/L], 2hPG ≥200 mg/dL [11.1 mmol/L], HbA 1c ≥6.5% [8 mmol/mol], or clinical diagnosis) was determined in 2,095 children without diabetes ages 10-19 years monitored through age 39, and in 2,005 adults ages 20-39 monitored through age 59. Areas under the receiver operating characteristic (ROC) curve for HbA 1c , FPG, and 2hPG in predicting diabetes within 10 years were compared. During long-term follow-up of children and adolescents who did not initially have diabetes, the incidence rate of subsequent diabetes was fourfold (in boys) as high and more than sevenfold (in girls) as high in those with HbA 1c ≥5.7% as in those with HbA 1c ≤5.3%-greater rate ratios than experienced by adults in the same HbA 1c categories. Analyses of ROCs revealed no significant differences between HbA 1c , FPG, and 2hPG in sensitivity and specificity for identifying children and adolescents who later developed diabetes. HbA 1c is a useful predictor of diabetes risk in children and can be used to identify prediabetes in children with other type 2 diabetes risk factors with the same predictive value as FPG and 2hPG. © 2017 by the American Diabetes Association.

Hemoglobin A1c as a Diagnostic Tool: Public Health Implications From an Actor–Network Perspective

PubMed Central

Rock, Melanie

2012-01-01

Public health arguments for collecting hemoglobin A1c (HbA1c) data, particularly in clinical settings, should be reframed to place more emphasis on nonmedical determinants of population health. We compare individual- with population-level interpretations of HbA1c titers. This comparison reveals that public health researchers need to pay close attention to diagnostic tests and their uses, including rhetorical uses. We also synthesize historical and current evidence to map out 2 possible scenarios for the future. In the first scenario, prevention efforts emphasize primary care and focus almost entirely downstream. The second scenario anticipates downstream interventions but also upstream interventions targeting environments. Our analysis adapts actor–network theory to strategic planning and forecasting in public health. PMID:22095361

[Glycosylated hemoglobin A1c as a diagnostic test for diabetes mellitus in adolescents with overweight and obesity].

PubMed

Rivera-Hernández, Aleida; Zurita-Cruz, Jessie Nallely; Garrido-Magaña, Eulalia; Fiorentini-Fayad, Gigliola Margaretta; Nishimura-Meguro, Elisa

2015-01-01

In 2009 it was introduced a new diagnostic criteria based on hemoglobin A1c (HbA1c) greater than or equal to 6.5 % in the adult population; some studies suggest that the cutoff may be smaller in pediatric population. The objective was to determine the utility of HbA1c greater than or equal to 6.5 % as a diagnostic test for DM in Mexican adolescents with overweight or obesity. Full somatometry was performed. Also, Tanner stage, blood pressure, blood glucose, glucose tolerance curve (GTC) and HbA1c were analyzed. Specificity, sensitivity, positive and negative predictive values and ROC curve were calculated for the diagnosis of DM with HbA1c. 109 adolescents between 10 and 16 years referred for obesity or overweight plus comorbidities were studied; 58 % were females, the age was of 13 ± 1.74 years, the BMI percentile 95.3, and the HbA1c 5.73 ± 0.9 %. It was made a diagnosis of DM in 9 cases (8.3 %), prediabetes in 8 (7.3 %) and normal glucose tolerance in 92 (84.4 %). The HbA1c mean was 5.6 ± 0.04, 5.7 ± 0.4, and 5.6 ± 0.73 %, respectively. HbA1c greater than or equal to 6.5 % had a sensitivity of 12.5 %, a specificity of 89.8 %, a PPV of 10.65 and a NPV of 14.28. The best cutoff point for diagnosing DM through ROC curve was 5.45 %, with a sensitivity of 62.5 %, a specificity of 57.1 %, PPV 2.53 and NPV 33.3. The level of HbA1c greater than or equal to 6.5 % had low sensitivity and specificity for the diagnosis of DM. A lower cutoff point is insufficient to use HbA1c as a diagnostic criterion. These results are consistent with the ones of other journals.

Utilizing Clinical Pharmacy Specialists to Address Access to Care Barriers in the Veteran Population for the Management of Diabetes.

PubMed

Edwards, Krystal L; Hadley, Ryan L; Baby, Nidhu; Yeary, Julianne C; Chastain, Lisa M; Brown, Crystal D

2017-08-01

To show that clinical pharmacy specialists (CPSs) can be utilized in remote facilities to provide appropriate diabetes outcomes along with potential cost savings. A retrospective cohort chart review conducted at the Veterans Affairs North Texas Healthcare System (VANTHCS) evaluated outcomes in patients with type 2 diabetes mellitus referred to CPSs at Fort Worth Outpatient Clinic (FWOPC) or the endocrinologist-managed specialty clinic at the Dallas VA Medical Center (DVAMC). The primary outcome was percentage of patients reaching hemoglobin A1c (HbA1c) goal of <8%. Secondary outcomes were percentage of patients reaching HbA1c <7%, time to reach HbA1c goals of <8% and <7%, and cost savings. There was no statistically significant difference in the number of patients reaching HbA1c goal <8% in the FWOPC (65.3%) compared to the DVAMC (55.8%). Secondary end points comparing FWOPC and DVAMC found no difference in patients reaching HbA1c <7% (20.8% vs 19.2%) and time to reach HbA1c goal of <8% (4.5 vs 6 months) and <7% (8.5 vs 7.5 months). Cost-saving analysis demonstrated a composite of US$350 292 could be saved by the VANTHCS facility if patients continued to be referred to CPS. CPSs can be utilized in diabetes management to provide similar health outcomes as the endocrinologist-managed clinic and to potentially allow for facility cost savings.

Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

PubMed

Jiao, Fang Fang; Fung, Colman Siu Cheung; Wong, Carlos King Ho; Wan, Yuk Fai; Dai, Daisy; Kwok, Ruby; Lam, Cindy Lo Kuen

2014-08-21

To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) led to improvements in biomedical outcomes, observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting. A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched by age, sex, and HbA1c level at baseline as the usual care group. Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment. Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes, proportion of subjects reaching treatment targets, observed and predicted cardiovascular risks. Compared to the usual care group, RAMP-DM group had lower cardiovascular events incidence (1.21% vs 2.89%, P = 0.003), and net decrease in HbA1c (-0.20%, P < 0.01), SBP (-3.62 mmHg, P < 0.01) and 10-year cardiovascular disease (CVD) risks (total CVD risk, -2.06%, P < 0.01; coronary heart disease (CHD) risk, -1.43%, P < 0.01; stroke risk, -0.71%, P < 0.01). The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c, and SBP/DBP. After adjusting for confounding variables, the significance remained for HbA1c, predicted CHD and stroke risks. The RAMP-DM resulted in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12 months follow-up, which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting. ClinicalTrials.gov, NCT02034695.

Can the Afinion HbA1c Point-of-Care instrument be an alternative method for the Tosoh G8 in the case of Hb-Tacoma?

PubMed

Lenters-Westra, Erna; Strunk, Annuska; Campbell, Paul; Slingerland, Robbert J

2017-02-01

Hb-variant interference when reporting HbA1c has been an ongoing challenge since HbA1c was introduced to monitor patients with diabetes mellitus. Most Hb-variants show an abnormal chromatogram when cation-exchange HPLC is used for the determination of HbA1c. Unfortunately, the Tosoh G8 generates what appears to be normal chromatogram in the presence of Hb-Tacoma, yielding a falsely high HbA1c value. The primary aim of the study was to investigate if the Afinion HbA1c point-of-care (POC) instrument could be used as an alternative method for the Tosoh G8 when testing for HbA1c in the presence of Hb-Tacoma. Whole blood samples were collected in K 2 EDTA tubes from individuals homozygous for HbA (n = 40) and heterozygous for Hb-Tacoma (n = 20). Samples were then immediately analyzed with the Afinion POC instrument. After analysis, aliquots of each sample were frozen at -80 °C. The frozen samples were shipped on dry ice to the European Reference Laboratory for Glycohemoglobin (ERL) and analyzed with three International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) Secondary Reference Measurement Procedures (SRMPs). The Premier Hb9210 was used as the reference method. When compared to the reference method, samples with Hb-Tacoma yielded mean relative differences of 31.8% on the Tosoh G8, 21.5% on the Roche Tina-quant Gen. 2 and 16.8% on the Afinion. The Afinion cannot be used as an alternative method for the Tosoh G8 when testing for HbA1c in the presence of Hb-Tacoma.

The reliability of in-hospital diagnoses of diabetes mellitus in the setting of an acute myocardial infarction.

PubMed

Arnold, Suzanne V; Lipska, Kasia J; Inzucchi, Silvio E; Li, Yan; Jones, Philip G; McGuire, Darren K; Goyal, Abhinav; Stolker, Joshua M; Lind, Marcus; Spertus, John A; Kosiborod, Mikhail

2014-01-01

Incident diabetes mellitus (DM) is important to recognize in patients with acute myocardial infarction (AMI). To develop an efficient screening strategy, we explored the use of random plasma glucose (RPG) at admission and fasting plasma glucose (FPG) to select patients with AMI for glycosylated hemoglobin (HbA1c) testing. Prospective registry of 1574 patients with AMI not taking glucose-lowering medication from 24 US hospitals. All patients had HbA1c measured at a core laboratory and admission RPG and ≥2 FPGs recorded during hospitalization. We examined potential combinations of RPG and FPG and compared these with HbA1c≥6.5%-considered the gold standard for DM diagnosis in these analyses. An RPG>140 mg/dL or FPG≥126 mg/dL had high sensitivity for DM diagnosis. Combining these into a screening protocol (if admission RPG>140, check HbA1c; or if FPG≥126 on a subsequent day, check HbA1c) led to HbA1c testing in 50% of patients and identified 86% with incident DM (number needed to screen (NNS)=3.3 to identify 1 case of DM; vs NNS=5.6 with universal HbA1c screening). Alternatively, using an RPG>180 led to HbA1c testing in 40% of patients with AMI and identified 82% of DM (NNS=2.7). We have established two potential selective screening methods for DM in the setting of AMI that could identify the vast majority of incident DM by targeted screening of 40-50% of patients with AMI with HbA1c testing. Using these methods may efficiently identify patients with AMI with DM so that appropriate education and treatment can be promptly initiated.

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Comparative study of serum/plasma glycation and lipid peroxidation of young patients with type 1 diabetes mellitus in relation to glycemic compensation and the occurrence of diabetic complications.

PubMed

Kostolanska, J; Jakus, V; Barak, L; Stanikova, A; Waczulikova, I

2010-01-01

We tried to investigate whether the AGEs in serum and lipoperoxides (LPO) monitoring were suitable for an early prediction of diabetic complications (DC) development in diabetological practice. We wanted to find whether it is better to divide the file according to the presence of DC or in terms of glycemic compensation in this study. 79 diabetic patients with duration of disease for at least 5 years were divided in respect to DC presence/absence and also to long-time glycemic compensation. HbA1c was measured by LPLC in fair capillary blood, s-AGEs were estimated spectrofluorimetrically and LPO iodimetrically and spectrophotometrically in serum. HbA1c, s-AGEs and LPO were significantly higher in the group with DC (+DC) vs. controls and also in -DC vs. controls. HbA1c and s-AGEs were significantly higher in +DC vs. patients without DC (-DC). HbA1c, s-AGEs and LPO were significantly higher in patients with poor glycemic compensation (PGC) compared to controls and HbA1c and LPO in patients with good glycemic compensation (GGC) compared to controls. HbA1c and s-AGEs were significantly higher in PGC vs. GGC. In the group of GGC we have found interesting significant correlations of HbA1c with HDL (r=0.451, p<0.05) and with LDL (r=-0.450, p<0.05). Our findings suggest that the monitoring of s-AGEs in poorly compensated diabetic patients and LPO in all may be very useful to recognize the risk of complications. The dividing of patient file in terms of long time glycemic compensation is more reliable for research of this issue (Tab. 3, Fig. 6, Ref. 41). Full Text in free PDF www.bmj.sk.

The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study.

PubMed

Younis, Arwa; Eskenazi, Dana; Goldkorn, Ronen; Leor, Jonathan; Naftali-Shani, Nili; Fisman, Enrique Z; Tenenbaum, Alexander; Goldenberg, Ilan; Klempfner, Robert

2017-05-22

Patients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available. A prospective, randomized, open-label study was performed in 60 patients with coronary artery disease (CAD) and type 2 diabetes, who participated in a cardiac rehabilitation program. After a washout period of 3 weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin/metformin therapy (intervention group: n = 40) vs. metformin alone (control group: n = 20) for a total of 12 weeks. Blinded assessment of interleukin-1ß (IL-1ß, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12 weeks. Mean age of study patients was 67 ± 9 years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12 weeks of follow up, levels of IL-1ß, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1ß among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001). The hsCRP was lowered by 60% in the vildagliptin/metformin group vs. 23% in the metformin group (p < 0.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p < 0.03). The addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1ß elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed. Trial registration NCT01604213.

Haematological and electrophoretic characterisation of β-thalassaemia in Yunnan province of Southwestern China

PubMed Central

Zhang, Jie; He, Jing; Mao, Xiaoqin; Zeng, Xiaohong; Chen, Hong; Su, Jie; Zhu, Baosheng

2017-01-01

Objectives β-Thalassaemia is widely found in Southwestern China. Characterisation of β-thalassaemia can improve screening and prenatal diagnosis for at-risk populations. Design A retrospective study. Methods In this study, the levels of haemoglobin alpha 2 (HbA2) and haemoglobin alpha (HbA) were analysed by gender for a total of 15 067 subjects screened by capillary electrophoresis. The cut-off value with the highest accuracy was established to identify β-thalassaemia in 723 patients suspected to have this disease. Haematological and electrophoretic characterisation of eight common types of β-thalassaemia were analysed in 486 β-thalassaemia subjects. Results HbA levels were significantly higher in men than in women, but there was no significant difference on HbA2 levels. A new cut-off value for the diagnosis of β-thalassaemia (HbA2≥4.0%) with the highest accuracy was proposed for the studied populations. Haemoglobin (Hb) was significantly higher in men compared with women (p<0.05), whereas no statistically significant differences were found for mean cell volume (MCV), mean cell haemoglobin (MCH), HbA and HbA2. The haemoglobin E (HbE) group showed comparatively higher values for haematological indices (Hb, MCV and MCH) than the other genotypes in heterozygous β-thalassaemia groups (p<0.05), and −28 (A>G) (HBB (β-globin):c.−78A>C) had significantly higher HbA2 values compared with other β-thalassaemia. Conclusions Ethnic groups have diversified β-globin gene mutations and considerable haematological variations. Our study will lay the foundation for screening programmes and clinical management of thalassaemia in Southwestern China. PMID:28143837

Haematological and electrophoretic characterisation of β-thalassaemia in Yunnan province of Southwestern China.

PubMed

Zhang, Jie; He, Jing; Mao, Xiaoqin; Zeng, Xiaohong; Chen, Hong; Su, Jie; Zhu, Baosheng

2017-01-31

β-Thalassaemia is widely found in Southwestern China. Characterisation of β-thalassaemia can improve screening and prenatal diagnosis for at-risk populations. A retrospective study. In this study, the levels of haemoglobin alpha 2 (HbA 2 ) and haemoglobin alpha (HbA) were analysed by gender for a total of 15 067 subjects screened by capillary electrophoresis. The cut-off value with the highest accuracy was established to identify β-thalassaemia in 723 patients suspected to have this disease. Haematological and electrophoretic characterisation of eight common types of β-thalassaemia were analysed in 486 β-thalassaemia subjects. HbA levels were significantly higher in men than in women, but there was no significant difference on HbA 2 levels. A new cut-off value for the diagnosis of β-thalassaemia (HbA 2 ≥4.0%) with the highest accuracy was proposed for the studied populations. Haemoglobin (Hb) was significantly higher in men compared with women (p<0.05), whereas no statistically significant differences were found for mean cell volume (MCV), mean cell haemoglobin (MCH), HbA and HbA 2 . The haemoglobin E (HbE) group showed comparatively higher values for haematological indices (Hb, MCV and MCH) than the other genotypes in heterozygous β-thalassaemia groups (p<0.05), and -28 (A>G) (HBB (β-globin):c.-78A>C) had significantly higher HbA 2 values compared with other β-thalassaemia. Ethnic groups have diversified β-globin gene mutations and considerable haematological variations. Our study will lay the foundation for screening programmes and clinical management of thalassaemia in Southwestern China. 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/.

The Ratio of Estimated Average Glucose to Fasting Plasma Glucose Level Is Superior to Glycated Albumin, Hemoglobin A1c, Fructosamine, and GA/A1c Ratio for Assessing β-Cell Function in Childhood Diabetes

PubMed Central

Lee, Ji Eun; Lee, Ji Woo; Fujii, Tatsuyoshi; Fujii, Noriyoshi; Choi, Jong Weon

2014-01-01

Objective. This study investigated the use of the estimated average glucose to fasting plasma glucose ratio (eAG/fPG ratio) to screen for β-cell function in pediatric diabetes. Methods. Glycated hemoglobin (HbA1c), glycated albumin (GA), fructosamine, insulin, and C-peptide levels were measured. The ratio of GA to HbA1c (GA/A1c ratio) was calculated, and the homeostasis model assessment of β-cell function (HOMA-β) was determined. Results. Median values of C-peptide, insulin, and HOMA-β levels were significantly higher in patients with an increased eAG/fPG ratio than in those with a decreased eAG/fPG ratio. C-peptide and HOMA-β levels were more closely correlated with the eAG/fPG ratio than with GA, HbA1c, the GA/A1c ratio, and fructosamine. In contrast, body mass index was significantly associated with GA, GA/A1c ratio, and fructosamine, but not with the eAG/fPG ratio and HbA1c levels. To test the diagnostic accuracies of the eAG/fPG ratio for identifying HOMA-β > 30.0% in patients with type 2 diabetes, the area under the ROC curve of the eAG/fPG ratio was significantly larger than that of the GA/A1c ratio [0.877 (95% CI, 0.780–0.942) versus 0.775 (95% CI, 0.664–0.865), P = 0.039]. Conclusions. A measurement of the eAG/fPG ratio may provide helpful information for assessing β-cell function in pediatric patients with diabetes. PMID:25013775

Is glycated albumin useful for differential diagnosis between fulminant type 1 diabetes mellitus and acute-onset autoimmune type 1 diabetes mellitus?

PubMed

Koga, Masafumi; Kanehara, Hideo; Bando, Yukihiro; Morita, Shinya; Kasayama, Soji

2015-12-07

Markedly elevated plasma glucose and relatively low HbA1c compared to plasma glucose is one diagnostic criterion for fulminant type 1 diabetes mellitus (FT1DM). Glycated albumin (GA) is a glycemic control marker that reflects glycemic control in shorter period than HbA1c. This study investigated whether GA is useful for differential diagnosis between FT1DM and acute-onset autoimmune type 1 diabetes mellitus (T1ADM) or not. This study included 38 FT1DM patients and 31 T1ADM patients in whom both HbA1c and GA were measured at the time of diagnosis. In FT1DM patients, as compared to T1ADM patients, both HbA1c and GA were significantly lower (HbA1c; 6.6±0.9% vs. 11.7±2.6%, P<0.0001, GA; 22.9±4.8% vs. 44.3±8.3%, P<0.0001). For differential diagnosis between FT1DM and T1ADM, ROC analysis showed that the optimum cut-off value for GA was 33.5% with sensitivity and specificity of 97.4% and 96.8%, respectively, while the optimum cut-off value for HbA1c was 8.7% with sensitivity and specificity of 100% and 83.9%, respectively. GA also may be useful for the differential diagnosis between FT1DM and T1ADM when the cut-off value can be set at 33.5%. Copyright © 2015 Elsevier B.V. All rights reserved.

Changes in Adenosine Deaminase Activity in Patients with Type 2 Diabetes Mellitus and Effect of DPP-4 Inhibitor Treatment on ADA Activity.

PubMed

Lee, Jae-Geun; Kang, Dong Gu; Yu, Jung Re; Kim, Youngree; Kim, Jinsoek; Koh, Gwanpyo; Lee, Daeho

2011-04-01

Dipeptidyl peptidase 4 (DPP-4, also known as CD26) binds with adenosine deaminase (ADA) to activate T lymphocytes. Here, we investigated whether ADA activity is specifically affected by treatment with DPP-4 inhibitor (DPP4I) compared with other anti-diabetic agents. Fasting ADA activity, in addition to various metabolic and biochemical parameters, were measured in 262 type 2 diabetes mellitus (T2DM) patients taking various anti-diabetic agents and in 46 non-diabetic control subjects. ADA activity was increased in T2DM patients compared with that in non-diabetic control subjects (mean±standard error, 23.1±0.6 U/L vs. 18.6±0.8 U/L; P<0.05). ADA activity was correlated with fasting plasma glucose (r=0.258, P<0.05), HbA1c (r=0.208, P<0.05), aspartate aminotransferase (r=0.325, P<0.05), and alanine aminotransferase (r=0.248, P<0.05). Compared with the well-controlled T2DM patients (HbA1c<7%), the poorly controlled group (HbA1c>9%) showed significantly increased ADA activity (21.1±0.8 U/L vs. 25.4±1.6 U/L; P<0.05). The effect of DPP4I on ADA activity in T2DM patients did not differ from those of other oral anti-diabetic agents or insulin. T2DM patients on metformin monotherapy showed a lower ADA activity (20.9±1.0 U/L vs. 28.1±2.8 U/L; P<0.05) compared with that of those on sulfonylurea monotherapy. Our results show that ADA activity is increased in T2DM patients compared to that in non-diabetic patients, is positively correlated with blood glucose level, and that DPP4I has no additional specific effect on ADA activity, except for a glycemic control- or HbA1c-dependent effect.

Prediction of the effect on antihyperglycaemic action of sitagliptin by plasma active form glucagon-like peptide-1.

PubMed

Kushiyama, Akifumi; Kikuchi, Takako; Tanaka, Kentaro; Tahara, Tazu; Takao, Toshiko; Onishi, Yukiko; Yoshida, Yoko; Kawazu, Shoji; Iwamoto, Yasuhiko

2016-06-10

To investigate whether active glucagon-like peptide-1 (GLP-1) is a prediction Factor of Effect of sitagliptin on patients with type 2 diabetes mellitus (GLP-1 FEST:UMIN000010645). Seventy-six patients with type 2 diabetes, who had insufficient glycemic control [Hemoglobin A1c (HbA1c) ≥ 7%] in spite of treatment with metformin and/or sulfonylurea, were included in the investigation. Patients were divided into three groups by tertiles of fasting plasma active GLP-1 level, before the administration of 50 mg sitagliptin. At baseline, body mass index, serum UA, insulin and HOMA-IR were higher in the high active GLP-1 group than in the other two groups. The high active GLP-1 group did not show any decline of HbA1c (7.6% ± 1.4% to 7.5% ± 1.5%), whereas the middle and low groups indicated significant decline of HbA1c (7.4 ± 0.7 to 6.8 ± 0.6 and 7.4 ± 1.2 to 6.9 ± 1.3, respectively) during six months. Only the low and middle groups showed a significant increment of active GLP-1, C-peptide level, a decreased log and proinsulin/insulin ratio after administration. In logistic analysis, the low or middle group is a significant explanatory variable for an HbA1c decrease of ≥ 0.5%, and its odds ratio is 4.5 (1.40-17.6) (P = 0.01) against the high active GLP-1 group. This remains independent when adjusted for HbA1c level before administration, patients' medical history, medications, insulin secretion and insulin resistance. Plasma fasting active GLP-1 is an independent predictive marker for the efficacy of dipeptidyl peptidase 4 inhibitor sitagliptin.

Effects of linagliptin monotherapy compared with voglibose on postprandial blood glucose responses in Japanese patients with type 2 diabetes: Linagliptin Study of Effects on Postprandial blood glucose (L-STEP).

PubMed

Fujitani, Yoshio; Fujimoto, Shimpei; Takahashi, Kiyohito; Satoh, Hiroaki; Hirose, Takahisa; Hiyoshi, Toru; Ai, Masumi; Okada, Yosuke; Gosho, Masahiko; Mita, Tomoya; Watada, Hirotaka

2016-11-01

To compare the efficacy on glycemic parameters between a 12-week administration of once-daily linagliptin and thrice-daily voglibose in Japanese patients with type 2 diabetes. In a multi-center, randomized, parallel-group study, 382 patients with diabetes were randomized to the linagliptin group (n=192) or the voglibose group (n=190). A meal tolerance test was performed at weeks 0 and 12. Primary outcomes were the change from baseline to week 12 in serum glucose levels at 2h during the meal tolerance test, HbA1c levels, and serum fasting glucose levels, which were compared between the 2 groups. Whereas changes in serum glucose levels at 2h during the meal tolerance test did not differ between the groups, the mean change in HbA1c levels from baseline to week 12 in the linagliptin group (-0.5±0.5% [-5.1±5.4mmol/mol]) was significantly larger than in the voglibose group (-0.2±0.5% [-2.7±5.4mmol/mol]). In addition, there was significant difference in changes in serum fasting glucose levels (-0.51±0.95mmol/L in the linagliptin group vs. -0.18±0.92mmol/L in the voglibose group, P<0.001). The incidences of hypoglycemia, serious adverse events (AEs), and discontinuations due to AEs were low and similar in both groups. However, gastrointestinal AEs were significantly lower in the linagliptin group (1.05% vs. 5.85%; P=0.01). These data suggested that linagliptin monotherapy had a stronger glucose-lowering effect than voglibose monotherapy with respect to HbA1c and serum fasting glucose levels, but not serum glucose levels 2h after the start of the meal tolerance test. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Elevated glycated hemoglobin predicts macrosomia among Asian Indian pregnant women (WINGS-9).

PubMed

Bhavadharini, Balaji; Mahalakshmi, Manni Mohanraj; Deepa, Mohan; Harish, Ranjani; Malanda, Belma; Kayal, Arivudainambi; Belton, Anne; Saravanan, Ponnusamy; Ranjit, Unnikrishnan; Uma, Ram; Anjana, Ranjit Mohan; Mohan, Viswanathan

2017-01-01

The aim of this study was to determine the optimal glycated hemoglobin (HbA1c) cut point for diagnosis of gestational diabetes mellitus (GDM) and to evaluate the usefulness of HbA1c as a prognostic indicator for adverse pregnancy outcomes. HbA1c estimations were carried out in 1459 pregnant women attending antenatal care centers in urban and rural Tamil Nadu in South India. An oral glucose tolerance test was carried out using 75 g anhydrous glucose, and GDM was diagnosed using the International Association of the Diabetes and Pregnancy Study Groups criteria. GDM was diagnosed in 195 women. Receiver operating curves showed a HbA1c cut point of ≥ 5.0% (≥31 mmol/mol) have a sensitivity of 66.2% and specificity of 56.2% for identifying GDM (area under the curve 0.679, confidence interval [CI]: 0.655-0.703). Women with HbA1c ≥ 5.0% (≥31 mmol/mol) were significantly older and had higher body mass index, greater history of previous GDM, and a higher prevalence of macrosomia compared to women with HbA1c < 5.0% (<31 mmol/mol). The adjusted odds ratio for macrosomia in those with HbA1c ≥ 5.0% (≥31 mmol/mol) was 1.92 (CI: 1.24-2.97, P = 0.003). However, other pregnancy outcomes were not significantly different. In Asian Indian pregnant women, a HbA1c of 5.0% (31 mmol/mol) or greater is associated with increased risk of macrosomia.

Efficacy of combination herbal product (Curcuma longa and Eugenia jambolana) used for diabetes mellitus.

PubMed

Rao, Sadia Saleem; Najam, Rahila

2016-01-01

The purpose of this research was to evaluate the efficacy of a combination herbal product that is traditionally used for managing diabetes mellitus. Herbal drug contains Curcuma longa and Eugenia jambolanain the ratio of 1:1. It was orally administered at the dose of 1082 mg/70 kg twice a day for a period of 6 weeks to alloxan induced diabetic rats and compared with glibenclamide (standard). The effects of drug were observed at intervals, with respect to random and fasting glucose levels. HbA1C was also monitored after the drug treatment to monitor the overall diabetic effect. Results revealed that the combination of two herbs significantly reduced fasting and random glucose levels with HbA1C of less than 6% (p<0.001) in comparison to diabetic control. The control of fasting blood glucose levels by herbal combination is similar to the standard drug, glibenclamide (p<0.05). Random glucose levels by herbal combination is better than standard drug after one week and six weeks of treatment (p<0.01 and p<0.001 respectively) and similar after third week of treatment (p<0.05). Also, herbal drug combination showed HbA1C closer to the standard drug. It shows that this herbal combination can be of potential benefit in managing diabetes mellitus in future.

Glycemic Control Associated With Secure Patient-Provider Messaging Within a Shared Electronic Medical Record

PubMed Central

Harris, Lynne T.; Koepsell, Thomas D.; Haneuse, Sebastien J.; Martin, Diane P.; Ralston, James D.

2013-01-01

OBJECTIVE To study differences in glycemic control and HbA1c testing associated with use of secure electronic patient-provider messaging. We hypothesized that messaging use would be associated with better glycemic control and a higher rate of adherence to HbA1c testing recommendations. RESEARCH DESIGN AND METHODS Retrospective observational study of secure messaging at Group Health, a large nonprofit health care system. Our analysis included adults with diabetes who had registered for access to a shared electronic medical record (SMR) between 2003 and 2006. We fit log-linear regression models, using generalized estimating equations, to estimate the adjusted rate ratio of meeting three indicators of glycemic control (HbA1c <7%, HbA1c <8%, and HbA1c >9%) and HbA1c testing adherence by level of previous messaging use. Multiple imputation and inverse probability weights were used to account for missing data. RESULTS During the study period, 6,301 adults with diabetes registered for access to the SMR. Of these individuals, 74% used messaging at least once during that time. Frequent use of messaging during the previous calendar quarter was associated with a higher rate of good glycemic control (HbA1c <7%: rate ratio, 1.26 [95% CI, 1.15–1.37]) and a higher rate testing adherence (1.20 [1.15–1.25]). CONCLUSIONS Among SMR users, recent and frequent messaging use was associated with better glycemic control and a higher rate of HbA1c testing adherence. These results suggest that secure messaging may facilitate important processes of care and help some patients to achieve or maintain adequate glycemic control. PMID:23628618

A pragmatic comparison of two diabetes education programs in improving type 2 diabetes mellitus outcomes.

PubMed

Dorland, Katherine; Liddy, Clare

2014-03-28

Although it is clear that education programs constitute key elements of improved diabetes management, uncertainty exists regarding the optimal method of delivering that education. In addition to the lack of consensus regarding the most appropriate delivery methods for these programs, there is a paucity of research which evaluates these methods in terms of specific clinical outcomes. This pragmatic study compares the effectiveness of two distinct diabetes education programs in improving clinical outcomes in patients with type 2 diabetes mellitus in a primary care setting. The two diabetes education classes (n = 80 enrolled) retrospectively evaluated were 'the ABC's of Diabetes' (one 2-hour didactic teaching session) and 'Conversation Maps' (3 highly interactive weekly classes, 6 hours in total). Eligible participants (n = 32) had their charts reviewed and outcome measures (i.e., glycosylated hemoglobin levels (HbA1c), low density lipoprotein (LDL), systolic blood pressure (SBP), diastolic blood pressure (DBP), and weight) recorded 1 year prior to and 6 months following the class. Pre- and post-class outcome measures were compared. A trend towards lower HbA1c was observed after completion of both classes, with an average reduction of 0.2%, and 0.6% after 6 months in the 'ABC's of Diabetes' class and 'Conversation Maps' class respectively. A significant decrease in weight was observed 6 months after the 'ABC's of Diabetes' class (p = 0.028), and in LDL after the 'Conversation Maps' class (p = 0.049). Patients with HbA1c ≥ 8% showed a drop of 1.1% in HbA1c 3 months after either class (p = 0.004). No significant difference in outcomes was found between the two diabetes education classes assessed. There was a trend towards improved glycemic control after both classes, and patients with high HbA1c levels demonstrated statistically significant improvements. This indicates that shorter sessions using didactic teaching methods may be equally effective in producing improvements in diabetes self-management as more intensive course formats.

Managing Type 2 Diabetes Mellitus through Periodical Hospital Visits in the Aftermath of the Great East Japan Earthquake Disaster: A Retrospective Case Series

PubMed Central

Nishikawa, Yoshitaka; Fukuda, Yuji; Tsubokura, Masaharu; Kato, Shigeaki; Nomura, Shuhei; Saito, Yasutoshi

2015-01-01

Aims To assess the impact of the Great East Japan Earthquake Disaster on daily diabetes practice and to determine the feasibility of controlling type 2 diabetes mellitus in an outpatient department. Methods We retrospectively reviewed the data on disaster-affected patients with type 2 diabetes who periodically attended outpatient department of Soma Central Hospital. There were 767 patients with type 2 diabetes mellitus in total. The primary outcome measure was the change in HbA1c. Results HbA1c levels of 58 patients with periodical hospital visits did not deteriorate after the disasters. Moreover, there observed no significant difference in the mean of HbA1c levels among all age and sex throughout the year. While several changes in diabetes medication usage occurred, DPP4-inhibitor was the only oral diabetic agent that increased in frequency (+60%). Conclusions Patients with type 2 diabetes who were managed with periodical hospital visits did not show significant deterioration in HbA1c levels. PMID:25946187

Managing Type 2 Diabetes Mellitus through Periodical Hospital Visits in the Aftermath of the Great East Japan Earthquake Disaster: A Retrospective Case Series.

PubMed

Nishikawa, Yoshitaka; Fukuda, Yuji; Tsubokura, Masaharu; Kato, Shigeaki; Nomura, Shuhei; Saito, Yasutoshi

2015-01-01

To assess the impact of the Great East Japan Earthquake Disaster on daily diabetes practice and to determine the feasibility of controlling type 2 diabetes mellitus in an outpatient department. We retrospectively reviewed the data on disaster-affected patients with type 2 diabetes who periodically attended outpatient department of Soma Central Hospital. There were 767 patients with type 2 diabetes mellitus in total. The primary outcome measure was the change in HbA1c. HbA1c levels of 58 patients with periodical hospital visits did not deteriorate after the disasters. Moreover, there observed no significant difference in the mean of HbA1c levels among all age and sex throughout the year. While several changes in diabetes medication usage occurred, DPP4-inhibitor was the only oral diabetic agent that increased in frequency (+60%). Patients with type 2 diabetes who were managed with periodical hospital visits did not show significant deterioration in HbA1c levels.

Fiber in Diet Is Associated with Improvement of Glycated Hemoglobin and Lipid Profile in Mexican Patients with Type 2 Diabetes.

PubMed

Velázquez-López, Lubia; Muñoz-Torres, Abril Violeta; García-Peña, Carmen; López-Alarcón, Mardia; Islas-Andrade, Sergio; Escobedo-de la Peña, Jorge

2016-01-01

Objective. To assess the association of dietary fiber on current everyday diet and other dietary components with glycated hemoglobin levels (HbA1c), glucose, lipids profile, and body weight body weight, in patients with type 2 diabetes. Methods. A cross-sectional survey of 395 patients with type 2 diabetes was performed. HbA1c, fasting glucose, triglycerides, and lipids profile were measured. Weight, waist circumference, blood pressure, and body composition were measured. Everyday diet with a semiquantitative food frequency questionnaire was evaluated. ANOVA, Kruskal-Wallis, chi-square tests and multivariate logistic regression were used in statistical analysis. Results. Higher fiber intake was associated with a low HbA1c, high HDL-c levels, low weight, and waist circumference. The highest tertile of calories consumption was associated with a higher fasting glucose level and weight. The highest tertile of carbohydrate consumption was associated with a lower weight. The lowest tertile of total fat and saturated fat was associated with the highest tertile of HDL-c levels, and lower saturated fat intake was associated with lower weight (p < 0.05). Conclusions. A higher content of fiber in the diet reduces HbA1c and triglycerides, while improving HDL-c levels. Increasing fiber consumption while lowering calorie consumption seems to be an appropriate strategy to reduce body weight and promote blood glucose control.

Real-world effectiveness, adherence and persistence among patients with type 2 diabetes mellitus initiating dulaglutide treatment.

PubMed

Mody, Reema; Grabner, Michael; Yu, Maria; Turner, Ralph; Kwan, Anita Y M; York, Whitney; Fernández Landó, Laura

2018-06-01

To assess glycemic effectiveness, adherence and persistence within 6 months of treatment initiation with dulaglutide, a once weekly GLP-1 receptor agonist, in a US real-world setting. This retrospective claims analysis included adults (≥18 years) with T2DM from the HealthCore Integrated Research Database, who had HbA1c laboratory results around initiation and within 6 months after initiation. Glycemic control was assessed by change in HbA1c from pre-initiation to post-initiation. Patients were considered adherent if their proportion of days covered (PDC) was ≥0.80; persistence was measured as days of continuous therapy from initiation to 6 months after initiation with no gaps >45 days between fills. Of the 308 analyzed patients, the majority (n = 188; 61%) were adherent to dulaglutide (mean PDC 0.76; SD 0.26), with 115 patients (37%) discontinuing treatment. Mean persistence was 152 days/5 months. Mean HbA1c decreased from 8.49% (SD 1.70, median 8.20%) at baseline to 7.59% (SD 1.51, median 7.30%) at follow-up, corresponding to a mean HbA1c change of -0.90% (95% confidence interval [CI] -1.08 to -0.73; p < .01; median -0.70%). Patients who were adherent to or persistent with dulaglutide experienced larger reductions (-1.14% and -1.12% respectively), as did those without prior GLP-1 RA use (-1.03%). The proportion of patients with HbA1c <7% increased from 18% to 40%. Dulaglutide was associated with a significant decrease in HbA1c levels 6 months after treatment initiation. Patients who adhered to or persisted with dulaglutide therapy, or were naïve to GLP-1 RA use, experienced greater decreases in HbA1c levels.

Combined use of fasting plasma glucose and glycated hemoglobin A1c in the screening of diabetes and impaired glucose tolerance.

PubMed

Hu, Yaomin; Liu, Wei; Chen, Yawen; Zhang, Ming; Wang, Lihua; Zhou, Huan; Wu, Peihong; Teng, Xiangyu; Dong, Ying; Zhou, Jia wen; Xu, Hua; Zheng, Jun; Li, Shengxian; Tao, Tao; Hu, Yumei; Jia, Yun

2010-09-01

The aim of this study is to assess the validity of combined use of fasting plasma glucose (FPG) and glycated hemoglobin A1c (HbA1c) as screening tests for diabetes and impaired glucose tolerance (IGT) in high-risk subjects. A total of 2,298 subjects were included. All subjects underwent a 75-g oral glucose tolerance test (OGTT) and HbA1c measurement. Receiver operating characteristic curve (ROC curve) analysis was used to examine the sensitivity and specificity of FPG and HbA1c for detecting diabetes and IGT, which was defined according to the 1999 World Health Organization (WHO) criteria. (1) Based on the ROC curve, the optimal cut point of FPG related to diabetes diagnosed by OGTT was 6.1 mmol/l that was associated with a sensitivity and specificity of 81.5 and 81.0%, respectively; The optimal cut point of HbA1c related to diabetes diagnosed by OGTT was 6.1%, which was associated with a sensitivity and specificity of 81.0 and 81.0%, respectively; The screening model using FPG > or = 6.1 mmol/l or HbA1c > or = 6.1% had sensitivity of 96.5% for detecting undiagnosed diabetes; the screening model using FPG > or = 6.1 mmol/l and HbA1c > or = 6.1% had specificity of 96.3% for detecting undiagnosed diabetes. (2) Based on the ROC curve, the optimal cut point of FPG related to IGT diagnosed by OGTT was 5.6 mmol/l that was associated with a sensitivity and specificity of 64.1 and 65.4%, respectively; The optimal cut point of HbA1c related to IGT diagnosed by OGTT was 5.6%, which was associated with a sensitivity and specificity of 66.2 and 51.0%, respectively; The screening model using FPG > or = 5.6 mmol/l or HbA1c > or = 5.6% had sensitivity of 87.9% for detecting undiagnosed IGT; The screening model using FPG > or = 5.6 mmol/l and HbA1c > or = 5.6% had specificity of 82.4% for detecting undiagnosed IGT. Compared with FPG or HbA1c alone, the simultaneous measurement of FPG and HbA1c (FPG and/or HbA1C) might be a more sensitive and specific screening tool for identifying high-risk individuals with diabetes and IGT at an early stage.

Increased blood glycohemoglobin A1c levels lead to overestimation of arterial oxygen saturation by pulse oximetry in patients with type 2 diabetes

PubMed Central

2012-01-01

Background Non-enzymatic glycation increases hemoglobin-oxygen affinity and reduces oxygen delivery to tissues by altering the structure and function of hemoglobin. Objectives We investigated whether an elevated blood concentration of glycosylated hemoglobin (HbA1c) could induce falsely high pulse oximeter oxygen saturation (SpO2) in type 2 diabetic patients during mechanical ventilation or oxygen therapy. Methods Arterial oxygen saturation (SaO2) and partial pressure of oxygen (PO2) were determined with simultaneous monitoring of SpO2 in 261 type 2 diabetic patients during ventilation or oxygen inhalation. Results Blood concentration of HbA1c was >7% in 114 patients and ≤ 7% in 147 patients. Both SaO2 (96.2 ± 2.9%, 95% confidence interval [CI] 95.7-96.7% vs. 95.1 ± 2.8%, 95% CI 94.7-95.6%) and SpO2 (98.0 ± 2.6%, 95% CI 97.6-98.5% vs. 95.3 ± 2.8%, 95% CI 94.9-95.8%) were significantly higher in patients with HbA1c >7% than in those with HbA1c ≤ 7% (Data are mean ± SD, all p < 0.01), but PO2 did not significantly differ between the two groups. Bland-Altman analysis demonstrated a significant bias between SpO2 and SaO2 (1.83 ±0.55%, 95% CI 1.73% -1.94%) and limits of agreement (0.76% and 2.92%) in patients with HbA1c >7%. The differences between SpO2 and SaO2 correlated closely with blood HbA1c levels (Pearson’s r = 0.307, p < 0.01). Conclusions Elevated blood HbA1c levels lead to an overestimation of SaO2 by SpO2, suggesting that arterial blood gas analysis may be needed for type 2 diabetic patients with poor glycemic control during the treatment of hypoxemia. PMID:22985301

Increased blood glycohemoglobin A1c levels lead to overestimation of arterial oxygen saturation by pulse oximetry in patients with type 2 diabetes.

PubMed

Pu, Li Jin; Shen, Ying; Lu, Lin; Zhang, Rui Yan; Zhang, Qi; Shen, Wei Feng

2012-09-17

Non-enzymatic glycation increases hemoglobin-oxygen affinity and reduces oxygen delivery to tissues by altering the structure and function of hemoglobin. We investigated whether an elevated blood concentration of glycosylated hemoglobin (HbA1c) could induce falsely high pulse oximeter oxygen saturation (SpO2) in type 2 diabetic patients during mechanical ventilation or oxygen therapy. Arterial oxygen saturation (SaO2) and partial pressure of oxygen (PO2) were determined with simultaneous monitoring of SpO2 in 261 type 2 diabetic patients during ventilation or oxygen inhalation. Blood concentration of HbA1c was >7% in 114 patients and ≤ 7% in 147 patients. Both SaO2 (96.2 ± 2.9%, 95% confidence interval [CI] 95.7-96.7% vs. 95.1 ± 2.8%, 95% CI 94.7-95.6%) and SpO2 (98.0 ± 2.6%, 95% CI 97.6-98.5% vs. 95.3 ± 2.8%, 95% CI 94.9-95.8%) were significantly higher in patients with HbA1c >7% than in those with HbA1c ≤ 7% (Data are mean ± SD, all p < 0.01), but PO2 did not significantly differ between the two groups. Bland-Altman analysis demonstrated a significant bias between SpO2 and SaO2 (1.83 ±0.55%, 95% CI 1.73% -1.94%) and limits of agreement (0.76% and 2.92%) in patients with HbA1c >7%. The differences between SpO2 and SaO2 correlated closely with blood HbA1c levels (Pearson's r = 0.307, p < 0.01). Elevated blood HbA1c levels lead to an overestimation of SaO2 by SpO2, suggesting that arterial blood gas analysis may be needed for type 2 diabetic patients with poor glycemic control during the treatment of hypoxemia.

A Korean multicenter study of prenatal risk factors for overt diabetes during the postpartum period after gestational diabetes mellitus.

PubMed

Shin, Na-Ri; Yoon, So-Yeon; Cho, Geum Joon; Choi, Suk-Joo; Kwon, Han-Sung; Hong, Soon Cheol; Kwon, Ja-Young; Oh, Soo-Young

2016-03-01

To identify prenatal risk factors for postpartum diabetes among pregnant women with gestational diabetes mellitus (GDM). In a retrospective study, baseline characteristics and data from a postpartum 75-g glucose tolerance test (GTT) were reviewed for patients with GDM who had delivered in four Korean tertiary institutions from 2006 to 2012. Clinical characteristics were compared between women with and those without postpartum diabetes. Cutoffs to predict postpartum diabetes and diagnostic values were calculated from receiver operating characteristic (ROC) curves. Of 1637 patients with GDM, 498 (30.4%) underwent a postpartum 75-g GTT. Postpartum diabetes was diagnosed in 40 (8.0%) patients and impaired glucose intolerance in 157 (31.5%). Women with postpartum diabetes had higher glycated hemoglobin (HbA1c) levels at GDM diagnosis (P=0.008) and higher 100-g GTT values (P<0.05 for all). In ROC curve analysis, optimal cutoffs for predicting postpartum diabetes were 0.058 for HbA1c level and 5.3 mmol/L (fasting), 10.9 mmol/L (1h), 10.2 mmol/L (2h), and 8.6 mmol/L (3h) for 100-g GTT. The highest sensitivity was observed for 3-h 100-g GTT (76.9%) and the highest positive predictive value was for HbA1c at diagnosis (15.2%). HbA1c level at GDM diagnosis and 100-g GTT values could be used to identify patients at high risk of postpartum diabetes who should undergo postpartum screening. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

HbA1c levels as a function of emotional regulation and emotional intelligence in patients with type 2 diabetes.

PubMed

Coccaro, Emil F; Drossos, Tina; Phillipson, Louis

2016-10-01

Understanding the role of emotion in glycemic control may be critical for the long-term treatment of patients with type 2 diabetes (T2D). In this study we investigated the relationship between measures of emotional regulation and emotional intelligence and HbA1c levels in adult patients with T2 diabetes. 100 adult patients with T2 diabetes completed assessments of emotional regulation (i.e., affect intensity/lability) and emotional intelligence and were then correlated with HbA1c levels with several relevant covariates. HbA1c levels were significantly associated with affect intensity (AI: r=.24, p=.018) and with emotional intelligence (EI: r=-.29, p=.004), but not affect lability. These results were the same even after adding income, state depression scores, insulin-dependent status, serum cholesterol, diabetes literacy and self-care as covariates (AI: β=.33, p=.001; EI: β=-.31, p=.002). Diabetes self-care, but not diabetes literacy, was also associated with HbA1c levels (β=-.29, p=.003). These data suggest that aspects of emotional regulation and emotional intelligence play a role in glycemic control in adult patients with T2 diabetes and do so even in the context of several variables relevant to diabetes. If so, interventions that can reduce affect intensity and/or increase emotional intelligence may represent a new strategy in the glycemic control of adult patients with T2 diabetes. Copyright © 2016 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Effect of low glycemic load diet on glycated hemoglobin (HbA1c) in poorly-controlled diabetes patients.

PubMed

Ziaee, Amir; Afaghi, Ahmad; Sarreshtehdari, Majied

2011-12-29

Different carbohydrate diets have been administrated to diabetic patients to evaluate the glycemic response, while Poor-controlled diabetes is increasing world wide. To investigate the role of an alternative carbohydrate diet on glycemic control, we explored the effect of a low glycemic load (Low GL)-high fat diet on glycemic response and also glycated hemoglobin (HbA1c) of poor-controlled diabetes patients. Hundred poorly-controlled diabetes patients, HbA1c > 8, age 52.8 ± 4.5 y, were administrated a low GL diet , GL = 67 (Energy 1800 kcal; total fat 36%; fat derived from olive oil and nuts 15%; carbohydrate 42%; protein 22%) for 10 weeks. Patients did their routine life style program during intervention. Fasting blood glucose and HbA1c before and after intervention with significant reduction were: 169 ± 17, 141 ± 12; 8.85% (73 mmol/mol) ± 0.22%, and 7.81% (62 mmol/mol) ± 0.27%; respectively (P < 0.001). Mean fasting blood glucose reduced by 28.1 ± 12.5 and HbA1c by 1.1% (11 mmol/mol) ± 0.3% (P=0.001). There was positive moderate correlation between HbA1c concentration before intervention and FBS reduction after intervention (P < 0.001, at 0.01 level, R =0.52), and strong positive correlation between FBS before intervention and FBS reduction (P < 0.001, at 0.01 level, R = 0.70). This study demonstrated that our alternative low glycemic load diet can be effective in glycemic control.

A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India-Outcome of screening.

PubMed

Priscilla, Susairaj; Nanditha, Arun; Simon, Mary; Satheesh, Krishnamoorthy; Kumar, Sathish; Shetty, Ananth Samith; Snehalatha, Chamukuttan; Johnston, Desmond G; Godsland, Ian F; Wareham, Nicholas J; Ramachandran, Ambady

2015-12-01

We describe a two-step screening approach using non-invasive risk assessment and glycated hemoglobin (HbA1c) to identify participants for a diabetes prevention trial. A total of 6030 non-diabetic persons of 35-55 years were screened using risk assessment for diabetes. Those with three or more risk factors were screened using point of care HbA1c test. For this study, participants in HbA1c categories of 6.0% (42.1 mmol/mol)-6.4% (46.4 mmol/mol) were selected and their characteristics were analyzed. Among 6030 persons, 2835 (47%) had three or more risk factors for diabetes. Among those screened with HbA1c, 43.2% (1225) had HbA1c values of <6.0% (42.1 mmol/mol), 46.8% (1327) had HbA1c values between 6.0% (42.1 mmol/mol) and ≤ 6.4% (46.4 mmol/mol) and 10% (283) had undiagnosed diabetes with ≥6.5% (47.5 mmol/mol). Positive family history was present in 53.2%, 81.7% were obese and 14.8% were overweight. Opportunistic screening using a two-step approach: diabetes risk profile and HbA1c measurement detected a large percentage of individuals with prediabetes. Prediabetic persons recruited to the trial had higher percentage of obesity and presence of positive family history than those who had lower HbA1c values. Outcomes from this trial will enable comparisons with the previous prevention studies that used blood glucose levels as the screening criteria. Copyright © 2015. Published by Elsevier Ireland Ltd.

Management of diabetes mellitus: is the pump mightier than the pen?

PubMed

Pickup, John C

2012-02-28

Continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) reduces HbA1c levels and hypoglycaemia in patients with type 1 diabetes mellitus (T1DM) compared with multiple daily insulin injections (MDI). The greatest reduction in HbA(1c) levels with CSII occurs in patients with the worst glycaemic control; therefore, the most appropriate and cost-effective use of CSII in adults with T1DM is in those who have continued, elevated HbA(1c) levels or disabling hypoglycaemic episodes with MDI (including the use of long-acting insulin analogues and structured patient education). The disadvantages of CSII include higher costs than MDI and the risk of ketosis in the event of pump failure. In children with T1DM, CSII may be used when MDI is considered impractical or inappropriate. Pumps are not generally recommended for patients with type 2 diabetes mellitus but may improve control in some subgroups. A new generation of smaller insulin infusion pumps with an integrated cannula, called patch pumps, could improve uptake of CSII in general. The important clinical question is not whether CSII is more efficacious than MDI in general adult T1DM, but whether CSII further improves glycaemic control when this control continues to be poor with MDI, and evidence exists that in most cases it does.

[Continuous insulin therapy versus multiple insulin injections in the management of type 1 diabetes: a longitutinal study].

PubMed

Ribeiro, Maria Estela Bellini; Del Roio Liberatore Junior, Raphael; Custodio, Rodrigo; Martinelli Junior, Carlos Eduardo

2016-01-01

To compare multiple doses of insulin and continuous insulin infusion therapy as treatment for type 1 diabetes melito. 40 patients with type 1 diabetes melito (21 female) with ages between 10 and 20 years (mean=14.2) and mean duration of diabetes of 7 years used multiple doses of insulin for at least 6 months and after that, continuous insulin infusion therapy for at least 6 months. Each one of the patients has used multiple doses of insulin and continuous insulin infusion therapy. For analysis of HbA1c, mean glycated hemoglobin levels (mHbA1c) were obtained during each treatment period (multiple doses of insulin and continuous insulin infusion therapy period). Although mHbA1c levels were lower during continuous insulin infusion therapy the difference was not statistically significant. During multiple doses of insulin, 14.2% had mHbA1c values below 7.5% vs. 35.71% while on continuous insulin infusion therapy; demonstrating better glycemic control with the use of continuous insulin infusion therapy. During multiple doses of insulin, 15-40 patients have severe hypoglycemic events versus 5-40 continuous insulin infusion therapy. No episodes of ketoacidosis events were recorded. This is the first study with this design comparing multiple doses of insulin and continuous insulin infusion therapy in Brazil showing no significant difference in HbA1c; hypoglycemic events were less frequent during continuous insulin infusion therapy than during multiple doses of insulin and the percentage of patients who achieved a HbA1c less than 7.5% was greater during continuous insulin infusion therapy than multiple doses of insulin therapy. Copyright © 2015 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

Effectiveness of a spanish language clinic for Hispanic youth with type 1 diabetes.

PubMed

Palau-Collazo, Miladys M; Rose, Paulina; Sikes, Kristin; Kim, Grace; Benavides, Valeria; Urban, Andrea; Weinzimer, Stuart A; Tamborlane, William V

2013-01-01

A pilot study was undertaken to determine whether establishment of a Spanish Language Diabetes Clinic (SLDC) for Spanish-speaking families conducted by a team of Spanish-speaking, Hispanic and nonHispanic clinicians provides a means to improve control of type 1 diabetes (T1D). The first 21 Hispanic pediatric patients with T1D who enrolled in the SLDC were matched to 21 Hispanic patients treated in the English Language Diabetes Clinic (ELDC) based on age and duration of diabetes. The two groups did not differ significantly with respect to gender, body mass index (BMI), or glycated hemoglobin (HbA1c). Patients in both groups were followed for 12 months. The mean (± standard deviation) baseline glycated hemoglobin (HbA1c) level in the SLDC group (8.4 ± 1.0%) was similar to that in the ELDC group (8.6 ± 1.4%, P = .83). HbA1c levels fell by 0.5 ± 1.0% (P = .01) during the year following enrollment in the SLDC but did not change significantly from baseline during the year of follow-up in the ELDC group (decrease of 0.2 ± 0.9%, P = .1). At the start of the study, only 5 patients (23%) in the SLDC group and 7 patients (33%) in the ELDC group met the ≤7.5% target HbA1c level. After 1 year, 10 of the SLDC patients (48%) and 4 of ELDC patients (19%) had HbA1c levels ≤7.5% (P = .01). Our preliminary findings support the hypothesis that overcoming language barriers by the establishment of a SLDC can be an effective means of improving metabolic control in youth with T1D in Hispanic families with limited English language skills.

P.L. 110-173: Provisions in the Medicare, Medicaid, and SCHIP Extension Act of 2007

DTIC Science & Technology

2008-02-07

option available to the Secretary. Section 113. Payment rate for certain diagnostic laboratory tests. Glycosylated hemoglobin ( HbA1c ) is used to...monitor how well blood glucose levels are controlled in diabetes patients. The current Medicare payment rate for HbA1c is tied to two HCPCS codes: 83036...and 83037. HCPCS code 83037 was developed in CRS-10 2006 to cover the testing for HbA1c by a device approved by the Food and Drug Administration (FDA

Nursing Case Management and Glycemic Control Among Brazilians With Type 2 Diabetes: Pragmatic Clinical Trial.

PubMed

Moreira, Ricardo Castanho; Mantovani, Maria de Fátima; Soriano, José Verdú

2015-01-01

Type 2 diabetes mellitus is a chronic condition that requires ongoing, life-long care in order to be controlled. The aims of the study were to assess the effect of nursing case management on glycated hemoglobin (HbA1c) levels compared to usual care in people with type 2 diabetes mellitus and to determine if effects of nursing case management varied by gender, age, duration of disease, education, and income. This is a pragmatic clinical trial, conducted in the municipality of Bandeirantes, Paraná, Brazil, in 2011 and 2012. Eighty individuals were recruited and randomized equally to receive nursing case management or usual care. Covariates were sociodemographic and clinical factors. The outcome was HbA1c measured at baseline, 6 months, and 12 months. The sample consisted predominately of women; most had been diagnosed with type 2 diabetes mellitus within the previous 5 years. Mean age was 50.14 (SD = 7.00), with 5.27 (SD = 4.39) years of schooling and an average HbA1c of 9.90% (SD = 2.49). Hemoglobin A1c was reduced from an average of 10.33% to 9.0% (p < .01) in the nursing case management group and from 9.57% to 8.93% (p = .05) in the usual care group; the group by time effect was not significant. Case management effects varied by younger age (p = .05), duration of type 2 diabetes less than 5 years (p = .03), up to 4 years of schooling (p = .04), and being in the lowest-income stratum (p = .02). Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline. The difference in proportional reduction of HbA1c between groups was not statistically significant.

Longitudinal trends in HbA1c and associations with comorbidity and all-cause mortality in Asian patients with type 2 diabetes: A cohort study.

PubMed

Luo, Miyang; Lim, Wei Yen; Tan, Chuen Seng; Ning, Yilin; Chia, Kee Seng; van Dam, Rob M; Tang, Wern Ee; Tan, Ngiap Chuan; Chen, Richard; Tai, E Shyong; Venkataraman, Kavita

2017-11-01

This study examined longitudinal trends in HbA1c in a multi-ethnic Asian cohort of diabetes patients, and the associations of these trends with future risk of acute myocardial infarction (AMI), stroke, end stage renal failure (ESRD) and all-cause mortality. 6079 participants with type 2 diabetes mellitus in Singapore were included. HbA1c measurements for the five years previous to recruitment were used to identify patterns of HbA1c trends. Outcomes were recorded through linkage with the National Disease Registry. The median follow-up for longitudinal trends in HbA1c was 4.1years and for outcomes was between 7.0 and 8.3years. HbA1c patterns were identified using latent class growth modeling, and associations with outcomes were analyzed using Cox proportional hazards models. Four distinct HbA1c patterns were observed; "low-stable" (72·2%), "moderate-stable" (22·0%), "moderate-increase" (2·9%), and "high-decrease" (2·8%). The risk of comorbidities and death was significantly higher in moderate-increase and high-decrease groups compared to the low-stable group; the hazard ratios for stroke, ESRD, and death for moderate increase group were 3.22 (95%CI 1.27-8.15), 4.76 (95%CI 1.92-11.83), and 1.88 (95%CI 1.15-3.07), respectively, and for high-decrease group were 2.16 (95%CI 1.02-4.57), 3.05 (95%CI 1.54-6.07), and 2.79 (95%CI 1.97-3.95), respectively. Individuals in the moderate-increase group were significantly younger, with longer diabetes duration, and greater proportions of Malays and Indians. Deteriorating HbA1c pattern and extremely high initial HbA1c are associated with increased risk of long-term comorbidities and death. Therapeutic interventions to alter longitudinal HbA1c trends may be helpful in reducing this risk. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Analysis of Hemoglobin A1c from Dried Blood Spot Samples with the Tina-quant® II Immunoturbidimetric Method

PubMed Central

Jones, Trevor G.; Warber, Kimbrough D.; Roberts, Billy D.

2010-01-01

Background Hemoglobin A1c (HbA1c) has been endorsed as a tool for the diagnosis of diabetes. This test requires instrumentation that may not be available in underdeveloped areas. Dried blood spot (DBS) samples collected by finger stick procedures offer a mechanism to transport samples to laboratories that do measure HbA1c. Methods Whole blood (ethylenediaminetetraacetic acid) was applied to Ahlstrom 226 filter paper. These DBS samples were compared to whole blood samples using the Roche Tina-quant® II immunoturbidometric assay. Hemoglobin A1c stability on DBS was assessed at three temperatures—4, 25, and 40°C—for up to 9 days. A 44-day study was also done for DBS at 20–25°C. Results The Tina-quant® II DBS method showed excellent agreement with whole blood HbA1c results (r2 = 0.99) with a slight positive mean bias of 0.08 ± 0.04% HbA1c (95% confidence interval). The variation in HbA1c on DBS samples subjected to different temperatures and times did not exceed 5.6%. Conclusions Dried blood spot samples represent an alternative to whole blood for HbA1c by measurement when transporting whole blood is not feasible. PMID:20307383

Exercise Therapy for Management of Type 2 Diabetes Mellitus: Superior Efficacy of Activity Monitors over Pedometers.

PubMed

Miyauchi, Masaaki; Toyoda, Masao; Kaneyama, Noriko; Miyatake, Han; Tanaka, Eitaro; Kimura, Moritsugu; Umezono, Tomoya; Fukagawa, Masafumi

2016-01-01

We compared the efficacy of activity monitor (which displays exercise intensity and number of steps) versus that of pedometer in exercise therapy for patients with type 2 diabetes. The study subjects were divided into the activity monitor group ( n = 92) and pedometer group ( n = 95). The primary goal was improvement in hemoglobin A1c (HbA1c). The exercise target was set at 8,000 steps/day and 20 minutes of moderate-intensity exercise (≥3.5 metabolic equivalents). The activity monitor is equipped with a triple-axis accelerometer sensor capable of measuring medium-intensity walking duration, number of steps, walking distance, calorie consumption, and total calorie consumption. The pedometer counts the number of steps. Blood samples for laboratory tests were obtained during the visits. The first examination was conducted at the start of the study and repeated at 2 and 6 months. A significant difference in the decrease in HbA1c level was observed between the two groups at 2 months. The results suggest that the use of activity level monitor that displays information on exercise intensity, in addition to the number of steps, is useful in exercise therapy as it enhances the concept of exercise therapy and promotes lowering of HbA1c in diabetic patients.

Changes in metabolic profiles after the Great East Japan Earthquake: a retrospective observational study

PubMed Central

2013-01-01

Background A magnitude 9.0 earthquake struck off eastern Japan in March 2011. Many survivors have been living in temporary houses provided by the local government since they lost their houses as a result of the great tsunami (tsunami group) or the expected high-dose radiation resulting from the nuclear accident at the Fukushima Daiichi Nuclear Power Plant (radiation group). The tsunami was more than 9 m high in Soma, Fukushima, which is located 30 km north of the Fukushima Daiichi Nuclear Power Plant and adjacent to the mandatory evacuation area. A health screening program was held for the evacuees in Soma in September 2011. The aim of this study was to compare the metabolic profiles of the evacuees before and after the disaster. We hypothesized that the evacuees would experience deteriorated metabolic status based on previous reports of natural disasters. Methods Data on 200 subjects who attended a health screening program in September or October of 2010 (pre-quake) and 2011 (post-quake) were retrospectively reviewed and included in this study. Pre-quake and post-quake results of physical examinations and laboratory tests were compared in the tsunami and radiation groups. A multivariate regression model was used to determine pre-quake predictive factors for elevation of hemoglobin A1c (HbA1c) in the tsunami group. Results Significantly higher values of body weight, body mass index, waist circumference, and HbA1c and lower high-density lipoprotein cholesterol levels were found at the post-quake screening when compared with the pre-quake levels (p = 0.004, p = 0.03, p = 0.008, p < 0.001, and p = 0.03, respectively). A significantly higher proportion of subjects in the tsunami group with high HbA1c, defined as ≥5.7%, was observed after the quake (34.3%) than before the quake (14.8%) (p < 0.001). Regional factors, periodic clinic visits, and waist circumference before the quake were identified as predictive factors on multivariate analysis for the deterioration of HbA1c. Conclusions Post-quake metabolic variables were impaired compared with pre-quake baseline levels in survivors who were living in temporary houses. A natural disaster could affect metabolic profiles, and careful follow-up for survivors should be planned. PMID:23521922

Changes in metabolic profiles after the Great East Japan Earthquake: a retrospective observational study.

PubMed

Tsubokura, Masaharu; Takita, Morihito; Matsumura, Tomoko; Hara, Kazuo; Tanimoto, Tetsuya; Kobayashi, Kazuhiko; Hamaki, Tamae; Oiso, Giichiro; Kami, Masahiro; Okawada, Tadaichi; Tachiya, Hidekiyo

2013-03-23

A magnitude 9.0 earthquake struck off eastern Japan in March 2011. Many survivors have been living in temporary houses provided by the local government since they lost their houses as a result of the great tsunami (tsunami group) or the expected high-dose radiation resulting from the nuclear accident at the Fukushima Daiichi Nuclear Power Plant (radiation group). The tsunami was more than 9 m high in Soma, Fukushima, which is located 30 km north of the Fukushima Daiichi Nuclear Power Plant and adjacent to the mandatory evacuation area. A health screening program was held for the evacuees in Soma in September 2011. The aim of this study was to compare the metabolic profiles of the evacuees before and after the disaster. We hypothesized that the evacuees would experience deteriorated metabolic status based on previous reports of natural disasters. Data on 200 subjects who attended a health screening program in September or October of 2010 (pre-quake) and 2011 (post-quake) were retrospectively reviewed and included in this study. Pre-quake and post-quake results of physical examinations and laboratory tests were compared in the tsunami and radiation groups. A multivariate regression model was used to determine pre-quake predictive factors for elevation of hemoglobin A1c (HbA1c) in the tsunami group. Significantly higher values of body weight, body mass index, waist circumference, and HbA1c and lower high-density lipoprotein cholesterol levels were found at the post-quake screening when compared with the pre-quake levels (p = 0.004, p = 0.03, p = 0.008, p < 0.001, and p = 0.03, respectively). A significantly higher proportion of subjects in the tsunami group with high HbA1c, defined as ≥ 5.7%, was observed after the quake (34.3%) than before the quake (14.8%) (p < 0.001). Regional factors, periodic clinic visits, and waist circumference before the quake were identified as predictive factors on multivariate analysis for the deterioration of HbA1c. Post-quake metabolic variables were impaired compared with pre-quake baseline levels in survivors who were living in temporary houses. A natural disaster could affect metabolic profiles, and careful follow-up for survivors should be planned.

The utilization of video-conference shared medical appointments in rural diabetes care.

PubMed

Tokuda, Lisa; Lorenzo, Lenora; Theriault, Andre; Taveira, Tracey H; Marquis, Lynn; Head, Helene; Edelman, David; Kirsh, Susan R; Aron, David C; Wu, Wen-Chih

2016-09-01

To explore whether Video-Shared Medical Appointments (video-SMA), where group education and medication titration were provided remotely through video-conferencing technology would improve diabetes outcomes in remote rural settings. We conducted a pilot where a team of a clinical pharmacist and a nurse practitioner from Honolulu VA hospital remotely delivered video-SMA in diabetes to Guam. Patients with diabetes and HbA1c ≥7% were enrolled into the study during 2013-2014. Six groups of 4-6 subjects attended 4 weekly sessions, followed by 2 bi-monthly booster video-SMA sessions for 5 months. Patients with HbA1c ≥7% that had primary care visits during the study period but not referred/recruited for video-SMA were selected as usual-care comparators. We compared changes from baseline in HbA1c, blood-pressure, and lipid levels using mixed-effect modeling between video-SMA and usual care groups. We also analyzed emergency department (ED) visits and hospitalizations. Focus groups were conducted to understand patient's perceptions. Thirty-one patients received video-SMA and charts of 69 subjects were abstracted as usual-care. After 5 months, there was a significant decline in HbA1c in video-SMA vs. usual-care (9.1±1.9 to 8.3±1.8 vs. 8.6±1.4 to 8.7±1.6, P=0.03). No significant change in blood-pressure or lipid levels was found between the groups. Patients in the video-SMA group had significantly lower rates of ED visits (3.2% vs. 17.4%, P=0.01) than usual-care but similar hospitalization rates. Focus groups suggested patient satisfaction with video-SMA and increase in self-efficacy in diabetes self-care. Video-SMA is feasible, well-perceived and has the potential to improve diabetes outcomes in a rural setting. Published by Elsevier Ireland Ltd.

A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis.

PubMed

Grotz, V Lee; Pi-Sunyer, Xavier; Porte, Daniel; Roberts, Ashley; Richard Trout, J

2017-08-01

The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control. Copyright © 2017 Heartland Food Products Group. Published by Elsevier Inc. All rights reserved.

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial.

PubMed

Pedersen-Bjergaard, Ulrik; Kristensen, Peter L; Beck-Nielsen, Henning; Nørgaard, Kirsten; Perrild, Hans; Christiansen, Jens S; Jensen, Tonny; Parving, Hans-Henrik; Thorsteinsson, Birger; Tarnow, Lise

2017-01-01

The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c. Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)). Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The usage of fasting glucose and glycated hemoglobin for the identification of unknown type 2 diabetes in high risk patients with morbid obesity.

PubMed

Valderhaug, Tone G; Sharma, Archana; Kravdal, Gunnhild; Rønningen, Reidun; Nermoen, Ingrid

2017-11-01

In spite of increased vigilance of undiagnosed type 2 diabetes (DM2), the prevalence of unknown DM2 in subjects with morbid obesity is not known. To assess the prevalence of undiagnosed DM2 and compare the performance of glycated A1c (HbA1c) and fasting glucose (FG) for the diagnosis of DM2 and prediabetes (preDM) in patients with morbid obesity. We measured fasting glucose and HbA1c in 537 consecutive patients with morbid obesity without previously known DM2. A total of 49 (9%) patients with morbid obesity had unknown DM2 out of which 16 (33%) fulfilled both the criteria for HbA1c and FG. Out of 284 (53%) subjects with preDM, 133 (47%) fulfilled both the criteria for HbA1c and FG. Measurements of agreement for FG and HbA1c were moderate for DM2 (κ = 0.461, p < .001) and fair for preDM (κ = 0.317, p < .001). Areas under the curve for FG and HbA1c in predicting unknown DM2 were 0.970 (95% CI 0.942, 0.998) and 0.894 (95% CI 0.837, 0.951) respectively. The optimal thresholds to identify unknown DM2 were FG ≥6.6 mmol/L and HbA1c ≥ 6.1% (43 mmol/mol). The prevalence of DM2 remains high and both FG and HbA1c identify patients with unknown DM2. FG was slightly superior to HbA1c in predicting and separating patients with unknown DM2 from patients without DM2. We suggest that an FG ≥6.6 mmol/L or an HbA1c ≥6.1% (43 mmol/mol) may be used as primary cut points for the identification of unknown DM2 among patients with morbid obesity.