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Sample records for a1c hba1c lipid

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. [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.

  8. Hemoglobin A1c (HbA1c) Test: MedlinePlus Lab Test Information

    MedlinePlus

    ... medlineplus.gov/labtests/hemoglobina1chba1ctest.html Hemoglobin A1c (HbA1c) Test To use the sharing features on this page, ... enable JavaScript. What is a hemoglobin A1c (HbA1c) test? A hemoglobin A1c (HbA1c) test measures the amount ...

  9. 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

  10. 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

  11. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial.

    PubMed

    Irwig, M S; Sood, P; Ni, D; Amass, T; Khurana, P S; Jayanthi, V V; Wang, L; Adler, S M

    2012-09-01

    To test (1) whether a diabetes scorecard can improve glycaemic control, blood pressure control, LDL cholesterol, aspirin usage and exercise; (2) if the scorecard will motivate and/or educate patients to improve their scores for subsequent visits; and (3) whether the scorecard will improve rates of clinical inertia. Five physicians enrolled 103 patients ≥ 40 years old with uncontrolled Type 2 diabetes [HbA(1c) ≥ 64 mmol/mol (8.0%)] to randomly receive either a diabetes scorecard or not during four clinical visits over a 9-month period. The population was predominantly urban with a disproportionately higher percentage of black people than the general population. Our scorecard assigned points to six clinical variables, with a perfect total score of 100 points corresponding to meeting all targets. The primary outcomes were total scores and HbA(1c) in the scorecard and control groups at 9 months. There were no significant differences between the control and scorecard groups at visits 1 and 4 in total score, HbA(1c) , blood pressure, LDL cholesterol, aspirin usage, exercise or knowledge about diabetic targets. By visit 4 both the control and scorecard groups had statistically significant improvements with their mean total score (9 and 7 points, respectively), HbA(1c) [-9 mmol/mol (-0.8%) and -15 mmol/mol (-1.4%), respectively] and aspirin usage (33% increase and 16% increase, respectively). Rates of clinical inertia were low throughout the study. A diabetes scorecard did not improve glycaemic control, blood pressure control, LDL cholesterol, aspirin usage, exercise or diabetic knowledge in an urban population with uncontrolled Type 2 diabetes. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  12. 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.

  13. 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

  14. Haemoglobin J-Baltimore can be detected by HbA1c electropherogram but with underestimated HbA1c value.

    PubMed

    Brunel, Valéry; Lahary, Agnčs; Chagraoui, Abdeslam; Thuillez, Christian

    2016-01-01

    Glycated haemoglobin (HbA(1c)) is considered the gold standard for assessing diabetes compensation and treatment. In addition, fortuitous detection of haemoglobin variants during HbA1c measurement is not rare. Recently, two publications reported different conclusions on accuracy of HbA(1c) value using capillary electrophoresis method in presence of haemoglobin J-Baltimore (HbJ).
Here we describe the fortuitous detection of unknown HbJ using capillary electrophoresis for measurement of HbA(1c). A patient followed for gestational diabetes in our laboratory presented unknown haemoglobin on Capillarys 2 Flex Piercing analyser which was identified as HbJ. HbJ is not associated with haematological abnormalities. High Performance Liquid Chromatography methods are known to possibly underestimate HbA(1c) value in the presence of this variant. This variant and its glycated form are clearly distinguished on electropherogram but HbJ was responsible for underestimating the true area of HbA(1c).
 Capillary electrophoresis is a good method for detecting HbJ but does not seem suitable for evaluation of HbA(1C) value in patients in presence of HbJ variant.

  15. 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.

  16. Should Studies of Diabetes Treatment Stratification Correct for Baseline HbA1c?

    PubMed Central

    Jones, Angus G.; Lonergan, Mike; Henley, William E.; Pearson, Ewan R.; Hattersley, Andrew T.; Shields, Beverley M.

    2016-01-01

    Aims Baseline HbA1c is a major predictor of response to glucose lowering therapy and therefore a potential confounder in studies aiming to identify other predictors. However, baseline adjustment may introduce error if the association between baseline HbA1c and response is substantially due to measurement error and regression to the mean. We aimed to determine whether studies of predictors of response should adjust for baseline HbA1c. Methods We assessed the relationship between baseline HbA1c and glycaemic response in 257 participants treated with GLP-1R agonists and assessed whether it reflected measurement error and regression to the mean using duplicate ‘pre-baseline’ HbA1c measurements not included in the response variable. In this cohort and an additional 2659 participants treated with sulfonylureas we assessed the relationship between covariates associated with baseline HbA1c and treatment response with and without baseline adjustment, and with a bias correction using pre-baseline HbA1c to adjust for the effects of error in baseline HbA1c. Results Baseline HbA1c was a major predictor of response (R2 = 0.19,β = -0.44,p<0.001).The association between pre-baseline and response was similar suggesting the greater response at higher baseline HbA1cs is not mainly due to measurement error and subsequent regression to the mean. In unadjusted analysis in both cohorts, factors associated with baseline HbA1c were associated with response, however these associations were weak or absent after adjustment for baseline HbA1c. Bias correction did not substantially alter associations. Conclusions Adjustment for the baseline HbA1c measurement is a simple and effective way to reduce bias in studies of predictors of response to glucose lowering therapy. PMID:27050911

  17. Use of Fructosyl Peptide Oxidase for HbA1c Assay

    PubMed Central

    Yonehara, Satoshi; Inamura, Norio; Fukuda, Miho; Sugiyama, Koji

    2015-01-01

    ARKRAY, Inc developed the world’s first automatic glycohemoglobin analyzer based on HPLC (1981). After that, ARKRAY developed enzymatic HbA1c assay “CinQ HbA1c” with the spread and diversification of HbA1c measurement (2007). CinQ HbA1c is the kit of Clinical Chemistry Analyzer, which uses fructosyl peptide oxidase (FPOX) for a measurement reaction. This report mainly indicates the developmental background, measurement principle, and future of the enzymatic method HbA1c reagent. PMID:25633966

  18. Multimedia education program and nutrition therapy improves HbA1c, weight, and lipid profile of patients with type 2 diabetes: a randomized clinical trial.

    PubMed

    Velázquez-López, Lubia; Muñoz-Torres, Abril Violeta; Medina-Bravo, Patricia; Vilchis-Gil, Jenny; Klϋnder-Klϋnder, Miguel; Escobedo-de la Peña, Jorge

    2017-11-01

    To evaluate the effect of a multimedia education program and nutrition therapy on metabolic control in patients with type 2 diabetes. What is the effect of a multimedia education program and nutritional therapy on metabolic control in type 2 diabetes? A randomized clinical trial was conducted in 351 patients randomly assigned to either an experimental group receiving a multimedia diabetes education program (MDE) and nutrition therapy (NT) (NT + MDE: n = 173), or to a control group who received nutrition therapy only (NT: n = 178). At baseline, 7, 14, and 21 months, the glycated hemoglobin (HbA1c), glucose, cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol were measured. Weight, body mass index (BMI), waist circumference (WC), fat percentage, fat and lean mass, systolic blood pressure (SBP), and diastolic (DBP) were also recorded. Glycated hemoglobin decreased in both groups, although the group with NT + MDE had a greater reduction, with a difference of -0.76% (95%CI -1.33 to -0.19) at 7 months and -0.73% (95%CI -1.37 to -0.09) at 21 months. Only in the NT + MDE did the glucose decrease at 7 (-41.2 mg/dL; 95%CI -52.0 to -30.5), 14 (-27.8 mg/dL; 95%CI -32.6 to -23.1), and 21 months (-36.6 mg/dL; 95%CI -46.6 to -26.6). Triglycerides and the atherogenic index decreased in both groups at 7 and 14 months; while only in the NT + MDE group did it decrease at 21 months. (p < 0.05). Weight decreased at 21 months in the NT + MDE group (-1.23, -2.29 at -0.16; p < 0.05). Nutrition therapy and a multimedia diabetes education program have a favorable impact on achieving metabolic control goals in type 2 diabetes.

  19. Structured education using Dose Adjustment for Normal Eating (DAFNE) reduces long-term HbA1c and HbA1c variability.

    PubMed

    Walker, G S; Chen, J Y; Hopkinson, H; Sainsbury, C A R; Jones, G C

    2018-06-01

    Previous evidence has demonstrated that participation in the Dose Adjustment for Normal Eating (DAFNE) education programme can reduce HbA 1c and severe hypoglycaemia in people with Type 1 diabetes. In a number of studies, increased HbA 1c variability has been associated with higher diabetic morbidity and mortality. No studies have examined the impact of structured education on HbA 1c variability in Type 1 diabetes. People with Type 1 diabetes who had attended DAFNE were identified for inclusion from the Scottish Care Information-Diabetes dataset. HbA 1c median and variability, expressed as coefficient of variation (CV) before and after DAFNE was calculated. Some 1061 individuals participated in DAFNE education and 687 met the inclusion criteria. A significant median reduction in HbA 1c [-3.5 mmol/mol (-0.3%)] was seen at 12 months with a significant reduction [-1.5 mmol/mol (-0.1%)] still seen at 60 months of follow-up. HbA 1c variability as measured by CV was significantly lower during the post-DAFNE period: 0.08 (IQR 0.05-0.12) reduced to 0.07 (IQR 0.05-0.10); P = 0.002. The data confirm that DAFNE participation improves glycaemic control in Type 1 diabetes with benefits being sustained for 5 years. This study is the first to demonstrate reduced HbA 1c variability after completion of structured education. This is new evidence of the beneficial impact of DAFNE on glycaemic profile. © 2018 Diabetes UK.

  20. Analysis of HbA1c on an automated multicapillary zone electrophoresis system.

    PubMed

    Rollborn, Niclas; Åkerfeldt, Torbjörn; Nordin, Gunnar; Xu, Xiao Yan; Mandic-Havelka, Aleksandra; Hansson, Lars-Olof; Larsson, Anders

    2017-02-01

    Hemoglobin A1c (HbA1c) is a frequently requested laboratory test and there is thus a need for high throughput instruments for this assay. We evaluated a new automated multicapillary zone electrophoresis instrument (Capillarys 3 Tera, Sebia, Lisses, France) for analysis of HbA1c in venous samples. Routine requested HbA1c samples were analyzed immunologically on a Roche c6000 instrument (n = 142) and then with the Capillarys 3 Tera instrument. The Capillarys 3 Tera instrument performed approximately 70 HbA1c tests/hour. There was a strong linear correlation between Capillarys 3 Tera and Roche Tina-Quant HbA1c Gen 3 assay (y = 1.003x - 0.3246 R 2  = .996). The total CV for the 12 capillaries varied between 0.8 and 2.2% and there was a good agreement between duplicate samples (R 2  = .997). In conclusion, the Capillarys 3 Tera instrument has a high assay capacity for HbA1c. It has a good precision and agreement with the Roche Tina-Quant HbA1c method and is well suited for high volume testing of HbA1c.

  1. 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

  2. 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

  3. 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.

  4. Is insulin the preferred treatment for HbA1c >9%?

    PubMed

    Bloomgarden, Zachary

    2017-09-01

    approaches are more effective than monotherapy, with a combination regimen the HbA1c reduction will not be directly additive, because the expected reduction decreases at lower baseline HbA1c levels. As an example of this, administration of canagliflozin 300 mg daily to patients with baseline HbA1c >9% reduced levels from 9.6% by 1.8%, whereas at a baseline HbA1c of 10% either canagliflozin 300 mg or metformin 2 g/day reduced HbA1c by 2%; the addition of both agents led to an HbA1c reduction by somewhat less than 3%, which appears concordant with a reduction by the second agent from approximately 8% (10% to 2%). Similar less-than-additive effects of the addition of exenatide QW to dapagliflozin have been reported, with HbA1c reduction from a baseline of 10.0%-10.1% of 1.9% and 1.6% with the individual agents, respectively, and a reduction of 2.2% with their combination. However, one may consider these approaches inferior to the expected HbA1c reduction with insulin, suggesting that insulin should, indeed, be the preferred treatment for people with T2D and HbA1c >9%. Rather, studies comparing basal insulin directly with glucagon-like peptide-1 (GLP-1) receptor agonists (RA) suggest that the latter agents may offer superior benefit. The Diabetes Therapy Utilization: Researching Changes in HBA1C, Weight, and Other Factors Through Intervention with Exenatide Once Weekly (DURATION)-3 and Liraglutide Effect and Action in Diabetes (LEAD)-5 studies compared exenatide QW and liraglutide, respectively, with insulin glargine. Those study participants in the highest quartile of baseline HbA1c had levels ≥9.0% and ≥8.9%, with the GLP-1RA leading to 0.3% and 0.2% greater reductions in HbA1c, respectively, than insulin glargine. Another study comparing T2D patients receiving oral agents given liraglutide with those given insulin glargine showed that those in the highest baseline HbA1c quartile (mean 10.6%) had an HbA1c reduction of 3.1% with either agent. In the exenatide QW study

  5. Considerably decreased risk of cardiovascular disease with combined reductions in HbA1c, blood pressure and blood lipids in type 2 diabetes: Report from the Swedish National Diabetes Register.

    PubMed

    Eeg-Olofsson, Katarina; Zethelius, Björn; Gudbjörnsdottir, Soffia; Eliasson, Björn; Svensson, Ann-Marie; Cederholm, Jan

    2016-07-01

    Assess the effect of risk factors changes on risk for cardiovascular disease and mortality in patients with type 2 diabetes selected from the Swedish National Diabetes Register. Observational study of 13,477 females and males aged 30-75 years, with baseline HbA1c 41-67 mmol/mol, systolic blood pressure 122-154 mmHg and ratio non-HDL:HDL 1.7-4.1, followed for mean 6.5 years until 2012. Four groups were created: a reference group (n = 6757) with increasing final versus baseline HbA1c, systolic blood pressure and non-HDL:HDL cholesterol during the study period, and three groups with decreasing HbA1c (n = 1925), HbA1c and systolic blood pressure (n = 2050) or HbA1c and systolic blood pressure and non-HDL:HDL (n = 2745). Relative risk reduction for fatal/nonfatal cardiovascular disease was 35% with decrease in HbA1c only (mean 6 to final 49 mmol/mol), 56% with decrease in HbA1c and systolic blood pressure (mean 12 to final 128 mmHg) and 75% with combined decreases in HbA1c, systolic blood pressure and non-HDL:HDL (mean 0.8 to final 2.1), all p < 0.001 adjusting for clinical characteristics, other risk factors, treatments and previous cardiovascular disease. Similar risk reductions were found for fatal/nonfatal coronary heart disease, fatal cardiovascular disease, all-cause mortality and also in a subgroup of 3038 patients with albuminuria. Considerable risk reductions for cardiovascular disease and mortality were seen with combined long-term risk factor improvement. © The Author(s) 2016.

  6. The changing relationship between HbA1c and FPG according to different FPG ranges.

    PubMed

    Guan, X; Zheng, L; Sun, G; Guo, X; Li, Y; Song, H; Tian, F; Sun, Y

    2016-05-01

    Since the American Diabetes Association included hemoglobin A1c (HbA1c) in the diagnostic criteria for diabetes in 2010, the clinical use of HbA1c has remained controversial. We explored the use of HbA1c for diagnosing diabetes and intermediate hyperglycemia in comparison with fasting plasma glucose (FPG). We screened 3710 adult subjects (mean age = 55.24 years) comprising 1704 males and 2006 females. We drew an receiver operating characteristic (ROC) curve to evaluate the ability of HbA1c to diagnose diabetes and intermediate hyperglycemia according to FPG. We used Kappa coefficient and Pearson's correlation coefficient to evaluate the relationship between HbA1c and FPG in different FPG ranges. The areas under ROC curve to diagnose diabetes and intermediate hyperglycemia were 0.859 (95 % CI 0.827-0.892) and 0.633 (95 % CI 0.615-0.651). The kappa coefficients between FPG and HbA1c for diagnosis of diabetes and intermediate hyperglycemia were 0.601 (P < 0.001) and 0.104 (P < 0.001). The Pearson's correlation coefficient of FPG and HbA1c was 0.640 (P < 0.001), but when we classified FPG as normal, intermediate hyperglycemia and diabetes, the coefficients became 0.07 (P = 0.002), 0.185 (P < 0.001) and 0.760 (P < 0.001), respectively. The relationship between HbA1c and FPG changed according to the different FPG ranges. When FPG was higher, the relationship was stronger. HbA1c and FPG were highly consistent in diagnosing diabetes, but they were not in predicting intermediate hyperglycemia.

  7. Trajectories of HbA1c Levels in Children and Youth with Type 1 Diabetes

    PubMed Central

    Pinhas-Hamiel, Orit; Hamiel, Uri; Boyko, Valentina; Graph-Barel, Chana; Reichman, Brian; Lerner-Geva, Liat

    2014-01-01

    Purpose To illustrate the distribution of Hemoglobin A1c (HbA1c) levels according to age and gender among children, adolescents and youth with type 1 diabetes (T1DM). Methods Consecutive HbA1c measurements of 349 patients, aged 2 to 30 years with T1DM were obtained from 1995 through 2010. Measurement from patients diagnosed with celiac disease (n = 20), eating disorders (n = 41) and hemoglobinopathy (n = 1) were excluded. The study sample comprised 4815 measurements of HbA1c from 287 patients. Regression percentiles of HbA1c were calculated as a function of age and gender by the quantile regression method using the SAS procedure QUANTREG. Results Crude percentiles of HbA1c as a function of age and gender, and the modeled curves produced using quantile regression showed good concordance. The curves show a decline in HbA1c levels from age 2 to 4 years at each percentile. Thereafter, there is a gradual increase during the prepubertal years with a peak at ages 12 to 14 years. HbA1c levels subsequently decline to the lowest values in the third decade. Curves of females and males followed closely, with females having HbA1c levels about 0.1% (1.1 mmol/mol) higher in the 25th 50th and 75th percentiles. Conclusion We constructed age-specific distribution curves for HbA1c levels for patients with T1DM. These percentiles may be used to demonstrate the individual patient's measurements longitudinally compared with age-matched patients. PMID:25275650

  8. HbA1c is outcome predictor in diabetic patients with sepsis.

    PubMed

    Gornik, Ivan; Gornik, Olga; Gasparović, Vladimir

    2007-07-01

    We have investigated predictive value of HbA1c for hospital mortality and length of stay (LOS) in patients with type 2 diabetes admitted because of sepsis. A prospective observational study was implemented in a university hospital, 286 patients with type 2 diabetes admitted with sepsis were included. Leukocyte count, CRP, admission plasma glucose, APACHE II and SOFA score were noted at admission, HbA1c was measured on the first day following admission. Hospital mortality and hospital length of stay (LOS) were the outcome measures. Admission HbA1c was significantly lower in surviving patients than in non-survivors (median 8.2% versus 9.75%, respectively; P<0.001). There was a significant correlation between admission HbA1c and hospital LOS of surviving patients (r=0.29; P<0.001). Logistic regression showed that HbA1c is an independent predictor of hospital mortality (odds ratio 1.36), together with female sex (OR 2.24), APACHE II score (OR 1.08) and SOFA score (OR 1.28). Multiple regression showed that HbA1c and APACHE II score are independently related to hospital LOS. According to our results, HbA1c is an independent predictive factor for hospital mortality and hospital LOS of diabetic patients with sepsis.

  9. 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.

  10. 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.

  11. 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.

  12. Impact of HbA1c Testing at Point of Care on Diabetes Management

    PubMed Central

    Schnell, Oliver; Crocker, J. Benjamin; Weng, Jianping

    2016-01-01

    Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like cardiovascular or renal disease. HbA1c testing is a vital step for effective diabetes management, however, given the low compliance to testing frequency and, commonly, a subsequent delay in the corresponding treatment modification, HbA1c at the point of care (POC) offers an opportunity for improvement of diabetes care. In this review, based on data from 1999 to 2016, we summarize the evidence supporting a further implementation of HbA1c testing at POC, discuss its limitations and propose recommendations for further development. PMID:27898388

  13. 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.

  14. 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/.

  15. 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.

  16. Understanding the new HbA1c units for the diagnosis of Type 2 diabetes.

    PubMed

    Braatvedt, Geoff D; Cundy, Tim; Crooke, Michael; Florkowski, Chris; Mann, Jim I; Lunt, Helen; Jackson, Rod; Orr-Walker, Brandon; Kenealy, Timothy; Drury, Paul L

    2012-09-21

    In New Zealand laboratories the measurement of glycated haemoglobin (HbA1c) for diagnosis of diabetes is now only reported in SI units of mmol/mol. HbA1c is now recommended as the preferred test to diagnose diabetes in most circumstances. The requirement for a second positive test in asymptomatic individuals is retained. An HbA1c greater than and equal to 50 mmol/mol (repeated on a second occasion in asymptomatic patients) is diagnostic of diabetes and a value less than and equal to 40 mmol/mol represents normal glucose tolerance. For patients with an initial HbA1c result of 41-49 mmol/mol, cardiovascular risk assessment and lifestyle interventions are recommended with repeat HbA1c screening in 6-12 months. For patients whose HbA1c is less than and equal to 40 mmol/mol, repeat screening (including for CVD risk) at intermittent intervals is recommended as per published guidelines.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Metrics for glycaemic control - from HbA1c to continuous glucose monitoring.

    PubMed

    Kovatchev, Boris P

    2017-07-01

    As intensive treatment to lower levels of HbA 1c characteristically results in an increased risk of hypoglycaemia, patients with diabetes mellitus face a life-long optimization problem to reduce average levels of glycaemia and postprandial hyperglycaemia while simultaneously avoiding hypoglycaemia. This optimization can only be achieved in the context of lowering glucose variability. In this Review, I discuss topics that are related to the assessment, quantification and optimal control of glucose fluctuations in diabetes mellitus. I focus on markers of average glycaemia and the utility and/or shortcomings of HbA 1c as a 'gold-standard' metric of glycaemic control; the notion that glucose variability is characterized by two principal dimensions, amplitude and time; measures of glucose variability that are based on either self-monitoring of blood glucose data or continuous glucose monitoring (CGM); and the control of average glycaemia and glucose variability through the use of pharmacological agents or closed-loop control systems commonly referred to as the 'artificial pancreas'. I conclude that HbA 1c and the various available metrics of glucose variability reflect the management of diabetes mellitus on different timescales, ranging from months (for HbA 1c ) to minutes (for CGM). Comprehensive assessment of the dynamics of glycaemic fluctuations is therefore crucial for providing accurate and complete information to the patient, physician, automated decision-support or artificial-pancreas system.

  9. [Assays of HbA1c and Amadori products in human biology].

    PubMed

    Gillery, P

    2014-09-01

    Different Amadori products, formed during the early steps of the non-enzymatic glycation of proteins, may be assayed in current practice in human biology. The most important marker is HbA1c, resulting from the binding of glucose to the N-terminal extremity of HbA beta chains. HbA1c may be evaluated by various techniques (ion exchange or affinity high performance liquid chromatography, capillary electrophoresis, immunoassay, enzymatic technique) and is considered the best marker of diabetic patient survey. Due to its irreversible and cumulative formation, it provides a retrospective information on the glycemic balance over the four to eight weeks preceding blood collection. It benefits from an international standardization, based on a reference method using liquid chromatography coupled to capillary electrophoresis or mass spectrometry, maintained by an international network of reference laboratories. When HbA1c assay cannot be used (anemia, hemolysis, hemoglobinopathy) or when a shorter period of glycemic equilibrium must be evaluated (child and adolescent, pregnancy, therapeutic changes), other Amadori products may be assayed, like plasma fructosamine (all plasma glycated proteins) or glycated albumin. Nevertheless, these assays are less used in practice, because their semiological value has been less evidenced. Besides, fructosamine assay lacks specificity, and glycated albumin assay has been described recently. An expanding use of HbA1c assay is expected, especially for the diagnosis of diabetes mellitus and the evaluation of other risks, especially cardiovascular ones. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  10. 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.

  11. K2-EDTA and K3-EDTA Greiner Tubes for HbA1c Measurement.

    PubMed

    Vrtaric, Alen; Filipi, Petra; Hemar, Marina; Nikolac, Nora; Simundic, Ana-Maria

    2016-02-01

    To determine whether K2-ethylenediaminetetraacetic acid (EDTA) and K3-EDTA Greiner tubes could be used interchangeably for glycosylated hemoglobin, type A1C (HbA1c) measurement via the Abbott Laboratories ARCHITECT chemiluminescent microparticle HbA1c assay on the ARCHITECT i2000SR immunoanalyzer at our university hospital. We drew blood from a total of 45 outpatients into plastic Greiner Vacuette tubes, some of which were lined with K2-EDTA and others with K3-EDTA anticoagulant. Data are presented as median and interquartile range values. We used the Wilcoxon test and Passing-Bablok regression for tube comparison. For K2-EDTA tubes median HbA1c concentration was 54 mmol/mol (41 to 71 mmol/mol) and for K3-EDTA tubes 56 mmol/mol (43 to 69 mmol/mol). There was no statistically significant difference between K2-EDTA and K3-EDTA (bias= -1.29 mmol/mol; P = 0.24). Passing-Bablok regression showed that there is no constant and proportional error: y = -0.23 (95% CI[-3.52 to 0.69]) + 1.00( 95% CI[0.98 to 1.06]) x. In this study, we provide evidence for the lack of any clinically and statistically significant bias between K2-EDTA and K3-EDTA HbA1c measurements. Thus, Greiner tubes lined with K2-EDTA and those lined with K3-EDTA can safely be used interchangeably to measure HbA1c via the Abbott Laboratories ARCHITECT assay. © American Society for Clinical Pathology, 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Interpretation of HbA1c : association with mean cell volume and haemoglobin concentration.

    PubMed

    Simmons, D; Hlaing, T

    2014-11-01

    The utility of HbA1c in diabetes diagnosis is reduced in settings associated with altered haemoglobin glycation. We have studied whether HbA1c varies with mean cell volume and mean cell haemoglobin concentration as measures of haemoglobin metabolism. Randomly selected adults from rural Victoria, Australia, were invited for biomedical assessment. After excluding patients with known diabetes and/or serum creatinine ≥ 0.12 mmol/l, 1315 adults were included. Demography, arthropometric measurements, oral glucose tolerance test, analyses of full blood count and HbA1c were undertaken. After adjusting for age, sex, ethnicity, BMI, town and socio-economic status, there were no significant differences in haemoglobin, mean cell volume or mean cell haemoglobin concentration by glycaemic status (defined by oral glucose tolerance test). HbA1c was significantly and independently associated with fasting glucose, town, mean cell haemoglobin concentration, ethnicity, age and BMI among men < 50 years (R² = 33.8%); fasting glucose, 2-h glucose, mean cell haemoglobin concentration and town among men ≥ 50 years (R² = 47.9%); fasting glucose, mean cell volume, mean cell haemoglobin concentration, town, 2-h glucose and age among women < 50 years (R² = 46.3%); fasting glucose, mean cell haemoglobin concentration, mean cell volume and 2-h glucose among women ≥ 50 years (R² = 51.6%). A generalized linear model showed a gradient from an adjusted mean HbA1c of 36 (95% CI 34-38) mmol/mol with a mean cell haemoglobin concentration of ≤ 320 g/l to 30 (95% CI 29-31) mmol/mol with a mean cell haemoglobin concentration of > 370 g/l. The gradient across mean cell volume was negative, but only by 1 mmol/mol (0.1%) HbA1c . A mean HbA1c difference of 5 mmol/mol (0.5%) across the mean cell haemoglobin concentration reference range suggests that an accompanying full blood count examination may be required for its use in the diagnosis of diabetes. Further studies are required to confirm this.

  13. Multicentre evaluation of the Premier Hb9210 HbA1c analyser

    PubMed Central

    John, W. Garry; Little, Randie; Sacks, David B.; Weykamp, Cas; Lenters-Westra, Erna; Hornsby, Theresa; Zhao, Zhen; Siebelder, Carla; Tennill, Alethea; English, Emma

    2017-01-01

    Background The accurate and precise quantification of HbA1c is essential for the diagnosis and routine monitoring of patients with diabetes. We report an evaluation of the Trinity Biotech Premier Hb9210 analyser (Bray, Ireland/Kansas City, US), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated haemoglobin. Methods We evaluated the analytical performance of the Hb9210 as part of a multicentre evaluation. The effect of haemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) reference systems, was assessed. Most of the centres participating also act as reference laboratories for both the IFCC standardisation network for HbA1c and the NGSP. Results The combined data from all centres showed total CVs of 2.71%, 2.32% and 2.14% at low medium and high values respectively for mmol/mol (SI units) and 1.62%, 1.59% and 1.68% for % (NGSP units), which are well below the recommended upper limits of 3% CV for SI (IFCC) units and 2% CV for % (NGSP). The analyser showed a good correlation to HbA1c methods currently used in clinical practice and the IFCC reference method procedure. Haemoglobin variants AC, AS, AE and AD do not affect the measurement of HbA1c. Overall the Hb9210 performs well across the whole analytical range. Conclusions The Hb9210 performs well and is suitable for clinical application in the analysis of HbA1c. PMID:25274956

  14. 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.

  15. Significance of HbA1c and its measurement in the diagnosis of diabetes mellitus: US experience.

    PubMed

    Juarez, Deborah Taira; Demaris, Kendra M; Goo, Roy; Mnatzaganian, Christina Louise; Wong Smith, Helen

    2014-01-01

    The 2014 American Diabetes Association guidelines denote four means of diagnosing diabetes. The first of these is a glycosylated hemoglobin (HbA1c) >6.5%. This literature review summarizes studies (n=47) in the USA examining the significance, strengths, and limitations of using HbA1c as a diagnostic tool for diabetes, relative to other available means. Due to the relatively recent adoption of HbA1c as a diabetes mellitus diagnostic tool, a hybrid systematic, truncated review of the literature was implemented. Based on these studies, we conclude that HbA1c screening for diabetes has been found to be convenient and effective in diagnosing diabetes. HbA1c screening is particularly helpful in community-based and acute care settings where tests requiring fasting are not practical. Using HbA1c to diagnose diabetes also has some limitations. For instance, HbA1c testing may underestimate the prevalence of diabetes, particularly among whites. Because this bias differs by racial group, prevalence and resulting estimates of health disparities based on HbA1c screening differ from those based on other methods of diagnosis. In addition, existing evidence suggests that HbA1c screening may not be valid in certain subgroups, such as children, women with gestational diabetes, patients with human immunodeficiency virus, and those with prediabetes. Further guidelines are needed to clarify the appropriate use of HbA1c screening in these populations.

  16. An alternative approach to modelling HbA1c trajectories in patients with type 2 diabetes mellitus.

    PubMed

    McEwan, Phil; Bennett, Hayley; Qin, Lei; Bergenheim, Klas; Gordon, Jason; Evans, Marc

    2017-05-01

    Time-dependent HbA1c trajectories in health economic models of type 2 diabetes mellitus (T2DM) are typically informed by the UK Prospective Diabetes Study (UKPDS). However, this approach may not accurately predict HbA1c progression in patients who do not conform to the demographic profile of the original UKPDS cohort. This study aimed to develop an alternative mathematical model (MM) to simulate HbA1c progression in T2DM. A systematic literature review identified studies, published between 2005 and 2015, that reported HbA1c in adult T2DM patients over a minimum duration of 18 months. Pooled data from eligible studies were used to develop an alternative MM equation for HbA1c progression, which was then contrasted with the UKPDS 68 progression equation in illustrative scenarios. A total of 68 studies were eligible for data extraction (mean follow-up time 4.1 years). HbA1c progression was highly heterogeneous across studies, varying with baseline HbA1c, treatment group and patient age. The MM equation was fitted with parameters for mean baseline HbA1c (8.3%), initial change in HbA1c (-0.62%) and upper quartile of maximum observed HbA1c (9.3%). Differences in HbA1c trajectories between the MM and UKPDS approaches altered the timing of therapy escalation in illustrative scenarios. The MM represents an alternative approach to simulate HbA1c trajectories in T2DM models, as UKPDS data may not adequately reflect the heterogeneity of HbA1c profiles observed in clinical studies. However, the choice of approach should ultimately be determined by the characteristics of individual patients under consideration and the clinical face validity of the modelled trajectories. © 2016 John Wiley & Sons Ltd.

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. Significant association of serum creatinine with HbA1C in impaired glucose tolerant Pakistani subjects

    PubMed Central

    Farasat, Tasnim; Sharif, Saima; Naz, Shagufta; Fazal, Sabiha

    2015-01-01

    Objective: The present study was conducted to assess the serum concentration of creatinine and determine its relationship with potential risk factors of diabetes in Impaired Glucose tolerance subjects. Methods: This cross sectional study was conducted on 100 IGT patients who attended Amin Hayat diabetic center in Lahore from January 2011- June 2011. Patients with age group 34-67 years, (both sexes) were included in the study. Different demographic parameters as age, BMI, WHR, B.P, personal history and socioeconomic status were recorded. Oral Glucose Tolerance Test was performed. The biochemical parameters including HbA1c, lipid profile, urea, uric acid, creatinine and bilirubin level were measured by chemistry analyzer. Results: A strong correlation between creatinine and HbA1c was observed. The level of creatinine was also significantly associated with age in IGT subjects. Creatinine is non-significantly correlated with Cholesterol, LDL-Chol and TG while negatively significantly associated with BMI, fasting blood glucose and HDL-Chol. Conclusion: The present study concluded significant association of serum creatinine with HbA1c, BMI and HDL cholesterol. PMID:26430445

  3. Significant association of serum creatinine with HbA1C in impaired glucose tolerant Pakistani subjects.

    PubMed

    Farasat, Tasnim; Sharif, Saima; Naz, Shagufta; Fazal, Sabiha

    2015-01-01

    The present study was conducted to assess the serum concentration of creatinine and determine its relationship with potential risk factors of diabetes in Impaired Glucose tolerance subjects. This cross sectional study was conducted on 100 IGT patients who attended Amin Hayat diabetic center in Lahore from January 2011- June 2011. Patients with age group 34-67 years, (both sexes) were included in the study. Different demographic parameters as age, BMI, WHR, B.P, personal history and socioeconomic status were recorded. Oral Glucose Tolerance Test was performed. The biochemical parameters including HbA1c, lipid profile, urea, uric acid, creatinine and bilirubin level were measured by chemistry analyzer. A strong correlation between creatinine and HbA1c was observed. The level of creatinine was also significantly associated with age in IGT subjects. Creatinine is non-significantly correlated with Cholesterol, LDL-Chol and TG while negatively significantly associated with BMI, fasting blood glucose and HDL-Chol. The present study concluded significant association of serum creatinine with HbA1c, BMI and HDL cholesterol.

  4. 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.

  5. 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

  6. Measurement of HbA1c and HbA2 by Capillarys 2 Flex Piercing HbA1c programme for simultaneous management of diabetes and screening for thalassemia

    PubMed Central

    Ke, Peifeng; Liu, Jiawei; Chao, Yan; Wu, Xiaobin; Xiong, Yujuan; Lin, Li; Wan, Zemin; Wu, Xinzhong; Xu, Jianhua; Zhuang, Junhua; Huang, Xianzhang

    2017-01-01

    Introduction Thalassemia could interfere with some assays for haemoglobin A1c (HbA1c) measurement, therefore, it is useful to be able to screen for thalassemia while measuring HbA1c. We used Capillarys 2 Flex Piercing (Capillarys 2FP) HbA1c programme to simultaneously measure HbA1c and screen for thalassemia. Materials and methods Samples from 498 normal controls and 175 thalassemia patients were analysed by Capillarys 2FP HbA1c programme (Sebia, France). For method comparison, HbA1c was quantified by Premier Hb9210 (Trinity Biotech, Ireland) in 98 thalassaemia patients samples. For verification, HbA1c from eight thalassaemia patients was confirmed by IFCC reference method. Results Among 98 thalassaemia samples, Capillarys 2FP did not provide an HbA1c result in three samples with HbH due to the overlapping of HbBart’s with HbA1c fraction; for the remaining 95 thalassaemia samples, Bland-Altman plot showed 0.00 ± 0.35% absolute bias between two systems, and a significant positive bias above 7% was observed only in two HbH samples. The HbA1c values obtained by Capillarys 2FP were consistent with the IFCC targets (relative bias below ± 6%) in all of the eight samples tested by both methods. For screening samples with alpha (α-) thalassaemia silent/trait or beta (β-) thalassemia trait, the optimal HbA2 cut-off values were ≤ 2.2% and > 2.8%, respectively. Conclusions Our results demonstrated the Capillarys 2FP HbA1c system could report an accurate HbA1c value in thalassemia silent/trait, and HbA2 value (≤ 2.2% for α-thalassaemia silent/trait and > 2.8% for β-thalassemia trait) and abnormal bands (HbH and/or HbBart’s for HbH disease, HbF for β-thalassemia) may provide valuable information for screening. PMID:28900367

  7. Measurement of HbA1c and HbA2 by Capillarys 2 Flex Piercing HbA1c programme for simultaneous management of diabetes and screening for thalassemia.

    PubMed

    Ke, Peifeng; Liu, Jiawei; Chao, Yan; Wu, Xiaobin; Xiong, Yujuan; Lin, Li; Wan, Zemin; Wu, Xinzhong; Xu, Jianhua; Zhuang, Junhua; Huang, Xianzhang

    2017-10-01

    Thalassemia could interfere with some assays for haemoglobin A 1c (HbA 1c ) measurement, therefore, it is useful to be able to screen for thalassemia while measuring HbA 1c . We used Capillarys 2 Flex Piercing (Capillarys 2FP) HbA 1c programme to simultaneously measure HbA 1c and screen for thalassemia. Samples from 498 normal controls and 175 thalassemia patients were analysed by Capillarys 2FP HbA 1c programme (Sebia, France). For method comparison, HbA 1c was quantified by Premier Hb9210 (Trinity Biotech, Ireland) in 98 thalassaemia patients samples. For verification, HbA 1c from eight thalassaemia patients was confirmed by IFCC reference method. Among 98 thalassaemia samples, Capillarys 2FP did not provide an HbA 1c result in three samples with HbH due to the overlapping of HbBart's with HbA 1c fraction; for the remaining 95 thalassaemia samples, Bland-Altman plot showed 0.00 ± 0.35% absolute bias between two systems, and a significant positive bias above 7% was observed only in two HbH samples. The HbA 1c values obtained by Capillarys 2FP were consistent with the IFCC targets (relative bias below ± 6%) in all of the eight samples tested by both methods. For screening samples with alpha (α-) thalassaemia silent/trait or beta (β-) thalassemia trait, the optimal HbA 2 cut-off values were ≤ 2.2% and > 2.8%, respectively. Our results demonstrated the Capillarys 2FP HbA 1c system could report an accurate HbA 1c value in thalassemia silent/trait, and HbA 2 value (≤ 2.2% for α-thalassaemia silent/trait and > 2.8% for β-thalassemia trait) and abnormal bands (HbH and/or HbBart's for HbH disease, HbF for β-thalassemia) may provide valuable information for screening.

  8. Elevated HbA1c and Fasting Plasma Glucose in Predicting Diabetes Incidence Among Older Adults

    PubMed Central

    Lipska, Kasia J.; Inzucchi, Silvio E.; Van Ness, Peter H.; Gill, Thomas M.; Kanaya, Alka; Strotmeyer, Elsa S.; Koster, Annemarie; Johnson, Karen C.; Goodpaster, Bret H.; Harris, Tamara; De Rekeneire, Nathalie

    2013-01-01

    OBJECTIVE To determine which measures—impaired fasting glucose (IFG), elevated HbA1c, or both—best predict incident diabetes in older adults. RESEARCH DESIGN AND METHODS From the Health, Aging, and Body Composition study, we selected individuals without diabetes, and we defined IFG (100–125 mg/dL) and elevated HbA1c (5.7–6.4%) per American Diabetes Association guidelines. Incident diabetes was based on self-report, use of antihyperglycemic medicines, or HbA1c ≥6.5% during 7 years of follow-up. Logistic regression analyses were adjusted for age, sex, race, site, BMI, smoking, blood pressure, and physical activity. Discrimination and calibration were assessed for models with IFG and with both IFG and elevated HbA1c. RESULTS Among 1,690 adults (mean age 76.5, 46% men, 32% black), 183 (10.8%) developed diabetes over 7 years. Adjusted odds ratios of diabetes were 6.2 (95% CI 4.4–8.8) in those with IFG (versus those with fasting plasma glucose [FPG] <100 mg/dL) and 11.3 (7.8–16.4) in those with elevated HbA1c (versus those with HbA1c <5.7%). When FPG and HbA1c were considered together, odds ratios were 3.5 (1.9–6.3) in those with IFG only, 8.0 (4.8–13.2) in those with elevated HbA1c only, and 26.2 (16.3–42.1) in those with both IFG and elevated HbA1c (versus those with normal FPG and HbA1c). Addition of elevated HbA1c to the model with IFG resulted in improved discrimination and calibration. CONCLUSIONS Older adults with both IFG and elevated HbA1c have a substantially increased odds of developing diabetes over 7 years. Combined screening with FPG and HbA1c may identify older adults at very high risk for diabetes. PMID:24135387

  9. 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.

  10. Erroneous HbA1c results in a patient with elevated HbC and HbF.

    PubMed

    Adekanmbi, Joy; Higgins, Trefor; Rodriguez-Capote, Karina; Thomas, Dylan; Winterstein, Jeffrey; Dixon, Tara; Gifford, Jessica L; Krause, Richard; Venner, Allison A; Clarke, Gwen; Estey, Mathew P

    2016-11-01

    HbA1c is used in the diagnosis and monitoring of diabetes mellitus (DM). Interference from hemoglobin variants is a well-described phenomenon, particularly with HPLC-based methods. While immunoassays may generate more reliable HbA1c results in the presence of some variants, these methods are susceptible to negative interference from high concentrations of HbF. We report a case where an accurate HbA1c result could not be obtained by any available method due to the presence of a compound hemoglobinopathy. HbA1c was measured by HPLC, immunoassay, and capillary electrophoresis. Hemoglobinopathy investigation consisted of a CBC, hemoglobin fractionation by HPLC and electrophoresis, and molecular analysis. HbA1c analysis by HPLC and capillary electrophoresis gave no result. Analysis by immunoassay yielded HbA1c results of 5.9% (Siemens DCA 2000+) and 5.1% (Roche Integra), which were inconsistent with other markers of glycemic control. Hemoglobinopathy investigation showed HbC with the hereditary persistence of fetal hemoglobin-2 Ghana deletion. Reliable HbA1c results may be unobtainable in the presence of some hemoglobinopathies. HPLC and capillary electrophoresis alerted the laboratory to the presence of an unusual hemoglobinopathy. Immunoassays generated falsely low results without warning, which could lead to missed diagnoses and under treatment of patients with DM. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. Discordance in the diagnosis of diabetes: Comparison between HbA1c and fasting plasma glucose.

    PubMed

    Ho-Pham, Lan T; Nguyen, Uyen D T; Tran, Truong X; Nguyen, Tuan V

    2017-01-01

    HbA1c has been introduced as a complementary diagnostic test for diabetes, but its impact on disease prevalence is unknown. This study evaluated the concordance between HbA1c and fasting plasma glucose (FPG) in the diagnosis of diabetes in the general population. The study was designed as a population based investigation, with participants being sampled from the Ho Chi Minh City, Vietnam. Blood samples were collected after overnight fasting and analyzed within 4 hours after collection. HbA1c was measured with high pressure liquid chromatography (Arkray Adams, Japan). FPG was measured by the hexokinase method (Advia Autoanalyzer; Bayer Diagnostics, Germany). Diabetes was defined as HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L. Prediabetes was classified as HbA1c between 5.7% and 6.4%. The study included 3523 individuals (2356 women) aged 30 years and above. Based on the HbA1c test, the prevalence of diabetes and prediabetes was 9.7% (95%CI, 8.7-10.7%; n = 342) and 34.6% (33.0-36.2; n = 1219), respectively. Based on the FPG test, the prevalence of diabetes and prediabetes was 6.3% (95%CI, 5.5-7.2%; n = 223) and 12.1% (11.1-13.2; n = 427). Among the 427 individuals identified by FPG as "pre-diabetes", 28.6% were classified as diabetes by HbA1c test. The weighted kappa statistic of concordance between HbA1c and FPG was 0.55, with most of the discordance being in the prediabetes group. These data indicate that there is a significant discordance in the diagnosis of diabetes between FPG and HbA1c measurements, and the discordance could have significant impact on clinical practice. FPG appears to underestimate the burden of undiagnosed diabetes.

  12. 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

  13. 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.

  14. Quality of HbA1c Measurement in the Practice

    PubMed Central

    Freckmann, Guido

    2015-01-01

    Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. However, the methodological aspects of this type of measurement have been given little attention lately due to its position as an established method of choice. Nevertheless, quite a number of issues face practical application, such as clinically relevant differences between different measurement methods—both lab-based and point-of-care (POCT) systems will show better or worse diabetes management results after switching methods; and there are a number of possible reasons that need to be known and observed in practice. The aim of this review is to draw attention to these problems from a German point of view and provide suggestions for appropriate measures to improve the situation. PMID:25691655

  15. 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.

  16. Influence of Erythropoiesis-Stimulating Agents on HbA1c and Fructosamine in Patients with Haemodialysis.

    PubMed

    Rasche, Franz Maximilian; Ebert, Thomas; Beckmann, Julia; Busch, Volker; Barinka, Filip; Rasche, Wilma Gertrud; Lindner, Tom H; Schneider, Jochen G; Schiekofer, Stephan

    2017-06-01

    HbA1c is the most accepted laboratory parameter for the long term observation of glucose control. There is still much of a debate about the use of HbA1c as a metabolic indicator in diabetic patients (DM) on haemodialysis (HD) and erythropoiesis-stimulating agent (ESA) therapy because of the altered erythrocyte turn over in patients with chronic kidney disease and haemodialysis (CKD5D). In 102 CKD5 patients with and without diabetes mellitus, we examined the dose dependent variability in HbA1c and fructosamine levels under haemodialysis and treated with epoetin α (n=48) and a new generation agent with continuous stimulation of methoxy polyethylene glycol epoetin beta (C.E.R.A.; n=54). HbA1c levels were affected by therapy with ESA treatments. ESA dose was inversely correlated with HbA1c and an escalation of 10.000 IU per week induced an estimated decrease of HbA1c of 0.6 percent. In addition, the increase of reticulocyte number as a marker for erythropoiesis was significantly inversely correlated with the increase of ΔHbA1c. ESA treatments had no such effect on the alternative metabolic parameter fructosamine. When compared, both therapeutic agents had comparable success in attaining haemoglobin (Hb) target values. C.E.R.A. showed better correlation and was more effective over a longer dose interval. Our results show that HbA1c levels in patients should be carefully interpreted based on interfering factors. Nevertheless, HbA1c is currently the most consistent parameter for use ascertaining metabolic status of patients suffering from diabetes mellitus. © Georg Thieme Verlag KG Stuttgart · New York.

  17. 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.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. Improving access to HbA1c in sub-Saharan Africa (IA3) cohort: cohort profile.

    PubMed

    Balde, Naby; Camara, Alioune; Sobngwi-Tambekou, Joelle; Balti, Eric Vounsia; Tchatchoua, Alain; Fezeu, Leopold; Limen, Serge; Ngamani, Sylvie; Ngapout, Suzanne; Kengne, Andre Pascal; Sobngwi, Eugene

    2017-01-01

    Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in diabetic patients, and lowering HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c measurement to patients may improve control. However, HbA1c is unavailable in most parts of Africa, a continent with one of the highest burden of diabetes. To translate these evidences, we are conducting a multicentric project in 10 health care facilities in Guinea and Cameroon to evaluate the feasibility and one-year benefit of affordable HbA1c measurement with immediate feedback to patients on diabetes control and related outcomes. We consecutively enrolled patients with diabetes mellitus independently of the type of disease. We hypothesised an average 1%-decrease in HbA1c in a 1000-patient study population, with a 20% increase in the number of patients reaching treatment goals within 12 months of intervention and follow-up. A total of 1, 349 diabetic patients aged 56.2±12.6 years are enrolled (813 in Cameroon and 536 in Guinea) of whom 59.8% are women. The mean duration of diabetes is 7.4±6.3 years and baseline HbA1c is 9.7±2.6% in Guinea and 8.6±2.5% in Cameroon. To investigate whether the introduction of routine HbA1c measurement with immediate feedback to patients and provision of relevant education would improve diabetes control after one year. The impact of the intervention on diabetes associated-complications and mortality warrant further assessment in the long term.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c.

    PubMed

    Gallwitz, Baptist; Dagogo-Jack, Samuel; Thieu, Vivian; Garcia-Perez, Luis-Emilio; Pavo, Imre; Yu, Maria; Robertson, Kenneth E; Zhang, Nan; Giorgino, Francesco

    2018-02-01

    To evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline glycated haemoglobin (HbA1c) in the dulaglutide clinical development programme (AWARD-1 to -6 and -8 clinical trials). Change in HbA1c was analysed by gender, duration of diabetes (<5, ≥5 years and <10, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials. In the pooled analysis of patients treated with dulaglutide 1.5 mg at 6 months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean -1.26% [95% confidence interval {CI} -1.36, -1.16]; women: LS mean -1.33% [95% CI -1.43, -1.24]) and among duration of diabetes subgroups (<5 years: LS mean -1.32% [95% CI -1.43, -1.22]; ≥5 and <10 years: LS mean -1.33% [95% CI -1.43, -1.22]; ≥10 years: -1.24% [95% CI -1.35, -1.14]). Patients with baseline HbA1c ≥8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (≥8.5%: LS mean -1.86% [95% CI -1.97, -1.75]; <8.5%: LS mean -1.02% [95% CI -1.12, -0.93]). Reductions in fasting blood glucose (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75 mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ≥8.5% than in those with <8.5%, except for the AWARD-4 study (combination with mealtime insulin). Across the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control

  12. Both high and low HbA1c predict incident heart failure in type 2 diabetes mellitus.

    PubMed

    Parry, Helen M; Deshmukh, Harshal; Levin, Daniel; Van Zuydam, Natalie; Elder, Douglas H J; Morris, Andrew D; Struthers, Allan D; Palmer, Colin N A; Doney, Alex S F; Lang, Chim C

    2015-03-01

    Type 2 diabetes mellitus is an independent risk factor for heart failure development, but the relationship between incident heart failure and antecedent glycemia has not been evaluated. The Genetics of Diabetes Audit and Research in Tayside Study study holds data for 8683 individuals with type 2 diabetes mellitus. Dispensed prescribing, hospital admission data, and echocardiography reports were linked to extract incident heart failure cases from December 1998 to August 2011. All available HbA1c measures until heart failure development or end of study were used to model HbA1c time-dependently. Individuals were observed from study enrolment until heart failure development or end of study. Proportional hazard regression calculated heart failure development risk associated with specific HbA1c ranges accounting for comorbidities associated with heart failure, including blood pressure, body mass index, and coronary artery disease. Seven hundred and one individuals with type 2 diabetes mellitus (8%) developed heart failure during follow up (mean 5.5 years, ±2.8 years). Time-updated analysis with longitudinal HbA1c showed that both HbA1c <6% (hazard ratio =1.60; 95% confidence interval, 1.38-1.86; P value <0.0001) and HbA1c >10% (hazard ratio =1.80; 95% confidence interval, 1.60-2.16; P value <0.0001) were independently associated with the risk of heart failure. Both high and low HbA1c predicted heart failure development in our cohort, forming a U-shaped relationship. © 2015 American Heart Association, Inc.

  13. 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.

  14. 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

  15. 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).

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. Impact of demographics and disease progression on the relationship between glucose and HbA1c.

    PubMed

    Claussen, Anetta; Møller, Jonas B; Kristensen, Niels R; Klim, Søren; Kjellsson, Maria C; Ingwersen, Steen H; Karlsson, Mats O

    2017-06-15

    Several studies have shown that the relationship between mean plasma glucose (MPG) and glycated haemoglobin (HbA1c) may vary across populations. Especially race has previously been referred to shift the regression line that links MPG to HbA1c at steady-state (Herman & Cohen, 2012). To assess the influence of demographic and disease progression-related covariates on the intercept of the estimated linear MPG-HbA1c relationship in a longitudinal model. Longitudinal patient-level data from 16 late-phase trials in type 2 diabetes with a total of 8927 subjects was used to study covariates for the relationship between MPG and HbA1c. The analysed covariates included age group, BMI, gender, race, diabetes duration, and pre-trial treatment. Differences between trials were taken into account by estimating a trial-to-trial variability component. Participants included 47% females and 20% above 65years. 77% were Caucasian, 9% were Asian, 5% were Black and the remaining 9% were analysed together as other races. Estimates of the change in the intercept of the MPG-HbA1c relationship due to the mentioned covariates were determined using a longitudinal model. The analysis showed that pre-trial treatment with insulin had the most pronounced impact associated with a 0.34% higher HbA1c at a given MPG. However, race, diabetes duration and age group also had an impact on the MPG-HbA1c relationship. Our analysis shows that the relationship between MPG and HbA1c is relatively insensitive to covariates, but shows small variations across populations, which may be relevant to take into account when predicting HbA1c response based on MPG measurements in clinical trials. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Systematic Diabetes Screening Using Point-of-Care HbA1c Testing Facilitates Identification of Prediabetes.

    PubMed

    Whitley, Heather P; Hanson, Courtney; Parton, Jason M

    2017-03-01

    This prospective longitudinal study compares diabetes screenings between standard practices vs systematically offered point-of-care (POC) hemoglobin A 1c (HbA 1c ) tests in patients aged 45 years or older. Systematically screened participants (n = 164) identified 63% (n = 104) with unknown hyperglycemia and 53% (n = 88) in prediabetes. The standard practice (n = 324) screened 22% (n = 73), most commonly by blood glucose (96%); 8% (n = 6) and 33% (n = 24) were found to have diabetes and prediabetes, respectively. The association between screening outcome and screening method was statistically significant ( P = 0.005) in favor of HbA 1C HbA 1c may be the most effective method to identify patients unknowingly living in hyperglycemia. Point-of-care tests further facilitate screening evaluation in a timely and feasible fashion. © 2017 Annals of Family Medicine, Inc.

  2. HbA1c as a Screening tool for Ketosis in Patients with Type 2 Diabetes Mellitus

    PubMed Central

    Zhu, Bing; Bu, Le; Zhang, Manna; Gusdon, Aaron M.; Zheng, Liang; Rampersad, Sharvan; Li, Jue; Qu, Shen

    2016-01-01

    Ketosis in patients with type 2 diabetes mellitus (T2DM) is overlooked due to atypical symptoms. The objective of this study is to evaluate the value of hemoglobin A1c (HbA1c) as a screening tool for ketosis in T2DM patients. This retrospective study consisted of 253 T2DM patients with ketosis at Shanghai 10th People’s Hospital during a period from January 1, 2011 to June 30, 2015. A control group consisted of 221 T2DM patients without ketosis randomly selected from inpatients during the same period. Receiver operating characteristic curve (ROC) analysis was used to examine the sensitivity and specificity of HbA1c as an indicator for ketosis. Higher HbA1c levels were correlated with ketosis. In patients with newly diagnosed T2DM, the area under the curve (AUC) was 0.832, with 95% confidence interval (CI) 0.754–0.911. The optimal threshold was 10.1% (87 mmol/mol). In patients with previously diagnosed T2DM, the AUC was 0.811 (95% CI: 0.767–0.856), with an optimal threshold of 8.6% (70 mmol/mol). HbA1c is a potential screening tool for ketosis in patients with T2DM. Ketosis is much more likely with HbA1c values at ≥10.1% in patients with newly diagnosed T2DM and HbA1c values at ≥8.6% in patients with previously diagnosed T2DM. PMID:28009017

  3. Ethnic dependent differences in diagnostic accuracy of glycated hemoglobin (HbA1c) in Canadian adults.

    PubMed

    Booth, Ronald A; Jiang, Ying; Morrison, Howard; Orpana, Heather; Rogers Van Katwyk, Susan; Lemieux, Chantal

    2018-02-01

    Previous studies have shown varying sensitivity and specificity of hemoglobin A1c (HbA1c) to identify diabetes and prediabetes, compared to 2-h oral glucose tolerance testing (OGTT) and fasting plasma glucose (FPG), in different ethnic groups. Within the Canadian population, the ability of HbA1c to identify prediabetes and diabetes in First Nations, Métis and Inuit, East and South Asian ethnic groups has yet to be determined. We collected demographic, lifestyle information, biochemical results of glycemic status (FPG, OGTT, and HbA1c) from an ethnically diverse Canadian population sample, which included a purposeful sampling of First Nations, Métis, Inuit, South Asian and East Asian participants. Sensitivity and specificity using Canadian Diabetes Association (CDA) recommended cut-points varied between ethnic groups, with greater variability for identification of prediabetes than diabetes. Dysglycemia (prediabetes and diabetes) was identified with a sensitivity and specificity ranging from 47.1% to 87.5%, respectively in Caucasians to 24.1% and 88.8% in Inuit. Optimal HbA1c ethnic-specific cut-points for dysglycemia and diabetes were determined by receiver operating characteristic (ROC) curve analysis. Our sample showed broad differences in the ability of HbA1c to identify dysglycemia or diabetes in different ethnic groups. Optimal cut-points for dysglycemia or diabetes in all ethnic groups were substantially lower than CDA recommendations. Utilization of HbA1c as the sole biochemical diagnostic marker may produce varying degrees of false negative results depending on the ethnicity of screened individuals. Further research is necessary to identify and validate optimal ethnic specific cut-points used for diabetic screening in the Canadian population. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

  4. 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.

  5. 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.

  6. The change points of HbA(1C) for detection of retinopathy in Chinese type 2 diabetic patients.

    PubMed

    Hou, Jia-Ning; Bi, Yu-Fang; Xu, Min; Huang, Yun; Li, Xiao-Ying; Wang, Wei-Qing; Chen, Yu-Hong; Ning, Guang

    2011-03-01

    To investigate the change points of HbA(1C) for detection of retinopathy in Chinese type 2 diabetic patients. This cross-sectional investigation included 992 diagnosed type 2 diabetic patients, who received non-mydriatic digital fundus photography examination. Joinpoint regression software was adopted to identify the change points of HbA(1C) in association with retinopathy prevalence. The mean age of all patients was 59.1 ± 8.4 years and the duration of diabetes was 5.5 (95% CI: 5.2-5.9) years. The prevalence of retinopathy was 10.3% in total, and 4.1%, 7.4% and 19.6% in patients with different diabetes duration of ≤ 5 years, 5-10 years and >10 years, respectively. The change point of HbA(1C) was 6.5% (95%CI 5.8-7.5%), at which retinopathy prevalence began to rise sharply. Furthermore, in subjects with diabetes duration ≤ 5 years, 5-10 years and >10 years, the change points of HbA(1C) were 8.1% (95%CI 7.9-8.3%), 6.1% (95%CI 5.7-6.8%), 5.6% (95%CI 5.1-8.1%) for detection of retinopathy, respectively. The steepest increase in retinopathy prevalence occurred when HbA(1C) reached 6.5%. However, the duration of diabetes should be taken into concern, when using the change points of HbA(1C) for detection of retinopathy in diabetic patients. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  7. 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.

  8. 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.

  9. The Presence of Diabetes and Higher HbA1c Are Independently Associated With Adverse Outcomes After Surgery.

    PubMed

    Yong, Priscilla H; Weinberg, Laurence; Torkamani, Niloufar; Churilov, Leonid; Robbins, Raymond J; Ma, Ronald; Bellomo, Rinaldo; Lam, Que T; Burns, James D; Hart, Graeme K; Lew, Jeremy F; Mårtensson, Johan; Story, David; Motley, Andrew N; Johnson, Douglas; Zajac, Jeffrey D; Ekinci, Elif I

    2018-06-01

    Limited studies have examined the association between diabetes and HbA 1c with postoperative outcomes. We investigated the association of diabetes, defined categorically, and the association of HbA 1c as a continuous measure, with postoperative outcomes. In this prospective, observational study, we measured the HbA 1c of surgical inpatients age ≥54 years at a tertiary hospital between May 2013 and January 2016. Patients were diagnosed with diabetes if they had preexisting diabetes or an HbA 1c ≥6.5% (48 mmol/mol) or with prediabetes if they had an HbA 1c between 5.7 and 6.4% (39 and 48 mmol/mol). Patients with an HbA 1c <5.7% (39 mmol/mol) were categorized as having normoglycemia. Baseline demographic and clinical data were obtained from hospital records, and patients were followed for 6 months. Random-effects logistic and negative binomial regression models were used for analysis, treating surgical units as random effects. We undertook classification and regression tree (CART) analysis to design a 6-month mortality risk model. Of 7,565 inpatients, 30% had diabetes, and 37% had prediabetes. After adjusting for age, Charlson comorbidity index (excluding diabetes and age), estimated glomerular filtration rate, and length of surgery, diabetes was associated with increased 6-month mortality (adjusted odds ratio [aOR] 1.29 [95% CI 1.05-1.58]; P = 0.014), major complications (1.32 [1.14-1.52]; P < 0.001), intensive care unit (ICU) admission (1.50 [1.28-1.75]; P < 0.001), mechanical ventilation (1.67 [1.32-2.10]; P < 0.001), and hospital length of stay (LOS) (adjusted incidence rate ratio [aIRR] 1.08 [95% CI 1.04-1.12]; P < 0.001). Each percentage increase in HbA 1c was associated with increased major complications (aOR 1.07 [1.01-1.14]; P = 0.030), ICU admission (aOR 1.14 [1.07-1.21]; P < 0.001), and hospital LOS (aIRR 1.05 [1.03-1.06]; P < 0.001). CART analysis confirmed a higher risk of 6-month mortality with diabetes in conjunction with other risk factors. Almost

  10. 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

  11. Effects of sevelamer on HbA1c, inflammation, and advanced glycation end products in diabetic kidney disease.

    PubMed

    Vlassara, Helen; Uribarri, Jaime; Cai, Weijing; Goodman, Susan; Pyzik, Renata; Post, James; Grosjean, Fabrizio; Woodward, Mark; Striker, Gary E

    2012-06-01

    Increased inflammation and oxidative stress may be caused by proteins and lipids modified by cytotoxic advanced glycation end products (AGEs) in food. Restricting food containing elevated AGEs improves these risk factors in diabetic CKD. Because diet adherence can be problematic, this study aimed to remove cytotoxic AGEs from food already ingested and to determine whether sevelamer carbonate sequesters cytotoxic AGEs in the gut, preventing their uptake and thereby reducing AGE-induced abnormalities. This single-center, randomized, 2-month, open-label, intention-to-treat, crossover study compared sevelamer carbonate with calcium carbonate treatment in stage 2-4 diabetic CKD. Participants received 2 months of treatment with one drug, had a 1-week washout, and then received the opposite drug for 2 months. Sevelamer carbonate reduced HbA1c, serum methylglyoxal, serum (ε)N-carboxymethyl-lysine, triglycerides, and 8-isoprostanes. Total cholesterol and fibroblast growth factor 23 were reduced by sevelamer carbonate, relative to calcium carbonate. AGE receptor 1 and sirtuin 1 mRNA were increased and PMNC TNFα levels were decreased by sevelamer carbonate, but not calcium carbonate. Medications and caloric and AGE intake remained unchanged. Sevelamer carbonate reversibly bound AGE-BSA at intestinal, but not stomach, pH. Sevelamer carbonate significantly reduces HbA1c, fibroblast growth factor 23, lipids, and markers of inflammation and oxidative stress, and markedly increases antioxidant markers, independently of phosphorus in patients with diabetes and early kidney disease. These novel actions of sevelamer carbonate on metabolic and inflammatory abnormalities in type 2 diabetes mellitus may affect progression of early diabetic CKD.

  12. Effects of Sevelamer on HbA1c, Inflammation, and Advanced Glycation End Products in Diabetic Kidney Disease

    PubMed Central

    Vlassara, Helen; Uribarri, Jaime; Cai, Weijing; Goodman, Susan; Pyzik, Renata; Post, James; Grosjean, Fabrizio; Woodward, Mark

    2012-01-01

    Summary Background and objectives Increased inflammation and oxidative stress may be caused by proteins and lipids modified by cytotoxic advanced glycation end products (AGEs) in food. Restricting food containing elevated AGEs improves these risk factors in diabetic CKD. Because diet adherence can be problematic, this study aimed to remove cytotoxic AGEs from food already ingested and to determine whether sevelamer carbonate sequesters cytotoxic AGEs in the gut, preventing their uptake and thereby reducing AGE-induced abnormalities. Design, setting, participants, & measurements This single-center, randomized, 2-month, open-label, intention-to-treat, crossover study compared sevelamer carbonate with calcium carbonate treatment in stage 2–4 diabetic CKD. Participants received 2 months of treatment with one drug, had a 1-week washout, and then received the opposite drug for 2 months. Results Sevelamer carbonate reduced HbA1c, serum methylglyoxal, serum εN-carboxymethyl-lysine, triglycerides, and 8-isoprostanes. Total cholesterol and fibroblast growth factor 23 were reduced by sevelamer carbonate, relative to calcium carbonate. AGE receptor 1 and sirtuin 1 mRNA were increased and PMNC TNFα levels were decreased by sevelamer carbonate, but not calcium carbonate. Medications and caloric and AGE intake remained unchanged. Sevelamer carbonate reversibly bound AGE-BSA at intestinal, but not stomach, pH. Conclusions Sevelamer carbonate significantly reduces HbA1c, fibroblast growth factor 23, lipids, and markers of inflammation and oxidative stress, and markedly increases antioxidant markers, independently of phosphorus in patients with diabetes and early kidney disease. These novel actions of sevelamer carbonate on metabolic and inflammatory abnormalities in type 2 diabetes mellitus may affect progression of early diabetic CKD. PMID:22461535

  13. 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.

  14. National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

    PubMed

    Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

    2015-01-01

    The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

  15. 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

  16. Labile glycated haemoglobin and carbamylated haemoglobin are still critical points for HbA1c measurement.

    PubMed

    Desmons, Aurore; Jaisson, Stéphane; Leroy, Nathalie; Gillery, Philippe; Guillard, Emmanuelle

    2017-06-15

    Haemoglobin A 1c (HbA 1c ) is a key analyte for the monitoring of glycemic balance in diabetic patients and is used for diabetes diagnosis in many countries. The potential interference of carbamylated haemoglobin (cHb) and labile glycated haemoglobin (LA 1c ) on HbA 1c assays must remain a matter of vigilance. Such a situation has occurred in our laboratory with a kit replacement on the Bio-Rad Variant™ II testing system, a cation-exchange high performance liquid chromatography (HPLC) system. With this method, LA 1c and cHb coeluted in a same peak which may have different consequences on HbA 1c values. The influence of increasing LA 1c and cHb values on HbA 1c results was studied with in vitro glycation and carbamylation of samples. Samples from patients with high and normal blood urea concentrations were assayed by HPLC and immunological assay. We observed that the degree of interference greatly varied depending on the nature of the interfering Hb fractions found under the so-called "LA 1c peak". Thus, we have decided to apply a decision tree using "LA 1c " thresholds depending on: (i) the retention time, (ii) the shape of the peak, (iii) other analytes, like urea. If the peak recognized as "LA 1c " is mainly formed by LA 1c, we consider that there is no interference until 4%. If the peak is mainly formed by cHb, we consider an interference threshold equal to 2%. This situation reminds that cHb and LA 1c remain critical issues in chromatography-based HbA 1c assays and that adapted criteria must be set up for result interpretation.

  17. Dietary patterns associated with HbA1c and LDL cholesterol among individuals with type 1 diabetes in China

    PubMed Central

    Jaacks, Lindsay M.; Crandell, Jamie; Mendez, Michelle A.; Lamichhane, Archana P.; Liu, Wei; Ji, Linong; Du, Shufa; Rosamond, Wayne; Popkin, Barry M.; Mayer-Davis, Elizabeth J.

    2015-01-01

    Aims To identify dietary patterns that influence cardiometabolic risk among individuals with type 1 diabetes (T1D) in China. Methods Data are from a cross-sectional study of T1D in China (n=99). Dietary intake was assessed using three 24-hour recalls. Reduced rank regression was used to identify dietary patterns from a set of 20 food groups that maximized the explained variation in glycated hemoglobin A1c (HbA1c) and low-density lipoprotein (LDL) cholesterol. Results Dietary pattern 1 was characterized by low intakes of wheat products and high-fat cakes, and high intakes of beans and pickled vegetables. Dietary pattern 2 was characterized by low intakes of high-fat cakes, nuts/seeds, fish/shellfish, and teas/coffee, and high intakes of rice and eggs. Participants in the highest tertile of dietary pattern 1 had significantly (p<0.05) higher HbA1c and LDL cholesterol compared to participants in the lowest tertile: mean difference in HbA1c was 1.0 percentage point (11mmol/mol) and in LDL cholesterol was 0.36 mmol/L after adjustment for age and household income. Dietary pattern 2 was not associated with HbA1c or LDL cholesterol. Conclusions We identified a dietary pattern that is significantly related to HbA1c and LDL cholesterol. These findings provide support for behavioral strategies to prevent complications in individuals with T1D in China. PMID:25630525

  18. HbA1c, systolic blood pressure variability and diabetic retinopathy in Asian type 2 diabetics.

    PubMed

    Foo, Valencia; Quah, Joanne; Cheung, Gemmy; Tan, Ngiap Chun; Ma Zar, Kyi Lin; Chan, Choi Mun; Lamoureux, Ecosse; Tien Yin, Wong; Tan, Gavin; Sabanayagam, Charumathi

    2017-02-01

    The aim of the present study was to examine the association between variability in HbA1c or systolic blood pressure (SBP) and diabetes-specific moderate retinopathy in Asians with type 2 diabetes (T2D). A retrospective study was conducted of 172 cases of moderate diabetic retinopathy (DR) cases and 226 controls without DR, matched for age, sex, and ethnicity. Serial HbA1c and SBP (range 3-6 readings) over the 2 years prior to photographic screening of DR were collected. Intrapersonal mean and SD values for HbA1c (iM-HbA1c and iSD-HbA1c) and SBP (iM-SBP and iSD-SBP) were derived. Moderate DR was assessed from digital retinal photographs and defined as levels >43 using the Early Treatment Diabetic Retinopathy Study scale. Cases of moderate DR had higher iM-HbA1c (8.2 % vs 7.3 %; P = 0.001), iSD-HbA1c (1.22 vs 0.64; P = 0.001), iM-SBP (136.8 vs 129.6 mmHg; P = 0.001) and iSD-SBP (13.3 vs 11.1; P = 0.002) than controls. In the multivariate regression model adjusted for age, gender, ethnicity, duration of diabetes, SBP, and HbA1c, iM-HbA1c and iM-SBP were significantly associated with moderate DR (odds ratio [OR] 1.80, 95 % confidence interval [CI] 1.37-2.36; and OR 1.03, 95 % CI 1.01-1.05, respectively). Neither iSD-HbA1c nor iSD-SBP were associated with moderate DR. When stratified by HbA1c <7 %, only iSD-SBP remained significantly associated with moderate DR (OR 1.11, 95 % CI 1.01-1.21). In a cohort of Asian patients with T2D, both higher mean HbA1c levels and SBP, but not their variability, were associated with moderate DR. Among those with good glycemic control, wider variability of SBP is associated with moderate DR. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  19. Estimation of glycaemic control in the past month using ratio of glycated albumin to HbA1c.

    PubMed

    Musha, I; Mochizuki, M; Kikuchi, T; Akatsuka, J; Ohtake, A; Kobayashi, K; Kikuchi, N; Kawamura, T; Yokota, I; Urakami, T; Sugihara, S; Amemiya, S

    2018-04-13

    To evaluate comprehensively the use of the glycated albumin to HbA 1c ratio for estimation of glycaemic control in the previous month. A total of 306 children with Type 1 diabetes mellitus underwent ≥10 simultaneous measurements of glycated albumin and HbA 1c . Correlation and concordance rates were examined between HbA 1c measurements taken 1 month apart (ΔHbA 1c ) and glycated albumin/HbA 1c ratio fluctuations were calculated as Z-scores from the cohort value at enrolment of this study cohort (method A) or the percent difference from the individual mean over time (method B). Fluctuations in glycated albumin/HbA 1c ratio (using both methods) were weakly but significantly correlated with ΔHbA 1c , whereas concordance rates were significant for glycaemic deterioration but not for glycaemic improvement. Concordance rates were higher using method B than method A. The glycated albumin/HbA 1c ratio was able to estimate glycaemic deterioration in the previous month, while estimation of glycaemic improvement in the preceding month was limited. Because method B provided a better estimate of recent glycaemic control than method A, the individual mean of several measurements of the glycated albumin/HbA 1c ratio over time may also identify individuals with high or low haemoglobin glycation phenotypes in a given population, such as Japanese children with Type 1 diabetes, thereby allowing more effective diabetes management. © 2018 Diabetes UK.

  20. Effect of ethnicity on HbA1c levels in individuals without diabetes: Systematic review and meta-analysis

    PubMed Central

    Freitas, Priscila Aparecida Correa; Gross, Jorge Luiz

    2017-01-01

    Aims/Hypothesis Disparities in HbA1c levels have been observed among ethnic groups. Most studies were performed in patients with diabetes mellitus (DM), which may interfere with results due to the high variability of glucose levels. We conducted a systematic review and meta-analysis to investigate the effect of ethnicity on HbA1c levels in individuals without DM. Methods This is a systematic review with meta-analysis. We searched MEDLINE and EMBASE up to September 2016. Studies published after 1996, performed in adults without DM, reporting HbA1c results measured by certified/standardized methods were included. A random effects model was used and the effect size was presented as weighted HbA1c mean difference (95% CI) between different ethnicities as compared to White ethnicity. Results Twelve studies met the inclusion criteria, totalling data from 49,238 individuals. There were significant differences between HbA1c levels in Blacks [0.26% (2.8 mmol/mol); 95% CI 0.18 to 0.33 (2.0 to 3.6), p <0.001; I2 = 90%, p <0.001], Asians [0.24% (2.6 mmol/mol); 95% CI 0.16 to 0.33 (1.7 to 3.6), p <0.001; I2 = 80%, p = 0.0006] and Latinos [0.08% (0.9 mmol/mol); IC 95% 0.06 to 0.10 (0.7 to 1.1); p <0.001; I2 = 0%; p = 0.72] when compared to Whites. Conclusions/Interpretation This meta-analysis shows that, in individuals without DM, HbA1c values are higher in Blacks, Asians, and Latinos when compared to White persons. Although small, these differences might have impact on the use of a sole HbA1c point to diagnose DM in all ethnic populations. PMID:28192447

  1. 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.

  2. 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.

  3. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.

    PubMed

    Karyekar, C S; Frederich, R; Ravichandran, S

    2013-08-01

    In four 24-week controlled studies, the antihyperglycaemic efficacy of saxagliptin was demonstrated in patients with type 2 diabetes mellitus as add-on therapy to glyburide, a thiazolidinedione, or metformin, and when used in initial combination with metformin vs. metformin monotherapy in drug-naive patients. Data from these studies were analysed to compare the proportions of patients who achieved specific reductions from baseline in glycated haemoglobin [HbA(1c); reductions of ≥ 0.5% and ≥ 0.7% in all studies (prespecified); reductions ≥ 1.0% in the add-on studies and ≥ 1.0% to ≥ 2.5% in the initial combination study (post hoc)] for saxagliptin vs. comparator at week 24. We report overall rates of glycaemic response defined by these reductions in HbA(1c) and rates of response without experiencing hypoglycaemia. Large glycaemic response rates were higher with saxagliptin 2.5 and 5 mg/day than with comparator (HbA(1c) ≥ 1.0%, 31.7-50.3% vs. 10.3-20.0%) as add-on therapy and higher with saxagliptin 5 mg/day as initial combination with metformin than with metformin monotherapy (HbA(1c) ≥ 2.0%, 68.3% vs. 49.8%) in drug-naive patients. Addition of saxagliptin was associated with a low incidence of hypoglycaemia; overall response rates and response rates excluding patients who experienced hypoglycaemia were similar. Analysis of several demographic and baseline clinical variables revealed no consistent correlations with response to saxagliptin. Whether receiving saxagliptin as an add-on therapy to glyburide, a thiazolidinedione, or metformin or in initial combination with metformin, a greater percentage of patients achieve clinically relevant large reductions in HbA(1c) vs. comparator, with a low incidence of hypoglycaemia. © 2013 Bristol-Myers Squibb Co. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

  4. 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.

  5. 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.

  6. 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.

  7. Advanced glycation end products, measured in skin, vs. HbA1c in children with type 1 diabetes mellitus.

    PubMed

    Banser, Alena; Naafs, Jolanda C; Hoorweg-Nijman, Jantine Jg; van de Garde, Ewoudt Mw; van der Vorst, Marja Mj

    2016-09-01

    Advanced glycation end products (AGEs) are considered major contributors to microvascular and macrovascular complications in adult patients with diabetes mellitus. AGEs can be measured non-invasively with skin autofluorescence (sAF). The primary aim was to determine sAF values in children with type 1 diabetes mellitus and to study correlations between sAF values and HbA1c and mean HbA1c over the year prior to measurement In children with type 1 diabetes mellitus, sAF values were measured using the AGE Reader®. Laboratory and anthropometric values were extracted from medical charts. Correlations were studied using Pearson's correlation coefficient. Multivariable linear regression analysis was conducted to evaluate the effect of multiple study parameters on sAF values. The mean sAF value was 1.33 ± 0.36 arbitrary units (AU) in children with type 1 diabetes mellitus (n = 144). sAF values correlated positively with HbA1c measured at the same time (r = 0.485; p < 0.001), mean HbA1c over the year prior to measurement (r = 0.578; p < 0.001), age (r = 0.337; p < 0.001), duration of type 1 diabetes mellitus (r = 0.277; p = 0.001), serum triglycerides (r = 0.399; p < 0.001), and total cholesterol (r = 0.352; p = 0.001). sAF values were significantly higher in patients with non-white skin (1.56 vs. 1.27 AU, respectively, p = 0.001). In children with type 1 diabetes, sAF values correlate strongly with single HbA1c and mean HbA1c, making the non-invasive sAF measurement an interesting alternative to provide information about cumulative hyperglycemic states. To determine the value of sAF measurement in predicting long-term microvascular and macrovascular complications, further prospective follow-up studies are needed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. CA6-02: Collaborative Goal Setting and HbA1c Control Among Patients With Diabetes

    PubMed Central

    Lafata, Jennifer Elston; Dobie, Elizabeth; Morris, Heather; Heisler, Michele; Werner, Rachel; Divine, George; Thomas, Abraham

    2012-01-01

    Background/Aims Helping patients set and follow up on goals may be an effective way to help patients improve their confidence (self-efficacy) and commitment to improve diabetes self- management. We evaluate associations among patient-reported use of collaborative goal setting with clinicians, patient-reported self-efficacy, and clinical control (measured by HbA1c) among patients with diabetes. Methods A cohort of insured patients aged 18+ years with diabetes who initiated oral mono-therapy between 2000–2005 was surveyed in 2008. The survey included the 3 collaborative goal-setting items from the Patient Assessment of Chronic Illness Care (PACIC), a 4-item measure of self-efficacy, measures of socio-demographics, age of diabetes onset, and height/weight. Survey data were joined with automated laboratory and encounter data for the 12 months prior to and following survey administration. A structural equation model (SEM), using path analysis and adjusting for baseline patient characteristics (including HbA1c and diabetes-related co-morbidities and complications), was fit to investigate relationships among collaborative goal setting, self-efficacy and HbA1c control. Results Completed surveys were available for 1070 patients (n=956 mail and n=114 telephone; 77% response rate). Survey respondents were on average 68 years, half were female, 60% white, 31% black, and 57% reported low self-efficacy. On average, patients reported engaging in collaborative goal setting with their clinicians ‘sometimes’ (mean = 3.1, range 1 [never]-5 [always]). At baseline, mean HbA1c was 7.2%, with 22% =8%. Results from the SEM did not support a direct relationship between the collaborative goal setting factor (Cronbach Alpha=0.83) and HbA1c control, but did support an indirect relationship (asymmetric distribution of products 95% CI = −0.02, −0.002) with increases in collaborative goal setting positively associated with a greater likelihood of average or high self-efficacy (beta, p

  9. Variation in Point-of-Care Testing of HbA1c in Diabetes Care in General Practice.

    PubMed

    Kristensen, Troels; Waldorff, Frans Boch; Nexøe, Jørgen; Skovsgaard, Christian Volmar; Olsen, Kim Rose

    2017-11-09

    Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes, and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators created a framework agreement regarding a new fee-for-service fee for the remuneration of POCT of HbA1c in general practice. According to secondary research, only the Capital Region of Denmark has allowed GPs to use this new incentive for POCT. The aim of this study is to use patient data to characterize patients with diabetes who have received POCT of HbA1c and analyze the variation in the use of POCT of HbA1c among patients with diabetes in Danish general practice. Methods: We use register data from the Danish Drug Register, the Danish Health Service Register and the National Patient Register from the year 2011 to define a population of 44,981 patients with diabetes (type 1 and type 2 but not patients with gestational diabetes) from the Capital Region. The POCT fee is used to measure the amount of POCT of HbA1c among patients with diabetes. Next, we apply descriptive statistics and multilevel logistic regression to analyze variation in the prevalence of POCT at the patient and clinic level. We include patient characteristics such as gender, age, socioeconomic markers, health care utilization, case mix markers, and municipality classifications. Results: The proportion of patients who received POCT was 14.1% and the proportion of clinics which were "POCT clinics" was 26.9%. There were variations in the use of POCT across clinics and patients. A part of the described variation can be explained by patient characteristics. Male gender, age differences (older age), short education, and other ethnicity imply significantly higher odds for POCT. High patient costs in general practice and other parts of primary care also imply higher odds for POCT. In contrast, high patient costs for drugs and/or morbidity in terms of the Charlson

  10. Variation in Point-of-Care Testing of HbA1c in Diabetes Care in General Practice

    PubMed Central

    Kristensen, Troels; Waldorff, Frans Boch; Nexøe, Jørgen; Skovsgaard, Christian Volmar; Olsen, Kim Rose

    2017-01-01

    Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes, and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators created a framework agreement regarding a new fee-for-service fee for the remuneration of POCT of HbA1c in general practice. According to secondary research, only the Capital Region of Denmark has allowed GPs to use this new incentive for POCT. The aim of this study is to use patient data to characterize patients with diabetes who have received POCT of HbA1c and analyze the variation in the use of POCT of HbA1c among patients with diabetes in Danish general practice. Methods: We use register data from the Danish Drug Register, the Danish Health Service Register and the National Patient Register from the year 2011 to define a population of 44,981 patients with diabetes (type 1 and type 2 but not patients with gestational diabetes) from the Capital Region. The POCT fee is used to measure the amount of POCT of HbA1c among patients with diabetes. Next, we apply descriptive statistics and multilevel logistic regression to analyze variation in the prevalence of POCT at the patient and clinic level. We include patient characteristics such as gender, age, socioeconomic markers, health care utilization, case mix markers, and municipality classifications. Results: The proportion of patients who received POCT was 14.1% and the proportion of clinics which were “POCT clinics” was 26.9%. There were variations in the use of POCT across clinics and patients. A part of the described variation can be explained by patient characteristics. Male gender, age differences (older age), short education, and other ethnicity imply significantly higher odds for POCT. High patient costs in general practice and other parts of primary care also imply higher odds for POCT. In contrast, high patient costs for drugs and/or morbidity in terms of the Charlson

  11. Implementation of the HbA1c IFCC unit --from the laboratory to the consumer: The New Zealand experience.

    PubMed

    Florkowski, Christopher; Crooke, Michael; Reed, Maxine

    2014-05-15

    In 2007, an international consensus statement recommended that HbA1c results should be reported world-wide in IFCC units (mmol/mol) and also the more familiar derived percentage units using a master equation. In New Zealand, the HbA1c IFCC units have been successfully implemented and used exclusively since 3rd October 2011 (following a 2 year period of reporting both units) for both patient monitoring and the diagnosis of diabetes, with a diagnostic cut-off of ≥50 mmol/mol. The consultation process in New Zealand dates back to 2003, well before the international recommendations were made. It reflects the close cooperation between the clinical and laboratory communities in New Zealand, particularly through the agency of the New Zealand Society for the Study of Diabetes (NZSSD), a key organisation in New Zealand open to all those involved in the care of people with diabetes and the national advisory body on scientific and clinical diabetes care and standards. There was a phased process of consultation designed to increase familiarity and comfort with the new units and the final step was coupled with the adoption of HbA1c as a diagnostic test with some evidence-based pragmatism around using the rounded cut-off. Genuine clinical engagement is vital in such a process. © 2013.

  12. The Effect of Prolonged Glucosamine Usage on HbA1c Levels and New-Onset Diabetes Mellitus in Overweight and Obese Middle-Aged Women.

    PubMed

    Gommans, Yvonne M M; Runhaar, Jos; Jacobs, Marloes L; Bierma-Zeinstra, Sita M A

    2017-06-01

    The aim of the present study was to evaluate the effect of a 2.5-year glucosamine sulfate intervention on hemoglobin A1c (HbA1c) levels and the incidence of new-onset diabetes mellitus over 6.5 years in middle-aged women with a body mass index ≥27 kg/m 2 . In total, 407 women were randomized into either oral crystalline glucosamine sulfate or placebo. At baseline, 1 year, 2.5 years, and 6.5 years, a blood sample for the HbA1c level was drawn and questionnaires were taken. After 6.5 years there were missing data for some variables, therefore, multiple imputation was used. With the imputed data, a generalized estimating equation was performed to analyze the effect of glucosamine sulfate usage over 6.5 years. Finally, these analyses were rerun for the 2 subgroups of participants with and without high HbA1c level (≥42 mmol/mol) at baseline. There was no significant effect of a 2.5-year glucosamine sulfate intervention on mean HbA1c level or on obtaining a high HbA1c level or new-onset diabetes mellitus over 6.5 years. The subgroup analyses of participants with and without high HbA1c level at baseline were also not statistically significant. However, participants with a high HbA1c level at baseline had higher odds ratios compared with the participants with a normal HbA1c at baseline. There was no effect of glucosamine sulfate on mean HbA1c level nor on obtaining a high HbA1c level or new-onset diabetes mellitus over 6.5 years, especially in participants with a normal HbA1c level at baseline. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin

    PubMed Central

    Karyekar, C S; Frederich, R; Ravichandran, S

    2013-01-01

    BackgroundIn four 24-week controlled studies, the antihyperglycaemic efficacy of saxagliptin was demonstrated in patients with type 2 diabetes mellitus as add-on therapy to glyburide, a thiazolidinedione, or metformin, and when used in initial combination with metformin vs. metformin monotherapy in drug-naive patients. MethodsData from these studies were analysed to compare the proportions of patients who achieved specific reductions from baseline in glycated haemoglobin [HbA1c; reductions of ≥ 0.5% and ≥ 0.7% in all studies (prespecified); reductions ≥ 1.0% in the add-on studies and ≥ 1.0% to ≥ 2.5% in the initial combination study (post hoc)] for saxagliptin vs. comparator at week 24. We report overall rates of glycaemic response defined by these reductions in HbA1c and rates of response without experiencing hypoglycaemia. ResultsLarge glycaemic response rates were higher with saxagliptin 2.5 and 5 mg/day than with comparator (HbA1c ≥ 1.0%, 31.7–50.3% vs. 10.3–20.0%) as add-on therapy and higher with saxagliptin 5 mg/day as initial combination with metformin than with metformin monotherapy (HbA1c ≥ 2.0%, 68.3% vs. 49.8%) in drug-naive patients. Addition of saxagliptin was associated with a low incidence of hypoglycaemia; overall response rates and response rates excluding patients who experienced hypoglycaemia were similar. Analysis of several demographic and baseline clinical variables revealed no consistent correlations with response to saxagliptin. ConclusionsWhether receiving saxagliptin as an add-on therapy to glyburide, a thiazolidinedione, or metformin or in initial combination with metformin, a greater percentage of patients achieve clinically relevant large reductions in HbA1c vs. comparator, with a low incidence of hypoglycaemia. PMID:23795975

  14. Application of Six Sigma Model to Evaluate the Analytical Quality of Four HbA1c Analyzers.

    PubMed

    Maesa, Jos Eacute M; Fern Aacute Ndez-Riejos, Patricia; S Aacute Nchez-Mora, Catalina; Toro-Crespo, Mar Iacute A De; Gonz Aacute Lez-Rodriguez, Concepci Oacute N

    2017-01-01

    The Six Sigma Model is a global quality management system applicable to the determination of glycated hemoglobin (HbA1c). In addition, this model can ensure the three characteristics influencing the patient risk: the correct performance of the analytical method with low inaccuracy and bias, the quality control strategy used by the laboratory, and the necessary quality of the analyte. The aim of this study is to use the Six Sigma Model for evaluating quality criteria in the determination of glycated hemoglobin HbA1c and its application to assess four different HbA1c analyzers. Four HbA1c analyzers were evaluated: HA-8180V®, D-100®, G8®, and Variant II Turbo®. For 20 consecutive days, two levels of quality control (high and low) provided by the manufacturers were measured in each of the instruments. Imprecision (CV), bias, and Sigma values (σ) were calculated with the data obtained and a method decision chart was developed considering a range of quality requirements (allowable total error, TEa). For a TEa = 3%, HA-8180V = 1.54 σ, D-100 = 1.63 σ, G8 = 2.20 σ, and Variant II Turbo = -0.08 σ. For a TEa = 4%, HA-8180V = 2.34 σ, D-100 = 2.32 σ, G8 = 3.74 σ, and Variant II Turbo = 0.16 σ. For a TEa = 10%, HA8180V = 7.12 σ, D-100 = 6.46 σ, G8 = 13.0 σ, and Variant II Turbo = 1.56 σ. Applying the Stockholm consensus and its subsequent Milan review to the results: the maximum level in quality requirements for HbA1c is an allowable total error (TEa) = 3%, G8 is located in region 2 σ (2.20), which is a poor result, and HA-8180V and D-100 are both in region 1 σ (1.54 and 1.63, respectively), which is an unacceptable analytical performance.

  15. HbA(1c) diagnostic categories and beta-cell function relative to insulin sensitivity in overweight/obese adolescents

    USDA-ARS?s Scientific Manuscript database

    The recommended HbA1c diagnostic categories remain controversial and their utility in doubt in pediatrics. We hypothesized that alterations in the pathophysiologic mechanisms of type 2 diabetes may be evident in the American Diabetes Association recommended at-risk/prediabetes category (HbA(1c) 5.7 ...

  16. 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…

  17. Should glycated haemoglobin (HbA1c) be used to detect people with type 2 diabetes mellitus and impaired glucose regulation?

    PubMed

    Mostafa, Samiul A; Davies, Melanie J; Srinivasan, Balasubramanian Thiagarajan; Carey, Marian E; Webb, David; Khunti, Kamlesh

    2010-11-01

    There is a need to simplify screening tests for type 2 diabetes mellitus (T2DM) so patients can be identified earlier and more efficiently. Glycated haemoglobin (HbA1c) has been recommended by some international organisations as a diagnostic tool for detecting T2DM and impaired glucose regulation (IGR, also termed prediabetes and includes impaired fasting glucose and/or impaired glucose tolerance). The HbA1c cut-point of ≥6.5% (48 mmol/mol) has been selected as diagnostic for T2DM, while the cut-points for IGR are debated by the different international organisations: an International Expert Committee has suggested using HbA1c 6.0-6.4% (42-46 mmol/mol); however, the American Diabetes Association has recommended using HbA1c 5.7-6.4% (39-46 mmol/mol). Some countries will adopt a new method of reporting HbA1c values in millimoles per mole (mmol/mol). Use of HbA1c has some logistical advantages over using an oral glucose tolerance test (OGTT). As patients do not need to fast, appointments do not need to be limited to the morning. The HbA1c result reflects longer term glycaemia and is less affected by recent physical/emotional stress. However, there is some debate as to whether HbA1c should replace fasting plasma glucose or the OGTT. As the two tests detect different people, some individuals with diabetes detected on OGTT will no longer be classified as having T2DM using HbA1c ≥6.5% criteria. Furthermore, some medical conditions can result in HbA1c assay measurements not reflecting glycaemic control over the last 2-3 months; these include haematological disorders, renal failure, and chronic excess alcohol consumption.

  18. The Stricter the Better? The Relationship between Targeted HbA1c Values and Metabolic Control of Pediatric Type 1 Diabetes Mellitus.

    PubMed

    Braun, Marcin; Tomasik, Bartlomiej; Wrona, Ewa; Fendler, Wojciech; Jarosz-Chobot, Przemyslawa; Szadkowska, Agnieszka; Zmysłowska, Agnieszka; Wilson, Jayne; Mlynarski, Wojciech

    2016-01-01

    It remains unclear how HbA1c recommendations influence metabolic control of paediatric patients with type 1 diabetes mellitus. To evaluate this we compared reported HbA1c with guideline thresholds. We searched systematically MEDLINE and EMBASE for studies reporting on HbA1c in children with T1DM and grouped them according to targeted HbA1c obtained from regional guidelines. We assessed the discrepancies in the metabolic control between these groups by comparing mean HbA1c extracted from each study and the differences between actual and targeted HbA1c. We included 105 from 1365 searched studies. The median (IQR) HbA1c for the study population was 8.30% (8.00%-8.70%) and was lower in "6.5%" than in "7.5%" as targeted HbA1c level (8.20% (7.85%-8.57%) versus 8.40% (8.20%-8.80%); p = 0.028). Median difference between actual and targeted HbA1c was 1.20% (0.80%-1.70%) and was higher in "6.5%" than in "7.5%" (1.70% (1.30%-2.07%) versus 0.90% (0.70%-1.30%), resp.; p < 0.001). Our study indicates that the 7.5% threshold results in HbA1c levels being closer to the therapeutic goal, but the actual values are still higher than those observed in the "6.5%" group. A meta-analysis of raw data from national registries or a prospective study comparing both approaches is warranted as the next step to examine this subject further.

  19. Frequency of self-monitoring blood glucose and attainment of HbA1c target values.

    PubMed

    Elgart, Jorge F; González, Lorena; Prestes, Mariana; Rucci, Enzo; Gagliardino, Juan J

    2016-02-01

    Test strips for self-monitoring of blood glucose (SMBG) represent in Argentina, around 50 % of diabetes treatment cost; the frequency of their use is closely associated with hyperglycemia treatment. However, the favorable impact of SMBG on attainment of HbA1c goal in different treatment conditions remains controversial. We therefore attempted to estimate the relationship between use of SMBG test strips and degree of attainment of metabolic control in an institution of our social security subsector (SSS) in which provision is fully covered and submitted to a regular audit system. Observational retrospective study using information of 657 patients with T2DM (period 2009-2010) from the database of the Diabetes and Other Cardiovascular Risk Factors Program (DICARO) of one institution of our SSS. DICARO provides-with an audit system-100 % coverage for all drugs and keeps records of clinical, metabolic and treatment data from every patient. The average monthly test strips/patient used for SMBG increased as a function of treatment intensification: Monotherapy with oral antidiabetic drugs (OAD) < combined OAD therapy < insulin treatment. In every condition, the number was larger in people with target HbA1c levels. Test strips represented the larger percentage of total prescription cost. In our population, the type of hyperglycemia treatment was the main driver of test strip use for SMBG; in every condition tested, targeted HbA1c values were associated with greater strip use. Patient education and prescription audit may optimize its use and treatment outcomes.

  20. 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.

  1. Asymmetric dimethylarginine in young people with Type 1 diabetes: a paradoxical association with HbA(1c).

    PubMed

    Marcovecchio, M L; Widmer, B; Turner, C; Dunger, D B; Dalton, R N

    2011-06-01

    Asymmetric dimethylarginine (ADMA) is an independent risk factor for cardiovascular disease and its concentrations are increased in several diseases, including diabetes. However, there is limited information on this plasma marker in young people, particularly in those with Type 1 diabetes. The aim of the present study was therefore to perform a longitudinal evaluation of plasma ADMA and of its determinants in young people with childhood-onset Type 1 diabetes. For measurement of ADMA using mass spectrometry, 1018 longitudinal stored blood samples were available from 330 young people with Type 1 diabetes followed in the Oxford Regional Prospective Study. Additional data concerning annual assessments of HbA(1c) , height, weight, insulin dose and three early morning urine samples for measurement of the albumin/creatinine ratio were available. ADMA levels were significantly higher in males than in females (mean ± SD: 0.477 ± 0.090 vs. 0.460 ± 0.089 μmol/l, P=0.002) and declined with chronological age (estimate ± SE: -0.0106 ± 0.0008, P<0.001). A significant inverse association was detected between ADMA and HbA(1c) (estimate ± SE:-0.0113 ± 0.001, P<0.001). ADMA levels were lower in subjects developing microalbuminuria (mean ± SD: 0.455 ± 0.093 vs. 0.476 ± 0.087 μmol/l, P=0.001) than in subjects with normoalbuminuria, but this difference disappeared after adjusting for HbA(1c) . In this longitudinal study, ADMA concentrations decreased with age and were significantly higher in males and lower in subjects developing microalbuminuria. These associations were largely explained by a paradoxical negative association between HbA(1c) and ADMA. We suggest that chronic hyperglycaemia might down-regulate mechanisms implicated in ADMA production or stimulate its metabolism confounding short-term associations with complications risk. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

  2. HbA1c Variability as an Independent Correlate of Nephropathy, but Not Retinopathy, in Patients With Type 2 Diabetes

    PubMed Central

    Penno, Giuseppe; Solini, Anna; Bonora, Enzo; Fondelli, Cecilia; Orsi, Emanuela; Zerbini, Gianpaolo; Morano, Susanna; Cavalot, Franco; Lamacchia, Olga; Laviola, Luigi; Nicolucci, Antonio; Pugliese, Giuseppe

    2013-01-01

    OBJECTIVE To examine the association of hemoglobin (Hb) A1c variability with microvascular complications in the large cohort of subjects with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. RESEARCH DESIGN AND METHODS Serial (3–5) HbA1c values collected in a 2-year period before enrollment were available from 8,260 subjects from 9 centers (of 15,773 patients from 19 centers). HbA1c variability was measured as the intraindividual SD of 4.52 ± 0.76 values. Diabetic retinopathy (DR) was assessed by dilated funduscopy. Chronic kidney disease (CKD) was defined based on albuminuria, as measured by immunonephelometry or immunoturbidimetry, and estimated glomerular filtration rate (eGFR) was calculated from serum creatinine. RESULTS Median and interquartile range of average HbA1c (HbA1c-MEAN) and HbA1c-SD were 7.57% (6.86–8.38) and 0.46% (0.29–0.74), respectively. The highest prevalence of microalbuminuria, macroalbuminuria, reduced eGFR, albuminuric CKD phenotypes, and advanced DR was observed when both HbA1c parameters were above the median and the lowest when both were below the median. Logistic regression analyses showed that HbA1c-SD adds to HbA1c-MEAN as an independent correlate of microalbuminuria and stages 1–2 CKD and is an independent predictor of macroalbuminuria, reduced eGFR, and stages 3–5 albuminuric CKD, whereas HbA1c-MEAN is not. The opposite was found for DR, whereas neither HbA1c-MEAN nor HbA1c-SD affected nonalbuminuric CKD. CONCLUSIONS In patients with type 2 diabetes, HbA1c variability affects (albuminuric) CKD more than average HbA1c, whereas only the latter parameter affects DR, thus suggesting a variable effect of these measures on microvascular complications. PMID:23491522

  3. Simple diagnosis of HbA1c using the dual-plasmonic platform integrated with LSPR and SERS

    NASA Astrophysics Data System (ADS)

    Heo, Nam Su; Kwak, Cheol Hwan; Lee, Hoomin; Kim, Dongjoo; Lee, Sunmook; Kim, Gi-bum; Kwon, Soonjo; Kim, Woo Sik; Huh, Yun Suk

    2017-07-01

    A plasmonic active chip was designed with a transparent polymer film self-assembled with gold nanoparticles (AuNPs). In this study, we demonstrated the feasibility and sensitivity of biosensors by employing a plasmonic resonance technique. AuNPs are widely used as biosensing probes because they facilitate stable immobilization of biomolecules. Transparent polymer film facilitated measurement of changes in absorbance via transmitted light and analysis of Raman scattering via scattered light. The cysteine rich protein G and anti-HbA1c were sequentially conjugated to self-assembled AuNPs on the transparent polymer film to detect a target protein. HbA1c, which is used as an indicator for diabetes diagnosis, was selected for target protein detection. We confirmed the linearly increased absorbance values with increasing HbA1c level (3.19-14.0%) by LSPR detection. We also verified the linear increase in SERS intensity as the concentration of anti-Hb increased from 10 ng mL-1 to 1 μg mL-1 by analyzing the SERS spectra of Cy3 labeled anti-Hb added substrates.

  4. Can HbA1c replace OGTT for the diagnosis of diabetes mellitus among Chinese patients with impaired fasting glucose?

    PubMed

    Yu, Esther Y T; Wong, Carlos K H; Ho, S Y; Wong, Samuel Y S; Lam, Cindy L K

    2015-12-01

    HbA1c ≥ 6.5% has been recommended as a diagnostic criterion for the detection of diabetes mellitus (DM) since 2010 because of its convenience, stability and significant correlation with diabetic complications. Nevertheless, the accuracy of HbA1c compared to glucose-based diagnostic criteria varies among subjects of different ethnicity and risk profile. This study aimed to evaluate the accuracy of HbA1c for diagnosing DM compared to the diagnosis by oral glucose tolerance test (OGTT) and the optimal HbA1c level to diagnose DM in primary care Chinese patients with impaired fasting glucose (IFG). A cross-sectional study was carried out in three public primary care clinics in Hong Kong. About 1128 Chinese adults with IFG (i.e. FG level between 5.6 and 6.9 mmol/l in the past 18 months) were recruited to receive paired OGTT and HbA1c tests. Sensitivities and specificities of HbA1c at different threshold levels for predicting DM compared to the diagnosis by OGTT were evaluated. A receiver operating characteristic (ROC) curve was used to determine the optimal cut-off level. Among the 1128 subjects (mean age 64.2±8.9 year, 48.8% male), 229 (20.3%) were diagnosed to have DM by OGTT. The sensitivity and specificity of HbA1c ≥6.5% were 33.2% and 93.5%, respectively, for predicting DM diagnosed by OGTT. The area under the ROC curve was 0.770, indicating HbA1c had fair discriminatory power. The optimal cut-off threshold of HbA1c was 6.3% for discriminating DM from non-DM, with sensitivity and specificity of 56.3% and 85.5%, respectively. HbA1c ≥ 5.6% has the highest sensitivity and negative predictive value of 96.1% and 94.5%, respectively. HbA1c ≥ 6.5% is highly specific in identifying people with DM, but it may miss the majority (66.8%) of the DM cases. An HbA1c threshold of <5.6% is more appropriate to be used for the exclusion of DM. OGTT should be performed for the confirmation of DM among Chinese patients with IFG who have an HbA1c between 5.6% and 6.4%. © The

  5. 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.

  6. One Drop | Mobile on iPhone and Apple Watch: An Evaluation of HbA1c Improvement Associated With Tracking Self-Care

    PubMed Central

    van Ginkel, Joost R; Marrero, David G; Rodbard, David; Huddleston, Brian; Dachis, Jeff

    2017-01-01

    Background The One Drop | Mobile app supports manual and passive (via HealthKit and One Drop’s glucose meter) tracking of self-care and glycated hemoglobin A1c (HbA1c). Objective We assessed the HbA1c change of a sample of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the One Drop | Mobile app on iPhone and Apple Watch, and tested relationships between self-care tracking with the app and HbA1c change. Methods In June 2017, we identified people with diabetes using the One Drop | Mobile app on iPhone and Apple Watch who entered two HbA1c measurements in the app 60 to 365 days apart. We assessed the relationship between using the app and HbA1c change. Results Users had T1D (n=65) or T2D (n=191), were 22.7% (58/219) female, with diabetes for a mean 8.34 (SD 8.79) years, and tracked a mean 2176.35 (SD 3430.23) self-care activities between HbA1c entries. There was a significant 1.36% or 14.9 mmol/mol HbA1c reduction (F=62.60, P<.001) from the first (8.72%, 71.8 mmol/mol) to second HbA1c (7.36%, 56.9 mmol/mol) measurement. Tracking carbohydrates was independently associated with greater HbA1c improvement (all P<.01). Conclusions Using One Drop | Mobile on iPhone and Apple Watch may favorably impact glycemic control. PMID:29187344

  7. 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

  8. One Drop | Mobile on iPhone and Apple Watch: An Evaluation of HbA1c Improvement Associated With Tracking Self-Care.

    PubMed

    Osborn, Chandra Y; van Ginkel, Joost R; Marrero, David G; Rodbard, David; Huddleston, Brian; Dachis, Jeff

    2017-11-29

    The One Drop | Mobile app supports manual and passive (via HealthKit and One Drop's glucose meter) tracking of self-care and glycated hemoglobin A 1c (HbA 1c ). We assessed the HbA 1c change of a sample of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the One Drop | Mobile app on iPhone and Apple Watch, and tested relationships between self-care tracking with the app and HbA 1c change. In June 2017, we identified people with diabetes using the One Drop | Mobile app on iPhone and Apple Watch who entered two HbA 1c measurements in the app 60 to 365 days apart. We assessed the relationship between using the app and HbA 1c change. Users had T1D (n=65) or T2D (n=191), were 22.7% (58/219) female, with diabetes for a mean 8.34 (SD 8.79) years, and tracked a mean 2176.35 (SD 3430.23) self-care activities between HbA 1c entries. There was a significant 1.36% or 14.9 mmol/mol HbA 1c reduction (F=62.60, P<.001) from the first (8.72%, 71.8 mmol/mol) to second HbA 1c (7.36%, 56.9 mmol/mol) measurement. Tracking carbohydrates was independently associated with greater HbA 1c improvement (all P<.01). Using One Drop | Mobile on iPhone and Apple Watch may favorably impact glycemic control. ©Chandra Y Osborn, Joost R van Ginkel, David G Marrero, David Rodbard, Brian Huddleston, Jeff Dachis. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 29.11.2017.

  9. Screening and correlates of depression and HbA1 C in United Arab Emirates (UAE) women with diabetes.

    PubMed

    Hawamdeh, Sana; Almakhzoomy, Ibtihal; Hayajneh, Yaseen

    2013-10-01

    The aim was to identify the relationship between socio-demographic characteristics of United Arab Emirates (UAE) women with diabetes and depression and to explore any differences between depressed and nondepressed patients in relation to glycemic control. One hundred eighty-two subjects completed the Beck Depression Inventory-II and a socio-demographic questionnaire (i.e., age, national status, economic status, level of education, and employment status). Glycemic control was assessed by glycosylated hemoglobin (HbA1C ). Ninety-two subjects were diagnosed with diabetes mellitus. A statistically significant higher incidence of depression was found in the subject group with diagnosed diabetes mellitus than in the nondiabetic subject group. A statistically significant relationship was found between depression status and type of diabetes (Type 1). A positive relationship between poor glycemic control and higher levels of depression was identified. A positively significant relationship was found between national status and level of depression among the diabetic sample, among whom at least half showed poor glycemic control (HbA1C levels > 7.5). Early detection of depression among women with diabetes is crucial to enhance treatment regimen adherence and glycemic control. As the UAE diabetic women are at even greater risk than other diabetic women, they need to be very carefully screened and evaluated for depression. © 2013 Wiley Periodicals, Inc.

  10. 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.

  11. Longer rewarming time in finger cooling test in association with HbA1c level in diabetics.

    PubMed

    Zeng, Shan; Chen, Qi; Wang, Xiang-Wen; Hong, Kui; Li, Ju-Xiang; Li, Ping; Cheng, Xiao-Shu; Su, Hai

    2016-09-01

    To assess if rewarming time in finger cooling test (FCT) as an indicator of microvascular dysfunction is abnormal in patients with type 2 diabetes mellitus (T2DM). Forty-three T2DM patients and 48 healthy controls with similarly distributed baseline demographic, clinical and laboratory parameters were subjected to FCT involving 60-second index finger immersion into water at 4°C. Finger temperature was measured before FCT (baseline-T), immediately after cooling stimulus (T0), and at one-minute intervals until baseline-T recovery. Temperature decline amplitude was calculated as the difference between T0 and baseline-T, and rewarming time as time elapsed from T0 to baseline-T recovery. T2DM patients compared with healthy controls had statistically similar baseline-T, significantly larger temperature decline amplitude, significantly lower T0, and significantly longer rewarming time. In T2DM patients, rewarming time positively correlated with T2DM duration (r=0.513, p<0.001) and glycated hemoglobin (HbA1c) level (r=0.446, p=0.003), which also were its independent predictors in multivariate regression analysis. Patients with T2DM display abnormal FCT results suggestive of microvascular dysfunction, with T2DM duration and HbA1c level independently predicting rewarming time. Copyright © 2016. Published by Elsevier Inc.

  12. Visceral fat area is associated with HbA1c but not dialysate-related glucose load in nondiabetic PD patients

    NASA Astrophysics Data System (ADS)

    Ho, Li-Chun; Yen, Chung-Jen; Chao, Chia-Ter; Chiang, Chih-Kang; Huang, Jenq-Wen; Hung, Kuan-Yu

    2015-08-01

    Factors associated with increased visceral fat area (VFA) have been well documented in the general population but rarely explored in nondiabetic individuals on peritoneal dialysis (PD). As glycosylated hemoglobin (HbA1c) is positively correlated with VFA in diabetic patients, we hypothesized that the same correlation would exist in nondiabetic PD patients. We enrolled 105 nondiabetic patients who had undergone chronic PD for more than 3 months. Each subject underwent an abdominal computed tomography (CT) scan, and the umbilicus cut was analyzed for VFA. VFA values, corrected for body mass index and subjected to natural logarithm transformations, were examined to determine whether they were correlated with HbA1c and other parameters. PD dialysates prescribed at the time of enrollment were recorded to calculate glucose load. We found that when 105 nondiabetic PD patients were classified according to tertiles of HbA1c, higher HbA1c was associated with larger VFA. Multiple linear regression analysis revealed that HbA1c was an independent determinant of VFA, while glucose load and other PD-specific factors were not. In summary, HbA1c, but not PD-related glucose load, was positively correlated with VFA in nondiabetic PD patients, suggesting clinical utility of HbA1c in the PD population.

  13. Select medications that unexpectedly lower HbA1c levels.

    PubMed

    Tillman, F; Kim, J

    2018-04-19

    A variety of medication classes are available for diabetes; however, treatment options become limited due to adverse effect profiles and cost. Current diabetes guidelines include agents not originally developed for diabetes treatment, bromocriptine and colesevelam. Other non-diabetes medications demonstrating haemoglobin A1c lowering, including agents for weight loss, depression, anaemia and coronary artery disease, are described in this review article. More research looking into the impact of non-diabetes medications on blood glucose may offer additional diabetes treatment strategies. © 2018 John Wiley & Sons Ltd.

  14. Comparison of annual variability in HbA1c and glycated albumin in patients with type 1 vs. type 2 diabetes mellitus.

    PubMed

    Koga, Masafumi; Murai, Jun; Morita, Shinya; Saito, Hiroshi; Kasayama, Soji

    2013-01-01

    It has been suggested that plasma glucose (PG) levels per se and long-term variations in PG levels are associated with diabetic vascular complications. Glycated albumin (GA) reflects shorter-term glycemic control, as well as postprandial PG levels, as compared to HbA1c. In this study, we hypothesized that GA more strongly reflects long-term variations in PG levels than HbA1c, and compared the variability of HbA1c and that of GA in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). This study included 8 T1DM patients and 48 T2DM patients. Over a 1-year period, HbA1c and GA were measured every month and the mean values and coefficients of variation (CV) for each patient were calculated. In both T1DM and T2DM patients, the CV of GA was significantly higher than the CV of HbA1c. Both the CV of HbA1c and the CV of GA were significantly higher in the T1DM patients than in the T2DM patients. The annual variability in GA was greater than that in HbA1c. In addition, the annual variability in HbA1c and that in GA in the T1DM patients were greater than in the T2DM patients. Our findings suggest that GA more accurately reflects long-term variations in PG levels than HbA1c. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. HbA1c variability in type 2 diabetes is associated with the occurrence of new-onset albuminuria within three years.

    PubMed

    Dorajoo, Sreemanee Raaj; Ng, Joceline Shi Ling; Goh, Jessica Hui Fen; Lim, Su Chi; Yap, Chun Wei; Chan, Alexandre; Lee, Joyce Yu Chia

    2017-06-01

    To evaluate the association between HbA1c coefficient of variation (HbA1c-CV) and 3-year new-onset albuminuria risk. A retrospective cohort study involving 716 normoalbuminuric type 2 diabetes patients was conducted between 2010 and 2014. HbA1c-CV was used to categorize patients into low, moderate or high variability groups. Multivariate logistic models were constructed and validated. Integrated discrimination (IDI) and net reclassification (NRI) improvement indices were used to quantify the added predictive value of HbA1c-CV. The mean age of our cohort was 56.1±12.9years with a baseline HbA1c of 8.3±1.3%. Over 3-years of follow-up, 35.2% (n=252) developed albuminuria. An incremental risk of albuminuria was observed with moderate (6.68-13.43%) and high (above 13.44%) HbA1c-CV categories demonstrating adjusted odds ratios of 1.63 (1.12-2.38) and 3.80 (2.10-6.97) for 3-year new-onset albuminuria, respectively. Including HbA1c-CV for 3-year new-onset albuminuria prediction improved model discrimination (IDI: 0.023, NRI: 0.293, p<0.05). The final model had a C-statistic of 0.760±0.018 on validation. HbA1c-CV improves 3-year prediction of new-onset albuminuria. Together with mean HbA1c, baseline urine albumin-to-creatinine ratio and presence of hypertension, accurate 3-year new-onset albuminuria prediction may be possible. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. How can point-of-care HbA1c testing be integrated into UK primary care consultations? - A feasibility study.

    PubMed

    Hirst, J A; Stevens, R J; Smith, I; James, T; Gudgin, B C; Farmer, A J

    2017-08-01

    Point-of-care (POC) HbA1c testing gives a rapid result, allowing testing and treatment decisions to take place in a single appointment. Trials of POC testing have not been shown to improve HbA1c, possibly because of how testing was implemented. This study aimed to identify key components of POC HbA1c testing and determine strategies to optimise implementation in UK primary care. This cohort feasibility study recruited thirty patients with type 2 diabetes and HbA1c>7.5% (58mmol/mol) into three primary care clinics. Patients' clinical care included two POC HbA1c tests over six months. Data were collected on appointment duration, clinical decisions, technical performance and patient behaviour. Fifty-three POC HbA1c consultations took place during the study; clinical decisions were made in 30 consultations. Five POC consultations with a family doctor lasted on average 11min and 48 consultations with nurses took on average 24min. Five POC study visits did not take place in one clinic. POC results were uploaded to hospital records from two clinics. In total, sixty-three POC tests were performed, and there were 11 cartridge failures. No changes in HbA1c or patient behaviour were observed. HbA1c measurement with POC devices can be effectively implemented in primary care. This work has identified when these technologies might work best, as well as potential challenges. The findings can be used to inform the design of a pragmatic trial to implement POC HbA1c testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  17. 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.

  18. Changes in HbA1c and Weight Following Transition to Continuous Subcutaneous Insulin Infusion Therapy in Adults With Type 1 Diabetes.

    PubMed

    Mehta, Sanjeev N; Andersen, Henrik Ullits; Abrahamson, Martin J; Wolpert, Howard A; Hommel, Eva E; McMullen, William; Ridderstråle, Martin

    2017-01-01

    Historically, intensive insulin therapy for type 1 diabetes (T1D) has improved glycemic control at the risk of adverse weight gain. The impact of continuous subcutaneous insulin infusion therapy (CSII) on weight in the current era remains unknown. We assessed changes in hemoglobin A1c (HbA1c) and weight in adults with T1D transitioning to CSII at 2 diabetes centers in Denmark and the United States. Patients with T1D, aged ≥18 years, managed with multiple daily injections (MDI) who transitioned to CSII between 2002 and 2013 were identified using electronic health record data from the Steno Diabetes Center (n = 600) and Joslin Diabetes Center (n = 658). Changes in HbA1c and weight after 1 year was assessed overall and by baseline HbA1c cut points. Multivariate regression assessed correlates of HbA1c reduction. In adults with T1D transitioning to CSII, clinically significant HbA1c reductions were found in patients with baseline HbA1c 8.0-8.9% (Steno, -0.7%; Joslin, -0.4%) and baseline HbA1c ≥9.0% (Steno, -1.1%; Joslin, -0.9%) ( P < .005 for all). Overall, there was no significant change in weight after 1 year at either center. Modest (<2%) weight gain was noted in patients with baseline HbA1c ≥9% at Steno (1.1 ± 0.3 kg, P < .0001) and Joslin (1.7 ± 1.1, P < .005). In multivariate models, HbA1c reduction was associated with higher HbA1c, older age, female sex at Steno ( R 2 = .28, P < .005), but only higher baseline HbA1c at Joslin ( R 2 = .19, P < .005). Adults with T1D with suboptimal glycemic control significantly improved HbA1c without a negative impact on weight 1 year after transitioning from MDI to CSII.

  19. 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.

  20. 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

  1. Early Glycemic Control and Magnitude of HbA1c Reduction Predict Cardiovascular Events and Mortality: Population-Based Cohort Study of 24,752 Metformin Initiators.

    PubMed

    Svensson, Elisabeth; Baggesen, Lisbeth M; Johnsen, Søren P; Pedersen, Lars; Nørrelund, Helene; Buhl, Esben S; Haase, Christiane L; Thomsen, Reimar W

    2017-06-01

    We investigated the association of early achieved HbA 1c level and magnitude of HbA 1c reduction with subsequent risk of cardiovascular events or death in patients with type 2 diabetes who initiate metformin. This was a population-based cohort study including all metformin initiators with HbA 1c tests in Northern Denmark, 2000-2012. Six months after metformin initiation, we classified patients by HbA 1c achieved (<6.5% or higher) and by magnitude of HbA 1c change from the pretreatment baseline. We used Cox regression to examine subsequent rates of acute myocardial infarction, stroke, or death, controlling for baseline HbA 1c and other confounding factors. We included 24,752 metformin initiators (median age 62.5 years, 55% males) with a median follow-up of 2.6 years. The risk of a combined outcome event gradually increased with rising levels of HbA 1c achieved compared with a target HbA 1c of <6.5%: adjusted hazard ratio (HR) 1.18 (95% CI 1.07-1.30) for 6.5-6.99%, HR 1.23 (1.09-1.40) for 7.0-7.49%, HR 1.34 (1.14-1.57) for 7.5-7.99%, and HR 1.59 (1.37-1.84) for ≥8%. Results were consistent for individual outcome events and robust by age-group and other patient characteristics. A large absolute HbA 1c reduction from baseline also predicted outcome: adjusted HR 0.80 (0.65-0.97) for Δ = -4, HR 0.98 (0.80-1.20) for Δ = -3, HR 0.92 (0.78-1.08) for Δ = -2, and HR 0.99 (0.89-1.10) for Δ = -1 compared with no HbA 1c change (Δ = 0). A large initial HbA 1c reduction and achievement of low HbA 1c levels within 6 months after metformin initiation are associated with a lower risk of cardiovascular events and death in patients with type 2 diabetes. © 2017 by the American Diabetes Association.

  2. 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.

  3. Impact of HbA1c criterion on the definition of glycemic component of the metabolic syndrome: the China health and nutrition survey 2009.

    PubMed

    Sun, Xingxing; Du, Tingting; Huo, Rui; Yu, Xuefeng; Xu, Lixian

    2013-11-05

    In 2009, a unified definition of metabolic syndrome (MetS) was proposed, of which, the glycemic component is defined on the basis of fasting plasma glucose (FPG) level. Recently, the American Diabetes Association (ADA) recommended the use of glycated hemoglobin (HbA1c) as an alternative to FPG to define prediabetes. Hence, we aim to compare the performance of HbA1c and FPG in the definition of glycemic component of the MetS among Chinese adults. We conducted a cross-sectional analysis of 7641 Chinese participants aged ≥18 years using data from the China Health and Nutrition Survey 2009. MetS was defined according to the consensus criteria in 2009. We compared the use of HbA1c versus FPG in the definition of the glycemic component of MetS. Increased HbA1c value was defined following the criterion of HbA1c cut-off point of ≥5.7% recommended by the ADA. Overall, 1136 (14.9%) had MetS according to FPG ≥ 5.6 mmol/l, and 1640 (21.5%) had MetS according to HbA1c ≥ 5.7%. Compared with individuals with FPG-based diagnosis of MetS, individuals with HbA1c-based diagnosis of MetS were older, had higher levels of LDL-C, magnesium, and transferrin, and lower levels of uric acid. Of those found to have MetS according to either FPG or HbA1c (n = 2008), overlap between HbA1c- and FPG-based diagnosis of MetS was limited (n = 768, 38.2%). The overlap index regarding MetS diagnosed by FPG or HbA1c persisted low in each evaluated subgroup (≤ 50.0%). We note limited overlap and poor agreement between FPG- and HbA1c-based diagnosis of MetS. Screening MetS through introduction of HbA1c in addition to FPG could contribute to identification of more people with MetS.

  4. [Capillary HbA1c determination on type 2 diabetes patients in a primary health centre].

    PubMed

    Font, María Teresa Carrera; Brichs, María Claustre Solé; Álvarez, María Clara Sala; Olivella, Jose María Navarro; Turó, Josefina Servent; Fernández, María Pilar Felipe

    2011-10-01

    To determine the reliability and practicability of the point-of-care- test (POCT) analyzer, Afinion, for capillary HbA1c testing. To assess the benefits of its implementation on the intra-annual follow up of type 2 diabetic patients. Descriptive cross-sectional study. Analytical validation of the Afinion reader. Primary Health Care (CAP Carmel and Bon Pastor Clinic Laboratory). A total of 94 type 2 diabetic patients selected according to their previous HbA1c value. We performed one capillary puncture and one venous extraction on each visit. The capillary sample was assessed in real time on the Afinion in the Primary Health Care Centre and the venous sample was sent to Bon Pastor Clinic Laboratory for assessment on an Afinion analyzer and by a high performance liquid chromatrography (HPLC) reference method. Practicability was assesses by both by the operators of the Afinion and the patients using an 11 question questionnaire. The efficiency in terms of process timings was also evaluated. Intra-serial coefficient of variation (CV) was lower than 1% and inter-serial lower than 3%. The regression analysis showed: Afinion capillary sample=0.95 Afinion venous+0.21. No systematic or proportional error was detected in the 95% confidence interval (95% CI). The comparison between venous HPLC and Afinion showed: Afinion capillary sample=0.80 HPLC+1.14. A statistically significant difference was shown for these values at the 95% CI. Practicability was valued by users from 7 to 9.2 (professionals) and from 7.7 to 9.2 (patients). Implementation of the Afinion capillary method for intra-annual testing in follow up of diabetic patients could result in the saving of 600-900 professional hours/year. Afinion seems to be a good choice for the intra-annual determination of HbA1c when compared to the traditional process due to its accessibility, practicability and efficiency. Professionals should know the limitations of the POCT method in order to consider the validity of the results

  5. Knowledge and Outcome Measure of HbA1c Testing in Asian Indian Patients with Type 2 Diabetes from a Tertiary Care Center

    PubMed Central

    Kumpatla, Satyavani; Medempudi, Srikanth; Manoharan, Deepa; Viswanathan, Vijay

    2010-01-01

    Aim: HbA1c test is considered to be the reliable measure for evaluating long-term glycemic control in type 2 diabetes. The purpose of this study was to evaluate whether knowledge about HbA1c test is associated with a better glycemic control. Materials and Methods: We conducted a cross-sectional survey of 480 (M:F; 287:193) adults with type 2 diabetes attending a tertiary care center during a period of four months. Baseline demographic and clinical data of all the subjects was obtained. Subject’s knowledge about HbA1c test and their target goal was assessed using a questionnaire. Recent HbA1c results were obtained from medical records. Results: Seventy four per cent of the subjects had awareness about HbA1c test and about 43% of those who knew HbA1c test also knew their target goal. 33% remember their last HbA1c result. The mean A1C of Group A was significantly lower when compared with Group B (8.1 ± 1.7 vs 9.2 ± 1.9, P<0.0001). Group C had lower A1C levels compared to Group D (7.7 ± 1.4 vs 8.5 ± 1.9, p<0.0001). Patients who kept their HbA1c less than 7% were significantly higher in Group C than in Group D. (37.8 vs 12.7%, p<0.00001). Subjects had good glycemic control with increasing levels of awareness about HbA1c. Conclusion: Majority of the diabetic patients who attended the tertiary care center for diabetes care knew HbA1c test and half of them were aware about their target goal. Awareness about HbA1c had a positive impact on maintenance of better glycemic control. PMID:20922109

  6. 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/.

  7. 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

  8. Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes – A feasibility study

    PubMed Central

    Kjome, Reidun Lisbet Skeide; Sandberg, Sverre; Sølvik, Una Ørvim

    2018-01-01

    Objectives Determine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway. Methods In this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument. Results Of the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%—6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits. Conclusion The pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been

  9. 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.

  10. Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes - A feasibility study.

    PubMed

    Risøy, Aslaug Johanne; Kjome, Reidun Lisbet Skeide; Sandberg, Sverre; Sølvik, Una Ørvim

    2018-01-01

    Determine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway. In this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument. Of the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%-6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits. The pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been validated for.

  11. Effect of iron deficiency anemia and iron supplementation on HbA1c levels - Implications for diagnosis of prediabetes and diabetes mellitus in Asian Indians.

    PubMed

    Madhu, S V; Raj, Abhishek; Gupta, Stuti; Giri, S; Rusia, Usha

    2017-05-01

    We investigated the effect of iron deficiency anemia (IDA) on levels of glycated hemoglobin (HbA1c) and to compare its levels before and after iron supplementations. Age and sex matched subjects were enrolled and clustered in 2 groups: IDA (n=62) and healthy controls (HC; n=60). HbA1c levels were estimated by HPLC. Hemogram were estimated by hematology analyser. Serum ferritin (ELISA) and other parameters of iron profile were measured by standard guidelines of ICSH. HbA1c values and iron studies were repeated after 3months of iron supplementation to determine the effect of iron therapy on HbA1c levels. Significantly higher HbA1c levels were observed in IDA subjects compared to HC (5.51±0.696 v/s 4.85±0.461%, p<0.001). A significant negative correlation was observed between HbA1c and hemoglobin, hematocrit, RBC count, MCH, MCHC and serum ferritin in IDA subjects (r=-0.632, -0.652, -0.384, -0.236, -0.192 and -0.441). Significant decline was noticed in HbA1c levels in IDA subjects after iron supplementation (5.51±0.696 before treatment v/s 5.044±0.603 post-treatment; p<0.001). Post treatment, 70% subjects (14/20) with HbA1c in pre-diabetes range normalised to normal glucose tolerance (NGT) range and out of 6 patients with pre-treatment HbA1c in diabetes range, 5 reverted to pre-diabetes range while 1 of them reverted to the NGT range. Caution must be exercised in interpreting the results of HbA1c in patients of IDA and iron deficiency must be corrected before diagnosing diabetes and pre-diabetes solely on the basis of HbA1c criteria. Copyright © 2016. Published by Elsevier B.V.

  12. Nutritional intervention and impact of polyphenol on glycohemoglobin (HbA1c) in non-diabetic and type 2 diabetic subjects: Systematic review and nmeta-analysis.

    PubMed

    Palma-Duran, Susana A; Vlassopoulos, Antonis; Lean, Mike; Govan, Lindsay; Combet, Emilie

    2017-03-24

    Polyphenols have been extensively studied for their antioxidant and anti-inflammatory properties. Recently, their antiglycative actions by oxidative stress modulation have been linked to the prevention of diabetes and associated complications. This article assesses the evidence for polyphenol interventions on glycohemoglobin (HbA1c) in non-diabetic, pre-diabetic, and type 2 diabetes mellitus (T2DM) subjects. A systematic review of polyphenols' clinical trials on HbA1c in humans was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis. Thirty-six controlled randomized trials with HbA1c values were included. Polyphenols (extracts, supplements, and foods) were supplemented (28 mg to 1.5 g) for 0.7 to 12 months. Combining all subjects (n = 1954, mean baseline HbA1c = 7.03%, 53 mmol/mol), polyphenol supplementation significantly (P < 0.001) lowered HbA1c% by -0.53 ± 0.12 units (-5.79 ± 0.13 mmol/mol). This reduction was significant (P < 0.001) in T2DM subjects, specifically (n = 1426, mean baseline HbA1c = 7.44%, 58 mmol/mol), with HbA1c% lowered by -0.21 ± 0.04 units (-2.29 ± 0.4 mmol/mol). Polyphenol supplementation had no significant effect (P > 0.21) in the non-diabetic (n = 258, mean baseline HbA1c = 5.47%, 36 mmol/mol) and the pre-diabetic subjects (n = 270, mean baseline HbA1c = 6.06%, 43 mmol/mol) strata: -0.39 ± 0.27 HbA1c% units (-4.3 ± 0.3 mmol/mol), and -0.38 ± 0.31 units (-4.2 ± 0.31 mmol/mol), respectively. In conclusion, polyphenols can successfully reduce HbA1c in T2DM without any intervention at glycemia, and could contribute to the prevention of diabetes complications.

  13. Prevalence of anxiety and depression among diabetic African patients in Guinea: association with HbA1c levels.

    PubMed

    Camara, A; Baldé, N M; Enoru, S; Bangoura, J S; Sobngwi, E; Bonnet, F

    2015-02-01

    The prevalence and risk factors associated with symptoms of anxiety and depression were determined in African people with diabetes. This cross-sectional study involved 491 outpatients with type 2 diabetes (T2D) recruited from four diabetes clinics (Conakry, Labé, Boké and Kankan) in Guinea. The Hospital Anxiety and Depression Scale (HADS) was used to evaluate symptoms of anxiety and depression. Logistic regression analysis stratified by gender was performed to identify the associated risk factors. Anxiety and depression symptoms were present in 58.7% and 34.4%, respectively, of the 491 patients with T2D (62.7% women, mean±SD age: 57.9±10.2years). Odds ratios (95% CI) of risk factors independently associated with anxiety were urban residence [2.98 (1.81-4.89)] in women, and low socioeconomic status [0.19 (0.05-0.70)] and HbA1c≥9.0% [2.61 (1.0-6.39)] in men. Factors associated with depression were urban residence [2.13 (1.27-3.58)], older age [1.03 (1.01-1.06)], low socioeconomic status [2.21 (1.34-3.66)] and no previous measurement of HbA1c [12.45 (1.54-100.34)] in women, and insulin therapy [2.28 (1.05-4.92)] and HbA1c≥9.0% [3.85 (1.02-14.48)] in men. Anxiety and depression symptoms in people with type T2D are common in Guinea. Urban residence, low socioeconomic status and high levels of HbA1c were significantly associated with a greater risk of anxiety and depression, highlighting the psychological burden related to diabetes in Africa. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  14. Treatment intensification without improved HbA1c levels in children and adolescents with Type 1 diabetes mellitus.

    PubMed

    Sildorf, S M; Hertel, N T; Thomsen, J; Fredheim, S; Hastrup, H; Pipper, C; Hertz, B; Svensson, J

    2016-04-01

    To examine trends in diabetes treatment in Danish children and adolescents with Type 1 diabetes mellitus, comparing treatment intensity with metabolic outcomes in the population, and to describe the challenges of population-based registries in a clinical setting with rapidly changing treatment methods. This observational study is based on the Danish national population registry of childhood diabetes, which includes 99% of children diagnosed with Type 1 diabetes before the age of 15 years. We included 4527 people diagnosed between 2000 and 2012. Self-monitored blood glucose measurements, insulin injections/boluses, treatment method and metabolic control quantifications were analysed and adjusted for the effects of gender and ethnicity, the combined effect of age, visit year and duration, and for the random effects of individual and hospital settings. Treatment was intensified via an increasing number of self-monitored blood glucose measurements and injections/boluses. More than six injections/boluses and an increased number of self-monitored blood glucose measurements were significantly associated with lower metabolic control. No reduction, however, in the overall mean HbA1c concentration was observed between 2005 [66 mmol/mol (8.2%)] and 2012 [65 mmol/mol (8.1%)]. Changed registration practices in 2009 introduced artificial jumps in data. Intensifying treatment alone does not lead to improved metabolic control in the overall population despite the appearance of lower HbA1c in individuals with a greater number of self-monitored blood glucose measurements and injections/boluses. The contradictory results reflect difficulties in using observational studies to predict results of intervention in the individual. Data collected from population-based registries need to be adjusted continuously to reflect changes in care. © 2015 Diabetes UK.

  15. Severe fatigue in type 1 diabetes: Exploring its course, predictors and relationship with HbA1c in a prospective study.

    PubMed

    Menting, Juliane; Nikolaus, Stephanie; van der Veld, William M; Goedendorp, Martine M; Tack, Cees J; Knoop, Hans

    2016-11-01

    To prospectively identify the course of severe fatigue, its predictors and the relationship with HbA 1c in patients with type 1 diabetes. 214 adult patients completed questionnaires on fatigue severity and fatigue-related factors at baseline. HbA 1c was retrieved from medical records. After 43months, fatigue severity and HbA 1c were reassessed in 194 patients. A logistic regression analysis was used to determine predictors of severe fatigue at follow-up with various cognitive-behavioral and clinical factors as potential predictors. The relationship between fatigue and HbA 1c was investigated in a sub-analysis by differentiating between patients with suboptimal glucose control [HbA 1c >7% (53mmol/mol)] and optimal glucose control [HbA 1c ⩽7% (53mmol/mol)]. The prevalence of severe fatigue was 40% at baseline and 42% at follow-up. In three out of four severely fatigued patients at baseline (76%), severe fatigue persisted over time. More depressive symptoms, more pain, sleep disturbances, lower self-efficacy concerning fatigue, less confidence in diabetes self-care, more fatigue severity at baseline and more diabetes complications predicted severe fatigue at follow-up. Over time, HbA 1c at baseline was positively associated with fatigue severity at follow-up in both groups (suboptimal glucose control: r=.18, p<.05; optimal glucose control: r=.09, p<.05). About three quarters of fatigued[corrected] patients with type 1 diabetes suffer from persistent fatigue. Aside from the number of diabetes complications, no clinical factors explained the persistence of fatigue. HbA 1c and fatigue were weakly associated in a sub-analysis. Since the strongest predictors of severe fatigue were cognitive-behavioral factors, behavioral interventions might be effective in decreasing fatigue. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. 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.

  17. 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.

  18. 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.

  19. HbA1c as a Predictor of Diabetes and as an Outcome in the Diabetes Prevention Program: A Randomized Clinical Trial

    PubMed Central

    2015-01-01

    OBJECTIVE Glycated hemoglobin (HbA1c), a standard measure of chronic glycemia for managing diabetes, has been proposed to diagnose diabetes and identify people at risk. The Diabetes Prevention Program (DPP) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study, the DPP Outcomes Study (DPPOS). We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c ≥6.5% (48 mmol/mol). RESEARCH DESIGN AND METHODS We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo, metformin, or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose (FPG) and 2-h postload glucose (2hPG) concentrations (1997 American Diabetes Association [ADA] criteria). HbA1c was measured but not used for study eligibility or outcomes. We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG, 2hPG, or HbA1c (2010 ADA criteria). RESULTS Baseline HbA1c predicted incident diabetes in all treatment groups. Diabetes incidence defined by HbA1c ≥6.5% was reduced by 44% by metformin and 49% by lifestyle during the DPP and by 38% by metformin and 29% by lifestyle throughout follow-up. Unlike the primary DPP and DPPOS findings based on glucose criteria, metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c. CONCLUSIONS HbA1c predicted incident diabetes. In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes, metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes. The long-term implications for other health outcomes remain to be determined. PMID:25336746

  20. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.

    PubMed

    Schernthaner, Guntram; Lavalle-González, Fernando J; Davidson, Jaime A; Jodon, Holly; Vijapurkar, Ujjwala; Qiu, Rong; Canovatchel, William

    2016-11-01

    To evaluate the proportion of patients with type 2 diabetes mellitus (T2DM) achieving reductions in both glycated hemoglobin (HbA1c) and body weight with canagliflozin, a sodium glucose co-transporter 2 inhibitor, versus sitagliptin over 52 weeks. Data were pooled from two, randomized, Phase 3 studies of canagliflozin 100 and 300 mg versus sitagliptin 100 mg as add-on to metformin, and canagliflozin 300 mg versus sitagliptin 100 mg as add-on to metformin plus sulfonylurea (N = 1856). The composite end points of change from baseline in both HbA1c <0% and body weight <0 kg, and attainment of HbA1c <7.0% and body weight reduction ≥5% at Week 52 were evaluated. Safety was assessed based on adverse event reports. Canagliflozin provided reductions in HbA1c and body weight over 52 weeks versus sitagliptin. A greater proportion of patients had both HbA1c and body weight reductions with canagliflozin 100 and 300 mg versus sitagliptin 100 mg (67.7%, 72.6%, and 44.1%, respectively). Among patients with HbA1c and body weight reductions, more patients achieved the composite end point of HbA1c <7.0% and body weight reduction ≥5% with canagliflozin 100 and 300 mg versus sitagliptin 100 mg (18.9%, 18.3%, and 5.7%, respectively). Canagliflozin was generally well tolerated. A greater proportion of patients with T2DM achieved reductions in both HbA1c and body weight, and more patients with HbA1c and body weight reductions achieved HbA1c <7.0% and body weight reduction ≥5% with canagliflozin versus sitagliptin over 52 weeks. www.ClinicalTrials.gov identifiers are NCT01106677; NCT01137812.

  1. Mitochondrial Haplogroups Modify the Effect of Diabetes Duration and HbA1c on Proliferative Diabetic Retinopathy Risk in Patients With Type 2 Diabetes.

    PubMed

    Mitchell, Sabrina L; Neininger, Abigail C; Bruce, Carleigh N; Chocron, Isaac M; Bregman, Jana A; Estopinal, Christopher B; Muhammad, Ayesha; Umfress, Allison C; Jarrell, Kelli L; Warden, Cassandra; Harlow, Paula A; Wellons, Melissa; Samuels, David C; Brantley, Milam A

    2017-12-01

    We previously demonstrated an association between European mitochondrial haplogroups and proliferative diabetic retinopathy (PDR). The purpose of this study was to determine how the relationship between these haplogroups and both diabetes duration and hyperglycemia, two major risk factors for diabetic retinopathy (DR), affect PDR prevalence. Our population consisted of patients with type 2 diabetes with (n = 377) and without (n = 480) DR. A Kruskal-Wallis test was used to compare diabetes duration and hemoglobin A1c (HbA1c) among mitochondrial haplogroups. Logistic regressions were performed to investigate diabetes duration and HbA1c as risk factors for PDR in the context of European mitochondrial haplogroups. Neither diabetes duration nor HbA1c differed among mitochondrial haplogroups. Among DR patients from haplogroup H, longer diabetes duration and increasing HbA1c were significant risk factors for PDR (P = 0.0001 and P = 0.011, respectively). Neither diabetes duration nor HbA1c was a significant risk factor for PDR in DR patients from haplogroup UK. European mitochondrial haplogroups modify the effects of diabetes duration and HbA1c on PDR risk in patients with type 2 diabetes. In our patient population, longer diabetes duration and higher HbA1c increased PDR risk in patients from haplogroup H, but did not affect PDR risk in patients from haplogroup UK. This relationship has not been previously demonstrated and may explain, in part, why some patients with nonproliferative DR develop PDR and others do not, despite similar diabetes duration and glycemic control.

  2. Single-Use Disposable Electrochemical Label-Free Immunosensor for Detection of Glycated Hemoglobin (HbA1c) Using Differential Pulse Voltammetry (DPV).

    PubMed

    Molazemhosseini, Alireza; Magagnin, Luca; Vena, Pasquale; Liu, Chung-Chiun

    2016-07-01

    A single-use disposable in vitro electrochemical immunosensor for the detection of HbA1c in undiluted human serum using differential pulse voltammetry (DPV) was developed. A three-electrode configuration electrochemical biosensor consisted of 10-nm-thin gold film working and counter electrodes and a thick-film printed Ag/AgCl reference electrode was fabricated on a polyethylene terephthalate (PET) substrate. Micro-fabrication techniques including sputtering vapor deposition and thick-film printing were used to fabricate the biosensor. This was a roll-to-roll cost-effective manufacturing process making the single-use disposable in vitro HbA1c biosensor a reality. Self-assembled monolayers of 3-Mercaptopropionic acid (MPA) were employed to covalently immobilize anti-HbA1c on the surface of gold electrodes. Electrochemical impedance spectroscopy (EIS) and X-ray photoelectron spectroscopy (XPS) confirmed the excellent coverage of MPA-SAM and the upward orientation of carboxylic groups. The hindering effect of HbA1c on the ferricyanide/ferrocyanide electron transfer reaction was exploited as the HbA1c detection mechanism. The biosensor showed a linear range of 7.5-20 µg/mL of HbA1c in 0.1 M PBS. Using undiluted human serum as the test medium, the biosensor presented an excellent linear behavior (R² = 0.999) in the range of 0.1-0.25 mg/mL of HbA1c. The potential application of this biosensor for in vitro measurement of HbA1c for diabetic management was demonstrated.

  3. Single-Use Disposable Electrochemical Label-Free Immunosensor for Detection of Glycated Hemoglobin (HbA1c) Using Differential Pulse Voltammetry (DPV)

    PubMed Central

    Molazemhosseini, Alireza; Magagnin, Luca; Vena, Pasquale; Liu, Chung-Chiun

    2016-01-01

    A single-use disposable in vitro electrochemical immunosensor for the detection of HbA1c in undiluted human serum using differential pulse voltammetry (DPV) was developed. A three-electrode configuration electrochemical biosensor consisted of 10-nm-thin gold film working and counter electrodes and a thick-film printed Ag/AgCl reference electrode was fabricated on a polyethylene terephthalate (PET) substrate. Micro-fabrication techniques including sputtering vapor deposition and thick-film printing were used to fabricate the biosensor. This was a roll-to-roll cost-effective manufacturing process making the single-use disposable in vitro HbA1c biosensor a reality. Self-assembled monolayers of 3-Mercaptopropionic acid (MPA) were employed to covalently immobilize anti-HbA1c on the surface of gold electrodes. Electrochemical impedance spectroscopy (EIS) and X-ray photoelectron spectroscopy (XPS) confirmed the excellent coverage of MPA-SAM and the upward orientation of carboxylic groups. The hindering effect of HbA1c on the ferricyanide/ferrocyanide electron transfer reaction was exploited as the HbA1c detection mechanism. The biosensor showed a linear range of 7.5–20 µg/mL of HbA1c in 0.1 M PBS. Using undiluted human serum as the test medium, the biosensor presented an excellent linear behavior (R2 = 0.999) in the range of 0.1–0.25 mg/mL of HbA1c. The potential application of this biosensor for in vitro measurement of HbA1c for diabetic management was demonstrated. PMID:27376299

  4. 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.

  5. 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

  6. Are Ethnic Disparities in HbA1c Levels Explained by Mental Wellbeing? Analysis of Population-Based Data from the Health Survey for England.

    PubMed

    Umeh, Kanayo

    2018-02-01

    It is unclear how ethnic differences in HbA 1c levels are affected by individual variations in mental wellbeing. Thus, the aim of this study was to assess the extent to which HbA 1c disparities between Caucasian and South Asian adults are mediated by various aspects of positive psychological functioning. Data from the 2014 Health Survey for England was analysed using bootstrapping methods. A total of 3894 UK residents with HbA 1c data were eligible to participate. Mental wellbeing was assessed using the Warwick-Edinburgh Mental Well-being Scale. To reduce bias BMI, blood pressure, diabetes status, and other factors were treated as covariates. Ethnicity directly predicted blood sugar control (unadjusted coefficient -2.15; 95% CI -3.64, -0.67), with Caucasians generating lower average HbA 1c levels (37.68 mmol/mol (5.6%)) compared to South Asians (39.87 mmol/mol (5.8%)). This association was mediated by positive mental wellbeing, specifically concerning perceived vigour (unadjusted effect 0.30; 95% CI 0.13, 0.58): South Asians felt more energetic than Caucasians (unadjusted coefficient -0.32; 95% CI -0.49, -0.16), and greater perceived energy predicted lower HbA 1c levels (unadjusted coefficient -0.92; 95% CI -1.29, -0.55). This mediator effect accounted for just over 14% of the HbA 1c variance and was negated after adjusting for BMI. Caucasian experience better HbA 1c levels compared with their South Asian counterparts. However, this association is partly confounded by individual differences in perceived energy levels, which is implicated in better glycaemic control, and appears to serve a protective function in South Asians.

  7. 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.

  8. Estimation of biological variation and reference change value of glycated hemoglobin (HbA(1c)) when two analytical methods are used.

    PubMed

    Ucar, Fatma; Erden, Gonul; Ginis, Zeynep; Ozturk, Gulfer; Sezer, Sevilay; Gurler, Mukaddes; Guneyk, Ahmet

    2013-10-01

    Available data on biological variation of HbA1c revealed marked heterogeneity. We therefore investigated and estimated the components of biological variation for HbA1c in a group of healthy individuals by applying a recommended and strictly designed study protocol using two different assay methods. Each month, samples were derived on the same day, for three months. Four EDTA whole blood samples were collected from each individual (20 women, 9 men; 20-45 years of age) and stored at -80°C until analysis. HbA1c values were measured by both high performance liquid chromatography (HPLC) (Shimadzu, Prominence, Japan) and boronate affinity chromatography methods (Trinity Biotech, Premier Hb9210, Ireland). All samples were assayed in duplicate in a single batch for each assay method. Estimations were calculated according to the formulas described by Fraser and Harris. The within subject (CV(I))-between subject (CV(G)) biological variations were 1.17% and 5.58%, respectively for HPLC. The calculated CV(I) and CV(G) were 2.15% and 4.03%, respectively for boronate affinity chromatography. Reference change value (RCV) for HPLC and boronate affinity chromatography was 5.4% and 10.4% respectively and individuality index of HbA(1c) was 0.35 and 0.93 respectively. This study for the first time described the components of biological variation for HbA1c in healthy individuals by two different assay methods. Obtained findings showed that the difference between CV(A) values of the methods might considerably affect RCV. These data regarding biological variation of HbA(1c) could be useful for a better evaluation of HbA(1c) test results in clinical interpretation. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  9. Relationships of diabetes-specific emotional distress, depression, anxiety, and overall well-being with HbA1c in adult persons with type 1 diabetes.

    PubMed

    Strandberg, Ragnhild Bjarkøy; Graue, Marit; Wentzel-Larsen, Tore; Peyrot, Mark; Rokne, Berit

    2014-09-01

    Emotional problems are common in adults with diabetes, and knowledge about how different indicators of emotional problems are related with glycemic control is required. The aim was to examine the relationships of diabetes-specific emotional distress, depression, anxiety, and overall well-being with glycosylated hemoglobin (HbA1c). Of the 319 adults with type 1 diabetes attending the endocrinology outpatient clinic at a university hospital in Norway, 235 (74%) completed the Diabetes Distress Scale, the Problem Areas in Diabetes Survey, the Hospital Anxiety and Depression Scale, and the World Health Organization-Five Well-Being Index. Blood samples were taken at the time of data collection to determine HbA1c. Regression analyses examined associations of diabetes-specific emotional distress, anxiety, depression, and overall well-being with HbA1c. The relationship between diabetes-specific emotional distress and HbA1c was tested for nonlinearity. Diabetes-specific emotional distress was related to glycemic control (DDS total: unstandardized coefficient=0.038, P<.001; PAID total: coefficient=0.021, P=.007), but depression, anxiety, and overall well-being were not. On the DDS, only regimen-related distress was independently related to HbA1c (coefficient=0.056, P<.001). A difference of 0.5 standard deviation of baseline regimen distress is associated with a difference of 0.6 in HbA1c. No significant nonlinearity was detected in the relationship between diabetes-specific distress and HbA1c. To stimulate adequate care strategies, health personnel should acknowledge depression and diabetes-specific emotional distress as different conditions in clinical consultations. Addressing diabetes-specific emotional distress, in particular regimen distress, in clinical consultation might improve glycemic control. Copyright © 2014. Published by Elsevier Inc.

  10. National continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement.

    PubMed

    Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

    2017-09-01

    This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control (IQC) practice of HbA1c has also been changed since National Center for Clinical Laboratories (NCCL) of China organized laboratories to report IQC data for HbA1c in 2012. Internal Quality Control information of 306 External Quality Assessment (EQA) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web-based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high-performance liquid chromatography (CE-HPLC) instead of Immunoturbidimetry, because CE-HPLC owed a lower intra-laboratory CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements. © 2016 Wiley Periodicals, Inc.

  11. 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.

  12. Temporal HbA1c patterns amongst patients with type 2 diabetes referred for specialist care: Data from the S4S-DINGO-Diabetes Informatics Group.

    PubMed

    Lam, Teresa; Hoffman, David M; Cukier, Kimberly; Darnell, David; Greenfield, Jerry R; Harrison, Natalie; Hng, Tien-Ming; Morrow, Anthony F; Cheung, N Wah

    2016-06-01

    To evaluate the achievement of HbA1c targets in patients with type 2 diabetes mellitus in specialist practice. This audit was undertaken by members of the S4S Diabetes Informatics Group (DINGO), a consortium of Australian endocrinologists in private practice who contribute de-identified data from their electronic medical record, Audit 4 (Software 4 Specialists, S4S, Australia & New Zealand) for audit purposes. Data from patients with type 2 diabetes was extracted. Inclusion criteria were: initial age<70years, baseline HbA1c>7% (53mmol/mol), with at least another HbA1c recorded in the next 2years, and a minimum of 2years follow-up. Data was analysed using a linear mixed effects model. Of the 4796 patients in the dataset with type 2 diabetes mellitus, 1379 patients fulfilled inclusion criteria. The median age at initial consultation was 57 (49-64)years. The median baseline HbA1c was 8.7 (7.8-9.8)% (72mmol/mol). There was a 1.0% reduction in HbA1c to 7.7 (7.1-8.6)% (61mmol/mol) (p<0.0001) in the first 3-6months following referral, after which there were no further changes. The initial reduction was maintained with minimal loss of control at 4years. By 3-6months, 24% of patients achieved the target HbA1c. Referral of patients with type 2 diabetes to an endocrinologist reduces HbA1c, and the effect is sustained over the medium term; however only a minority of patients reach targets. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Physical activity and change in fasting glucose and HbA1c: a quantitative meta-analysis of randomized trials.

    PubMed

    Boniol, Mathieu; Dragomir, Miruna; Autier, Philippe; Boyle, Peter

    2017-11-01

    A systematic review was conducted of randomized trials which evaluated the impact of physical activity on the change in fasting glucose and HbA1c. A literature search was conducted in PubMed until December 2015. Studies reporting glucose or HbA1c at baseline and at the end of study were included, and the change and its variance were estimated from studies with complete data. Mixed-effect random models were used to estimate the change of fasting glucose (mg/dl) and HbA1c (%) per additional minutes of physical activity per week. A total of 125 studies were included in the meta-analysis. Based on 105 studies, an increase of 100 min in physical activity per week was associated with an average change of -2.75 mg/dl of fasting glucose (95% CI -3.96; -1.55), although there was a high degree of heterogeneity (83.5%). When restricting the analysis on type 2 diabetes and prediabetes subjects (56 studies), the average change in fasting glucose was -4.71 mg/dl (95% CI -7.42; -2.01). For HbA1c, among 76 studies included, an increase of 100 min in physical activity per week was associated with an average change of -0.14% of HbA1c (95% CI -0.18; -0.09) with heterogeneity (73%). A large degree of publication bias was identified (Egger test p < 0.001). When restricting the analysis on type 2 diabetes and prediabetes subjects (60 studies), the average change in HbA1c was -0.16% (95% CI -0.21; -0.11). This analysis demonstrates that moderate increases in physical activity are associated with significant reductions in both fasting glucose and HbA1c.

  14. Visit-to-Visit Variations in Fasting Plasma Glucose and HbA1c Associated With an Increased Risk of Alzheimer Disease: Taiwan Diabetes Study.

    PubMed

    Li, Tsai-Chung; Yang, Chun-Pai; Tseng, Shih-Ting; Li, Chia-Ing; Liu, Chiu-Shong; Lin, Wen-Yuan; Hwang, Kai-Lin; Yang, Sing-Yu; Chiang, Jen-Huai; Lin, Cheng-Chieh

    2017-09-01

    The relationship between glycemic variability and the incidence of Alzheimer disease (AD) in patients with type 2 diabetes mellitus (T2DM) is unclear. The aim of this study was to examine visit-to-visit variations in fasting plasma glucose (FPG) and glycated hemoglobin (HbA 1c ) represented by the coefficient of variation (CV) and to determine whether they were independently associated with AD, irrespective of HbA 1c and other traditional risk factors in such patients. Patients with T2DM enrolled in the National Diabetes Care Management Program, age ≥60 years, and without diagnosis of AD ( n = 16,706) were included in the study. Potential risk factors were analyzed using extended Cox proportional hazards regression models for competing risk of mortality on AD incidence. During a median follow-up of 8.88 years, 831 incident cases of AD were identified, with a crude incidence rate of 3.5/1,000 person-years. After adjustment for sociodemographic factors, lifestyle behaviors, diabetes-related variables, FPG and HbA 1c , drug-related variables, and comorbidities, both FPG CV and HbA 1c CV were found to be significant predictors of AD, with corresponding hazard ratios of 1.27 (95% CI 1.06-1.52) for the third tertile in FPG CV and 1.32 (95% CI 1.11-1.58) for the third tertile in HbA 1c CV. FPG CV and HbA 1c CV are independently associated with AD. The associations between glycemic variability and AD demonstrated in this study suggest a linked pathophysiological mechanism, which is worthy of further investigation. Further research is required to confirm our results and to evaluate whether FPG CV and HbA 1c CV can be valuable therapeutic targets for patients with T2DM at risk. © 2017 by the American Diabetes Association.

  15. Fasting and 2-hour plasma glucose, and HbA1c in pregnancy and the postpartum risk of diabetes among Chinese women with gestational diabetes.

    PubMed

    Liu, Huikun; Zhang, Shuang; Wang, Leishen; Leng, Junhong; Li, Weiqin; Li, Nan; Li, Min; Qiao, Yijuan; Tian, Huiguang; Tuomilehto, Jaakko; Yang, Xilin; Yu, Zhijie; Hu, Gang

    2016-02-01

    Very few studies have assessed the association of fasting and 2h glucose, and HbA1c during pregnancy with postpartum diabetes risk among women with prior gestational diabetes mellitus (GDM). We assessed the association of fasting glucose, 2h glucose and HbA1c at 26-30 gestational weeks with postpartum diabetes risk among women with prior GDM. A cohort study in 1263 GDM women at 1-5 years after delivery was performed. Cox proportional hazards regression models were used to evaluate the association of fasting and 2h plasma glucose, and HbA1c at 26-30 gestational weeks with the risk of diabetes at postpartum. The multivariable-adjusted (age, pre-pregnancy body mass index, weight gain during pregnancy, current body mass index, family history of diabetes, marital status, education, family income, smoking status, passive smoking, leisure-time physical activity, alcohol drinking, and intake of energy, saturated fat, and dietary fiber) hazard ratios of postpartum diabetes were 1.61 (95% confidence interval [CI]: 1.36-1.91) for each 1 mmol/l increase in fasting glucose during pregnancy, 1.63 (95% CI: 1.45-1.84) for each 1 mmol/l increase in 2h glucose during pregnancy, 2.11 (95% CI: 1.50-2.97) for each 1 unit (%) increase in HbA1c during pregnancy. When fasting glucose, 2h glucose and HbA1c during pregnancy were entered multivariable-adjusted model simultaneously, 2h glucose and HbA1c but not fasting glucose remained to be significant and positive predictors for postpartum diabetes. For women with prior GDM, 2h plasma glucose and HbA1c during pregnancy are independent predictors of postpartum diabetes, but fasting plasma glucose during pregnancy is not. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Fasting and 2-hour plasma glucose, and HbA1c in pregnancy and the postpartum risk of diabetes among Chinese women with gestational diabetes

    PubMed Central

    Liu, Huikun; Zhang, Shuang; Wang, Leishen; Leng, Junhong; Li, Weiqi; Li, Nan; Li, Min; Qiao, Yijuan; Tian, Huiguang; Tuomilehto, Jaakko; Yang, Xilin; Yu, Zhijie; Hu, Gang

    2015-01-01

    Aims Very few studies have assessed the association of fasting and 2-hour glucose, and HbA1c during pregnancy with postpartum diabetes risk among women with prior gestational diabetes (GDM). We assessed the association of fasting glucose, 2-hour glucose and HbA1c at 26-30 gestational weeks with postpartum diabetes risk among women with prior GDM. Methods A cohort study in 1,263 GDM women at 1–5 years after delivery was performed. Cox proportional hazards regression models were used to evaluate the association of fasting and 2-hour plasma glucose, and HbA1c at 26-30 gestational weeks with the risk of diabetes at postpartum. Results The multivariable-adjusted (age, pre-pregnancy body mass index, weight gain during pregnancy, current body mass index, family history of diabetes, marital status, education, family income, smoking status, passive smoking, leisure-time physical activity, alcohol drinking, and intake of energy, saturated fat, and dietary fiber) hazard ratios of postpartum diabetes were 1.61 (95% confidence interval [CI]: 1.36–1.91) for each 1 mmol/l increase in fasting glucose during pregnancy, 1.63 (95% CI: 1.45–1.84) for each 1 mmol/l increase in 2-hour glucose during pregnancy, 2.11 (95% CI: 1.50–2.97) for each 1 unit (%) increase in HbA1c during pregnancy. When fasting glucose, 2-hour glucose and HbA1c during pregnancy were entered multivariable-adjusted model simultaneously, 2-hour glucose and HbA1c but not fasting glucose remained to be significant and positive predictors for postpartum diabetes. Conclusions For women with prior GDM, 2-hour plasma glucose and HbA1c during pregnancy are independent predictors of postpartum diabetes, but fasting plasma glucose during pregnancy is not. PMID:26686048

  17. 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.

  18. 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

  19. Effect of age on the diagnostic efficiency of HbA1c for diabetes in a Chinese middle-aged and elderly population: The Shanghai Changfeng Study.

    PubMed

    Wu, Li; Lin, Huandong; Gao, Jian; Li, Xiaoming; Xia, Mingfeng; Wang, Dan; Aleteng, Qiqige; Ma, Hui; Pan, Baishen; Gao, Xin

    2017-01-01

    Glycated hemoglobin A1c (HbA1c) ≥6.5% (or 48mmol/mol) has been recommended as a new diagnostic criterion for diabetes; however, limited literature is available regarding the effect of age on the HbA1c for diagnosing diabetes and the causes for this age effect remain unknown. In this study, we investigated whether and why age affects the diagnostic efficiency of HbA1c for diabetes in a community-based Chinese population. In total, 4325 participants without previously known diabetes were enrolled in this study. Participants were stratified by age. Receiver operating characteristic curve (ROC) was plotted for each age group and the area under the curve (AUC) represented the diagnostic efficiency of HbA1c for diabetes defined by the plasma glucose criteria. The area under the ROC curve in each one-year age group was defined as AUCage. Multiple regression analyses were performed to identify factors inducing the association between age and AUCage based on the changes in the β and P values of age. The current threshold of HbA1c (≥6.5% or 48mmol/mol) showed low sensitivity (35.6%) and high specificity (98.9%) in diagnosing diabetes. ROC curve analyses showed that the diagnostic efficiency of HbA1c in the ≥75 years age group was significantly lower than that in the 45-54 years age group (AUC: 0.755 vs. 0.878; P<0.001). Pearson correlation analysis showed that the AUCage of HbA1c was negatively correlated with age (r = -0.557, P = 0.001). When adjusting the red blood cell (RBC) count in the multiple regression model, the negative association between age and AUCage disappeared, with the regression coefficient of age reversed to 0.001 and the P value increased to 0.856. The diagnostic efficiency of HbA1c for diabetes decreased with aging, and this age effect was induced by the decreasing RBC count with age. HbA1c is unsuitable for diagnosing diabetes in elderly individuals because of their physiologically decreased RBC count.

  20. Effect of age on the diagnostic efficiency of HbA1c for diabetes in a Chinese middle-aged and elderly population: The Shanghai Changfeng Study

    PubMed Central

    Gao, Jian; Li, Xiaoming; Xia, Mingfeng; Wang, Dan; Aleteng, Qiqige; Ma, Hui; Pan, Baishen

    2017-01-01

    Background and aims Glycated hemoglobin A1c (HbA1c) ≥6.5% (or 48mmol/mol) has been recommended as a new diagnostic criterion for diabetes; however, limited literature is available regarding the effect of age on the HbA1c for diagnosing diabetes and the causes for this age effect remain unknown. In this study, we investigated whether and why age affects the diagnostic efficiency of HbA1c for diabetes in a community-based Chinese population. Methods In total, 4325 participants without previously known diabetes were enrolled in this study. Participants were stratified by age. Receiver operating characteristic curve (ROC) was plotted for each age group and the area under the curve (AUC) represented the diagnostic efficiency of HbA1c for diabetes defined by the plasma glucose criteria. The area under the ROC curve in each one-year age group was defined as AUCage. Multiple regression analyses were performed to identify factors inducing the association between age and AUCage based on the changes in the β and P values of age. Results The current threshold of HbA1c (≥6.5% or 48mmol/mol) showed low sensitivity (35.6%) and high specificity (98.9%) in diagnosing diabetes. ROC curve analyses showed that the diagnostic efficiency of HbA1c in the ≥75 years age group was significantly lower than that in the 45–54 years age group (AUC: 0.755 vs. 0.878; P<0.001). Pearson correlation analysis showed that the AUCage of HbA1c was negatively correlated with age (r = -0.557, P = 0.001). When adjusting the red blood cell (RBC) count in the multiple regression model, the negative association between age and AUCage disappeared, with the regression coefficient of age reversed to 0.001 and the P value increased to 0.856. Conclusions The diagnostic efficiency of HbA1c for diabetes decreased with aging, and this age effect was induced by the decreasing RBC count with age. HbA1c is unsuitable for diagnosing diabetes in elderly individuals because of their physiologically decreased RBC

  1. Risk of progression to diabetes from prediabetes defined by HbA1c or fasting plasma glucose criteria in Koreans.

    PubMed

    Kim, Chul-Hee; Kim, Hong-Kyu; Kim, Eun-Hee; Bae, Sung-Jin; Choe, Jaewon; Park, Joong-Yeol

    2016-08-01

    To examine the abilities of HbA1c and fasting plasma glucose (FPG) criteria predicting 5-year progression rate to diabetes in Korean adults with prediabetes. Participants included 17,971 Koreans (aged 20-79years) who underwent routine medical check-ups at a mean interval of 5.2years (3.1-6.7years). Prediabetes was defined as FPG 5.6-6.9mmol/l or HbA1c 5.7-6.4% (39-46mmol/mol). Incident diabetes was defined as FPG⩾7.0mmol/l, HbA1c⩾6.5% (48mmol/mol), or initiation of antidiabetic medications. At baseline, the prevalence of prediabetes was 30.6% (n=5495) by FPG and 20.4% (n=3664) by HbA1c criteria. The 5-year progression rate to diabetes was significantly higher in prediabetes identified by HbA1c than by FPG tests (14.7% vs. 10.4%, P<0.001). Of individuals diagnosed with prediabetes by only one test, those by HbA1c alone had a higher risk of progression to diabetes than those diagnosed by FPG alone (6.0% vs. 3.9%, P<0.001). Receiver operating characteristic curve analysis showed that area under the curve was greater for HbA1c (0.855, 95% CI 0.840-0.870) than for FPG (0.830, 0.813-0.846) (P=0.016). After adjustment for conventional risk factors, the odds ratio (OR) of developing diabetes was higher in participants with prediabetes identified by HbA1c (OR 9.91, 8.24-11.9) than by FPG (OR 7.29, 5.97-8.89) (P=0.026). Although fewer individuals with prediabetes were identified by HbA1c than by FPG criteria, the ability to predict progression to diabetes was stronger for HbA1c than for FPG in Koreans. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. 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.

  3. 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.

  4. 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.

  5. Glycemic excursions are positively associated with HbA1c reduction from baseline after treatment with acarbose in patients with type 2 diabetes on metformin monotherapy.

    PubMed

    Wang, Jun-Sing; Lee, I-Te; Lee, Wen-Jane; Lin, Shi-Dou; Su, Shih-Li; Tu, Shih-Te; Tseng, Yao-Hsien; Lin, Shih-Yi; Sheu, Wayne Huey-Herng

    2017-03-01

    The aim of the present study was to examine the association between glycemic excursions before treatment and HbA1c reduction after treatment intensification with acarbose or glibenclamide in patients with type 2 diabetes (T2D). Patients receiving single or dual oral antidiabetic drug treatment with an HbA1c of 7.0-11.0 % (53-97 mmol/mol) were switched to metformin monotherapy (500 mg, t.i.d.) for 8 weeks, followed by randomization to either acarbose (100 mg, t.i.d.) or glibenclamide (5 mg, t.i.d.) as add-on treatment for 16 weeks. Glycemic excursions were assessed as mean amplitude of glycemic excursions (MAGE) with 72-h ambulatory continuous glucose monitoring. Treatment efficacy was evaluated as relative HbA1c reduction (%), calculated as (baseline HbA1c - post-treatment HbA1c)/baseline HbA1c × 100. Fifty patients (mean [±SD] age 53.5 ± 8.2 years, 48 % men, mean baseline HbA1c 8.4 ± 1.2 %) were analyzed. Baseline MAGE was positively correlated with relative HbA1c reduction from baseline in patients treated with acarbose (r = 0.421, P = 0.029) but not glibenclamide (r = 0.052, P = 0.813). Linear regression analysis revealed that the association between baseline MAGE and relative HbA1c reduction from baseline (β = 0.125, P = 0.029) in patients treated with acarbose remained significant after adjustment for several confounders (P < 0.05 for all models). In patients with T2D on metformin monotherapy, baseline MAGE was positively correlated with relative HbA1c reduction from baseline after treatment with acarbose, but not glibenclamide. These findings highlight the importance of glycemic excursions in individualized treatment for patients with T2D. © 2016 Ruijin Hospital, Shanghai JiaoTong University School of Medicine (SJTU), Chinese Society of Endocrinology and Chinese Endocrinologist Association and John Wiley & Sons Australia, Ltd.

  6. 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

  7. 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.

  8. [Effects of applying behavior modification to improve HbA1C levels in a diabetic patient].

    PubMed

    Chen, Wen-Chun; Huang, You-Rong; Lin, Chiu-Chu

    2010-04-01

    Diabetes is a chronic disease. To prevent and delay complications, diabetic patients must adjust their lifestyle as part of a comprehensive approach to disease control. Diabetic patients must be able to self-manage their disease and establish healthy habits in their daily routine. In this study, prior to intervention, the subject was unable to control her diet, do exercise, check sugars properly or integrate disease management effectively into her daily routine. By applying self-regulation theory through the keeping of a diary for sugar and daily activity self-monitoring, she became able to self-assess the causes of poor disease control. Such further facilitated her setting goals and developing strategies to link her habits with disease management. When failing to achieve goals even after execution, she could consider the factors contributing to the failure and modify her behaviors, goals and/or strategies accordingly. We helped this patient learn behavior modification methods in order to achieve her goal of better HbA(1)C control. This case example may help clinical nursing educators move beyond the confines of the traditional one-way educational model to guide diabetic patients to achieve good sugar control. We hope our findings help many chronic disease sufferers achieve self-management objectives in order to assume greater self-care responsibilities.

  9. Effects of common hemoglobin variants on HbA1c measurements in China: results for α- and β-globin variants measured by six methods.

    PubMed

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

    2018-04-07

    HbA1c is a widely used biomarker for diabetes mellitus management. Here, we evaluated the accuracy of six methods for determining HbA1c values in Chinese patients with common α- and β-globin chains variants in China. Blood samples from normal subjects and individuals exhibiting hemoglobin variants were analyzed for HbA1c, using Sebia Capillarys 2 Flex Piercing (C2FP), Bio-Rad Variant II Turbo 2.0, Tosoh HLC-723 G8 (ver. 5.24), Arkray ADAMS A1c HA-8180V fast mode, Cobas c501 and Trinity Ultra2 systems. DNA sequencing revealed five common β-globin chain variants and three common α-globin chain variants. The most common variant was Hb E, followed by Hb New York, Hb J-Bangkok, Hb G-Coushatta, Hb Q-Thailand, Hb G-Honolulu, Hb Ube-2 and Hb G-Taipei. Variant II Turbo 2.0, Ultra2 and Cobas c501 showed good agreement with C2FP for most samples with variants. HLC-723 G8 yielded no HbA1c values for Hb J-Bangkok, Hb Q-Thailand and Hb G-Honolulu. Samples with Hb E, Hb G-Coushatta, Hb G-Taipei and Hb Ube-2 produced significant negative biases for HLC-723 G8. HA-8180V showed statistically significant differences for Hb E, Hb G-Coushatta, Hb G-Taipei, Hb Q-Thailand and Hb G-Honolulu. HA-8180V yielded no HbA1c values for Hb J-Bangkok. All methods showed good agreement for samples with Hb New York. Some common hemoglobin variants can interfere with HbA1c determination by the most popular methods in China.

  10. High-intensity aerobic interval training improves aerobic fitness and HbA1c among persons diagnosed with type 2 diabetes.

    PubMed

    Støa, Eva Maria; Meling, Sondre; Nyhus, Lill-Katrin; Glenn Strømstad; Mangerud, Karl Magnus; Helgerud, Jan; Bratland-Sanda, Solfrid; Støren, Øyvind

    2017-03-01

    It remains to be established how high-intensity aerobic interval training (HAIT) affects risk factors associated with type 2 diabetes (TD2). This study investigated effects of HAIT on maximal oxygen uptake (VO 2max ), glycated Hemoglobin type A1C (HbA1c), insulin resistance (IR), fat oxidation (FatOx), body weight (BW), percent body fat (%BF), lactate threshold (LT), blood pressure (BP), and blood lipid profile (BLP) among persons with T2D. Results were compared to the effects after a moderate-intensity training (MIT) program. Thirty-eight individuals with T2D completed 12 weeks of supervised training. HAIT consisted of 4 × 4 min of walking or running uphill at 85-95% of maximal heart rate, and MIT consisted of continuous walking at 70-75% of maximal heart rate. A 21% increase in VO 2max (from 25.6 to 30.9 ml kg -1  min -1 , p < 0.001), and a reduction in HbA1c by -0.58% points (from 7.78 to 7.20%, p < 0.001) was found in HAIT. BW and body mass index (BMI) was reduced by 1.9% (p < 0.01). There was a tendency towards an improved FatOx at 60% VO 2max (14%, p = 0.065). These improvements were significant different from MIT. Both HAIT and MIT increased velocity at LT, and reduced %BF, waist circumference, hip circumference, and BP, with no significant differences between the two groups. Correlations were found between change in VO 2max and change in HbA1c when the two intervention groups were combined (R = -0.52, p < 0.01). HAIT is an effective exercise strategy to improve aerobic fitness and reduce risk factors associated with T2D.

  11. 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...

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. Challenges in HbA1C Level as a Diagnostic Tool of Diabetes and Pre-Diabetes in Middle-Aged Population: The Bangladesh Study.

    PubMed

    Begum, A; Muttalib, M A; Arefin, M N; Hoque, M R; Sheme, Z A; Akter, N; Paul, U K

    2016-10-01

    Worldwide prevalence of diabetes is found to be the human health at an alarming rate. However, large numbers of patient remain undiagnosed. Oral glucose tolerance test (OGTT) still is regarded as gold standard in diagnosis of blood glucose abnormality. Although the less number of bodies are considering measurement of HbA1C as an alternate tool to identify risk group. This study was undertaken to evaluate the role of measurement of HbA1C in the diagnosis of diabetes and pre-diabetes in middle-aged Bangladeshi subjects and carried out in the department of Biochemistry, BIRDEM from July 2013 to June 2014. A total 177 subjects of age within the range of 30-45 years were selected for the purpose and classified into healthy control (n=62) pre-diabetes (n=69) and diabetes (n=46) groups based on the values of OGTT. Middle aged Bangladeshi subjects attending Bangladesh Institute of Research & Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) hospital, the HbA1C values were 5.0-5.6% in control group, 5.6-6.2% in pre-diabetes and 8.1-9.7% in diabetes group (95% CI). The optimal cut-off value of HbA1C related to pre-diabetes diagnosed by OGTT was 5.6%, which showed the sensitivity 47.8%, specificity 74.2%, positive predictive value 67.3% and negative predictive value 58.5%. Variants of hemoglobin especially Hemoglobin E (HbE) is prevalent in South East Asia including Bangladesh. The presence of genetic variants of hemoglobin can profoundly affect the accuracy of HbA1C measurements. So measurement of HbA1C may not be used as an alternate tool of OGTT to identify people of diabetes and pre-diabetes in certain situation.

  18. Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets.

    PubMed

    Lenters-Westra, Erna; English, Emma

    2017-08-28

    As a reference laboratory for HbA1c, it is essential to have accurate and precise HbA1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA1c (Cobas c513) and Tosoh G11 using different quality targets. The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols. Each of the evaluated HbA1c methods had CVs <3% in SI units and <2% in NGSP units at 46 mmol/mol (6.4%) and 72 mmol/mol (8.7%) and passed the NGSP criteria when compared with six secondary reference measurement procedures (SRMPs). Sigma was 8.6 for Abbott Enzymatic, 3.3 for Roche Cobas c513 and 6.9 for Tosoh G11. No clinically significant interference was detected for the common Hb variants for the three methods. All three methods performed well and are suitable for clinical application in the analysis of HbA1c. Partly based on the result of this study, the Abbott Enzymatic method on the Architect c4000 and the Roche Gen.3 HbA1c on the Cobas c513 are now official, certified IFCC and NGSP SRMPs in the IFCC and NGSP networks. Sigma metrics quality criteria presented in a graph distinguish between good and excellent performance.

  19. Reduced endothelial activation after exercise is associated with improved HbA1c in patients with type 2 diabetes and coronary artery disease.

    PubMed

    Byrkjeland, Rune; Njerve, Ida U; Arnesen, Harald; Seljeflot, Ingebjørg; Solheim, Svein

    2017-03-01

    We have previously reported insignificant changes in HbA 1c after exercise in patients with both type 2 diabetes and coronary artery disease. In this study, we investigated the effect of exercise on endothelial function and possible associations between changes in endothelial function and HbA 1c . Patients with type 2 diabetes and coronary artery disease ( n = 137) were randomised to 12 months exercise or standard follow-up. Endothelial function was assessed by circulating biomarkers (E-selectin, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, von Willebrand factor, tissue plasminogen activator antigen, asymmetric dimethylarginine and L-arginine/asymmetric dimethylarginine ratio). Differences between the randomised groups were analysed by analysis of covariance and correlations by Spearman's rho or Pearson's correlation. No effect of exercise on endothelial function was demonstrated. The changes in HbA 1c in the exercise group correlated with changes in E-selectin ( r = 0.56, p < 0.001), intercellular adhesion molecule-1 ( r = 0.27, p = 0.052), vascular cell adhesion molecule-1 ( r = 0.32, p = 0.022) and tissue plasminogen activator antigen ( r = 0.35, p =  0.011). HbA 1c decreased significantly more in patients with versus without a concomitant reduction in E-selectin ( p =  0.002), intercellular adhesion molecule-1 ( p =  0.011), vascular cell adhesion molecule-1 ( p =  0.028) and tissue plasminogen activator antigen ( p =  0.009). Exercise did not affect biomarkers of endothelial function in patients with both type 2 diabetes and coronary artery disease. However, changes in biomarkers of endothelial activation correlated with changes in HbA 1c , and reduced endothelial activation was associated with improved HbA 1c after exercise.

  20. 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.

  1. The effects of non-attendance information therapy on the control of glycosylated hemoglobin (HbA1C) in type 2 diabetic patients.

    PubMed

    Yarahmadi, Azam; Zare-Farashbandi, Firoozeh; Kachuei, Ali; Nouri, Rasoul; Hassanzadeh, Akbar

    2014-01-01

    Patient education plays an important role in the control of diabetes. Nonattendance education, enabling elimination of limitations caused by time and space and facilitating the relationship between patient and care liaison is an effective, simple, and cheap method. The aim of this study is determination of the effects of nonattendance information therapy on the control of glycosylated hemoglobin (HbA1C) in type 2 diabetic patients in Isfahan. The present study was an interventional semi experimental study with pretest and post-test and control groups. Statistical population were type 2 diabetics patients of the Isfahan Endocrine and Metabolism Research Center, of whom 64 people were randomly selected and divided into intervention and control groups. First, the preliminary data were collected using the HbA1c test in patients. Then, the intervention group received training package and Short Message Service (SMS) for eight weeks. After one-month incubation period, HbA1c was again determined in both groups. Data were analyzed using t-test, paired t-test and Mann-Whitney U and Chi-square tests. Results showed that diabetes patients' HbA1c in the intervention group was significantly lower after the intervention through training packages and SMS service compared to before the intervention (P < 0.001). Comparison of the two groups showed that there was a significant difference in the HbA1C between the intervention and control groups (P = 0.048). Follow-up of education of patients with type 2 diabetes through training packages and SMS services had significant effects on the control of the patients' HbA1C. Also due to the low cost and high effectiveness of this method, it is recommended to health-care providers and treatment groups. This study also showed that having medical librarians along with treatment group can have a positive effect on the type 2 diabetic patients' health.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Effective Utilization of Oral Hypoglycemic Agents to Achieve Individualized HbA1c Targets in Patients with Type 2 Diabetes Mellitus.

    PubMed

    Bannister, Margaret; Berlanga, Jenny

    2016-09-01

    Type 2 diabetes is a progressive condition that may require the combination of three oral treatments to achieve optimal glycemic management to prevent microvascular and macrovascular complications whilst minimizing the risk of acute complications and side effects or adverse reactions to treatments. With the widening availability of treatment options and increasing importance of individualized treatment pathways, including personalized HbA1c targets, this article will explore the mode of action of currently available oral treatments, factors to consider when individualizing HbA1c targets, the relevance of estimated glomerular filtration rate assessment, and the importance of reviewing the clinical impact of all treatment decisions.

  7. 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.

  8. 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

  9. 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

  10. Verification of a novel point-of-care HbA1c device in real world clinical practice by comparison to three high performance liquid chromatography instruments.

    PubMed

    Wang, Yufei; Peng, Wei; Tang, Junling; Dong, Lu; Gu, Chengchen; Zhang, Xin; Zhou, Jian; Jia, Weiping

    2018-06-15

    A real world clinical study was designed and conducted to evaluate the performance of a novel point-of-care device for determination of glycated haemoglobin A 1c (HbA 1c ), A1C EZ 2.0, in daily clinical practice. Five hundred and fourteen subjects were included in this study, and divided into three groups. HbA 1c was measured by A1C EZ 2.0 and three different high performance liquid chromatography (HPLC) devices: Bio-Rad Variant II Turbo, Tosoh HLC-723 G8 and Premier Hb9210 separately. Precision of A1C EZ 2.0 was also evaluated. Results obtained from A1C EZ 2.0 and all HPLC devices are correlated. Passing-Bablok regression analysis shows the equation of A1C EZ 2.0 results against the mean of HPLC devices with corresponding 95% confidence intervals (95% CI) for the intercept and slope is y = 0.10 (- 0.17 to 0.10) + 1.00 (1.00 to 1.04) x. Bland-Altman difference plot shows that the mean relative difference between A1C EZ 2.0 and Variant II Turbo, G8, Hb9210 and all HPLC results is 2.5%, 0.6%, 0.4% and 1.1%, respectively. In addition, 121 pairs of results determined by using both venous and capillary blood prove that the difference of two kinds of blood sample causes no notable variation when measured by A1C EZ 2.0. Precision study gives 2.3% and 1.9% of total coefficient of variation for normal and abnormal HbA 1c sample in A1C EZ 2.0. HbA 1c values measured by A1C EZ 2.0 were in good accordance with the results obtained with the reference HPLC devices.

  11. 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.

  12. 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

  13. Derivation & validation of glycosylated haemoglobin (HbA1c) cut-off value as a diagnostic test for type 2 diabetes in south Indian population

    PubMed Central

    Mohan, Alladi; Reddy, S. Aparna; Sachan, Alok; Sarma, K.V.S.; Kumar, D. Prabath; Panchagnula, Mahesh V.; Rao, P.V.L.N. Srinivasa; Kumar, B. Siddhartha; Krishnaprasanthi, P.

    2016-01-01

    Background & Objectives: Glycosylated haemoglobin (HbA1c) has been in use for more than a decade, as a diagnostic test for type 2 diabetes. Validity of HbA1c needs to be established in the ethnic population in which it is intended to be used. The objective of this study was to derive and validate a HbA1c cut-off value for the diagnosis of type 2 diabetes in the ethnic population of Rayalaseema area of south India. Methods: In this cross-sectional study, consecutive patients suspected to have type 2 diabetes underwent fasting plasma glucose (FPG) and 2 h post-load plasma glucose (2 h-PG) measurements after a 75 g glucose load and HbA1c estimation. They were classified as having diabetes as per the American Diabetes Association criteria [(FPG ≥7 mmol/l (≥126 mg/dl) and/or 2 h-PG ≥11.1 mmol/l (≥200 mg/dl)]. In the training data set (n = 342), optimum cut-off value of HbA1c for defining type 2 diabetes was derived by receiver-operator characteristic (ROC) curve method using oral glucose tolerance test results as gold standard. This cut-off was validated in a validation data set (n = 341). Results: On applying HbA1c cut-off value of >6.3 per cent (45 mmol/mol) to the training data set, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosing type 2 diabetes were calculated to be 90.6, 85.2, 80.8 and 93.0 per cent, respectively. When the same cut-off value was applied to the validation data set, sensitivity, specificity, PPV and NPV were 88.8, 81.9, 74.0 and 92.7 per cent, respectively, although the latter were consistently smaller than the proportions for the training data set, the differences being not significant. Interpretation & conclusions: HbA1c >6.3 per cent (45 mmol/mol) appears to be the optimal cut-off value for the diagnosis of type 2 diabetes applicable to the ethnic population of Rayalaseema area of Andhra Pradesh state in south India. PMID:27934801

  14. Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis.

    PubMed

    Arch, Barbara N; Blair, Joanne; McKay, Andrew; Gregory, John W; Newland, Paul; Gamble, Carrol

    2016-10-24

    Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres

  15. Effects of exercise training on HbA1c and VO2peak in patients with type 2 diabetes and coronary artery disease: A randomised clinical trial.

    PubMed

    Byrkjeland, Rune; Njerve, Ida U; Anderssen, Sigmund; Arnesen, Harald; Seljeflot, Ingebjørg; Solheim, Svein

    2015-09-01

    Few exercise trials have focused on patients with both type 2 diabetes and coronary artery disease. We investigated the effects of 1 year of exercise training on HbA1c and VO(2peak) in these patients. Patients with type 2 diabetes and coronary artery disease (n = 137) were randomised to combined exercise training or control group. HbA(1c) was measured at the beginning and end of the study. Changes in VO(2peak), and also ventilatory threshold and time to exhaustion, were assessed by cardiopulmonary exercise testing. No differences in changes between the randomised groups were observed in HbA1c and VO(2peak), whereas ventilatory threshold and time to exhaustion increased significantly in the exercise group compared with the controls (p = 0.046 and p = 0.034). In patients without previous acute myocardial infarction and diabetes microvascular complications (n = 46), the exercise group did improve HbA1c and VO(2peak) compared with the controls (p = 0.052 and p = 0.035). No significant effects of exercise training on HbA(1c) or VO(2peak) were observed in patients with type 2 diabetes and coronary artery disease, although improvements were seen in patients without vascular complications beyond coronary artery disease, implying that the degree of vascular disease may influence exercise responses. Ventilatory threshold and time to exhaustion did increase significantly, indicating improved exercise performance despite the minor change in VO(2peak). © The Author(s) 2015.

  16. Comparison of traditional diabetes risk scores and HbA1c to predict type 2 diabetes mellitus in a population based cohort study.

    PubMed

    Krabbe, Christine Emma Maria; Schipf, Sabine; Ittermann, Till; Dörr, Marcus; Nauck, Matthias; Chenot, Jean-François; Markus, Marcello Ricardo Paulista; Völzke, Henry

    2017-11-01

    Compare performances of diabetes risk scores and glycated hemoglobin (HbA1c) to estimate the risk of incident type 2 diabetes mellitus (T2DM) in Northeast Germany. We studied 2916 subjects (20 to 81years) from the Study of Health in Pomerania (SHIP) in a 5-year follow-up period. Diabetes risk scores included the Cooperative Health Research in the Region of Augsburg (KORA) base model, the Danish diabetes risk score and the Data from the Epidemiological Study on the Insulin Resistance syndrome (D.E.S.I.R) clinical risk score. We assessed the performance of each of the diabetes risk scores and the HbA1c for 5-year risk of T2DM by the area under the receiver-operating characteristic curve (AUC) and calibration plots. In SHIP, the incidence of T2DM was 5.4% (n=157) in the 5-year follow-up period. Diabetes risk scores and HbA1c achieved AUCs ranging from 0.76 for the D.E.S.I.R. clinical risk score to 0.82 for the KORA base model. For diabetes risk scores, the discriminative ability was lower for the age group 55 to 74years. For HbA1c, the discriminative ability also decreased for the group 55 to 74years while it was stable in the age group 30 to 64years old. All diabetes risk scores and the HbA1c showed a good prediction for the risk of T2DM in SHIP. Which model or biomarker should be used is driven by its context of use, e.g. the practicability, implementation of interventions and availability of measurement. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. 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.

  18. Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction.

    PubMed

    Patzer, Karl-Heinz; Ardjomand, Payam; Göhring, Katharina; Klempt, Guido; Patzelt, Andreas; Redzich, Markus; Zebrowski, Mathias; Emmerich, Susanne; Schnell, Oliver

    2018-05-01

    Medical practices face challenges of time and cost pressures with scarce resources. Point-of-care testing (POCT) has the potential to accelerate processes compared to central laboratory testing and can increase satisfaction of physicians, staff members, and patients. The objective of this study was to evaluate the effects of introducing HbA1c POCT in practices specialized in diabetes. Three German practices that manage 400, 550, and 950 diabetes patients per year participated in this evaluation. The workflow and required time before and after POCT implementation (device: Alere Afinion AS100 Analyzer) was evaluated in each practice. Physician (n = 5), staff (n = 9), and patient (n = 298) satisfaction was assessed with questionnaires and interviews. After POCT implementation the number of required visits scheduled was reduced by 80% (88% vs 17.6%, P < .0001), the number of venous blood collections by 75% (91% vs 23%, P < .0001). Of patients, 82% (vs 13% prior to POCT implementation) were able to discuss their HbA1c values with treating physicians immediately during their first visit ( P < .0001). In two of the practices the POCT process resulted in significant time savings of approximately 20 and 22 working days per 1000 patients per year (95% CI 2-46; 95% CI 10-44). All physicians indicated that POCT HbA1c implementation improved the practice workflow and all experienced a relief of burden for the office and the patients. All staff members indicated that they found the POCT measurement easy to perform and experienced a relief of burden. The majority (61.3%) of patients found the capillary blood collection more pleasant and 83% saw an advantage in the immediate availability of HbA1c results. The implementation of HbA1c POCT leads to an improved practice workflow and increases satisfaction of physicians, staff members and patients.

  19. 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.

  20. Boronate-functionalized hydrogel as a novel biosensing interface for the glycated hemoglobin A1c (HbA1c) based on the competitive binding with signaling glycoprotein.

    PubMed

    Han, Yong Duk; Kim, Ka Ram; Park, Yoo Min; Song, Seung Yeon; Yang, Yong Ju; Lee, Kangsun; Ku, Yunhee; Yoon, Hyun C

    2017-08-01

    According to recent increases in public healthcare costs associated with diabetes mellitus, the development of new glycemic monitoring techniques based on the biosensing of glycated hemoglobin A1c (HbA 1c ), a promising long-term glycemic biomarker, has become a major challenge. In the development of HbA 1c biosensors for point-of-care applications, the selection of an effective biorecognition layer that provides a high reaction yield and specificity toward HbA 1c is regarded as the most significant issue. To address this, we developed a novel HbA 1c biosensing interfacial material by the integration of boronate hydrogel with glass fiber membrane. In the present study, a new boronate-functionalized hydrogel was designed and spatio-selectively photopolymerized on a hydrophilic glass fiber membrane by using N-hydroxyethyl acrylamide, 3-(acrylamido)phenylboronic acid, and bis(N,N'-methylene-bis-acrylamide). Using this approach, the boronic acid group, which specifically recognizes the cis-diol residue of glucose on the HbA 1c molecule, can be three-dimensionally coated on the surface of the glass fiber network with a high density. Because this network structure of boronate hydrogel-grafted fibers enables capillary-driven fluid control, facile HbA 1c biosensing in a lateral flow assay concept could be accomplished. On the proposed HbA 1c biosensing interface, various concentrations of HbA 1c (5-15%) in blood-originated samples were sensitively measured by a colorimetric assay using horseradish peroxidase, a glycoenzyme can generate chromogenic signal after the competitive binding against HbA 1c to the boronic acid residues. Based on the demonstrated advantages of boronate hydrogel-modified membrane including high analytical performance, easy operation, and cost-effectiveness, we expect that the proposed biorecognition interfacial material can be applied not only to point-of-care HbA 1c biosensors, but also to the quantitative analysis of other glycoprotein biomarkers

  1. Association of prediabetes, defined by fasting glucose, HbA1c only, or combined criteria, with the risk of cardiovascular disease in Koreans.

    PubMed

    Kim, Hong-Kyu; Lee, Jung Bok; Kim, Seon Ha; Jo, Min-Woo; Kim, Eun Hee; Hwang, Jenie Yoonoo; Bae, Sung Jin; Jung, Chang Hee; Lee, Woo Je; Park, Joong-Yeol; Park, Gyung-Min; Kim, Young-Hak; Choe, Jaewon

    2016-09-01

    The aim of the present study was to compare the association between cardiovascular diseases (CVD) and prediabetes defined by either fasting plasma glucose (FPG), HbA1c, or their combination in a Korean population. In all, 76 434 South Koreans who voluntarily underwent a general health examination in the Health Screening & Promotion Center (Asan Medical Center) were analyzed after excluding patients with a previous history of CVD. Cardiovascular events and death due to CVD during a median follow-up period of 3.1 years (interquartile range 1.9-4.3 years) were identified from the Nationwide Health Insurance Claims Database and death certificates using ICD-10 codes. Age- and sex-adjusted hazard ratios (HRs) for overall CVD events were significantly greater for subjects with prediabetes defined by FPG only (HR 1.19; 95% confidence interval [CI] 1.08-1.31), HbA1c only (HR 1.28; 95% CI 1.16-1.42), and combined criteria (HR 1.20; 95% CI 1.09-1.32) compared with the normoglycemic group. After adjusting for multiple conventional risk factors (e.g. hypertension, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, smoking status, family history of CVD, and BMI), the HRs for overall CVD were significantly increased only for participants with prediabetes defined by HbA1c. Age- and sex-adjusted HRs for major ischemic heart disease events were significantly increased for subjects with prediabetes defined either by HbA1c or combined criteria. Similarly, age- and sex-adjusted HRs for percutaneous coronary intervention were significantly higher for subjects with prediabetes defined by HbA1c only. For diabetes, the multivariate-adjusted HRs for all outcomes were significantly increased by all three criteria. Adding an HbA1c criterion when defining prediabetes in Koreans can help identify individuals with an increased risk of CVD. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  2. 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.

  3. 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

  4. Association of glycated albumin to HbA1c ratio with diabetic retinopathy but not diabetic nephropathy in patients with type 2 diabetes.

    PubMed

    Umayahara, Yutaka; Fujita, Yohei; Watanabe, Hirotaka; Kasai, Noriko; Fujiki, Noritaka; Hatazaki, Masahiro; Koga, Masafumi

    2017-04-01

    The ratio of glycated albumin to HbA1c (GA/HbA1c ratio) is a known indicator that reflects fluctuations in plasma glucose. In this study, the association of the GA/HbA1c ratio to diabetic nephropathy and diabetic retinopathy in patients with type 2 diabetes was investigated. Among patients with type 2 diabetes, 613 patients (364 males and 249 females, aged 63.2±12.5, body mass index (BMI) 25.4±4.8kg/m 2 ) were enrolled. Patients with overt proteinuria, reduced renal function, or anemia were excluded. In a comparison between patients with and without diabetic nephropathy, significance was observed in insulin therapy, HbA1c, and GA. In addition, in a comparison between patients with and without diabetic retinopathy, the GA/HbA1c ratio along with insulin therapy, HbA1c, and GA showed significant differences. When the GA/HbA1c ratios were divided into three groups and compared, the rates of diabetic nephropathy did not show any significance, while the rate of diabetic retinopathy increased significantly as the GA/HbA1c ratio increased. In multivariable analyses, while insulin therapy and BMI were the significant independent variables for diabetic nephropathy, insulin therapy and the GA/HbA1c ratios were the significant independent variable for diabetic retinopathy. The GA/HbA1c ratio was associated with diabetic retinopathy, but not with diabetic nephropathy in patients with type 2 diabetes. These results suggest that the development and progression of diabetic retinopathy is associated with plasma glucose fluctuations. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  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

  6. [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%.

  7. Change in HbA1c Levels between the Age of 8 Years and the Age of 12 Years in Dutch Children without Diabetes: The PIAMA Birth Cohort Study

    PubMed Central

    Jansen, Hanneke; Wijga, Alet H.; Scholtens, Salome; Koppelman, Gerard H.; Postma, Dirkje S.; Brunekreef, Bert; de Jongste, Johan C.; Smit, Henriëtte A.; Stolk, Ronald P.

    2015-01-01

    Objective HbA1c is associated with cardiovascular risk in persons without diabetes and cardiovascular risk accumulates over the life course. Therefore, insight in factors determining HbA1c from childhood onwards is important. We investigated (lifestyle) determinants of HbA1c at age 12 years and the effects of growth on change in HbA1c and the tracking of HbA1c between the age of 8 and 12 years. Study Design and Methods Anthropometric measurements were taken and HbA1c levels were assessed in 955 children without diabetes aged around 12 years participating in the PIAMA birth cohort study. In 363 of these children HbA1c was also measured at age 8 years. Data on parents and children were collected prospectively by questionnaires. Results We found no significant association between known risk factors for diabetes and HbA1c at age 12 years. Mean(SD) change in HbA1c between ages 8 and 12 years was 0.6(0.7) mmol/mol per year (or 0.1(0.1) %/yr). Anthropometric measures at age 8 and their change between age 8 and 12 years were not associated with the change in HbA1c. 68.9% of the children remained in the same quintile or had an HbA1c one quintile higher or lower at age 8 years compared to age 12 years. Conclusion The lack of association between known risk factors for diabetes and HbA1c suggest that HbA1c in children without diabetes is relatively unaffected by factors associated with glycaemia. HbA1c at age 8 years is by far the most important predictor of HbA1c at age 12. Therefore, the ranking of HbA1c levels appear to be fairly stable over time. PMID:25875773

  8. 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.

  9. Investigation of Two Models to Set and Evaluate Quality Targets for HbA1c: Biological Variation and Sigma-metrics

    PubMed Central

    Weykamp, Cas; John, Garry; Gillery, Philippe; English, Emma; Ji, Linong; Lenters-Westra, Erna; Little, Randie R.; Roglic, Gojka; Sacks, David B.; Takei, Izumi

    2016-01-01

    Background A major objective of the IFCC Task Force on implementation of HbA1c standardization is to develop a model to define quality targets for HbA1c. Methods Two generic models, the Biological Variation and Sigma-metrics model, are investigated. Variables in the models were selected for HbA1c and data of EQA/PT programs were used to evaluate the suitability of the models to set and evaluate quality targets within and between laboratories. Results In the biological variation model 48% of individual laboratories and none of the 26 instrument groups met the minimum performance criterion. In the Sigma-metrics model, with a total allowable error (TAE) set at 5 mmol/mol (0.46% NGSP) 77% of the individual laboratories and 12 of 26 instrument groups met the 2 sigma criterion. Conclusion The Biological Variation and Sigma-metrics model were demonstrated to be suitable for setting and evaluating quality targets within and between laboratories. The Sigma-metrics model is more flexible as both the TAE and the risk of failure can be adjusted to requirements related to e.g. use for diagnosis/monitoring or requirements of (inter)national authorities. With the aim of reaching international consensus on advice regarding quality targets for HbA1c, the Task Force suggests the Sigma-metrics model as the model of choice with default values of 5 mmol/mol (0.46%) for TAE, and risk levels of 2 and 4 sigma for routine laboratories and laboratories performing clinical trials, respectively. These goals should serve as a starting point for discussion with international stakeholders in the field of diabetes. PMID:25737535

  10. Association of HbA1c with emotion regulation, intolerance of uncertainty, and purpose in life in type 2 diabetes mellitus.

    PubMed

    Rasmussen, Norman H; Smith, Steven A; Maxson, Julie A; Bernard, Matthew E; Cha, Stephen S; Agerter, David C; Shah, Nilay D

    2013-10-01

    The extant literature lacks breadth on psychological variables associated with health outcome for type 2 diabetes mellitus (T2DM). This investigation extends the scope of psychological information by reporting on previously unpublished factors. To investigate if intolerance of uncertainty, emotion regulation, or purpose in life differentiate T2DM adults with sustained high HbA(1c) (HH) vs. sustained acceptable HbA(1c) (AH). Cross-sectional observational study. Adult patients with diagnosed T2DM meeting inclusionary criteria for AH, HH, or a nondiabetic reference group (NDR) were randomly selected and invited to participate. Patients who consented and participated resulted in a final sample of 312 subgrouped as follows: HH (n = 108); AH (n = 98); and NDR (n = 106). Data sources included a survey, self-report questionnaires, and electronic medical record (EMR). HH individuals with T2DM reported lower purpose in life satisfaction (p = 0.005) compared to the NDR group. The effect size for this finding is in the small-to-medium range using Cohen's guidelines for estimating clinical relevance. The HH-AH comparison on purpose in life was nonsignificant. The emotion regulation and intolerance of uncertainty comparisons across the three groups were not significant. The present study determined that lower purpose in life satisfaction is associated with higher HbA(1c). In a T2DM patient with sustained high HbA(1c), the primary care clinician is encouraged to consider screening for purpose in life satisfaction by asking a single question such as "Do the things you do in your life seem important and worthwhile?" The patient's response will assist the clinician in determining if meaning or purpose in life distress may be interferring with diabetes self-care. If this is the case, the clinician can shift the conversation to the value of behavioral and emotional health counseling. Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  11. Group Medical Visits (GMVs) in primary care: an RCT of group-based versus individual appointments to reduce HbA1c in older people

    PubMed Central

    Khan, Karim M; Windt, Adriaan; Davis, Jennifer C; Dawes, Martin; Liu-Ambrose, Teresa; Madden, Ken; Marra, Carlo A; Housden, Laura; Hoppmann, Christiane; Adams, David J

    2015-01-01

    Introduction Type 2 diabetes mellitus (T2DM) affects more than 1.1 million Canadians aged ≥65 years. Group Medical Visits are an emerging health service delivery method. Recent systematic reviews show that they can significantly reduce glycated haemoglobin (HbA1c) levels, but Group Visits have not been evaluated within primary care. We intend to determine the clinical effectiveness, quality of life and economic implications of Group Medical Visits within a primary care setting for older people with T2DM. Methods and analysis A 2-year proof-of-concept, single-blinded (measurement team) randomised control trial to test the efficacy of Group Medical Visits in an urban Canadian primary care setting. Participants ≥65 years old with T2DM (N=128) will be equally randomised to either eight groups of eight patients each (Group Medical Visits; Intervention) or to Individual visits (Standard Care; Controls). Those administering cointerventions are not blinded to group assignment. Our sample size is based on estimates of variance (±1.4% for HbA1c) and effect size (0.9/1.4=0.6) from the literature and from our own preliminary data. Forty participants per group will provide a β likelihood of 0.80, assuming an α of 0.05. A conservative estimation of an effect size of 0.7/1.4 changes the N in the power calculation to 59 per group. Hence, we aim to enrol 64 participants in each study arm. We will use intention-to-treat analysis and compare mean HbA1c (% glycosylated HbA1c) (primary outcome) of Intervention/Control participants at 12 months, 24 months and 1 year postintervention on selected clinical, patient-rated and economic measures. Trial registration number NCT02002143. PMID:26169803

  12. Exposure to Household Air Pollution from Biomass-Burning Cookstoves and HbA1c and Diabetic Status among Honduran Women.

    PubMed

    Rajkumar, Sarah; Clark, Maggie L; Young, Bonnie N; Benka-Coker, Megan L; Bachand, Annette M; Brook, Robert D; Nelson, Tracy L; Volckens, John; Reynolds, Stephen J; L'Orange, Christian; Good, Nicholas; Koehler, Kirsten; Africano, Sebastian; Osorto Pinel, Anibal B; Peel, Jennifer L

    2018-06-13

    Household air pollution from biomass cookstoves is estimated to be responsible for more than two and a half million premature deaths annually, primarily in low and middle-income countries where cardiometabolic disorders, such as Type II Diabetes, are increasing. Growing evidence supports a link between ambient air pollution and diabetes, but evidence for household air pollution is limited. This cross-sectional study of 142 women (72 with traditional stoves and 70 with cleaner-burning Justa stoves) in rural Honduras evaluated the association of exposure to household air pollution (stove type, 24-hour average kitchen and personal fine particulate matter [PM 2.5 ] mass and black carbon) with glycated hemoglobin (HbA1c) levels and diabetic status based on HbA1c levels. The prevalence ratio [PR] per interquartile range increase in pollution concentration indicated higher prevalence of prediabetes/diabetes (versus normal HbA1c) for all pollutant measures (e.g., PR per 84 μg/m 3 increase in personal PM 2.5 , 1.49; 95% confidence interval [CI], 1.11 - 2.01). Results for HbA1c as a continuous variable were generally in the hypothesized direction. These results provide some evidence linking household air pollution with the prevalence of prediabetes/diabetes, and, if confirmed, suggest that the global public health impact of household air pollution may be broader than currently estimated. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  13. Evaluation of Performance of Laboratories and Manufacturers Within the Framework of the IFCC model for Quality Targets of HbA1c.

    PubMed

    Weykamp, Cas; Siebelder, Carla

    2017-11-01

    HbA1c is a key parameter in diabetes management. For years the test has been used exclusively for monitoring of long-term diabetic control. However, due to improvement of the performance, HbA1c is considered more and more for diagnosis and screening. With this new application, quality demands further increase. A task force of the International Federation of Clinical Chemistry and Laboratory Medicine developed a model to set and evaluate quality targets for HbA1c. The model is based on the concept of total error and takes into account the major sources of analytical errors in the medical laboratory: bias and imprecision. Performance criteria are derived from sigma-metrics and biological variation. This review shows 2 examples of the application of the model: at the level of single laboratories, and at the level of a group of laboratories. In the first example data of 125 individual laboratories of a recent external quality assessment program in the Netherlands are evaluated. Differences between laboratories as well as their relation to method principles are shown. The second example uses recent and 3-year-old data of the proficiency test of the College of American Pathologists. The differences in performance between 26 manufacturer-related groups of laboratories are shown. Over time these differences are quite consistent although some manufacturers improved substantially either by better standardization or by replacing a test. The IFCC model serves all who are involved in HbA1c testing in the ongoing process of better performance and better patient care.

  14. Effects of a healthier snack on snacking habits and glycated Hb (HbA1c): a 6-week intervention study.

    PubMed

    Yan, Mary R; Parsons, Andrew; Whalley, Gillian A; Rush, Elaine C

    2016-12-01

    Dietary behaviour modification may change eating habits and reduce the impact of poor nutrition. This study aimed to evaluate the effects of daily consumption of a healthier snack bar on snacking habits and glycated Hb (HbA1c) within a 6-week intervention. In all, twenty-eight participants were randomly allocated to two groups to either consume the bars as the main snack for 6 weeks (n 14) or receipt of the bars was delayed for 6 weeks (n 14) following a stepped-wedge design. All participants had HbA1c concentrations measured at weeks -1, 0, 4, 6, 10 and 12. A short dietary habits questionnaire was self-completed at weeks 0, 6 and 12. Participants consumed the bars they received instead of other snacks, and found that the healthier snack bar was acceptable as part of their daily dietary pattern. Over the 12 weeks, there was a significant reduction in intake of biscuits, cakes and pies (approximately 2 servings/week, P<0·05) in both groups. Fruit juice intake was reduced (approximately 1 serving/week, P=0·029) in the first group. In all, twenty participants (71·4 %) experienced a decrease (n 15) or no change (n 5) in HbA1c (range 0-4 mmol/mol), whereas eight participants experienced an increase in HbA1c (range 0·5-2·5 mmol/mol). There was high compliance with the healthier snack intervention and a trend towards a favourable effect on glucose homoeostasis. Habitual snacking behaviour has the potential to be improved through changes in the food supply, and in the longer term may reduce the impact of poor nutrition on public health.

  15. A pilot service-evaluation examining change in HbA1c related to the prescription of internet-based education films for type 2 diabetes.

    PubMed

    Rice, S; Cranch, H; Littlemore, K; Mortimer, J; Platts, J; Stephens, J W

    2017-06-01

    We undertook a pilot service-evaluation of prescribed internet-based patient education films for patients with type 2 diabetes. The uptake was 28% and film watching was associated with a relative mean difference in HbA1c of -9.0mmol/mol in the film watchers compared to non-watchers over a three-month period (P=0.0008). Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  16. Identifying Glucokinase Monogenic Diabetes in a Multiethnic Gestational Diabetes Mellitus Cohort: New Pregnancy Screening Criteria and Utility of HbA1c.

    PubMed

    Rudland, Victoria L; Hinchcliffe, Marcus; Pinner, Jason; Cole, Stuart; Mercorella, Belinda; Molyneaux, Lynda; Constantino, Maria; Yue, Dennis K; Ross, Glynis P; Wong, Jencia

    2016-01-01

    Glucokinase monogenic diabetes (GCK-maturity-onset diabetes of the young [MODY]) should be differentiated from gestational diabetes mellitus (GDM) because management differs. New pregnancy-specific screening criteria (NSC) have been proposed to identify women who warrant GCK genetic testing. We tested NSC and HbA1c in a multiethnic GDM cohort and examined projected referrals for GCK testing. Using a GDM database, 63 of 776 women had a postpartum oral glucose tolerance test suggestive of GCK-MODY. Of these 63 women, 31 agreed to undergo GCK testing. NSC accuracy and HbA1c were examined. Projected referrals were calculated by applying the NSC to a larger GDM database (n = 4,415). Four of 31 women were confirmed as having GCK-MODY (prevalence ∼0.5-1/100 with GDM). The NSC identified all Anglo-Celtic women but did not identify one Indian woman. The NSC will refer 6.1% of GDM cases for GCK testing, with more Asian/Indian women referred despite lower disease prevalence. Antepartum HbA1c was not higher in those with GCK-MODY. The NSC performed well in Anglo-Celtic women. Ethnic-specific criteria should be explored. © 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.

  17. 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

  18. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.

    PubMed

    Hermanides, J; Nørgaard, K; Bruttomesso, D; Mathieu, C; Frid, A; Dayan, C M; Diem, P; Fermon, C; Wentholt, I M E; Hoekstra, J B L; DeVries, J H

    2011-10-01

    To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group. Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

  19. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial.

    PubMed

    Wayne, Noah; Perez, Daniel F; Kaplan, David M; Ritvo, Paul

    2015-10-05

    Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using

  20. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial

    PubMed Central

    Wayne, Noah; Perez, Daniel F; Kaplan, David M

    2015-01-01

    Background Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. Objective To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. Methods In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). Results A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in

  1. Use of snacks in insulin-treated people with diabetes mellitus and association with HbA1c , weight and quality of life: a cross sectional study.

    PubMed

    Heller, T; Kloos, C; Keßler, D; Müller, N; Thierbach, R; Wolf, G; Müller, U A

    2015-03-01

    Insulin therapies with prandial injections offer the possibility to skip snacks or omit meals. It is unclear how many people with insulin-treated diabetes mellitus eat snacks and whether they snack for their own comfort or only on the recommendation of healthcare professionals. In 2004, 163 consecutive people with insulin-treated diabetes seen in a university outpatient department were interviewed regarding their diet and degree of satisfaction with their meals. Fifty-five had Type 1 diabetes [age 47 years; diabetes duration 18 years; BMI 27 kg/m(2) ; HbA1c 62 mmol/mol (7.8%)], 53 had Type 2 diabetes with biphasic insulin therapy [age 68 years; diabetes duration 17 years; BMI 31 kg/m(2) ; HbA1c 60 mmol/mol (7.6%)] and 55 had Type 2 diabetes with prandial insulin therapy [age 60 years; diabetes duration 16 years; BMI 33 kg/m(2) ; HbA1c 59 mmol/mol (7.6%)]. Eighty per cent of those with Type 1 diabetes ate snacks, together with 77% of the Type 2 diabetes/biphasic group and 62% of the Type 2 diabetes/prandial group. Most participants (91% Type 1 diabetes, 88% Type 2 diabetes/biphasic group, 82% Type 2 diabetes/prandial group) liked to have snacks. The time at which they ate snacks was the same for both diabetes types. There were no differences between participants with Type 1 diabetes who snacked and those who did not in terms of age (P = 0.350), BMI (P = 0.368), HbA1c (P = 0.257) and time since diagnosis (P = 0.846). Participants with Type 2 diabetes who ate snacks were older than those who did not (biphasic: P = 0.006; prandial: P = 0.008). There were no differences in terms of BMI (biphasic: P = 0.731; prandial: P = 0.393), HbA1c (biphasic: P = 0.747; prandial: P = 0.616) and time since diagnosis (biphasic: P = 0.06; prandial: P = 0.620). Most people with insulin-treated diabetes eat snacks voluntarily and not because of physicians' instructions. There were no correlations between the use of snacks and HbA1c , BMI and

  2. 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.

  3. Association of African genetic ancestry with fasting glucose and HbA1c levels in non-diabetic individuals: the Boston Area Community Health (BACH) Prediabetes Study.

    PubMed

    Meigs, James B; Grant, Richard W; Piccolo, Rebecca; López, Lenny; Florez, Jose C; Porneala, Bianca; Marceau, Lisa; McKinlay, John B

    2014-09-01

    To test among diabetes-free urban community-dwelling adults the hypothesis that the proportion of African genetic ancestry is positively associated with glycaemia, after accounting for other continental ancestry proportions, BMI and socioeconomic status (SES). The Boston Area Community Health cohort is a multi-stage 1:1:1 stratified random sample of self-identified African-American, Hispanic and white adults from three Boston inner city areas. We measured 62 ancestry informative markers, fasting glucose (FG), HbA1c, BMI and SES (income, education, occupation and insurance status) and analysed 1,387 eligible individuals (379 African-American, 411 Hispanic, 597 white) without clinical or biochemical evidence of diabetes. We used three-heritage multinomial linear regression models to test the association of FG or HbA1c with genetic ancestry proportion adjusted for: (1) age and sex; (2) age, sex and BMI; and (3) age, sex, BMI and SES. Mean age- and sex-adjusted FG levels were 5.73 and 5.54 mmol/l among those with 100% African or European ancestry, respectively. Using per cent European ancestry as the referent, each 1% increase in African ancestry proportion was associated with an age- and sex-adjusted FG increase of 0.0019 mmol/l (p = 0.01). In the BMI- and SES-adjusted model the slope was 0.0019 (p = 0.02). Analysis of HbA1c gave similar results. A greater proportion of African genetic ancestry is independently associated with higher FG levels in a non-diabetic community-based cohort, even accounting for other ancestry proportions, obesity and SES. The results suggest that differences between African-Americans and whites in type 2 diabetes risk may include genetically mediated differences in glucose homeostasis.

  4. Clinical Study to Evaluate the Association Between Sensorineural Hearing Loss and Diabetes Mellitus in Poorly Controlled Patients Whose HbA1c >8.

    PubMed

    Srinivas, C V; Shyamala, V; Shiva Kumar, B R

    2016-06-01

    The relationship between sensorineural hearing loss (SNHL) and Diabetes mellitus has been known since more than 150 years. The pathophysiology of diabetes related hearing loss is speculative. Hearing loss is usually, bilateral, gradual onset, affecting higher frequencies. This study aims at knowing the prevalence of SNHL in DM and its relation to age, sex, duration of DM and control of DM. A total of 50 type 2 diabetics of age group 30-65 years were involved in the study. FBS, PPBS, HbA1c of all the subjects were done and later subjected to PTA. The type and severity of hearing loss was noted. Occurrence of SNHL was later compared with age, sex, duration, and control of DM. Sensorineural hearing loss was found in 66 % of type II diabetic patients and 34 % were found normal. Out of 50 diabetes mellitus patients, 33 patients had SNHL. All cases of SNHL detected were of gradual in onset and no one had hearing loss of sudden onset. Normal hearing was found in 34 % of patients, whereas 54 % of patients had mild hearing loss and 12 % of patients had moderate hearing loss. Association of hearing loss of DM patients with sex of the patient is insignificant. However there is significant association between older age group, longer duration and uncontrolled DM with that of SNHL. In subjects with HbA1c more than 8 and duration of diabetes mellitus more than 10 years prevalence of SNHL is more than 85 %, which is statistically significant. Sensorineural hearing loss in diabetes mellitus is gradually progressive involving high frequency thresholds. Hearing threshold increases with increasing age duration of diabetes and also high level of HbA1c greater than 8 %.

  5. 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.

  6. Fall in C-Peptide During First 4 Years From Diagnosis of Type 1 Diabetes: Variable Relation to Age, HbA1c, and Insulin Dose.

    PubMed

    Hao, Wei; Gitelman, Steven; DiMeglio, Linda A; Boulware, David; Greenbaum, Carla J

    2016-10-01

    We aimed to describe the natural history of residual insulin secretion in Type 1 Diabetes TrialNet participants over 4 years from diagnosis and relate this to previously reported alternative clinical measures reflecting β-cell secretory function. Data from 407 subjects from 5 TrialNet intervention studies were analyzed. All subjects had baseline stimulated C-peptide values of ≥0.2 nmol/L from mixed-meal tolerance tests (MMTTs). During semiannual visits, C-peptide values from MMTTs, HbA1c, and insulin doses were obtained. The percentage of individuals with stimulated C-peptide of ≥0.2 nmol/L or detectable C-peptide of ≥0.017 nmol/L continued to diminish over 4 years; this was markedly influenced by age. At 4 years, only 5% maintained their baseline C-peptide secretion. The expected inverse relationships between C-peptide and HbA1c or insulin doses varied over time and with age. Combined clinical variables, such as insulin-dose adjusted HbA1c (IDAA1C) and the relationship of IDAA1C to C-peptide, also were influenced by age and time from diagnosis. Models using these clinical measures did not fully predict C-peptide responses. IDAA1C ≤9 underestimated the number of individuals with stimulated C-peptide ≥0.2 nmol/L, especially in children. Current trials of disease-modifying therapy for type 1 diabetes should continue to use C-peptide as a primary end point of β-cell secretory function. Longer duration of follow-up is likely to provide stronger evidence of the effect of disease-modifying therapy on preservation of β-cell function. © 2016 by the American Diabetes Association.

  7. Fall in C-Peptide During First 4 Years From Diagnosis of Type 1 Diabetes: Variable Relation to Age, HbA1c, and Insulin Dose

    PubMed Central

    Gitelman, Steven; DiMeglio, Linda A.; Boulware, David; Greenbaum, Carla J.

    2016-01-01

    OBJECTIVE We aimed to describe the natural history of residual insulin secretion in Type 1 Diabetes TrialNet participants over 4 years from diagnosis and relate this to previously reported alternative clinical measures reflecting β-cell secretory function. RESEARCH DESIGN AND METHODS Data from 407 subjects from 5 TrialNet intervention studies were analyzed. All subjects had baseline stimulated C-peptide values of ≥0.2 nmol/L from mixed-meal tolerance tests (MMTTs). During semiannual visits, C-peptide values from MMTTs, HbA1c, and insulin doses were obtained. RESULTS The percentage of individuals with stimulated C-peptide of ≥0.2 nmol/L or detectable C-peptide of ≥0.017 nmol/L continued to diminish over 4 years; this was markedly influenced by age. At 4 years, only 5% maintained their baseline C-peptide secretion. The expected inverse relationships between C-peptide and HbA1c or insulin doses varied over time and with age. Combined clinical variables, such as insulin-dose adjusted HbA1c (IDAA1C) and the relationship of IDAA1C to C-peptide, also were influenced by age and time from diagnosis. Models using these clinical measures did not fully predict C-peptide responses. IDAA1C ≤9 underestimated the number of individuals with stimulated C-peptide ≥0.2 nmol/L, especially in children. CONCLUSIONS Current trials of disease-modifying therapy for type 1 diabetes should continue to use C-peptide as a primary end point of β-cell secretory function. Longer duration of follow-up is likely to provide stronger evidence of the effect of disease-modifying therapy on preservation of β-cell function. PMID:27422577

  8. The role of socio-economic and clinical factors on HbA1c in children and adolescents with type 1 diabetes: an Italian multicentre survey.

    PubMed

    Gesuita, Rosaria; Skrami, Edlira; Bonfanti, Riccardo; Cipriano, Paola; Ferrito, Lucia; Frongia, Paola; Iafusco, Dario; Iannilli, Antonio; Lombardo, Fortunato; Mozzillo, Enza; Paleari, Renata; Rabbone, Ivana; Sabbion, Alberto; Salvatoni, Alessandro; Scaramuzza, Andrea; Schiaffini, Riccardo; Sulli, Nicoletta; Toni, Sonia; Carle, Flavia; Cherubini, Valentino

    2017-05-01

    To identify the role of the family's socio-economic and clinical characteristics on metabolic control in children and adolescents with type 1 diabetes. In this cross-sectional, multicentre study, 768 subjects with type 1 diabetes under 18 years of age were consecutively recruited from January 2008 to February 2009. Target condition was considered for HbA 1c values <7.5% (<58 mmol/mol). A multiple correspondence analysis (MCA) was performed to analyze the association between the socio-economic and clinical characteristics of the participants. A logistic regression analysis was performed to identify factors associated with the subjects metabolic control. In both analyses, the family's socio-economic status was represented, measured by the Hollingshead Four-Factor Index of Social Status (SES) or by parental years of education. A total of 28.1% of subjects reached target HbA1c values. The MCA identified a strong association between at-target condition and several factors: high levels of SES or high levels of parental education, the use of the carbohydrate counting system, the use of insulin pumps, the use of the insulin delivery system over a short period of time, a normal body mass index. The logistic regression analysis showed that SES and the mother's years of education were significantly associated with the target condition [odds ratio (OR): 1.01, 95% confidence interval (CI): 1.01-1.03, p = 0.029; OR: 1.05, 95% CI: 1.01-1.10, p = 0.027, respectively). Personal, clinical, and family characteristics were found to be associated with HbA 1c target. Their identification can be crucial in addressing strategies to optimize metabolic control and improve diabetes management. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Meal replacement reduces insulin requirement, HbA1c and weight long-term in type 2 diabetes patients with >100 U insulin per day.

    PubMed

    Kempf, K; Schloot, N C; Gärtner, B; Keil, R; Schadewaldt, P; Martin, S

    2014-04-01

    Despite high insulin doses, good glycaemic control is often lacking in type 2 diabetes patients and new therapeutic options are needed. In a proof of principle study, an energy-restricted, protein-rich meal replacement (PRMR) was examined as a means of reducing insulin requirement, HbA1C and body weight. Obese type 2 diabetes patients (n = 22) with >100 U insulin per day replaced, in week 1, the three main meals with 50 g of PRMR (Almased-Vitalkost) each (= 4903 kJ day(-1) ). In weeks 2-4, breakfast and dinner were replaced, and, in weeks 5-12, only dinner was replaced. Clinical parameters were determined at baseline, and after 4, 8 and 12 weeks, as well as after 1.5 years of follow-up. The Wilcoxon signed-rank test was used for the intention-to-treat analysis and the Mann-Whitney U-test for subgroup analyses. The 12-week-programme was completed by 15 participants (68%). After 1 week, the mean insulin dose was reduced from 147 (75) U to 91 (55) U day(-1) (P = 0.0001), and to 65 (32) U (P < 0.0001) after 12 weeks of study. Over a period of 12 weeks, HbA1c decreased from 8.8% (1.4%) to 8.1% (1.6%) (P = 0.048) and weight decreased from 118.0 (19.7) kg to 107.4 (19.2) kg (P < 0.0001). Moreover, body mass index, waist and hip circumference, fasting blood glucose, triglycerides and high-density lipoprotein cholesterol improved significantly. After 1.5 years, insulin requirement and weight remained significantly lower than baseline. Participants who continued PRMR further reduced their HbA1c, weight and insulin dose. Two patients were able to stop insulin therapy altogether. Energy-restricted PRMR was effective in reducing insulin requirement of type 2 diabetes patients with intensified insulin therapy accompanied by a reduction of HbA1c, weight and other cardiometabolic risk factors. With the continuous use of PRMR, glycaemic control might be improved in the long term. © 2013 The British Dietetic Association Ltd.

  10. Size and shape of the associations of glucose, HbA1c, insulin and HOMA-IR with incident type 2 diabetes: the Hoorn Study.

    PubMed

    Ruijgrok, Carolien; Dekker, Jacqueline M; Beulens, Joline W; Brouwer, Ingeborg A; Coupé, Veerle M H; Heymans, Martijn W; Sijtsma, Femke P C; Mela, David J; Zock, Peter L; Olthof, Margreet R; Alssema, Marjan

    2018-01-01

    Glycaemic markers and fasting insulin are frequently measured outcomes of intervention studies. To extrapolate accurately the impact of interventions on the risk of diabetes incidence, we investigated the size and shape of the associations of fasting plasma glucose (FPG), 2 h post-load glucose (2hPG), HbA 1c , fasting insulin and HOMA-IR with incident type 2 diabetes mellitus. The study population included 1349 participants aged 50-75 years without diabetes at baseline (1989) from a population-based cohort in Hoorn, the Netherlands. Incident type 2 diabetes was defined by the WHO 2011 criteria or known diabetes at follow-up. Logistic regression models were used to determine the associations of the glycaemic markers, fasting insulin and HOMA-IR with incident type 2 diabetes. Restricted cubic spline logistic regressions were conducted to investigate the shape of the associations. After a mean follow-up duration of 6.4 (SD 0.5) years, 152 participants developed diabetes (11.3%); the majority were screen detected by high FPG. In multivariate adjusted models, ORs (95% CI) for incident type 2 diabetes for the highest quintile in comparison with the lowest quintile were 9.0 (4.4, 18.5) for FPG, 6.1 (2.9, 12.7) for 2hPG, 3.8 (2.0, 7.2) for HbA 1c , 1.9 (0.9, 3.6) for fasting insulin and 2.8 (1.4, 5.6) for HOMA-IR. The associations of FPG and HbA 1c with incident diabetes were non-linear, rising more steeply at higher values. FPG was most strongly associated with incident diabetes, followed by 2hPG, HbA 1c , HOMA-IR and fasting insulin. The strong association with FPG is probably because FPG is the most frequent marker for diabetes diagnosis. Non-linearity of associations between glycaemic markers and incident type 2 diabetes should be taken into account when estimating future risk of type 2 diabetes based on glycaemic markers.

  11. Longitudinal relationship between diabetes-specific emotional distress and follow-up HbA1c in adults with Type 1 diabetes mellitus

    PubMed Central

    Strandberg, R B; Graue, M; Wentzel-Larsen, T; Peyrot, M; Thordarson, H B; Rokne, B

    2015-01-01

    Aim To examine whether diabetes-specific emotional distress was related to follow-up glycaemic control in adults with Type 1 diabetes mellitus. Methods Adults with Type 1 diabetes mellitus completed the Diabetes Distress Scale and reported sociodemographic information when attending a clinical consultation at a university endocrinology unit. Blood samples to determine baseline HbA1c were taken during consultations. All respondents’ HbA1c measurements registered from January 2009 to December 2011 were collected from medical records. The relationship between baseline diabetes-specific emotional distress and HbA1c was examined with linear mixed-effects models in 175 patients with complete data. Results After controlling for confounders, baseline diabetes-specific emotional distress and glycaemic control were significantly associated (fixed-effect coefficient 0.40, P < 0.001) and the regimen-related distress subscale had the strongest association with glycaemic control (fixed-effect coefficient 0.47, P < 0.001). The two-item measure of diabetes-specific distress had a weaker but still significant association with glycaemic control (fixed-effect coefficient 0.31, P < 0.001). None of these relationships was significant after adjusting for the baseline HbA1c. Conclusions People with elevated baseline diabetes-specific emotional distress are at risk of prolonged suboptimum glycaemic control; therefore, elevated diabetes-specific emotional distress, especially regimen-related distress, might be an important marker for prolonged suboptimum glycaemic control, and might indicate a need for special attention regarding patient self-management. What’s new? In adults with Type 1 diabetes, elevated baseline diabetes-specific emotional distress is associated with worse glycaemic control over a 1–3-year period and regimen-related distress had the strongest association with subsequent glycaemic control. Baseline diabetes-specific emotional distress is associated with the

  12. The glycated albumin to HbA1c ratio is elevated in patients with fulminant type 1 diabetes mellitus with onset during pregnancy.

    PubMed

    Koga, Masafumi; Shimizu, Ikki; Murai, Jun; Saito, Hiroshi; Kasayama, Soji; Kobayashi, Tetsuro; Imagawa, Akihisa; Hanafusa, Toshiaki

    2013-01-01

    Fulminant type 1 diabetes mellitus (FT1DM) develops as a result of very rapid and almost complete destruction of pancreatic β cell. The most common form of type 1 diabetes mellitus with onset during pregnancy has been shown to be FT1DM at least in Japan. We previously reported that the ratio of glycated albumin (GA) to HbA1c (GA/HbA1c ratio) is elevated in FT1DM patients at the diagnosis. In the present study, we investigated whether the GA/HbA1c ratio is also elevated in FT1DM with onset during pregnancy (P-FT1DM). The study subjects consisted of 7 patients with P-FT1DM. Ten patients with untreated type 2 diabetes mellitus (T2DM) discovered during pregnancy (P-T2DM) and 9 non-pregnant women with untreated T2DM (NP-T2DM) were used as controls. All study patients satisfied HbA1c < 8.7%, the diagnostic criteria for FT1DM. The GA/HbA1c ratio in the P-FT1DM patients at the diagnosis was significantly higher than that in the P-T2DM patients and the NP-T2DM patients. The GA/HbA1c ratio was ≥ 3.0 in all P-FT1DM patients, whereas it was < 3.0 in 8 of 10 P-T2DM patients and all NP-T2DM patients. The GA/HbA1c ratio was also elevated in P-FT1DM patients at the diagnosis compared with T2DM with or without pregnancy.

  13. Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

    PubMed

    Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

    2016-04-27

    using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers. Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual. ClinicalTrials.gov: NCT01714986.

  14. A Protein Diet Score, Including Plant and Animal Protein, Investigating the Association with HbA1c and eGFR—The PREVIEW Project

    PubMed Central

    Mikkilä, Vera; Raitakari, Olli T.; Hutri-Kähönen, Nina; Dragsted, Lars O.; Poppitt, Sally D.; Silvestre, Marta P.; Feskens, Edith J.M.

    2017-01-01

    Higher-protein diets have been advocated for body-weight regulation for the past few decades. However, the potential health risks of these diets are still uncertain. We aimed to develop a protein score based on the quantity and source of protein, and to examine the association of the score with glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR). Analyses were based on three population studies included in the PREVIEW project (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World): NQplus, Lifelines, and the Young Finns Study. Cross-sectional data from food-frequency questionnaires (n = 76,777 subjects) were used to develop a protein score consisting of two components: 1) percentage of energy from total protein, and 2) plant to animal protein ratio. An inverse association between protein score and HbA1c (slope −0.02 ± 0.01 mmol/mol, p < 0.001) was seen in Lifelines. We found a positive association between the protein score and eGFR in Lifelines (slope 0.17 ± 0.02 mL/min/1.73 m2, p < 0.0001). Protein scoring might be a useful tool to assess both the effect of quantity and source of protein on health parameters. Further studies are needed to validate this newly developed protein score. PMID:28714926

  15. A Protein Diet Score, Including Plant and Animal Protein, Investigating the Association with HbA1c and eGFR-The PREVIEW Project.

    PubMed

    Møller, Grith; Sluik, Diewertje; Ritz, Christian; Mikkilä, Vera; Raitakari, Olli T; Hutri-Kähönen, Nina; Dragsted, Lars O; Larsen, Thomas M; Poppitt, Sally D; Silvestre, Marta P; Feskens, Edith J M; Brand-Miller, Jennie; Raben, Anne

    2017-07-17

    Higher-protein diets have been advocated for body-weight regulation for the past few decades. However, the potential health risks of these diets are still uncertain. We aimed to develop a protein score based on the quantity and source of protein, and to examine the association of the score with glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR). Analyses were based on three population studies included in the PREVIEW project (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World): NQplus, Lifelines, and the Young Finns Study. Cross-sectional data from food-frequency questionnaires ( n = 76,777 subjects) were used to develop a protein score consisting of two components: 1) percentage of energy from total protein, and 2) plant to animal protein ratio. An inverse association between protein score and HbA1c (slope -0.02 ± 0.01 mmol/mol, p < 0.001) was seen in Lifelines. We found a positive association between the protein score and eGFR in Lifelines (slope 0.17 ± 0.02 mL/min/1.73 m², p < 0.0001). Protein scoring might be a useful tool to assess both the effect of quantity and source of protein on health parameters. Further studies are needed to validate this newly developed protein score.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. [Effect of the Disease Management Program on HbA1c Value in Type 2 Diabetes Mellitus Patients: A Retrospective Comparison between Disease Management Programs and Standard Care].

    PubMed

    Wiefarn, Stefan; Kostev, Karel; Heumann, Christian; Rettelbach, Anja

    2017-10-01

    Background  This retrospective study aims to measure the effect of the disease management program (DMP) for type 2 diabetes mellitus (T2DM) patients on HbA 1c value within Germany. Methods  This study is based on patient data from the Disease Analyzer panel (IMS Health). An adequate control group was created using 2:1 propensity score matching. After matching, the analysis included 14 759 patients. Of these, 5875 participated in a DMP while 8884 received standard care. The DMP effect was estimated on the basis of the matched data, using an unpaired t-test. In addition, subgroups were considered from the perspective of personalized medicine. Results  The reduction in HbA 1c values in the DMP group amounted to an average of 1.0 percentage point (baseline HbA 1c  = 8.1 vs. final HbA 1c  = 7.1), while the SC group was able to achieve an average reduction in HbA 1c values of 0.9 percentage point (baseline HbA 1c  = 8.1 vs. final HbA 1c  = 7.2). The DMP group thus achieved an average reduction in HbA 1c values that exceeded that of the SC group by only 0.1 percentage point (95 % CI: 0.04 - 0.16). Descriptively, it also became apparent that patients from the DMP group received a greater average number of annual prescriptions and had more HbA 1c measurements. The subgroup analysis identified groups of patients who benefit more from DMPs than others. Thus, young patients or patients who are being treated by diabetologists are able to benefit most from a DMP. Furthermore, the baseline HbA 1c value has an influence on the DMP effect. Conclusion  T2DM patients in the DMP exhibit a significantly higher reduction in HbA 1c value. However, it is questionable whether this effect is clinically relevant. Certain groups of patients benefit more from DMPs than others. Nevertheless, further studies are needed in order to better understand the impact of the DMP on HbA 1c value and the reasons for the subgroup effects. Such studies should be carried

  1. 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

  2. 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

  3. Percentiles of fasting serum insulin, glucose, HbA1c and HOMA-IR in pre-pubertal normal weight European children from the IDEFICS cohort.

    PubMed

    Peplies, J; Jiménez-Pavón, D; Savva, S C; Buck, C; Günther, K; Fraterman, A; Russo, P; Iacoviello, L; Veidebaum, T; Tornaritis, M; De Henauw, S; Mårild, S; Molnár, D; Moreno, L A; Ahrens, W

    2014-09-01

    The aim of this study is to present age- and sex-specific reference values of insulin, glucose, glycosylated haemoglobin (HbA1c) and the homeostasis model assessment to quantify insulin resistance (HOMA-IR) for pre-pubertal children. The reference population consists of 7074 normal weight 3- to 10.9-year-old pre-pubertal children from eight European countries who participated in at least one wave of the IDEFICS ('identification and prevention of dietary- and lifestyle-induced health effects in children and infants') surveys (2007-2010) and for whom standardised laboratory measurements were obtained. Percentile curves of insulin (measured by an electrochemiluminescence immunoassay), glucose, HbA1c and HOMA-IR were calculated as a function of age stratified by sex using the general additive model for location scale and shape (GAMLSS) method. Levels of insulin, fasting glucose and HOMA-IR continuously show an increasing trend with age, whereas HbA1c shows an upward trend only beyond the age of 8 years. Insulin and HOMA-IR values are higher in girls of all age groups, whereas glucose values are slightly higher in boys. Median serum levels of insulin range from 17.4 and 13.2 pmol l(-1) in 3-<3.5-year-old girls and boys, respectively, to 53.5 and 43.0 pmol l(-1) in 10.5-<11-year-old girls and boys. Median values of glucose are 4.3 and 4.5 mmol l(-1) in the youngest age group and 49.3 and 50.6 mmol l(-1) in the oldest girls and boys. For HOMA-IR, median values range from 0.5 and 0.4 in 3-<3.5-year-old girls and boys to 1.7 and 1.4 in 10.5-<11-year-old girls and boys, respectively. Our study provides the first standardised reference values for an international European children's population and provides the, up to now, largest data set of healthy pre-pubertal children to model reference percentiles for markers of insulin resistance. Our cohort shows higher values of Hb1Ac as compared with a single Swedish study while our percentiles for the other glucose

  4. A Comparison Between the Effect of Cuminum Cyminum and Vitamin E on the Level of Leptin, Paraoxonase 1, HbA1c and Oxidized LDL in Diabetic Patients

    PubMed Central

    Samani Keihan, Ghatreh; Gharib, Mohammad Hossein; Momeni, Ali; Hemati, Zohreh; Sedighin, Roya

    2016-01-01

    Diabetes is one of the most common metabolic diseases in the world. Vitamin E reduces protein glycation and improves insulin sensitivity, while cumin is effective in remission of diabetes. Therefore this study was designed to evaluate the effects of vitamin E and cumin essential oil, on the blood level of leptin,glycosylated hemoglobin (HbA1C) and also on lipid profile in diabetic patients.In this double blind clinical trial, 95 diabetic patients were selected and randomly dividedinto three groups.The first group received cumin essential oil in capsule form. The second group received Vitamin E, and the third group was used ascontrol receiving oral gelatin capsules as placebo for three months period.Blood glucose, lipid profile, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), leptin, HbA1c, oxidized LDL (oxLDL), and paraoxonase1 activity were measured. The results showed reduction in oxLDL and significant increase in paraoxonase 1 in Vitamin E group by the end of the third month period (P<0.05). Cumin group showed decrease in blood glucose, HbA1C, triglyceride, leptin and ox-LDL. ApoA1 and paraoxonase1 were also increased by cumin treatment (P<0.05).Diabetic complications may have been reduced by intake of Vitamin E and cumin essential oil. Cumin in comparison with vitamin E has broader impact and it is more beneficial in terms of ability to reduce the diabetic index. PMID:28357199

  5. 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.

  6. HbA1c presents low sensitivity as a post-pregnancy screening test for both diabetes and prediabetes in Greek women with history of gestational diabetes mellitus.

    PubMed

    Apostolakis, Michael; Paschou, Stavroula A; Zapanti, Evangelia; Sarantopoulou, Vasiliki; Vasileiou, Vasiliki; Anastasiou, Eleni

    2018-06-11

    Women with a history of gestational diabetes mellitus (GDM) are at increased risk for type 2 diabetes (T2D). It is thus recommended that an oral glucose tolerance test (OGTT) be performed after delivery. Recently, the use of glycated haemoglobin A1c (HbA1c) has been proposed as a simpler and faster method to diagnose glucose disorders. The aim of this study was to investigate whether HbA1c measurement can replace OGTT in the detection of prediabetes and T2D in women with a history of GDM. We studied 1336 women (35.3 ± 5.8 years old) with a history of GDM 16.6 ± 28.2 months after delivery. All women were evaluated through an OGTT and a simultaneous HbA1c measurement. American Diabetes Association (ADA) criteria were used for the assessment of glucose disorders. Sensitivity and specificity of HbA1c were measured for the prediction of T2D and prediabetes, while Cohen's coefficient of agreement (k) was calculated. ROC analysis was performed to evaluate the sensitivity and specificity of HbA1c. Based on OGTT, 725 women (54.3%) were normal, 406 (30.4%) presented impaired fasting glucose (IFG), 48 (3.6%) impaired glucose tolerance (IGT), 74 (5.5%) combined IFG+IGT, and 83 presented with T2D (6.2%). By contrast, using HbA1c as a screening test, 1150 women (94.1%) were normal, while 49 (4.0%) had prediabetes and 23 (1.9%) T2D. Sensitivity of HbA1c for the diagnosis of prediabetes was 5.3% in comparison to OGTT, specificity was 99.2%, while for the diagnosis of T2D, the percentages were 29.6 and 100%, respectively. The consistency in classifying impaired glucose tolerance between HbA1c and OGTT was 59.7%. Cohen's coefficient of agreement was k = 0.116, indicating slight agreement. Performing a ROC curve, the optimal value of distinctive ability of HbA1c was 4.6% in the case of prediabetes, while for diabetes, it was 5.5%. This study provided evidence that HbA1c can identify fewer women with prediabetes and T2D than OGTT, indicating that HbA1c cannot be

  7. The Effects of a Mindfulness-Based Intervention on Emotional Distress, Quality of Life, and HbA1c in Outpatients With Diabetes (DiaMind)

    PubMed Central

    van Son, Jenny; Nyklíček, Ivan; Pop, Victor J.; Blonk, Marion C.; Erdtsieck, Ronald J.; Spooren, Pieter F.; Toorians, Arno W.; Pouwer, François

    2013-01-01

    OBJECTIVE Emotional distress is common in outpatients with diabetes, affecting ∼20–40% of the patients. The aim of this study was to determine the effectiveness of group therapy with Mindfulness-Based Cognitive Therapy (MBCT), relative to usual care, for patients with diabetes with regard to reducing emotional distress and improving health-related quality of life and glycemic control. RESEARCH DESIGN AND METHODS In the present randomized controlled trial, 139 outpatients with diabetes (type 1 or type 2) and low levels of emotional well-being were randomized to MBCT (n = 70) or a waiting list group (n = 69). Primary outcomes were perceived stress (Perceived Stress Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), mood (Profiles of Mood States), and diabetes-specific distress (Problem Areas In Diabetes). Secondary outcomes were health-related quality of life (12-Item Short-Form Health Survey), and glycemic control (HbA1c). Assessments were conducted at baseline and at 4 and 8 weeks of follow-up. RESULTS Compared with control, MBCT was more effective in reducing stress (P < 0.001, Cohen d = 0.70), depressive symptoms (P = 0.006, d = 0.59), and anxiety (P = 0.019, d = 0.44). In addition, MBCT was more effective in improving quality of life (mental: P = 0.003, d = 0.55; physical: P = 0.032, d = 0.40). We found no significant effect on HbA1c or diabetes-specific distress, although patients with elevated diabetes distress in the MBCT group tended to show a decrease in diabetes distress (P = 0.07, d = 0.70) compared with the control group. CONCLUSIONS Compared with usual care, MBCT resulted in a reduction of emotional distress and an increase in health-related quality of life in diabetic patients who had lower levels of emotional well-being. PMID:23193218

  8. A Mediterranean diet improves HbA1c but not fasting blood glucose compared to alternative dietary strategies: a network meta-analysis.

    PubMed

    Carter, P; Achana, F; Troughton, J; Gray, L J; Khunti, K; Davies, M J

    2014-06-01

    Overweight or obese individuals with type 2 diabetes are encouraged to lose weight for optimal glucose management, yet many find this difficult. Determining whether alterations in dietary patterns irrespective of weight loss can aid glucose control has not been fully investigated. We conducted a systematic review and meta-analysis aiming to determine the effects of a Mediterranean diet compared to other dietary interventions on glycaemic control irrespective of weight loss. Electronic databases were searched for controlled trials that included a Mediterranean diet intervention. The interventions included all major components of the Mediterranean diet and were carried out in free-living individuals at high risk or diagnosed with type 2 diabetes. Network meta-analysis compared all interventions with one another at the same time as maintaining randomisation. Analyses were conducted within a Bayesian framework. Eight studies met the inclusion criteria, seven examined fasting blood glucose (n = 972), six examined fasting insulin (n = 1330) and three examined HbA1c (n = 487). None of the interventions were significantly better than the others in lowering glucose parameters. The Mediterranean diet reduced HbA1c significantly compared to usual care but not compared to the Palaeolithic diet. The effect of alterations in dietary practice irrespective of weight loss on glycaemic control cannot be concluded from the present review. The need for further research in this area is apparent because no firm conclusions about relative effectiveness of interventions could be drawn as a result of the paucity of the evidence. © 2013 The British Dietetic Association Ltd.

  9. Conversion of gestational diabetes mellitus to future Type 2 diabetes mellitus and the predictive value of HbA1c in an Indian cohort.

    PubMed

    Gupta, Y; Kapoor, D; Desai, A; Praveen, D; Joshi, R; Rozati, R; Bhatla, N; Prabhakaran, D; Reddy, P; Patel, A; Tandon, N

    2017-01-01

    To investigate the distribution of and risk factors for dysglycaemia (Type 2 diabetes and prediabetes) in women with previous gestational diabetes mellitus in India. All women (n = 989) from two obstetric units in New Delhi and Hyderabad with a history of gestational diabetes were invited to participate, of whom 366 (37%) agreed. Sociodemographic, medical and anthropometric data were collected and 75-g oral glucose tolerance test were carried out. Within 5 years (median 14 months) of the pregnancy in which they were diagnosed with gestational diabetes, 263 (72%) women were dysglycaemic, including 119 (32%) and 144 (40%) with Type 2 diabetes and prediabetes, respectively. A higher BMI [odds ratio 1.16 per 1-kg/m 2 greater BMI (95% CI 1.10, 1.28)], presence of acanthosis nigricans [odds ratio 3.10, 95% CI (1.64, 5.87)], postpartum screening interval [odds ratio 1.02 per 1 month greater screening interval 95% CI (1.01, 1.04)] and age [odds ratio 1.10 per 1-year older age 95% CI (1.04, 1.16)] had a higher likelihood of having dysglycaemia. The American Diabetes Association-recommended threshold HbA 1c value of ≥ 48 mmol/mol (6.5%) had a sensitivity and specificity of 81.4 and 90.7%, respectively, for determining the presence of Type 2 diabetes postpartum. The high post-pregnancy conversion rates of gestational diabetes to diabetes reported in the present study reinforce the need for mandatory postpartum screening and identification of strategies for preventing progression to Type 2 diabetes. Use of the American Diabetes Association-recommended HbA 1c threshold for diabetes may lead to significant under-diagnosis. © 2016 Diabetes UK.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. Effects of exenatide twice daily, exenatide once weekly or insulin in patients with type 2 diabetes and baseline HbA1c ≥10.0%: Two pooled analyses including 20 randomised controlled trials.

    PubMed

    Busch, Robert S; Ruggles, James; Han, Jenny; Hardy, Elise

    2017-12-01

    Patients with advanced type 2 diabetes (T2D) and high glycated haemoglobin (HbA1c) values can be difficult to treat because of their severe metabolic disease. This pooled analysis examined the treatment effects of exenatide twice daily (BID), exenatide once weekly (QW) and insulin in patients with high baseline HbA1c (≥10.0%). This post hoc analysis used pooled data from 12 and 8 randomised controlled trials of exenatide BID and exenatide QW, respectively. Patients with T2D who completed at least 24 weeks of treatment with exenatide BID, exenatide QW or insulin (insulin glargine, insulin detemir or insulin aspart) were categorised by baseline HbA1c. Patients with HbA1c ≥10.0% were included in the analysis. Both exenatide and insulin reduced HbA1c (mean ± SE reduction: -2.0% ± 0.2% [exenatide] and -2.1% ± 0.2% [insulin] in the exenatide BID studies, and -2.6% ± 0.1% [exenatide] and -2.1% ± 0.2% [insulin] in the exenatide QW studies; all P < .001). Body weight decreased with exenatide and increased with insulin. Systolic blood pressure decreased with exenatide QW. Insulin dose increased over the course of treatment. The most common adverse events with exenatide were gastrointestinal. Insulin was associated with some hypoglycaemia risk. Hypoglycaemia events occurred infrequently with exenatide when given without sulphonylureas. For patients with high HbA1c, treatment with exenatide or insulin both improved glycaemic control. Given the associated weight loss and low risk of hypoglycaemia, exenatide may be a suitable alternative to treatment with insulin in certain patients with T2D and high HbA1c. © 2017 John Wiley & Sons Ltd.

  15. Association of the average rate of change in HbA1c with severe adverse events: a longitudinal evaluation of audit data from the Bavarian Disease Management Program for patients with type 2 diabetes mellitus.

    PubMed

    Bonke, Florian C; Donnachie, Ewan; Schneider, Antonius; Mehring, Michael

    2016-02-01

    In patients with type 2 diabetes mellitus, the effects of HbA1c variability on macrovascular events remain uncertain. The present investigation evaluates the association of HbA1c variability with non-fatal cardiovascular events, emergency admissions and episodes of severe hypoglycaemia in a cohort of patients newly started on insulin therapy. HbA1c variability was defined as the rate of change in values between observations. The medical records of 406,356 patients enrolled in a disease management programme for type 2 diabetes mellitus were analysed to identify a cohort of 13,777 patients with observed transition to insulin therapy. The cohort was observed for a period of at least 5 years. Cox regression models were applied to quantify the association of HbA1c variability with the events of interest. The models reveal a significant non-linear association between HbA1c variability and the risk of experiencing myocardial infarction, stroke and hypoglycaemia. The lowest risk is seen with a variability of approximately 0.5% (5.5 mmol/mol) per quarter. Using Cox models to predict survival curves for the cohort with hypothetical HbA1c variability of 0.5% (5.5 mmol/mol) and 1.5% (16.4 mmol/mol) per quarter, the proportion experiencing myocardial infarction within 2 years increases significantly from 1% to 10%. The proportion experiencing stroke increases from 1% to 29%, hypoglycaemia from 2% to 24% and the risk of emergency admission from 2% to 21%. In patients newly started on insulin therapy, rapid and higher HbA1c variability is associated with an increased risk of myocardial infarction, stroke, severe hypoglycaemia and emergency admission.

  16. 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.

  17. Use of HbA1c for Diagnoses of Diabetes and Prediabetes: Comparison with Diagnoses Based on Fasting and 2-Hr Glucose Values and Effects of Gender, Race, and Age

    PubMed Central

    Moellering, Douglas R.

    2014-01-01

    Abstract Background: Glycated hemoglobin (HbA1c) has been advocated for the diagnosis of diabetes and prediabetes. Its performance has been commonly assessed in corroboration with elevated fasting plasma glucose (FPG), but not the combination of FPG and 2-hr glucose values. This study assesses receiver operating characteristics (ROC) curves of HbA1c pertaining to the diagnoses of prediabetes and diabetes by FPG and/or 2-hr glucose, and the effects of age, gender, and race. Methods: We assessed the utility of HbA1c for diagnosing diabetes and prediabetes among 5395 adults without known diabetes from the National Health and Nutrition Examination Survey (NHANES) 2005–2010. Results: Current cutoffs of HbA1c for diabetes (6.5%) or prediabetes (5.7%) exhibited low sensitivity (0.249 and 0.354, respectively) and high specificity in identifying patients diagnosed using both FPG and 2-hr glucose, resulting in large false-negative rates (75.1% and 64.9%). Misdiagnosis rates increased with age and in non-Hispanic whites and Mexican Americans. When HbA1c was combined with FPG for diagnoses, the false-negative rate remained high for diabetes (45.7%), but was reduced for prediabetes (9.2%). Conclusions: When assessed against diagnoses using both FPG and 2-hr glucose, HbA1c had low sensitivity and high specificity for identifying diabetes and prediabetes, which varied as a function of age and race. Regarding recently released American Diabetes Association (ADA) and joint European guidelines, it is important to consider that HbA1c values below 6.5% and 5.7% do not reliably exclude the presence of diabetes and prediabetes, respectively. Overall, the data argue for greater use of oral glucose tolerance tests (OGTTs) and both FPG and 2-hr glucose values for diagnosis of diabetes and prediabetes. PMID:24512556

  18. 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

  19. MTNR1B rs10830963 is associated with fasting plasma glucose, HbA1C and impaired beta-cell function in Chinese Hans from Shanghai

    PubMed Central

    2010-01-01

    Background Genome-wide association studies (GWAS) in White Europeans have shown that genetic variation rs10830963 in melatonin receptor 1B gene (MTNR1B) is associated with fasting glucose and type 2 diabetes, which has also been replicated in several Asian populations. As a variant in the gene involved in the regulation of circadian rhythms, the effect of the variant on sleep status remains unknown. This study aimed to investigate the effects of MTNR1B rs10830963 on fasting glucose, type 2 diabetes and sleep status in Chinese Hans. Methods MTNR1B rs10830963 was genotyped in a population-based cohort including 3,210 unrelated Chinese Hans from Beijing and Shanghai, and tested for associations with risk of type 2 diabetes, diabetes-related traits and sleep status. Results We confirmed the associations of MTNR1B rs10830963 with fasting glucose (beta = 0.11 mmol/l, 95%CI [0.03, 0.18], P = 0.005), glycated hemoglobin (HbA1c) (beta = 0.07%, 95%CI [0.02,0.12], P = 0.004) and homeostasis model assessment of beta-cell function (HOMA-B) (beta = -5.01%, 95%CI [-8.24,-1.77], P = 0.003) in the Shanghai, but not in the Beijing subpopulation (P ≥ 0.58). The effect size of MTNR1B rs10830963 on fasting glucose in Shanghai Chinese Hans was comparable to that reported from other Asian populations. We found no evidence of associations with type 2 diabetes (OR 1.05 [0.90-1.23], P = 0.54), homeostasis model assessment of insulin sensitivity (HOMA-S) (P = 0.86) or sleep status (P ≥ 0.44). Conclusions A common variant in MTNR1B was associated with fasting glucose, HbA1C and HOMA-B but not with sleep status in Chinese Hans from Shanghai, strengthening the role of MTNR1B rs10830963 in fasting glycemia and impaired beta-cell function. PMID:20398260

  20. 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

  1. 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

  2. The effect of diabetes self-management education on HbA1c and quality of life in African-Americans: a systematic review and meta-analysis.

    PubMed

    Cunningham, Amy T; Crittendon, Denine R; White, Neva; Mills, Geoffrey D; Diaz, Victor; LaNoue, Marianna D

    2018-05-16

    Type 2 diabetes presents a major morbidity and mortality burden in the United States. Diabetes self-management education (DSME) is an intervention associated with improved hemoglobin A1c(HbA1c) and quality of life(QOL), and is recommended for all individuals with type 2 diabetes. African-Americans have disproportionate type 2 diabetes morbidity and mortality, yet no prior meta-analyses have examined DSME outcomes exclusively in this population. This systematic review and meta-analysis examined the impact of DSME on HbA1c and QOL in African-Americans compared to usual care. Randomized controlled trials, cluster-randomized trials, and quasi-experimental interventions were included. 352 citations were retrieved; 279 abstracts were reviewed, and 44 full-text articles were reviewed. Fourteen studies were eligible for systematic review and 8 for HbA1c meta-analysis; QOL measures were too heterogeneous to pool. Heterogeneity of HbA1c findings was assessed with Cochran's Q and I 2 . HbA1c weighted mean difference between intervention and usual care participants was not significant: - 0.08%[- 0.40-0.23];χ 2  = 84.79 (p < .001), I 2  = 92%, (n = 1630). Four of five studies measuring QOL reported significant improvements for intervention participants. Meta-analysis results showed non-significant effect of DSME on HbA1c in African-Americans. QOL did show improvement and is an important DSME outcome to measure in future trials. Further research is needed to understand effectiveness of DSME on HbA1c in this population. PROSPERO registration: CRD42017057282 .

  3. 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.

  4. 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.

  5. 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

  6. Shifting from glucose diagnostic criteria to the new HbA(1c) criteria would have a profound impact on prevalence of diabetes among a high-risk Spanish population.

    PubMed

    Costa, B; Barrio, F; Cabré, J-J; Piñol, J-L; Cos, F-X; Solé, C; Bolibar, B; Castell, C; Lindström, J; Barengo, N; Tuomilehto, J

    2011-10-01

    To investigate changes in the prevalence of diabetes and pre-diabetes by shifting from 2-h plasma glucose and/or fasting plasma glucose diagnostic criteria to the proposed new HbA(1c) -based criteria when applied to a Mediterranean population detected to have a high risk of Type 2 diabetes. Individuals without diabetes aged 45-75 years (n = 2287) were screened using the Finnish Diabetes Risk Score questionnaire, a 2-h oral glucose tolerance test plus HbA(1c) test. Prevalence and degree of diagnostic overlap between three sets of criteria (2-h plasma glucose, fasting plasma glucose and HbA(1c) ) and three diagnostic categories (normal, pre-diabetes and diabetes) were calculated. Defining diabetes by a single HbA(1c) measurement resulted in a dramatic decrease in prevalence (1.3%), particularly in comparison with diabetes defined by 2-h plasma glucose (8.6%), but was also significant with regard to fasting plasma glucose (2.8%). A total of 201 screened subjects (8.8%) were classified as having diabetes and 1023 (44.7%) as having pre-diabetes based on at least one of these criteria; among these, the presence of all three criteria simultaneously classified only 21 and 110 individuals respectively, about ten percent of each group. The single overlap index between subjects diagnosed as having diabetes by 2-h plasma glucose/fasting plasma glucose vs. HbA(1c) was 13.9/28%. Similarly, the single overlap index regarding pre-diabetes was 19.2/27.1%. A shift from the glucose-based diagnosis to the HbA(1c) -based diagnosis for diabetes will reduce diabetes prevalence with a low overall or single degree of overlap between diagnostic categories in this high-risk Spanish population. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

  7. Results of an Innovative Education, Training and Quality Assurance Program for Point-of-Care HbA1c Testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

    PubMed Central

    Shephard, Mark D; Gill, Janice P

    2003-01-01

    This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA1c testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services. The quality assurance program comprised four elements: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA1c testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA1c. The short and long term performance of each service’s DCA 2000 was reviewed monthly and at the end of each six month testing cycle. The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA1c testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA1c testing has ensured the program’s sustainability. Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA1c testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments. PMID:18568052

  8. 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

  9. Screening for pre-diabetes to predict future diabetes using various cut-off points for HbA(1c) and impaired fasting glucose: the Toranomon Hospital Health Management Center Study 4 (TOPICS 4).

    PubMed

    Heianza, Y; Arase, Y; Fujihara, K; Tsuji, H; Saito, K; Hsieh, S D; Kodama, S; Shimano, H; Yamada, N; Hara, S; Sone, H

    2012-09-01

    To evaluate various screening criteria for pre-diabetes to identify which combination of impaired fasting glucose and elevated HbA(1c) values performs most effectively in predicting future diabetes in a large cohort of Japanese individuals. The study included 4670 men and 1571 women without diabetes (diabetes: fasting plasma glucose ≥ 7.0 mmol/l, HbA(1c) ≥ 48 mmol/mol (≥ 6.5%), or self-reported clinician-diagnosed diabetes). Pre-diabetes was diagnosed by a combination of impaired fasting glucose (fasting plasma glucose 5.6-6.9 mmol/l or 6.1-6.9 mmol/l) and elevated HbA(1c) [39-46 mmol/mol (5.7-6.4%) or 42-46 mmol/mol (6.0-6.4%)]. During a 5-year follow-up, 338 incident cases of diabetes occurred. The combination of HbA(1c) 39-46 mmol/mol (5.7-6.4%) and fasting plasma glucose 5.6-6.9 mmol/l yielded the highest sensitivity (86%) and generated a large population-attributable per cent risk (78%) for predicting development of diabetes. Among individuals classified as having pre-diabetes by any of the four combined criteria, 20.5-32.0% reverted to the normoglycaemic state as having neither elevated HbA(1c) nor impaired fasting glucose at the last follow-up examination. At 5.6 years after the baseline examination, however, pre-diabetic individuals who fulfilled both HbA(1c) 42-46 mmol/mol (6.0-6.4%) and fasting plasma glucose 6.1-6.9 mmol/l had a 100% cumulative risk of developing diabetes. The combination of HbA(1c) 39-46 mmol/mol (5.7-6.4%) and fasting plasma glucose 5.6-6.9 mmol/l would have the best performance in reducing the likelihood of missing future cases of diabetes. Identifying pre-diabetic individuals who strictly fulfil HbA(1c) 42-46 mmol/mol (6.0-6.4%) and fasting plasma glucose 6.1-6.9 mmol/l would predict definite progression to diabetes. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  10. Ethnic differences in cross-sectional associations between impaired glucose regulation, identified by oral glucose tolerance test or HbA1c values, and cardiovascular disease in a cohort of European and South Asian origin.

    PubMed

    Eastwood, S V; Tillin, T; Mayet, J; Shibata, D K; Wright, A; Heasman, J; Beauchamp, N; Forouhi, N G; Hughes, A D; Chaturvedi, N

    2016-03-01

    We contrasted impaired glucose regulation (prediabetes) prevalence, defined according to oral glucose tolerance test or HbA1c values, and studied cross-sectional associations between prediabetes and subclinical/clinical cardiovascular disease (CVD) in a cohort of European and South Asian origin. For 682 European and 520 South Asian men and women, aged 58-85 years, glycaemic status was determined by oral glucose tolerance test or HbA1c thresholds. Questionnaires, record review, coronary artery calcification scores and cerebral magnetic resonance imaging established clinical plus subclinical coronary heart and cerebrovascular disease. Prediabetes was more prevalent in South Asian participants when defined by HbA1c rather than by oral glucose tolerance test criteria. Accounting for age, sex, smoking, systolic blood pressure, triglycerides and waist-hip ratio, prediabetes was associated with coronary heart disease and cerebrovascular disease in European participants, most obviously when defined by HbA1c rather than by oral glucose tolerance test [odds ratios for HbA1c -defined prediabetes 1.60 (95% CI 1.07, 2.39) for coronary heart disease and 1.57 (95% CI 1.00, 2.51) for cerebrovascular disease]. By contrast, non-significant associations were present between oral glucose tolerance test-defined prediabetes only and coronary heart disease [odds ratio 1.41 (95% CI 0.84, 2.36)] and HbA1c -defined prediabetes only and cerebrovascular disease [odds ratio 1.39 (95% CI 0.69, 2.78)] in South Asian participants. Prediabetes defined by HbA1c or oral glucose tolerance test criteria was associated with cardiovascular disease (defined as coronary heart and/or cerebrovascular disease) in Europeans [odds ratio 1.95 (95% CI 1.31, 2.91) for HbA1c prediabetes criteria] but not in South Asian participants [odds ratio 1.00 (95% CI 0.62, 2.66); ethnicity interaction P = 0.04]. Prediabetes appeared to be less associated with cardiovascular disease in the South Asian than in the European

  11. Clinical characteristics of type 2 diabetes patients with discordance between HbA1c and fasting plasma glucose in the real world: An analysis of the ORBIT study.

    PubMed

    Shu, Hua; Lu, Juming; Zhang, Puhong; Zhu, Dongshan; Li, Xian; Ji, Jiachao; Zhao, Fang; Ji, Linong

    2018-05-01

    We aimed to determine the clinical characteristics of type 2 diabetes patients on basal insulin therapy with inadequate glucose control due to discordance between glycated haemoglobin (HbA 1c ) and fasting plasma glucose (FPG) in the real world. This was a retrospective analysis of data from the ORBIT study in China. Clinical characteristics of patients with discordance between HbA 1c and FPG at baseline and at the end of 6 months of follow-up were analysed using multinomial logistic regression in 4 study groups divided by HbA 1c and FPG. Overall, of 6721 patients initiated on basal insulin, 853 achieved HbA 1c  < 7% but FPG ≥ 7 mmol/L (group 2), while 997 had FPG < 7 mmol/L but HbA 1c  ≥ 7% (group 3) at the end of follow-up. Patients in group 3 had a longer duration of type 2 diabetes compared with those in group 2 (7.22 ± 5.30 vs 6.00 ± 4.80 y, P < .05). Patients on glargine (32.90%) or detemir (36.88%) treatment accounted for a higher proportion of patients with both HbA 1c and FPG controlled than those on neutral protamine Hagedorn therapy (23.45%; P < .05). Per the multinomial logistic analysis, higher frequency of self-monitoring of blood glucose (SMBG) and use of glargine or detemir therapy were significantly inversely associated with risk of discordance between HbA 1c and FPG, while dose of insulin was a risk factor for discordance at the end of follow-up (all P < .05). Patients treated with insulin analogues (glargine or detemir), instead of neutral protamine Hagedorn, and with more frequent SMBG are more likely to exhibit concordance between HbA 1c and FPG. Copyright © 2018 John Wiley & Sons, Ltd.

  12. Fasting plasma glucose and variation in cardiometabolic risk factors in people with high-risk HbA1c-defined prediabetes: A cross-sectional multiethnic study.

    PubMed

    Srivanichakorn, Weerachai; Godsland, Ian F; Thomson, Hazel; Misra, Shivani; Phisalprapa, Pochamana; Charatcharoenwitthaya, Phunchai; Pramyothin, Pornpoj; Washirasaksiri, Chaiwat; Snehalatha, Chamukuttan; Ramachandran, Ambady; Alberti, K George M M; Johnston, Desmond G; Oliver, Nick S

    2017-12-01

    Variation in cardiometabolic risk in prediabetes and any impacts of ethnicity on such variation have been little studied. In an ethnically diverse dataset, selected according to a high-risk HbA1c-based definition of prediabetes, we have investigated relationships between glycaemia and cardiometabolic risk factors and the influence of ethnicity on these relationships. We undertook a cross-sectional analysis of baseline data from a diabetes prevention study in the UK and a chronic care clinic in Thailand, selected for people without diabetes (fasting plasma glucose <7.0 mmol/l) with HbA1c 6.0-6.4% (42-47 mmol/mol). Thai (n=158) and UK White (n=600), South Asian (n=112), Black (n=70) and other/mixed (n=103) groups were distinguished and measurements included fasting plasma glucose (FPG), blood pressure (BP), lipids and insulin resistance-related risk factors (IRFs). Independently of individual characteristics including ethnicity, only systolic BP was weakly associated with FPG (beta coefficient 1.76 (95%CI 0.10-3.42), p 0.03) and only LDL-c with IFG (FPG 5.6 to <7) (adjusted -0.14 (-0.27, -0.003) p 0.04). There were no significant independent associations with cardiometabolic risk factors when categories of impaired fasting glucose (FPG ≥ 6.1 to <7.0 mmol/L) were considered. Relative to White, South Asian ethnicity was independently associated with lower systolic and diastolic BP, Black with lower triglycerides, cholesterol/HDL-c ratio and having 2 or more IRFs, and Thai with lower cholesterol/HDL-c ratio and all three non-white ethnicities with lower total and LDL cholesterol. In high-risk HbA1c-defined prediabetes additional measurement of FPG will add little to evaluation of cardiometabolic risk. Additionally, UK Whites tend to have the most adverse cardiometabolic profile of any ethnic group. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Effect of fasting ramadan in diabetes control status - application of extensive diabetes education, serum creatinine with HbA1c statistical ANOVA and regression models to prevent hypoglycemia.

    PubMed

    Aziz, Kamran M A

    2013-09-01

    Ramadan fasting is an obligatory duty for Muslims. Unique physiologic and metabolic changes occur during fasting which requires adjustments of diabetes medications. Although challenging, successful fasting can be accomplished if pre-Ramadan extensive education is provided to the patients. Current research was conducted to study effective Ramadan fasting with different OHAs/insulins without significant risk of hypoglycemia in terms of HbA1c reductions after Ramadan. ANOVA model was used to assess HbA1c levels among different education statuses. Serum creatinine was used to measure renal functions. Pre-Ramadan diabetes education with alteration of therapy and dosage adjustments for OHAs/insulin was done. Regression models for HbA1c before Ramadan with FBS before sunset were also synthesized as a tool to prevent hypoglycemia and successful Ramadan fasting in future. Out of 1046 patients, 998 patients fasted successfully without any episodes of hypoglycemia. 48 patients (4.58%) experienced hypoglycemia. Χ(2) Test for CRD/CKD with hypoglycemia was also significant (p-value < 0.001). Significant associations and linear regression were found for HbA1c and sunset FBS; RBS post-dawn with RBS mid-day and FBS at sunset. The proposed regression models of this study can be used as a guide in future for Ramadan diabetes management. Some relevant patents are also outlined in this paper.

  14. Body mass index standard deviation score and obesity in children with type 1 diabetes in the Nordic countries. HbA1c and other predictors of increasing BMISDS.

    PubMed

    Birkebaek, N H; Kahlert, J; Bjarnason, R; Drivvoll, A K; Johansen, A; Konradsdottir, E; Pundziute-Lyckå, A; Samuelsson, U; Skrivarhaug, T; Svensson, J

    2018-05-21

    Intensified insulin therapy may increase body weight and cause obesity. This study compared body mass index standard deviation score (BMISDS) and obesity rate in children with type 1 diabetes (T1D) in Denmark, Iceland, Norway and Sweden, and uncovered predictors for increasing BMISDS. Data registered in the Nordic national childhood diabetes databases during the period 2008-2012 on children below 15 years with T1D for more than 3 months were compiled, including information on gender, age, diabetes duration, hemoglobin A 1c (HbA 1c ), insulin dose, severe hypoglycemia (SH), treatment modality, height and weight. The Swedish reference chart for BMI was used for calculating BMISDS. Totally, 11 025 children (48% females) (30 994 registrations) were included. Medians by the last recorded examination were: age, 13.5 years; diabetes duration, 4.3 years; HbA 1c , 7.9% (63 mmol/mol); insulin dose, 0.8 IU/kg/d and BMISDS, 0.70. Obesity rate was 18.5%. Adjusted mean BMISDS (BMISDS adj) was inversely related to HbA 1c and directly to diabetes duration. Higher BMISDS adj was found in those with an insulin dose above 0.6 IU/kg/d, and in girls above 10 years. Pump users had higher BMISDS adj than pen users, and patients with registered SH had higher BMISDS adj than patients without SH (both P < .001). Obesity rate in children with T1D in the Nordic countries is high, however, with country differences. Low HbA 1c , long diabetes duration, higher insulin dose, pump treatment and experiencing a SH predicted higher BMISDS. Diabetes caregivers should balance the risk of obesity and the benefit of a very low HbA 1c. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. 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.

  16. The influence of baseline risk on the relation between HbA1c and risk for new cardiovascular events and mortality in patients with type 2 diabetes and symptomatic cardiovascular disease.

    PubMed

    Bots, Sophie H; van der Graaf, Yolanda; Nathoe, Hendrik M W; de Borst, Gert Jan; Kappelle, Jaap L; Visseren, Frank L J; Westerink, Jan

    2016-07-19

    Strict glycaemic control in patients with type 2 diabetes has proven to have microvascular benefits while the effects on CVD and mortality are less clear, especially in high risk patients. Whether strict glycaemic control would reduce the risk of future CVD or mortality in patients with type 2 diabetes and pre-existing CVD, is unknown. This study aims to evaluate whether the relation between baseline HbA1c and new cardiovascular events or mortality in patients with type 2 diabetes and pre-existing cardiovascular disease (CVD) is modified by baseline vascular risk. A cohort of 1096 patients with type 2 diabetes and CVD from the Second Manifestations of ARTerial Disease (SMART) study was followed. The relation between HbA1c at baseline and future vascular events (composite of myocardial infarction, stroke and vascular mortality) and all-cause mortality was evaluated with Cox proportional hazard analyses in a population that was stratified for baseline risk for vascular events as calculated with the SMART risk score. The mean follow-up duration was 6.9 years for all-cause mortality and 6.4 years for vascular events, in which period 243 and 223 cases were reported, respectively. A 1 % increase in HbA1c was associated with a higher risk for all-cause mortality (HR 1.18, 95 % CI 1.06-1.31). This association was also found in the highest SMART risk quartile (HR 1.33, 95 % CI 1.11-1.60). There was no relation between HbA1c and the occurrence of cardiovascular events during follow-up (HR 1.03, 95 % CI 0.91-1.16). The interaction term between HbA1c and SMART risk score was not significantly related to any of the outcomes. In patients with type 2 diabetes and CVD, HbA1c is related to the risk of all-cause mortality, but not to the risk of cardiovascular events. The relation between HbA1c and all-cause mortality in patients with type 2 diabetes and vascular disease is not dependent on baseline vascular risk.

  17. 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.

  18. Performance of glycated haemoglobin (HbA1c) as a screening test for diabetes and impaired glucose tolerance (IGT) in a high risk population--the Brazilian Xavante Indians.

    PubMed

    Franco, L J; Dal Fabbro, A L; Martinez, E Z; Sartorelli, D S; Silva, A S; Soares, L P; Franco, L F; Kuhn, P C; Vieira-Filho, J P B; Moisés, R S

    2014-11-01

    To examine the properties of HbA1c to detect diabetes and IGT in adult Brazilian Xavante Indians, a high risk population for diabetes. The survey was carried out between October 2010 and January 2012 and based on a 75 g oral glucose tolerance test (OGTT). Basal and 2h capillary glycaemia were measured by HemoCue Glucose 201+; HbA1c using an automated high-performance liquid chromatography analyzer (Tosoh G7). 630 individuals aged ≥ 20 years were examined and 80 had a previous diagnosis of diabetes. Sensitivity, specificity and accuracy for HbA1c ≥ 6.5% (≥ 48 mmol/mol) were 71.3%, 90.5% and 87.2%. The areas under the ROC curve (AUC) was 0.88 (95%CI: 0.83-0.93). To identify IGT, HbA1c values between 5.7% and 6.4% (39-47 mmol/mol) presented sensitivity, specificity and accuracy of 87.2%, 24.7% and 51.4%, with an AUC of 0.62 (95%CI: 0.57-0.67). The ADA/WHO proposed cut-off of 6.5% (48 mmol/mol) for HbA1c was adequate to detect diabetes among the Xavante. However, the performance of the ADA proposed cut-off points for pre-diabetes, when used to detect IGT was inadequate and should not be recommended. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. 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

  20. 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

  1. Genome-wide association study identifies common loci influencing circulating glycated hemoglobin (HbA1c) levels in non-diabetic subjects: the Long Life Family Study (LLFS).

    PubMed

    An, Ping; Miljkovic, Iva; Thyagarajan, Bharat; Kraja, Aldi T; Daw, E Warwick; Pankow, James S; Selvin, Elizabeth; Kao, W H Linda; Maruthur, Nisa M; Nalls, Micahel A; Liu, Yongmei; Harris, Tamara B; Lee, Joseph H; Borecki, Ingrid B; Christensen, Kaare; Eckfeldt, John H; Mayeux, Richard; Perls, Thomas T; Newman, Anne B; Province, Michael A

    2014-04-01

    Glycated hemoglobin (HbA1c) is a stable index of chronic glycemic status and hyperglycemia associated with progressive development of insulin resistance and frank diabetes. It is also associated with premature aging and increased mortality. To uncover novel loci for HbA1c that are associated with healthy aging, we conducted a genome-wide association study (GWAS) using non-diabetic participants in the Long Life Family Study (LLFS), a study with familial clustering of exceptional longevity in the US and Denmark. A total of 4088 non-diabetic subjects from the LLFS were used for GWAS discoveries, and a total of 8231 non-diabetic subjects from the Atherosclerosis Risk in Communities Study (ARIC, in the MAGIC Consortium) and the Health, Aging, and Body Composition Study (HABC) were used for GWAS replications. HbA1c was adjusted for age, sex, centers, 20 principal components, without and with BMI. A linear mixed effects model was used for association testing. Two known loci at GCK rs730497 (or rs2908282) and HK1 rs17476364 were confirmed (p<5e-8). Of 25 suggestive (5e-8A1c was further adjusted for BMI. Further validations are crucial for the remaining suggestive loci including the emerged variant near OR10R3P/SPTA1. The analysis reconfirmed two known GWAS loci (GCK, HK1) and identified 25 suggestive loci including one reconfirmed variant in G6PC2 and one replicated variant near OR10R3P/SPTA1. Future focused survey of sequence elements containing mainly functional and regulatory variants may yield additional findings. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Effects comparison between low glycemic index diets and high glycemic index diets on HbA1c and fructosamine for patients with diabetes: A systematic review and meta-analysis.

    PubMed

    Wang, Qiong; Xia, Wei; Zhao, Zhigang; Zhang, Huifeng

    2015-10-01

    The purpose of this study is to evaluate the effect of low glycemic index (GI) through the comparison of low-GI foods group and high-GI foods group on glycemic control (the measurements were HbA1c and fructosamine) for patients with diabetes. The studies were retrieved from databases including PubMed, MEDLINE, Springer, Elsevier Science Direct, Cochrane Library and Google scholar from their inception to August 2014. Review Manager 5.1 and STATA package v.11.0 software were applied for the meta-analysis. Standard mean difference (SWD) and its corresponding 95% confidence interval (CI) for HbA1c and fructosamine of patients with diabetes were collected and calculated in a fixed or random effects model when appropriate. Subgroup analysis stratified by study design, geographic area of participants and types of diabetes were also conducted. There were significant differences of overall effects on HbA1c between low-GI foods group and high-GI foods group (SWD=-0.42, 95%CI=-0.69 to -0.16, P<0.01) in patients with diabetes, and the subgroup analysis indicated that significant differences of HbA1c were also found between the two groups in crossover study, in Australian population and American population, as well as in type 2 diabetes. The overall fructosamine was also significantly different in patients with diabetes between low-GI foods and high-GI foods group (SMD=-0.44, 95%CI=-0.82 to -0.06, P=0.02). Our results suggest that low-GI diets achieve a more beneficial effect on glycemic control than that of high-GI foods diets. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  3. Arm, Leg, and Foot Skin Water in Persons With Diabetes Mellitus (DM) in Relation to HbA1c Assessed by Tissue Dielectric Constant (TDC) Technology Measured at 300 MHz.

    PubMed

    Mayrovitz, Harvey N; Volosko, Irina; Sarkar, Bansari; Pandya, Naushira

    2017-05-01

    DM is associated with structural skin changes. However, few studies have investigated changes in dermal water and specifically its relationship to glucose control as measured by HbA1c. Our goal was to test the hypothesis that skin water, assessed by its tissue dielectric constant (TDC), is inversely related to HbA1c. Water content of 3 skin sites (forearm, lower leg, and foot dorsum) of 50 persons with DM was estimated by measuring TDC at 300 MHz. TDC is the ratio of tissue dielectric constant to vacuum and depends on free and bound water in the measured volume. TDC was measured in triplicate to 4 depths, 0.5. 1.5, 2.5, and 5.0 mm to include different skin components. At each site increased measurement depth showed (1) a significant decrease in absolute TDC values and (2) a significant increase in foot-to-arm TDC ratios. TDC values at forearm were shown to be greater than at either leg or foot. However, testing of these 50 patients at 3 sites and 4 skin depths did not show any significant relationship between TDC and HbA1c or fasting glucose. The data indicate no relationship between TDC values, as indices for skin water, and HbA1c or fasting glucose. This implies that skin TDC values to assess skin property features and changes in persons with DM are not sensitive to recent glucose control. Furthermore, the results introduce a newly applied TDC technology useful to assess skin properties of persons with DM.

  4. Substantial improvement in HbA1c following a treatment and teaching programme for people with type 2 diabetes on conventional insulin therapy in an in- and outpatient setting.

    PubMed

    Kuniss, Nadine; Müller, Ulrich A; Kloos, Christof; Müller, Regina; Starrach, Gerd; Jörgens, Viktor; Kramer, Guido

    2018-02-01

    The aim of the study was to assess the efficacy of a patient education programme (DTTP) for the optimisation of conventional insulin therapy in patients with type 2 diabetes in an in- and outpatient setting. The study was designed as a prospective, longitudinal trial. Thirty-three people with diabetes (females 54.5%, age 61.0 years, diabetes duration 12.7 years, HbA1c 9.3%) from ten general practices in Thuringia (outpatient group) participated in a DTTP for conventional insulin therapy. Thirty-three individuals-matched pairs-(female 72.7%, age 63.2 years, diabetes duration 13.6 years, HbA1c 9.7%) who were hospitalised for the optimisation of conventional insulin therapy participated in the same DTTP during their hospitalisation. All individuals were invited to participate in an outpatient follow-up visit 12 months after participation in the DTTP. All participants were re-examined after 1.0 ± 0.2 years. HbA1c improved in both groups equally by 1.2% in the outpatient group and 1.3% in the inpatient group. Insulin dosage increased marginally within the outpatient group (+ 0.09 units/kg/day, p = 0.023) and remained stable within the inpatients. Blood glucose self-monitoring increased significantly in both groups without inter-group difference (+ 7.9 vs. + 6.4 tests per week). Participation in an out- or inpatient DTTP improved substantially HbA1c levels in people with type 2 diabetes on conventional insulin treatment. Probably, the improved adjustment of the eating behaviour to the insulin therapy was the reason for improved metabolic control. Guidelines should recommend "refresher" programmes when metabolic control deteriorates before an intensification of blood glucose-lowering treatment.

  5. Description of a New Predictive Modeling Approach That Correlates the Risk and Associated Cost of Well-Defined Diabetes-Related Complications With Changes in Glycated Hemoglobin (HbA1c)

    PubMed Central

    Fortwaengler, Kurt; Parkin, Christopher G.; Neeser, Kurt; Neumann, Monika; Mast, Oliver

    2017-01-01

    The modeling approach described here is designed to support the development of spreadsheet-based simple predictive models. It is based on 3 pillars: association of the complications with HbA1c changes, incidence of the complications, and average cost per event of the complication. For each pillar, the goal of the analysis was (1) to find results for a large diversity of populations with a focus on countries/regions, diabetes type, age, diabetes duration, baseline HbA1c value, and gender; (2) to assess the range of incidences and associations previously reported. Unlike simple predictive models, which mostly are based on only 1 source of information for each of the pillars, we conducted a comprehensive, systematic literature review. Each source found was thoroughly reviewed and only sources meeting quality expectations were considered. The approach allows avoidance of unintended use of extreme data. The user can utilize (1) one of the found sources, (2) the found range as validation for the found figures, or (3) the average of all found publications for an expedited estimate. The modeling approach is intended for use in average insulin-treated diabetes populations in which the baseline HbA1c values are within an average range (6.5% to 11.5%); it is not intended for use in individuals or unique diabetes populations (eg, gestational diabetes). Because the modeling approach only considers diabetes-related complications that are positively associated with HbA1c decreases, the costs of negatively associated complications (eg, severe hypoglycemic events) must be calculated separately. PMID:27510441

  6. 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.

  7. Feedback of personal retinal images appears to have a motivational impact in people with non-proliferative diabetic retinopathy and suboptimal HbA1c: findings of a pilot study.

    PubMed

    Rees, G; Lamoureux, E L; Nicolaou, T E; Hodgson, L A B; Weinman, J; Speight, J

    2013-09-01

    To conduct a pilot study to explore the potential impact of visual feedback of personal retinal images on diabetes outcomes. Twenty-five participants with non-proliferative diabetic retinopathy and suboptimal HbA(1c) (> 53 mmol/mol; > 7%) were randomized to receive visual feedback of their own retinal images or to a control group. At baseline and 3-month follow-up, HbA(1c), standard measures of beliefs, diabetes-related distress and self-care activities were assessed. In unadjusted models, relative to controls, the intervention group showed significantly greater improvement in HbA(1c) at 3-month follow-up (-0.6% vs. +0.3%, P < 0.01), as well as enhanced motivation to improve blood glucose management (P < 0.05). This small pilot study provides preliminary evidence that visual feedback of personal retinal images may offer a practical educational strategy for clinicians in eye care services to improve diabetes outcomes in non-target compliant patients. A fully powered randomized controlled trial is required to confirm these findings and determine the optimal use of feedback to produce sustained effects. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  8. Association of Exposure to Radio-Frequency Electromagnetic Field Radiation (RF-EMFR) Generated by Mobile Phone Base Stations with Glycated Hemoglobin (HbA1c) and Risk of Type 2 Diabetes Mellitus.

    PubMed

    Meo, Sultan Ayoub; Alsubaie, Yazeed; Almubarak, Zaid; Almutawa, Hisham; AlQasem, Yazeed; Hasanato, Rana Muhammed

    2015-11-13

    Installation of mobile phone base stations in residential areas has initiated public debate about possible adverse effects on human health. This study aimed to determine the association of exposure to radio frequency electromagnetic field radiation (RF-EMFR) generated by mobile phone base stations with glycated hemoglobin (HbA1c) and occurrence of type 2 diabetes mellitus. For this study, two different elementary schools (school-1 and school-2) were selected. We recruited 159 students in total; 96 male students from school-1, with age range 12-16 years, and 63 male students with age range 12-17 years from school-2. Mobile phone base stations with towers existed about 200 m away from the school buildings. RF-EMFR was measured inside both schools. In school-1, RF-EMFR was 9.601 nW/cm² at frequency of 925 MHz, and students had been exposed to RF-EMFR for a duration of 6 h daily, five days in a week. In school-2, RF-EMFR was 1.909 nW/cm² at frequency of 925 MHz and students had been exposed for 6 h daily, five days in a week. 5-6 mL blood was collected from all the students and HbA1c was measured by using a Dimension Xpand Plus Integrated Chemistry System, Siemens. The mean HbA1c for the students who were exposed to high RF-EMFR was significantly higher (5.44 ± 0.22) than the mean HbA1c for the students who were exposed to low RF-EMFR (5.32 ± 0.34) (p = 0.007). Moreover, students who were exposed to high RF-EMFR generated by MPBS had a significantly higher risk of type 2 diabetes mellitus (p = 0.016) relative to their counterparts who were exposed to low RF-EMFR. It is concluded that exposure to high RF-EMFR generated by MPBS is associated with elevated levels of HbA1c and risk of type 2 diabetes mellitus.

  9. 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

  10. Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes? A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials.

    PubMed

    Hou, Can; Carter, Ben; Hewitt, Jonathan; Francisa, Trevor; Mayor, Sharon

    2016-11-01

    To investigate the effect of mobile phone applications (apps) on glycemic control (HbA 1c ) in the self-management of diabetes. Relevant studies that were published between 1 January 1996 and 1 June 2015 were searched from five databases: Medline, CINAHL, Cochrane Library, Web of Science, and Embase. Randomized controlled trials that evaluated diabetes apps were included. We conducted a systematic review with meta-analysis and GRADE (Grading of Recommendations Assessment, Development and Evaluation) of the evidence. Participants from 14 studies (n = 1,360) were included and quality assessed. Although there may have been clinical diversity, all type 2 diabetes studies reported a reduction in HbA 1c . The mean reduction in participants using an app compared with control was 0.49% (95% Cl 0.30, 0.68; I 2 = 10%), with a moderate GRADE of evidence. Subgroup analyses indicated that younger patients were more likely to benefit from the use of diabetes apps, and the effect size was enhanced with health care professional feedback. There was inadequate data to describe the effectiveness of apps for type 1 diabetes. Apps may be an effective component to help control HbA 1c and could be considered as an adjuvant intervention to the standard self-management for patients with type 2 diabetes. Given the reported clinical effect, access, and nominal cost of this technology, it is likely to be effective at the population level. The functionality and use of this technology need to be standardized, but policy and guidance are anticipated to improve diabetes self-management care. © 2016 by the American Diabetes Association.

  11. 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

  12. 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.

  13. 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.

  14. Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy.

    PubMed

    Tentolouris, Nicholas; Lathouris, Panagiotis; Lontou, Stavroula; Tzemos, Kostas; Maynard, John

    2013-04-01

    We examined the accuracy of random capillary glucose (RCG) and two noninvasive screening methods, the ADA diabetes risk test (DRT) and skin fluorescence spectroscopy (SFS) as measured by Scout DS for detecting HbA1c-defined dysglycemia or type 2 diabetes in an at-risk cohort. Subjects were recruited at two clinical sites for a single non-fasting visit. Each subject had measurements of height, weight and waist circumference. A diabetes score was calculated from skin fluorescence measured on the left forearm. A finger prick was done to measure RCG and HbA1c (A1C). Health questionnaires were completed for the DRT. Increasing dysglycemia was defined as A1C ≥ 5.7% (39 mmol/mol) or ≥ 6.0% (42 mmol/mol). Type 2 diabetes was defined as A1C ≥ 6.5% (47.5 mmol/mol). 398 of 409 subjects had complete data for analysis with means for age, body mass index, and waist of 52 years, 27 kg/m(2) and 90 cm. 51% were male. Prevalence of A1C ≥ 5.7%, ≥ 6.0% and ≥ 6.5% were 54%, 34% and 12%, respectively. Areas under the curve (AUC) for detection of increasing levels dysglycemia or diabetes for RCG were 63%, 66% and 72%, for the ADA DRT the AUCs were 75%, 76% and 81% and for SFS the AUCs were 82%, 84% and 90%, respectively. For each level of dysglycemia or diabetes, the SFS AUC was significantly higher than RCG or the ADA DRT. The noninvasive skin fluorescence spectroscopy measurement outperformed both RCG and the ADA DRT for detection of A1C-defined dysglycemia or diabetes in an at-risk cohort. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  15. 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.

  16. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c ≥64 mmol/mol: a group-based randomised controlled trial.

    PubMed

    Mohn, Jannike; Graue, Marit; Assmus, Jõrg; Zoffmann, Vibeke; Thordarson, Hrafnkell; Peyrot, Mark; Rokne, Berit

    2017-07-03

    To determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA 1c and type 1 diabetes mellitus (DM) was superior to 'care as usual' in improving HbA 1c and psychological functioning. An outpatient clinic at a university hospital in Western Norway. A total of 178 adults (all Caucasian) aged 18-55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA 1c ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy. Intervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology. The primary outcome was HbA 1c and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale). Among participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA 1c (B -0.18, CI (-0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B -6.96, CI (-11.40, -2.52), p=0.002), total DDS (B -5.15, CI (-9.34, -0.96), p=0.016), DDS emotional burden (B -7.19, CI (-13.20, -1.19), p=0.019) and self-esteem (B 1.43, CI (0.34, 2.52), p=0.011). Results from this

  17. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c ≥64 mmol/mol: a group-based randomised controlled trial

    PubMed Central

    Mohn, Jannike; Graue, Marit; Assmus, Jõrg; Zoffmann, Vibeke; Thordarson, Hrafnkell; Peyrot, Mark; Rokne, Berit

    2017-01-01

    Objectives To determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA1c and type 1 diabetes mellitus (DM) was superior to ‘care as usual’ in improving HbA1c and psychological functioning. Setting An outpatient clinic at a university hospital in Western Norway. Participants A total of 178 adults (all Caucasian) aged 18–55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA1c ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy. Intervention Intervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology. Primary and secondary outcome measures The primary outcome was HbA1c and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale). Results Among participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA1c (B −0.18, CI (−0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B −6.96, CI (−11.40, −2.52), p=0.002), total DDS (B −5.15, CI (−9.34, −0.96), p=0.016), DDS emotional burden

  18. Multivariate Prediction Equations for HbA1c Lowering, Weight Change, and Hypoglycemic Events Associated with Insulin Rescue Medication in Type 2 Diabetes Mellitus: Informing Economic Modeling.

    PubMed

    Willis, Michael; Asseburg, Christian; Nilsson, Andreas; Johnsson, Kristina; Kartman, Bernt

    2017-03-01

    Type 2 diabetes mellitus (T2DM) is chronic and progressive and the cost-effectiveness of new treatment interventions must be established over long time horizons. Given the limited durability of drugs, assumptions regarding downstream rescue medication can drive results. Especially for insulin, for which treatment effects and adverse events are known to depend on patient characteristics, this can be problematic for health economic evaluation involving modeling. To estimate parsimonious multivariate equations of treatment effects and hypoglycemic event risks for use in parameterizing insulin rescue therapy in model-based cost-effectiveness analysis. Clinical evidence for insulin use in T2DM was identified in PubMed and from published reviews and meta-analyses. Study and patient characteristics and treatment effects and adverse event rates were extracted and the data used to estimate parsimonious treatment effect and hypoglycemic event risk equations using multivariate regression analysis. Data from 91 studies featuring 171 usable study arms were identified, mostly for premix and basal insulin types. Multivariate prediction equations for glycated hemoglobin A 1c lowering and weight change were estimated separately for insulin-naive and insulin-experienced patients. Goodness of fit (R 2 ) for both outcomes were generally good, ranging from 0.44 to 0.84. Multivariate prediction equations for symptomatic, nocturnal, and severe hypoglycemic events were also estimated, though considerable heterogeneity in definitions limits their usefulness. Parsimonious and robust multivariate prediction equations were estimated for glycated hemoglobin A 1c and weight change, separately for insulin-naive and insulin-experienced patients. Using these in economic simulation modeling in T2DM can improve realism and flexibility in modeling insulin rescue medication. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All

  19. The difference between oats and beta-glucan extract intake in the management of HbA1c, fasting glucose and insulin sensitivity: a meta-analysis of randomized controlled trials.

    PubMed

    He, Li-xia; Zhao, Jian; Huang, Yuan-sheng; Li, Yong

    2016-03-01

    Increasing oats and beta-glucan extract intake has been associated with improved glycemic control, which is associated with the reduction in the development of diabetes. This study aims to assess the different effects between oat (whole and bran) and beta-glucan extract intake on glycemic control and insulin sensitivity. PubMed, Embase, Medline, The Cochrane Library, CINAHL and Web of Science were searched up to February 2014. We included randomized controlled trials with interventions that lasted at least four weeks that compared oats and beta-glucan (extracted from oats or other sources) intake with a control. A total of 1351 articles were screened for eligibility, and relevant data were extracted from 18 studies (n = 1024). Oat product dose ranged from 20 g d(-1) to 136 g d(-1), and beta-glucan extract dose ranged from 3 g d(-1) to 10 g d(-1). Compared with the control, oat intake resulted in a greater decrease in fasting glucose and insulin of subjects (P < 0.05), but beta-glucan extract intake did not. Furthermore, oat intake resulted in a greater decrease in glycosylated hemoglobin (HbA1c) (P < 0.001, I(2) = 0%) and fasting glucose (P < 0.001, I(2) = 68%) after removing one study using a concentrate and a different design and fasting insulin of type 2 diabetes (T2D) (P < 0.001, I(2) = 0%). The intake of oats and beta-glucan extracted from oats were effective in decreasing fasting glucose (P = 0.007, I(2) = 91%) and fasting insulin of T2D (P < 0.001, I(2) = 0%) and tented to lower HbA1c (P = 0.09, I(2) = 92%). Higher consumption of whole oats and oat bran, but not oat or barley beta-glucan extracts, are associated with lower HbA1c, fasting glucose and fasting insulin of T2D, hyperlipidaemic and overweight subjects, especially people with T2D, which supports the need for clinical trials to evaluate the potential role of oats in approaching to the management of glycemic control and insulin sensitivity of diabetes or metabolic syndrome subjects.

  20. Evaluation of the HbA1c Reduction Cut Point for a Nonglycemic Effect on Cardiovascular Benefit of Hypoglycemic Agents in Patients with Type 2 Diabetes Based on Endpoint Events.

    PubMed

    Wu, Yuchao; Tang, Lizhi; Zhang, Fang; Yan, Zhe; Li, Jing; Tong, Nanwei

    2018-01-01

    Atherosclerotic cardiovascular disease (ASCVD) is a major cause of death among patients with diabetes but can be improved by certain hypoglycemic agents. However, adjudicating criteria on whether improvements are a glycemic or nonglycemic effect of these agents remain unclear. Hypoglycemic agents that produce a cardiovascular benefit in nondiabetic patients are considered to do so via a nonglycemic effect. We performed a subgroup analysis for primary and secondary prevention or very high risk of ASCVD in patients with type 2 diabetes (T2DM). Where glycosylated hemoglobin (HbA1c) was reduced to the same extent in a head-to-head comparison, cardiovascular benefits were judged as a nonglycemic effect. Furthermore, by analyzing the endpoints of four important randomized controlled intensive glucose control studies, UKPDS33, ADVANCE, ACCORD, and VADT, we calculated the cut point of HbA1c reduction for a nonglycemic effect on cardiovascular benefit by hypoglycemic agents in ASCVD groups of different severities. For the ASCVD primary prevention group of T2DM, UKPDS33 indicated a reduction in HbA1c < 0.9%, and a cardiovascular benefit within 10 years was considered a nonglycemic effect. For ASCVD secondary prevention or in the very high-risk group, pioglitazone exerted a nonglycemic effect on cardiovascular benefit in nondiabetic patients with insulin resistance; metformin may exert a similar effect in T2DM patients in a head-to-head study. Analysis of T2DM intensive glucose control studies showed a reduction in HbA1c of <1.0%, and a cardiovascular benefit after approximately 5 years was deemed a nonglycemic effect. For ASCVD primary prevention in T2DM, a reduction in HbA1c < 0.9% and a cardiovascular benefit within 10 years were considered a nonglycemic effect. For ASCVD secondary prevention or in a very high-risk population, a reduction in HbA1c < 1.0% and a cardiovascular benefit within about 5 years were also considered a nonglycemic effect.