Search

Objectives The US Centers for Medicare & Medicaid Services proposed in 2019 that glycated hemoglobin A1c (HbA1c) be a CLIA′88 regulated analyte. People who commented expressed concerns that the proposed acceptance limit (AL, HbA1c in NGSP unit) ±10% for proficiency testing (PT) would be unable to maintain already improved analytical performance and guarantee the clinical utility of HbA1c testing. Assessing impact of various ALs on PT performance is needed to provide scientific evidence for adopting an appropriate AL. Methods Ten patient EDTA-whole blood specimens were distributed to 318 and 336 laboratories in the 2018 and 2019 PT events organized by Shanghai Center for Clinical Laboratory (SCCL). HbA1c concentrations were measured by participants using various methodologies commonly used in the USA and China. Targets were determined using secondary reference measurement procedures (SRM) at SCCL. “Failed Results” were those outside the SRM-defined target ± AL (5% through 10%). Laboratories with Failed Results ≥2 out of five samples per PT event obtained Event Unsatisfactory Status. Results HbA1c target values ranged 33.3 mmol/mol (5.2 NGSP%) −102.2 mmol/mol (11.5 NGSP%) for 2018 event, and 33.3 mmol/mol (5.2 NGSP%) −84.7 mmol/mol (9.9 NGSP%) for 2019 event. Overall Laboratory Event Unsatisfactory Rates were 11.3–12.2%, 4.8–5.3%, 0.9–3.1%, 0.6–2.2%, 0.6–1.4% and 0.6–1.4%, at AL of ±5, ±6, ±7, ±8, ±9 and ±10%, respectively. Conclusions The AL (in NGSP unit) of ±6% or ±7% for PT evaluation of HbA1c results would be appropriate, with satisfactory event scores for about 95% of participant laboratories in a PT event.

Worldwide, the prevalence of diabetes has continued to increase rapidly. This gives rise to concerns regarding appropriate diabetes management to ensure optimal glycemic control. Untreated or uncontrolled diabetes can lead to a host of complications, such as cardiovascular diseases, an increased likelihood of morbidity and mortality (Deshpande, Harris-Hayes, & Schootman, 2008). A challenging problem which arises in diabetes management is the limitations of current blood glucose monitoring techniques. Electronic medical devices can potentially overcome the persistent problems in the healthcare industry. Thus, for this study, it was of interest to investigate whether advanced machine learning methods and Anura, a smartphone-based transdermal optical imaging technology (TOI) that assess health markers, can be a viable solution for diabetes management. Objectives: To examine the validity of TOI and a novel machine algorithm for diabetes prediction (i.e diabetes and non-diabetes). We compared the diabetes classification from TOI’s obtained glycated hemoglobin A1c (HbA1c) concentrations against data obtained from FDA approved blood immunoassay. Methods: In the present study, we used a kitchen sink random forest machine algorithm for diabetes prediction. The data set was obtained from 513 participants recruited during their annual physical examination at the Health Management Center of The Affiliated Hospital of Hangzhou Normal University, China. This included participant’s TOI and blood immunoassay determined HbA1c concentrations. To validate the model, pristine testing was done on 400 pristine participants pseudo randomly selected during 20 trials of training/testing. Results: The confusion matrix found TOI to have a classification accuracy of 66%, and the ROC curve of the RF classifier found TOI to have a ROC AUC of 0.69. Conclusions: The present study provides evidence for the potential use of the TOI technology, Anura, for contactless, non-invasive, and inexpensive assessments of diabetes.

Objective: The objective is to determine the pattern and prevalence of diabetic retinopathy (DR) among patients living with diabetes mellitus. Methodology: Descriptive cross-sectional study in a tertiary hospital. Questionnaires were used to obtain data from eligible participants. Visual acuity measurement, fundal examination, and photography were performed together with fasting blood glucose and glycated hemoglobin A1c. The Statistical Package for Social Sciences (SPSS) for Windows version 20 was used for data analysis. Results: Overall 200 patients were enrolled of which 75.5% were female. The participant's mean age was 53.8 ± 11.7 years. DR was present in 53/200 (26.5%) of participants, of which 52 (98.1%) had nonproliferative DR (NPDR), and 1 (1.9%) had proliferative DR (PDR). NPDR was mild in 44/53 (83.0%) and moderate in 8/53 (15.1%) patients. Evidence of sight-threatening DR was found in 37/200 (18.5%) of participants (36 had diabetic macular edema and 1 had PDR + DMO). Conclusions: DR was present in 26.5% of the study participants, and 18.5% had sight-threatening DR mainly due to DMO. This finding underscores the need for routine screening of all people living with diabetes to detect early DMO and provide treatment to prevent visual loss.

The purpose of this study was to evaluate the effects of intermittent fasting on glycemic control and body composition in adults with obesity and type 2 diabetes. Although intermittent fasting has shown some promise in improving glucoregulatory indicators and body composition in adults with obesity, there is currently no systematic review evaluating these effects in adults with obesity and type 2 diabetes. A database search of PubMed, CINHAL, and MEDLINE identified five studies that met inclusion criterion. All studies were randomized controlled trials in adult subjects (

Positron emission tomography/computed tomography (PET/CT) with 18F-fluorodeoxyglucose (FDG) is a useful imaging modality that visualizes glucose utilization. Diffuse colonic FDG uptake is frequently observed in patients being treated for diabetes mellitus (DM), especially with metformin. The aim of this study was to evaluate whether patients without increased colonic FDG uptake after taking oral hypoglycemic agents (OHA) are associated with insufficient glycemic control. A total of 279 subjects who underwent FDG PET/CT scans for health examinations and had been diagnosed with DM and taken an OHA before the day of the FDG PET/CT were included. Colonic FDG uptake in the study subjects was visually assessed, and the maximal and mean standard uptake value (SUV) was measured. Fasting blood glucose and glycated hemoglobin A1c (HbA1c) levels at both baseline and follow-up visits as well as DM management were compared according to the colonic FDG uptake. The mean age of study subjects was 48.8 years old, and 251 of subjects were male. Positive colonic FDG uptake was observed in 200 (71.7%) subjects. Fasting blood glucose and Hb1Ac levels on the day of FDG PET/CT were higher in subjects without positive colonic FDG uptake than those with positive colonic FDG uptake (p ≤ 0.001). But there was no significant difference between the two groups at follow-up visits. Patients with DM who did not show increased colonic FDG uptake after taking OHA were associated with higher fasting blood glucose and HbA1c levels on the day of FDG PET/CT.

We investigated racial variation in glycemic control (glycated hemoglobin A1c [HbA1c]) with fracture risk in geriatric patients with diabetes. Compared to an HbA1c of 7.0-7.9% [53-63 mmol/mol], HbA1c ≥9.0% [≥75 mmol/mol] was associated with increased fracture risk among Blacks and those of Unknown race only. This increase was attenuated in Blacks after accounting for the relative frequency of patient-provider interaction.

Cilj: Procijeniti učinkovitost strukturirane edukacije za osobe sa šećernom bolešću po pitanju napretka u znanju i redukcije glikiranog hemoglobina HbA1c. Ispitanici i metode: Istraživanje je obuhvatilo ukupno 102 pacijenta (20 sa šećernom bolesti tipa 1 i 82 sa šećernom bolesti tipa 2), prosječne dobi 60 godina (20 – 80 godina), koji su u periodu od srpnja 2017. do siječnja 2018. bili upućeni u Dnevnu bolnicu za endokrinologiju, dijabetes i bolesti metabolizma Kliničkog bolničkog centra Rijeka s ciljem provođenja grupne strukturirane edukacije za osobe sa šećernom bolešću. Polaznici su zamoljeni da ispune upitnik prije početka edukacije te po njenu završetku. Upitnik se sastojao od 12 pitanja, od kojih je 11 bilo po principu točnog/netočnog odgovora, dok se posljednje pitanje iz upitnika odnosilo na pacijentovu samoprocjenu educiranosti o šećernoj bolesti (Tablica 1). Vrijednost glikiranog hemoglobina HbA1c mjerena je inicijalno te 3 mjeseca po provedenoj edukaciji. Za statističku obradu podataka korišteni su Microsoft Excel (Microsoft Office), MedCalc v12.1.3 (MedCalc Software bvba, Ostend, Belgium) i Statistica v13.3 (StatSoft Inc., Tulsa, Oklahoma, United States), a razina statističke značajnosti procijenjena je na P < 0,05. Rezultati: Po završenoj edukaciji značajno se povisio broj postignutih točnih odgovora (4,1 ± 2,3 vs 9,3 ± 1,6, P < 0,001), snizila se vrijednost glikiranog hemoglobina HbA1c (8,0 ± 1,8 % vs 7,1 ± 1,3 %, P < 0,001) te utrostručio broj polaznika koji su za sebe smatrali da su adekvatno educirani o šećernoj bolesti (28,4 % vs 84,3 %, P < 0,001). Zaključci: Po provedenoj edukaciji zabilježen je značajan napredak u znanju, popraćen redukcijom glikiranog hemoglobina HbA1c od 0,9 %, čime je dokazana učinkovitost strukturirane edukacije., Aim: To evaluate the effect of diabetes structured education on knowledge and glycemic control. Patients and methods: The study included 102 patients with diabetes mellitus (20 patients with type 1 diabetes and 82 patients with type 2 diabetes), aged 20-80 years (median age 60 years), consecutively referred to Diabetes outpatient clinic structured education program at Clinical Hospital Centre Rijeka, within a six month period. Patients were asked to complete 12-item questionnaire before the education program and immediately after its completion. The maximum possible score was 11 (1 point for each correctly answered item), since the last item of the questionnaire was knowledge self-assessment (Table 1). Glycated hemoglobin A1c was measured initially and 3 months after the education program. Data were analyzed using Microsoft Excel (Microsoft Office), MedCalc v12.1.3 (MedCalc Software bvba, Ostend, Belgium) and Statistica v13.3 (StatSoft Inc., Tulsa, Oklahoma, United States). Criterion for statistical significance was estimated on P

Objective We examined whether diabetic ketoacidosis (DKA), a serious complication of type 1 diabetes (T1D) was more prevalent among Non-Hispanic (NH) Black and Hispanic patients with T1D and laboratory-confirmed coronavirus disease 2019 (COVID-19) compared with NH Whites. Method This is a cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 52 clinical sites in the United States, data were collected from April to August 2020. We examined the distribution of patient factors and DKA events across NH White, NH Black, and Hispanic race/ethnicity groups. Multivariable logistic regression analysis was performed to examine the odds of DKA among NH Black and Hispanic patients with T1D as compared with NH White patients, adjusting for potential confounders, such as age, sex, insurance, and last glycated hemoglobin A1c (HbA1c) level. Results We included 180 patients with T1D and laboratory-confirmed COVID-19 in the analysis. Forty-four percent (n = 79) were NH White, 31% (n = 55) NH Black, 26% (n = 46) Hispanic. NH Blacks and Hispanics had higher median HbA1c than Whites (%-points [IQR]: 11.7 [4.7], P Conclusion We found that among T1D patients with COVID-19 infection, NH Black patients were more likely to present in DKA compared with NH White patients. Our findings demonstrate additional risk among NH Black patients with T1D and COVID-19.

Objective: To investigate the diagnostic value of glycated hemoglobin A1c (HbA1c) in detecting gestational diabetes mellitus (GDM).Methods: Pregnant women at gestational age 24 weeks or more, who h...

A novel amperometric biosensor prototype was fabricated using screen printing technique. The disposable single-use strips were made from conductive carbon ink and modified with fructosyl amino acid oxidase. The electrodes and conducting paths were made solely with carbon ink and characterized by conductivity and cyclic voltammetry. The biosensor showed high current output, large linearity, and effectiveness for fructosyl valine as well as human blood samples. Amperometric studies were carried out using both fructosyl valine and human blood samples. With 5 uL sample volume, the biosensor showed strong amperometric response with good linearity for a wide range (0 to 8 mM). Diabetic and healthy blood samples showed sufficient difference in their amperometric responses that correlate well with their different hemoglobin A1c levels. These results demonstrate the feasibility of using this type of inexpensive single-use biosensor strips as the basis for determining hemoglobin A1c levels for diabetic patients.

Background Recent studies have discussed the relationship between body mass index (BMI) and glycated albumin (GA) level. However, the extent of the influence of BMI on GA remains uncertain. We investigated the associations between BMI and GA, glycated hemoglobin A1c (HbA1c) and GA/HbA1c, and to analyze the influence of obesity on GA, HbA1c, and GA/HbA1c in both Chinese diabetic and non-diabetic populations. Methods A total of 2562 participants, including 1177 men and 1385 women (age 20–80 y), were enrolled. Each subject underwent a 75-g oral glucose tolerance test. Serum GA was detected using a liquid enzyme method, and HbA1c was assayed using high-performance liquid chromatography. Results In the diabetic patients (n = 1223), the GA, HbA1c, and GA/HbA1c levels were 16.7 ± 3.0%, 6.6 ± .9% (49 ± 9 mmol/mol), and 2.51 ± .33, respectively. In the non-diabetic subjects (n = 1339), the GA, HbA1c, and GA/HbA1c concentrations were 13.8 ± 1.7%, 5.6 ± .4% (38 ± 4 mmol/mol), and 2.47 ± .31, respectively. Decreasing trends in the GA and GA/HbA1c concentrations and an increasing trend in the HbA1c concentration (all P for trend .05). Moreover, in the diabetic and non-diabetic populations, BMI was negatively correlated with GA (standardized β = −.167 and − .231, both P Conclusions In both diabetic and non-diabetic populations, GA and GA/HbA1c levels are independently and negatively associated with BMI. For every 1 kg/m2 increment in BMI, the absolute value of GA decreases approximately .13%.

Diabetes is one of the largest health emergencies of the twenty-first century and it is increasing with alarming rate throughout the world. Glycemic Control in diabetes patients is an important issue in minimizing diabetes related complications and deaths. Institution based comparative cross-sectional study was conducted from March to April, 2017. Glycated Hemoglobin A1c and biochemical profiles were determined using Huma Meter A1c and ABX PENTRA 400 clinical chemistry analyzer. Independent t-test to compare groups, bivariate and multi variable logistic regression analysis were used. A P-value

The aim of this study was to test the serum concentrations of fatty acid-binding protein 4(FABP4) in children with type 1 diabetes mellitus (T1DM) and to determine the relationship between patients with good and poor glycaemic control who were classified according to their glycated hemoglobin A1c (HbA1c) levels.Children with T1DM were selected consecutively from our department from May 2016 to May 2017. For comparison, the same non-diabetic, age, sex, BMI and pubertal stage-matched healthy children were selected consecutively among non-diabetic children. Serum levels of FABP4 were batch analyzed using a commercially available ELISA assay. Patients were categorized into two groups according to their glycaemic control (Poor glycaemic control is HbA1c7.0% and good is ≤7.0%).In this study, 118 children with T1DM and 118 control cases were included. The mean serum FABP4 concentrations were significantly (P.001) higher in T1DM as compared to controls. There was a modest correlation between serum concentrations of FABP4 and duration of diabetes (r=0.484, P.001). Fifty-two patients were defined as poor glycaemic control (HbA1c7.0%). The mean serum FABP4 concentrations were significantly (P=.002) higher in the poor glycaemic control as compared to the good glycaemic control. After adjusting for all other predictors, FABP4 remained an independent poor glycaemic control indictor with an adjusted OR of 1.07 (95% CI, 1.01-1.13; P=.03).The present results indicated that FABP4 concentrations were increased and independently associated with the poor glycaemic control in Chinese children with T1DM.

Background: Glycated hemoglobin A1c (HbA1c) among diabetic hemodialysis patients continues to be the standard of care, although its limitations are well recognized. This study evaluated glycated albumin (GA) and glycated serum protein (GSP) as alternatives to HbA1c in detecting glycemic control among diabetic hemodialysis patients using continuous-glucose-monitoring (CGM)-derived glucose as reference standard. Methods: A CGM system (iPRO) was applied for 7 days in 37 diabetic hemodialysis patients to determine glycemic control. The accuracy of GA and GSP versus HbA1c in detecting a 7-day average glucose ≥184 mg/dL was evaluated via receiver-operating-characteristic (ROC) analysis. Results: CGM-derived glucose exhibited strong correlation (r = 0.970, p < 0.001) and acceptable agreement with corresponding capillary glucose measurements obtained by the patients themselves in 1,169 time-points over the 7-day-long CGM. The area under ROC curve (AUC) for GA, GSP, and HbA1c to detect poor glycemic control was 0.976 (0.862–1.000), 0.682 (0.502–0.862), and 0.776 (0.629–0.923) respectively. GA levels >20.3% had 90.9% sensitivity and 96.1% specificity in detecting a 7-day average glucose ≥184 mg/dL. The AUC for GA was significantly higher than the AUC for GSP (difference between areas: 0.294, p < 0.001) and the AUC for HbA1c (difference between areas: 0.199, p < 0.01). Conclusion: Among diabetic hemodialysis patients, GA is a stronger indicator of poor glycemic control assessed with 7-day-long CGM when compared to GSP and HbA1c.

Previously, we reported that short-term continuous glucose monitoring (CGM) with the professional iPro2© CGM device is a good clinical indicator of glycated hemoglobin (HbA1c) levels. However, there was no significant correlation between CGM and HbA1c levels when HbA1c levels were >8.0%. To further investigate this issue, we performed a similar study using the FreeStyle Libre Pro©, a newer device that does not require glucose calibration and allows patients to be examined for up to 14 days. Fifty-nine patients (68% women, 32% men) were examined. Twenty-eight and 31 patients presented with type 1 and type 2 diabetes, respectively. Clinically assessed HbA1c levels were compared to blood glucose levels determined by the FreeStyle Libre Pro© for up to 14 days (10.7 ± 3.7 days). We found a significant correlation between HbA1c and CGM levels even when HbA1c levels were >8.0%. Additionally, the correlation between HbA1c and average glucose was identified with the modern CGM and was found to deviate substantially from the new suggested formula. More importantly, we found a more robust correlation between HbA1c and CGM levels in patients with type 2 diabetes. Overestimation or underestimation of blood glucose levels through CGM might increase the risks of inappropriate clinical treatment of diabetes patients. Our results indicate the need for proper CGM data interpretation individualized for each patient to better assist the determination of customized treatments for patients.

Background Due to a high prevalence of thalassemia in southwest China, the diagnostic value of glycated hemoglobin A1c (HbA1c) is limited in the local population. Glycated albumin (GA) must also be measured for glucose monitoring. We sought to explore the relationships between HbA1c and GA. Methods We analyzed 3,414 participants and allocated to four groups: GA > 14% and HbA1c > 5.7% (group 1), GA > 14% and HbA1c ≤ 5.7% (group 2), GA ≤ 14% and HbA1c > 5.7% (group 3), and GA ≤ 14% and HbA1c ≤ 5.7% (group 4). We used stepwise multivariable logistic regression analysis to study the inconsistency of HbA1c and GA. Furthermore, we explored their association using multiple linear regression (MLR), random forest regression (RFR), and 3 blended models. Finally, we performed sensitivity analyses by changing the thresholds of HbA1c (6.5%) and GA (12% or 16%). Results There were 934 participants in group 1, 86 in group 2, 964 in group 3, and 1,430 in group 4. Age, high-density lipoprotein-cholesterol concentration, and red blood cell count were associated with the discordance in HbA1c and GA values. We constructed an RFR model that included MLR predictions as independent variables and could explain 97.80% of the variance in HbA1c in the training set, and 91.65% in the cross-validation set. Our results remained robust in 3 sensitivity analyses. Conclusions HbA1c and GA values are inconsistent in the population we studied. A model that blends MLR and RFR can be used to correct HbA1c values when conflicting HbA1c and GA values are encountered in patients.

[No abstract available] 2-s2.0-85059518584 PubMed: 30231621

(1) Background: To assess the suitability of replacing conventional markers used for insulin resistance and dysglycemia by HbA1c in both the quantitative and qualitative metabolic syndrome (MetS) definition criteria, (2) Methods: Confirmatory factorial analysis was used to compare three quantitative definitions of MetS that consisted of many single-factor models, one of which included HbA1c as the dysglycemia indicator. After that, the model with the better goodness-of-fit was selected. Furthermore, a new MetS qualitative definition was proposed by replacing fasting plasma glucose with HbA1c &gt, 5.7% in the International Diabetes Federation (IDF) definition. The clinical performance of these two MetS criteria (IDF and IDF-modified including HbA1c as the dysglycemia indicator) to predict vascular damage (pulse wave velocity [PWv], intima media thickness [IMT] and albumin-to-creatinine ratio [ACR]) was estimated, (3) Results: The single-factor model including HbA1c showed the better goodness-of-fit (&chi, 2 = 2.45, df = 2, p = 0.293, CFI = 0.999, SRMR = 0.010). Additionally, the IDF-modified criteria gained in clinical performance to predict vascular damage (diagnostic Odds Ratio: 6.94, 1.34 and 1.90) for pulse wave velocity (PWv), intima media thickness (IMT) and albumin-to-creatinine ratio (ACR), respectively, and (4) Conclusions: These data suggest that HbA1c could be considered as a useful component to be included in the MetS definition.

Objective: To test whether the addition of an insulin pump or continuous glucose monitor (CGM) related to reduced glycated hemoglobin A1c (HbA1c) in large cohort of children, 5–9 years old, and within 1 year of their type 1 diabetes (T1D) diagnosis. Research Design and Methods: The study uses data from families of children with recent-onset T1D and who were between 5 and 9 years old. Study analyses used children's HbA1c values at baseline and at the 6-month follow-up. Parents reported on family demographics and children's T1D device use in their daily management (e.g., insulin pump or CGM). Children's mean T1D duration was 4.70 ± 3.28 months at baseline, so the 6-month assessment point was ∼12 months postdiagnosis. Results: One hundred-eleven families participated. At baseline, child mean age was 7.51 ± 1.37 years, and mean child HbA1c was 7.65% ± 1.40%. In addition, 17% of children used an insulin pump, and 17.1% of children used CGM. Six months later, 35.1% of children had started an insulin pump and 25.2% had started CGM. Repeated measures analyses of variance results showed a smaller overall HbA1c between baseline and 6 months for children using an insulin pump versus children not on a pump. For CGM, results showed that children starting a CGM during this window had a significantly lower HbA1c level than children who had not started on CGM. Conclusions: The study results suggest that early initiation of either an insulin pump or CGM in children newly diagnosed with T1D may help to improve child HbA1c levels within the first 12 months of diabetes.

In this article, a simple capillary electrophoresis (CE) method was developed to analyze the glycated hemoglobin A1c (HbA1c) in light of the goal to monitor the long-term blood glucose concentration on diabetic patients, and it is the first time to report the binding constant of sodium tetraborate (Na2B4O7) and HbA1c in CE system. It is also found that the addition of Spermidine (Spd) can inhibit electroosmotic flow (EOF) well, thereby improving the resolution of the analytes. And a Spd concentration of a few mM is proper to provide perfect resolutions. Finally, the performance of the developed CE method was validated by analyzing actual blood specimens, of which the value of HbA1c was found to be close to the results of Sebia's CE method, showing an acceptable ability to separate hemoglobin forms. We expect this method will provide an inspiration to investigate hemoglobins (Hbs).

Background. Our previous study indicated that serum 1,5-anhydroglucitol (1,5-AG) levels slightly increased after a glucose load; therefore, this study was conducted to explore short-term changes in 1,5-AG levels after a steamed bread meal test (SBMT) and compare the agreement of 1,5-AG, glycated albumin (GA), and glycated hemoglobin A1c (HbA1c) levels between fasting and postprandial states after an SBMT. Methods. 104 participants were recruited and underwent a 100 g SBMT. Fasting, 30 min, and 120 min of 1,5-AG, GA, and HbA1c were measured. Results. Levels of 1,5-AG slightly increased from 30 to 120 min after an SBMT (P<0.01), and HbA1c and GA levels showed stability at 30 and 120 min. The Passing-Bablok regression linear equation showed that postprandial 1,5-AG, GA, and HbA1c levels were well fitted (all P>0.05), and Bland-Altman difference plot showed that 100% of data points for HbA1c30 and HbA1c120 fell within the limits of agreement; 94.2%, 96.2%, 95.2%, and 95.2% of data points for 1,5-AG30, 1,5-AG120, GA30, and GA120 fell within the limits of agreement, respectively. Conclusion. Agreement analyses indicated good stability of 1,5-AG, GA, and HbA1c levels after the SBMT. HbA1c had an optimal stability, which was superior to that of GA or 1,5-AG.

Background Glycated albumin (GA) levels are affected by body fat and its distribution. We explored the association of waist circumference (WC) with GA and to assess the extent to which WC influences GA. Methods We recruited 1799 subjects (age 26–82 y) from communities. GA was determined using the enzyme method, and glycated hemoglobin A1c (HbA1c) was detected using high-performance liquid chromatography. Results Subjects with central obesity had lower GA and GA/HbA1c than those without (both P Conclusions The GA value was reduced by approximately 0.15% for each 5 cm increment in WC, suggesting that more attention should be paid to actual blood glucose underestimated by GA in obese people.

Objective: To describe the effect of hemoglobin Wayne variant on hemoglobin A1c (A1c) accuracy and to stress the importance of patient-physician communication and trust.Methods: We present the clinical history and laboratory findings of 2 patients, with a review of related literature.Results: Two older patients were diagnosed with diabetes mellitus (DM) and suffered from frequent hypoglycemia resulting from titrating their diabetes medications based on an extremely elevated A1c (>11% &lsqb;97 mmol/mol]) obtained through high-performance liquid chromatography. Discrepancies were noticed between their blood glucose logs and their A1c results. Ultimately, both were found to have heterogenous hemoglobin Wayne variant by hemoglobin electrophoresis. Repeat immunoassay found the A1c to be very low, in the 5 to 6.2% (31 to 44 mmol/mol) range. One of the patients did not even meet diagnostic criteria for DM.Abbreviations: A1c = glycated hemoglobin;DM = diabetes mellitus;HPLC = high-performance liquid chromatographyConclusion: A1c testing is susceptible to misinterpretation due to multiple interfering factors. Hemoglobin variants should be considered as a differential when there are discrepancies between A1c and blood glucose levels. Trust between the patient and the physician is essential in raising clinical suspicion and avoiding potentially lethal outcomes.

Hypoglycemia is the major side effect of insulin therapy. The elderly are especially vulnerable to episodes of hypoglycemia, and with greater risks of complications such as falls. Two new long-acting basal insulins, glargine-300 (Gla-300) and degludec, are associated with lower incidences of hypoglycemia than previously available basal insulins. One of them, Gla-300, was studied in the elderly and has a lower incidence of hypoglycemia in patients over 65 years old. These new data should be incorporated into decision making when treating the elderly patient with insulin, whether they have type 1 or 2 diabetes. Abbreviations: A1c = glycated hemoglobin A1c Gla-100 = glargine 100 U/mL Gla-300 = glargine 300 U/mL GLP-1 RA = glucagon-like peptide-1 receptor analogue

Abbreviations: CGM = continuous glucose monitoring DCGM = Dexcom G4 Platinum CGM DKA = diabetic ketoacidosis DM = diabetes mellitus HbA1c = glycated hemoglobin A1c SGLT-2 = sodium glucose cotransporter 2

Background and Aims We undertook this study to compare the prevalence of coronary artery calcification (CAC) across glycated hemoglobin A1c (HbA1c) in nondiabetic males and to evaluate the impact of insulin resistance on CAC in relation to HbA1c levels. Methods A cross-sectional study was performed in 18,504 adult males without diabetes mellitus and cardiovascular disease (CVD). CAC scores were measured by multidetector computed tomography; CAC was defined as a CAC score >0. Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR). Subjects were grouped by HbA1c quartile (≤5.4%, 5.4–5.6%, 5.7%, 5.8–6.4%). Results Thirteen percent of subjects ( n = 2,406) had a CAC score >0. The prevalence of CAC increased with increasing HbA1c quartile (9.4%, 11.1%, 14.1%, 17.3%). Crude odds ratios (ORs) for CAC were 1.2, 1.58 and 2.01 for the HbA1c quartiles 2, 3, and 4 when compared with the first quartile. Mean HOMA-IR levels were different among HbA1C categories and CAC status. HOMA-IR levels were higher in subjects with CAC than in those without, except in the third HbA1c quartile. Stratification by HbA1c showed a significant association between CAC and insulin resistance only in the first (OR 1.67) and fourth (OR 1.33) HbA1c quartile. After adjustment for CV risk factors, insulin resistance remained an independent predictor of CAC only in the first HbA1c quartile. Conclusions Our study demonstrated that not only glucose status represented by HbA1c but also insulin resistance might be associated with CAC in non-diabetic Korean men. The magnitude of association of CAC with insulin resistance was greater in the lowest HbA1c quartile group.

Objectives: This study aimed to determine the relationship between glycaemic control and carotid atherosclerotic disease among patients with acute ischaemic stroke (AIS). Methods: This retrospective cross-sectional study took place in the Neurology Department of King Fahad Hospital of University, Khobar, Saudi Arabia, from April to October 2017. Data were collected from the medical records of 244 patients with a diagnosis of AIS confirmed by computed tomography. Doppler ultrasounds of the carotid artery were performed to determine the presence of increased carotid intima media thickness (CIMT) and plaques. Results: Significantly higher mean glycated haemoglobin (HbA1c) levels were noted in cases with high CIMT values (P = 0.002), but not in cases with carotid plaques (P = 0.360). In addition, there was a significant association between diabetes mellitus (DM) and high CIMT (P = 0.045), but not with carotid plaques (P = 0.075). Finally, while dyslipidaemia and age were independently correlated with high CIMT values (P = 0.034 and 0.050 each). Conclusion: High HbA1c levels were associated with high CIMT values, but not with carotid plaques. Therefore, HbA1c levels may be useful as an indirect marker of the initial stages of carotid artery atherosclerosis.Keywords: Glycated Hemoglobin A1c; Diabetes Mellitus; Carotid Intima-Media Thickness; Atherosclerotic Plaque; Stroke.

Background: The diagnostic cutoff points for indicators of type 2 diabetes mellitus (T2DM) in the pediatric population have not been defined thus far. Methods: A retrospective, single-center study was conducted from April 2003 to May 2016. We enrolled 236 overweight or obese children and adolescents aged 4–17 years. Thirty-nine (26.9%) of 145 patients had T2DM according to the oral glucose tolerance test results. Results: A glycated hemoglobin (HbA1c) level of 6.5% had a sensitivity and specificity of 87.2% and 98.5%, respectively, for detecting T2DM. The optimal HbA1c cutoff level for T2DM was >6.2% (94.7% sensitivity, 95.5% specificity). Conclusions: We observed that the use of an HbA1c level of 6.5% had a lower sensitivity for detecting T2DM than an HbA1c level of >6.2%.

BackgroundThe 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). ObjectiveWe 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. MethodsIn 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. ResultsUsers 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

Aims: Our aim was to investigate the impact of glycemic variability (GV) on the relationship between glucose management indicator (GMI) and laboratory glycated hemoglobin A1c (HbA1c). Methods: Adult patients with type 1 diabetes mellitus (T1D) were enrolled from five hospitals in China. All subjects wore the iPro™2 system for 14 days before HbA1c was measured at baseline, 3 months and 6 months. Data derived from iPro™2 sensor was used to calculate GMI and GV parameters [standard deviation (SD), glucose coefficient of variation (CV), and mean amplitude of glycemic excursions (MAGE)]. Differences between GMI and laboratory HbA1c were assessed by the absolute value of the hemoglobin glycation index (HGI). Results: A total of 91 sensor data and corresponding laboratory HbA1c, as well as demographic and clinical characteristics were analyzed. GMI and HbA1c were 7.20 ± 0.67% and 7.52 ± 0.73%, respectively. The percentage of subjects with absolute HGI 0 to lower than 0.1% was 21%. GMI was significantly associated with laboratory HbA1c after basic adjustment (standardized β = 0.83, p Conclusions: This study validated the GMI formula using the iPro™2 sensor in adult patients with T1D. GV influenced the relationship between GMI and laboratory HbA1c.

Summary Data from different studies correlating the serum 25(OH)D levels with the metabolic and glycemic parameters in type 2 diabetes patients are still varying. The objective if this study was to describe the correlation between serum 25(OH)D levels and some metabolic parameters in Bulgarian type 2 diabetes patients on oral antidiabetic drugs. One hundred type 2 diabetes patients participated - 56 men and 44 women. The mean age and diabetes duration of the women was 59.0 and 9.8 years, of the men - 58.0 and 7.7 years respectively. Complete patient history was taken and physical examination was performed (body weight and height, waist circumference). Body composition was measured on a leg-to-leg body impedance analyzer (TBF-215, Tanita Corp., Tokyo, Japan). Serum levels of vitamin D were measured by electro-hemi-luminescent detection as 25-(ОН) D Total (ECLIA, Elecsys 2010, Roche Diagnostics, Switzerland). Glycated hemoglobin A1c was measured on a NycoCard reader (Alere™). Total, HDL-cholesterol (direct) and triglycerides were analyzed on a Cobas Integra 400+ analyzer. Correlation analysis was performed on a SPSS 13.0 for Windows platform and included 10 curves. The data were first analyzed for the group as a whole and then separately for men and women as well as in the different vitamin D tertiles. The mean serum 25-OH-vitamin D levels were 23.8 ± 12.1 nmol/l in women and 33.3 ± 20.0 nmol/l in men. We were unable to find any statistically significant correlation between serum 25(OH) vitaminand the serum lipids (cholesterol profile and triglycerides). On the contrary, there was a weak correlation with the glycated hemoglobin A1c (cubic model, R2 = 0.178, p = 0.05) and the BMI (inverse model, R2 = 0.101, p = 0.038). The sub-analyses (men versus women or according to tertiles of vitamin D) did not produce any additional information. The influence of vitamin D on the parameters of the metabolic control in type 2 diabetes is very weak on an individual level. It might be only demonstrated in large epidemiological surveys.

Objective To compare the effectiveness of a free-mix of aspart (A) and detemir (D) insulins (ADIM) with a commonly used premixed fixed-ratio aspart and neutral protamine Hagedorn (NPH) insulin mixture (ANIM) in young children with type 1 diabetes (T1D) treated with twice-daily injections. The trial thus compares not only D vs. NPH, but also flexible, personalized insulin preparations vs. a fixed premixed preparation. Research design and methods This single-center, open-label, randomized trial included 82 children with T1D. Patients stayed on ANIM for 1 yr of optimization of disease management, then were randomized to either ANIM (N = 41) or ADIM (N = 41) for another year. Outcomes Frequency of severe or symptomatic episodes, glycated hemoglobin A1c (HbA1c), and blood glucose (BG) values. Results Compared with ANIM, ADIM decreases symptomatic hypoglycemia by approximately 2 fold (p < 0.001) and severe hypoglycemia by 7–10 fold (p = 0.04). ADIM somewhat reduced BG variation. Mean HbA1c was comparable on ADIM (7.9 ± 0.8 %; 63 ± 9 mmol/mol) and ANIM (8.2 ± 0.7 %; 66 ± 8 mmol/mol). Conclusions Using a free-mixing preparation of aspart and detemir insulin decreases hypoglycemia in young children with type 1 diabetes.

Heavy metals, defined as metals with densities higher than 5g/cm3, have the ability to interact with various physiological processes in the body with cardiovascular consequences. We sought to gain better understanding between the relationship of serum levels of heavy metals and serum total and LDL

Submitted for publication December 7, 2015 Accepted for publication December 16, 2015 From the MedStar Health Research and Diabetes Institutes, Washington, DC. Address correspondence to Michelle F. Magee, MedStar Health Research and Diabetes Institutes MDI, 100 Irving Street NW, EB4114, Washington, DC 20010. E-mail: michelle.f.magee@medstar.net DOI:10.4158/EP151162.CO To purchase reprints of this article, please visit: www.aace.com/reprints. Copyright © 2016 AACE. Abbreviations: A1C = glycated hemoglobin A1C; GLP-1 = glucagonlike peptide-1.

Many efforts have been made lately to develop cost-effective, simple, and reproducible tests for diabetes screening besides the already established fasting plasma glucose, the oral glucose tolerance test, and the glycated hemoglobin A1c. Several tests have been proposed lately, based on the measurement of the so-called advanced glycation endproducts (AGEs). AGEs production is exacerbated during hyperglycemia, and their accumulation in different tissues reflects the degree and duration of dysglycemia. The human lens represents a tissue where AGEs accumulation can be particularly well assessed. The present article comments on the article by Cahn et al. published in this issue of the Journal of Diabetes Science and Technology. Cahn and coauthors tested a new scanning confocal biomicroscope for its accuracy to detect noninvasively subjects with diabetes or at risk for developing diabetes.

The development of cost-effective, simple, and reproducible tests for diabetes screening represents a priority of modern medicine in light of the increasing prevalence of diabetes mellitus. Besides fasting plasma glucose, the oral glucose tolerance test, and glycated hemoglobin A1c, several tests have been proposed, among them the assessment of skin fluorescence spectroscopy (SFS). This article comments on the article by Olson and coauthors published in this issue of Journal of Diabetes Science and Technology and comprehensively reviews related available information. Overall, SFS seems to represent an easy-to-use, noninvasive tool that adds value to existing tests for diabetes screening.

BACKGROUND: Hyperglycemia has been detected in many critically ill patients in the department of emergency medicine. But its mechanism and prognosis have not been well elucidated. In this study, we measured the serum level of glycated hemoglobin A1C (HbA1c) in critically ill patients to evaluate the effects of hyperglycemia on the prognosis of the patients. METHODS: A total of 826 critically ill patients, who had been treated at the Department of Emergency Medicine of Chaoyang Hospital during October 2006 and November 2007, were divided into a diabetes mellitus group (n=184) and a non-diabetes mellitus group (642) according to whether they had diabetes mellitus. Fasting glucose and HbA1c were measured in all patients. Those in the diabetes mellitus group were further assigned to a drug therapy subgroup and a non-drug therapy subgroup; the serum level of HbA1c and its relationship with short-term outcome were evaluated. RESULTS: Fasting glucose increased in 78.8% of the patients (88.6% in the diabetes mellitus group, and 75.9% in the non-diabetes mellitus group, P8.33 mmol/L than in those with fasting blood glucose

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

As retinopathy is used as a defining threshold of diabetes, we assessed the glycated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) values associated with an increased risk of 5-year incidence of retinopathy.We studied HbA1c, FPG, and optic fundus findings of 2605 individuals without previously diagnosed diabetes annually during a 5-year period. Retinopathy was examined using non-mydriatic, 45° digital fundus photography. Baseline levels were stratified as5.3 [34], 5.3-5.6 [34-38], 5.7-6.0 [39-42], 6.1-6.4 [43-47], and ⩾6.5% [48mmol/mol] for HbA1c and5.0, 5.0-5.5, 5.6-6.0, 6.1-6.9, and ⩾7.0mmol/L for FPG. Cox proportional hazard models were used to analyze hazard ratios (HRs) associated with HbA1c or FPG for incident retinopathy.During a total of 11845 person-years, we identified 50 (1.9%) cases of incident retinopathy. The adjusted HRs for incident retinopathy associated with a one-standard deviation increase in HbA1c and FPG were 1.2 (95% confidence intervals: 1.1-1.4) and 1.2 (1.1-1.4), respectively. These HRs were significantly higher for a HbA1c level ⩾6.5% (48mmol/mol) (3.4 [1.1-10.2]) or FPG level ⩾7.0mmol/L (3.6 [1.1-11.6]) than for a HbA1c level5.3% (34mmol/mol) or FPG level5.0mmol/L.A HbA1c value of 6.5% (48mmol/mol) and FPG value of 7.0mmol/L might be proper as diabetes diagnostic thresholds that indicate a high risk of future retinopathy.

Glycated hemoglobin A1c is used to estimate glycemic control. However, its value upon ICU admission may be altered by critical illness and not reflect true glycemic status. We assessed the relationship between ICU admission glycated hemoglobin A1c and premorbid glycated hemoglobin A1c levels.Retrospective observational cohort study.Two tertiary ICUs in Australia.Cohort of 69 critically ill patients with diabetes and glycated hemoglobin A1c levels measured upon ICU admission and during the month prior to admission.Measurement of glycated hemoglobin A1c.Mean (SD) glycated hemoglobin A1c level was 7.5% (1.8%) upon ICU admission and 7.8% (2.0%) in previous measurements from the preceding 30 days. The change in glycated hemoglobin A1c did not correlate with time elapsed between the two measurements (r = 0.00005; p = 0.95), but there was a strong correlation between admission glycated hemoglobin A1c levels and premorbid glycated hemoglobin A1c levels (r = 0.89; p0.001).Glycated hemoglobin A1c levels are not altered by the onset of critical illness. Glycated hemoglobin A1c quantified at ICU admission can, therefore, be used to reliably estimate chronic glycemic control and guide acute glycemic therapy.

Objectives: This study aimed to highlight the association of HbA1c with diabetic related complications. Material and Methods: This retrospective study has been conducted in endocrinology department of Alnoor Specialist Hospital, Makkah, Saudi Arabia, from January 2007 to December 2009. Data has been collected from diabetic patients’ files that were referred to the diabetes outpatient department either because of consultation from other health care centers or from other departments of the same hospital due to diabetes related complications. Patients’ files were reviewed for levels of HbA1c and diabetes related complications. The values of HbA1c were considered at the time of diagnosis of complications. Results: The total study subjects were 110 with mean HbA1C was 7.3 with range (5.9-11.3). Only significant association between the HbA1c and diabetic septic foot was seen (p value=0.037) while values of regression showed that HbA1c is best correlated with cardiovascular disease (R=0.39, Beta =0.004 and pvalue = 0.104). Conclusion: Our study results showed insignificant association between the HbA1c and diabetic complications except that of with diabetic septic foot.

Aim: Many reports have shown that vegetable intake is effective in inhibiting the onset and progression of diabetes mellitus, although the amount of vegetable intake required to be effective remains as unclear. The present study therefore aimed to clarify the relationship between the amount of vegetable intake and glycated hemoglobin A1c (HbA1c) and other metabolic parameters using male Japanese type 2 diabetic patients aged 65 years or older as subjects. Method: Participants were 417 male type 2 diabetic patients aged 65 years or older enrolled in the Japanese Elderly Diabetes Intervention Trial. Dietary intakes were measured by using the Food Frequency Questionnaires method. The patients were divided into five groups by their daily total vegetable intake (A1: ∼100 g, A2: 100∼150 g, A3: 150∼200 g, A4: 200∼300 g, A5: 300 g∼), and compared HbA1c and other metabolic parameters. Furthermore, the relationship between daily green vegetable intake and HbA1c and other metabolic parameters were examined among five groups divided by quintile methods. Results: There were significant decreases in HbA1c, triglycerides and waist circumference with an increase of total vegetable intake. A significant decrease of HbA1c levels was observed in patients with a daily total vegetable intake of 150 g or more. Furthermore, there was a significant decrease of serum triglyceride levels in patients with a total vegetable intake of 200 g or more. HbA1c levels showed a decreasing tendency with the increase of green vegetable intake, and HbA1c levels in the Q1 group (green vegetable intake: less than 40 g) was significantly higher than those in the other four groups (anovaP = 0.025). In addition, there were significant decreases of body mass index, triglyceride levels and waist circumference with the increase of green vegetable intake. Triglyceride levels decreased significantly from the Q3 group (green vegetable intake: 70 g or more) to the Q5 group (green vegetable intake: 130 g or more; anovaP = 0.016). In the group with a lower intake of total vegetables and green vegetables, the protein energy ratio decreased significantly. As a result, the fat energy ratio and energy intake tended to increase with the decrease of total and green vegetable intakes. Furthermore, intake of grains, sweets and alcoholic beverages increased with the decrease of total vegetable intake. In contrast, intake of nuts, potatoes, sugar, legumes, fruit, seaweed and fish increased with the increase of total vegetable intake Conclusions: Daily total vegetable intake of 200 g or more, and green vegetable intake of 70 g or more correlated with improved control of HbA1c and triglyceride levels in elderly type 2 diabetes patients through achieving a well-balanced diet. Geriatr Gerontol Int 2012; 12 (Suppl. 1): 50–58.

Objectives: This study aimed to compare the value of serum glycated albumin (GA) level versus glycated hemoglobin A1c (HbA1c) for evaluating the presence and severity of coronary artery disease (CAD) in patients with type 2 diabetes mellitus (T2DM). Methods: Serum GA and blood HbA1c levels were measured in 829 consecutive T2DM patients with or without angiographically documented significant CAD (≥70% diameter stenosis). Results: Serum GA levels were higher in diabetic patients with significant CAD than in those without (20.57 ± 4.23 vs. 19.00 ± 4.48%; p < 0.001), but HbA1c was similar in the two groups (7.74 ± 1.34 vs. 7.51 ± 1.37% p > 0.05). Compared to HbA1c, GA correlated more closely with the sum of significant stenotic lesions (r = 0.275, p < 0.001 and r = 0.092, p = 0.019) and the extent index (r = 0.375, p < 0.001 and r = 0.091, p = 0.019). The area under the curve of GA was larger than that of HbA1c for detecting the presence of significant CAD (0.637 vs. 0.568; p = 0.046) and 3-vessel disease (0.620 vs. 0.536; p = 0.039). GA, but not HbA1c, was independently associated with significant CAD. Conclusions: Serum GA level is a better indicator than HbA1c for evaluating the presence and severity of CAD and predicting major adverse cardiac events in patients with T2DM.

To investigate which glycemic index is more strongly associated with colorectal neoplasia.This cross-sectional study enrolled 2,776 participants in a comprehensive health management program which included measurement of fasting plasma glucose and HbA1c, along with screening colonoscopy. Primary outcome was colorectal adenoma with or without dysplasia. Risk factors for colorectal neoplasia were determined by the multivariate regression analysis, which evaluated the interrelationship among different glycemic indices in a hierarchical way.Colorectal neoplasms were found in 605 (21.79%) examinees, 68 (2.45%) of whom had high-risk tumors. Glycemic indices including diagnosis of diabetes mellitus, fasting plasma glucose, and HbA1c were all associated with colorectal tumors in the univariate analysis. However, HbA1c outperformed the other two markers as an independent risk factor (adjusted odds ratio, 1.22; 95% confidence interval, 1.10-1.36%) for colorectal neoplasia. Moreover, only HbA1c remained independently associated with colorectal tumor after patients with established diagnosis of diabetes (n = 132) were excluded. We also identified age, male gender, and smoking were independent risk factors for colorectal neoplasia.HbA1c as compared with fasting plasma glucose is more strongly and independently associated with colorectal neoplasia. Further research is warranted to elucidate the value of HbA1c in stratifying risk of colorectal cancer.