Fingerstick Precision and Total Error of a Point-of-Care HbA1c Test

Background:Point-of-care (POC) HbA1c tests hold the promise of reducing the rates of undiagnosed diabetes, provided they exhibit acceptable analytical performance. The precision and total error of the POC (Afinion™ HbA1c Dx) test were investigated using whole blood samples obtained by fingerstick and venipuncture.Methods:Fingerstick samples spanning the assay range were collected from 61 subjects at three representative POC sites. At each site, six fingerstick samples were obtained from each subject and tested on the POC test across two (Afinion AS100) instruments. Repeatability, between-operator, and between-instrument components of variance were calculated using analysis of variance (ANOVA). Four venous samples (low, threshold, medium, and high HbA1c) were measured in duplicate across three instruments using three reagent lots, twice per day over 20-days. Repeatability, between-run, between-day, between-lot, and between-instrument components of variance were calculated. These fingerstick and venous blood results, combined with estimates of imprecision and bias from a prior investigation, allowed for the calculation of the total coefficient of variation (CV) and total error of the POC test using fingerstick and venous whole blood samples.Results:The total imprecision ranged from 1.30% to 2.03% CV using fingerstick samples and from 1.31% to 1.64% CV using venous samples. The total error ranged from 2.87% to 4.75% using fingerstick samples and from 2.93% to 3.80% using venous samples.Conclusions:The POC test evaluated here is precise across its measuring range using both fingerstick and venous whole blood. The calculated total error of the test is well under the accepted quality requirement of ≤6%.     

8种糖化血红蛋白床旁检测仪性能的分析

目的 提出一套评估HbA1C床旁检测（POC）仪器性能验证的程序。方法针对一篇已发表的评估HbA1CPOC仪器性能的研究,依据临床和实验室标准化研究院（CLSI）EP-5文件获得不精密度,CLSIEP-9文件获得比对数据,运用误差网格图对比,对结果进行分析。结果HbA1C不精密度分析显示,两个不同浓度水平（约5％和11％）的C唰范围为1．4％（HbA1c浓度6．3％）～5．3%（HbA1c浓度6．1％）,8台仪器中仅2台满足c蹦为3．O％要求,建议浓度范围在医学决定水平上,HbA1C两个浓度水平最好为6．5％和9．0％。方法比对中,按照美国国家糖化血红蛋白标准化组织（NGSP）0．85％的标准,仅2台仪器能满足性能要求。结论HbA1cPOC仪器为患者监测血糖带来了便利,但其性能暂不理想。     

Laboratory Advances in Hemoglobin A1c Measurement: Hemoglobin A1c Point-of-Care Assays; a New World with a Lot of Consequences!

Background

Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols.

Methods

The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center.

Results

At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods.

Conclusion

Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly.     

A1cNow? InView?: A New Simple Method for Office-Based Glycohemoglobin Measurement

Background

Glycohemoglobin A1c (HbA1c) is a universally accepted tool for glycemic control. Portable HbA1c devices for use in physicians'' offices are desirable because they provide immediate results that physicians can share with their patients. This has been shown to enhance self-management in patients with diabetes. We undertook this study to evaluate the accuracy and precision of a recently introduced device, the A1cNow® InView™ capillary monitor.

Methods

Previously tested EDTA-preserved whole blood samples from our laboratory pool were preselected based on the results of HbA1c to cover a range from 4 to 13%. HbA1c was then measured using an A1cNow InView capillary monitor. Blinded aliquots of these samples were then sent to a National Glycohemoglobin Standardization Program (NGSP)-certified reference laboratory for comparison. One sample with a laboratory HbA1c result of 9.2% was measured with the InView device nine successive times to assess the device precision. The consistency between the measurement of HbA1c measured by the reference laboratory and the A1cNow InView device was analyzed via linear regression.

Results

Thirty-five samples were tested. The correlation between HbA1c measured by the InView device and the reference laboratory, as well as our own laboratory, was 0.96. The coefficient of variation was 2.71%.

Conclusions

Results of this study confirm the accuracy and precision of the InView capillary HbA1c monitor. However, the feasibility, reproducibility, and cost-effectiveness of this promising device in the real-life settings of physicians'' offices must be verified by prospective clinical studies.     

Factors associated with hypoglycemia unawareness and severe hypoglycemia in type 1 diabetes mellitus patients

Aims/IntroductionSeveral factors are associated with hypoglycemia unawareness and severe hypoglycemia, but few large studies have analyzed Japanese patients with type 1 diabetes. The aim of this study was to analyze the risk factors for hypoglycemia unawareness and severe hypoglycemia in Japanese type 1 diabetes patients.Materials and MethodsA self‐administered questionnaire investigated events, complications and treatments associated with hypoglycemia in patients with type 1 diabetes. Multiple logistic regression analysis of factors associated with hypoglycemia unawareness and severe hypoglycemia requiring medical treatment was carried out. The coefficient of variation (CV) of blood glucose levels was determined using blood samples collected at six outpatient visits.ResultsOf the 1,619 participants, 44.2% and 10.4% experienced hypoglycemia unawareness and severe hypoglycemia, respectively. Mean HbA1c levels in patients with hypoglycemia unawareness were lower than those in patients without hypoglycemia unawareness. The type 1 diabetes subtype, glycated hemoglobin (HbA1c) level, CV of blood glucose levels and history of severe hypoglycemia requiring medical treatment were significant independent variables predicting the presence of hypoglycemia unawareness. The glucose CV and a history of hypoglycemia unawareness were significant independent variables predicting severe hypoglycemia requiring medical treatment. In stratified analyses of patients divided into four groups according to glucose CV and HbA1c levels, the high‐glucose‐CV/low‐HbA1c group had the highest odds ratios for hypoglycemia unawareness (2.60) and severe hypoglycemia requiring medical treatment (2.55).ConclusionsThe ambulant glucose CV correlated with both hypoglycemia unawareness and severe hypoglycemia. Patients with high glucose CV and low HbA1c are at high risk of such adverse events, and their treatment strategies should be reviewed.     

Acute and Chronic Glucose Control in Critically Ill Patients With Diabetes: The Impact of Prior Insulin Treatment

Background:Emerging data highlight the interactions of preadmission glycemia, reflected by admission HbA1c levels, glycemic control during critical illness, and mortality. The association of preadmission insulin treatment with outcomes is unknown.Methods:This observational cohort study includes 5245 patients admitted to the medical-surgical intensive care unit of a university-affiliated teaching hospital. Three groups were analyzed: patients with diabetes with prior insulin treatment (DM-INS, n = 538); patients with diabetes with no prior insulin treatment (DM-No-INS, n = 986); no history of diabetes (NO-DM, n = 3721). Groups were stratified by HbA1c level: <6.5%; 6.5%-7.9% and >8.0%.Results:Among the three strata of HbA1c, mean blood glucose (BG), coefficient of variation (CV), and hypoglycemia increased with increasing HbA1c, and were higher for DM-INS than for DM-No-INS. Among patients with HbA1c < 6.5%, mean BG ≥ 180 mg/dL and CV > 30% were associated with lower severity-adjusted mortality in DM-INS compared to patients with mean BG 80-140 mg/dL and CV < 15%, (P = .0058 and < .0001, respectively), but higher severity-adjusted mortality among DM-No-INS (P = .0001 and < .0001, respectively) and NON-DM (P < .0001 and < .0001, respectively). Among patients with HbA1c ≥ 8.0%, mean BG ≥ 180 mg/dL was associated with lower severity-adjusted mortality for both DM-INS and DM-No-INS than was mean BG 80-140 mg/dL (p < 0.0001 for both comparisons).Conclusions:Significant differences in mortality were found among patients with diabetes based on insulin treatment and HbA1c at home and post-admission glycemic control. Prospective studies need to confirm an individualized approach to glycemic control in the critically ill.     

Glycated Hemoglobin Measurement: Comparison of Three Methods Versus High Performance Liquid Chromatography

Background:HbA1c result provide information on metabolic control in diabetes mellitus (DM) and could also be used for its diagnosis. For its determination, the laboratory must be certified by the National Glycohemoglobin Standardization Program (NGSP) or the International Federation of Clinical Chemistry (IFCC) and comply with a strict quality control program.Aims:To determine the correlation and agreement between HbA1c results measured by three analytical methods (enzymatic, turbidimetric, and capillary electrophoresis) versus HPLC.Methods:Method comparison—1245 samples from equal number of subjects at 45 Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad—ALAC) centers, centralizing sample processing and operator. Statistical analysis—analysis of variance (ANOVA) and nonparametric Friedman ANOVA test for related samples, means, and medians. Correlation and concordance—Pearson’s correlation and linear regression, intraclass correlation coefficient (Passing and Bablock and Bland and Altman).Results:The comparison of mean values obtained by the four methods showed statistically significant, but clinically irrelevant, differences: HbA1c by HPLC versus Electrophoresis 0.06% (0.42 mmol/mol) P = .000 (± 1.96 DS -0.070 -0.047), Enzymatic 0.087% (1 mmol/mol) P = .000 (± 1.96 DS 0.077 0.098), Turbidimetric 0.056% (0.38 mmol/mol) P = 0.000 (± 1.96 DS -0.067 -0.044). Their concordance showed intraclass correlation of single measures of 0.982 P < .001 (95% CI 0.987 - 0.9838).Conclusions:The three methods present low variability and high correlation versus the HPLC.     

Glycemic Metrics Derived From Intermittently Scanned Continuous Glucose Monitoring

Background:Glucose data from intermittently scanned continuous glucose monitoring (isCGM) is a combination of scanned and imported glucose values. The present knowledge of glycemic metrics originate mostly from glucose data from real-time CGM sampled every five minutes with a lack of information derived from isCGM.Methods:Glucose data obtained with isCGM and hemoglobin A1c (HbA1c) were obtained from 169 patients with type 1 diabetes. Sixty-one patients had two observations with an interval of more than three months.Results:The best regression line of HbA1c against mean glucose was observed from 60 days prior to HbA_1c measurement as compared to 14, 30, and 90 days. The difference between HbA1c and estimated HbA1c (=glucose management indicator [GMI]) first observed correlated with the second observation (R2 0.61, P < .001). Time in range (TIR, glucose between 3.9 and 10 mmol/L) was significantly related to GMI (R2 0.87, P < .001). A TIR of 70% corresponded to a GMI of 6.8% (95% confidence interval, 6.3-7.4). The fraction of patients with the optimal combination of TIR >70% and time below range (TBR) <4% was 3.6%. The fraction of patients with TBR>4% was four times higher for those with high glycemic variability (coefficient of variation [CV] >36%) than for those with lower CV.Conclusion:The individual difference between HbA1c and GMI was reproducible. High glycemic variability was related to increased TBR. A combination of TIR and TBR is suggested as a new composite quality indicator.     

Increased incidence of pre-diabetes mellitus at a department of rheumatology: a retrospective study

Abstract

We aimed to retrospectively review the incidence of pre-diabetes mellitus (preDM), one of the factors in metabolic syndrome screening, in patients with rheumatic diseases. We examined the levels of hemoglobin A1c (HbA1c) in a total of 498 patients with rheumatic diseases between April 2007 and March 2008 at the Department of Rheumatology in Nagasaki University Hospital. Of the 498 patients, 409 (82.1%) had HbA1c levels higher than 5.6% (National Glycohemoglobin Standardization Program; NGSP) and were recommended for health guidance with a focus on metabolic syndrome. Serum HbA1c levels higher than 6.0%, a possible indicator of DM, were seen in 227 patients (45.6%). Serum HbA1c levels higher than 6.5%, which constitute a high risk for DM, were found in 115 patients (23.1%). PreDM increased gradually with age. Our results suggest that the incidence of preDM may be higher in patients with rheumatic diseases than in patients with other diseases and that these patients should receive healthcare guidance to prevent metabolic syndrome.     

Childhood Diabetes in the Nordic Countries: A Comparison of Quality Registries

Background:In 2008 a Nordic collaboration was established between the quality registries in Denmark, Iceland, Norway, and Sweden to improve quality of care for children with diabetes. This study aimed to describe those registries and confirm that the registry variables are comparable. Selected variables were used to demonstrate outcome measurements.Methods:The organization of the registries and methodology are described. Cross-sectional data for patients between birth and 14.9 years with type 1 diabetes mellitus in 2009 (n = 6523) from 89 centers were analyzed. Variables were age, gender, and diabetic ketoacidosis at onset, together with age, gender, HbA1c, insulin regimen, and severe hypoglycemia at follow-up in 2009.Results:All 4 registries use a standardized registration at the onset of diabetes and at follow-up, conducted at the local pediatric diabetes centers. Methods for measuring HbA1c varied as did methods of registration for factors such as hypoglycemia. No differences were found between the outcomes of the clinical variables at onset. Significant variations were found at follow-up for mean HbA1c, the proportion of children with HbA1c < 57 mmol/mol (NGSP/DCCT 7.4%), (range 15-31%), the proportion with insulin pumps (range 34-55%), and the numbers with severe hypoglycemia (range 5.6-8.3/100 patient years).Conclusions:In this large unselected population from 4 Nordic countries, a high proportion did not reach their treatment target, indicating a need to improve the quality of pediatric diabetes care. International collaboration is needed to develop and harmonize quality indicators and offers possibilities to study large geographic populations, identify problems, and share knowledge.     

Accuracy and precision of the Axis-Shield Afinion hemoglobin A1c measurement device

Background

The Afinion HbA1c (Axis-Shield) is a newer point-of-care device for measurement of hemoglobin A1c (A1C) using a boronate affinity method unlike the more commonly used DCA immunoassay method (Siemens Medical Solutions Diagnostics). The Afinion’s accuracy and precision, when compared with high-performance liquid chromatography (HPLC) and DCA methods, have not been established in pediatric practice settings.

Methods

Capillary blood was collected from 700 subjects with diabetes mellitus at seven Pediatric Diabetes Consortium sites. Each subject’s A1C was measured locally using Afinion and DCA devices, and by a central laboratory (University of Minnesota) using a Tosoh HPLC method. In addition, repeated measurements on six whole blood samples provided by the National Glycohemoglobin Standardization Program (NGSP) were taken at three clinical centers using the Afinion and DCA methods and centrally using the Tosoh HPLC method to assess the precision of each device.

Results

The coefficient of variation for measurements of whole blood samples for precision analysis was 2% for Afinion, 3% for DCA, and 1% for HPLC. In the patient samples measured at the seven clinic sites, the Afinion generated higher A1C results than the HPLC (mean difference = +0.15; p < 0.001), while the DCA produced lower values (mean difference = -0.19; p < 0.001). The absolute differences with HPLC were similar for the Afinion and DCA (median 0.2%) with a slight advantage for the Afinion when compared with DCA (p < 0.001 by rank test). The DCA tended to read lower than HPLC, particularly at high A1C levels (p < 0.001), while the Afinion’s accuracy did not vary by A1C.

Conclusions

When compared to the central laboratory HPLC method, the differences between the results of the Afinion and DCA devices are clinically insignificant, and the Afinion and DCA have similar accuracy and precision when used in pediatric practice settings.     

Analysis of Point-of-Care and Over-the-Counter Testing Methods for Hemoglobin A1c: How Good Do They Need To Be?

In this issue of Journal of Diabetes Science and Technology, Chang and colleagues evaluate the performance of the A1CNow^® SELFCHECK device for measurement of hemoglobin A1c (HbA1c). The authors discuss the potential advantages of point-of-care (POC) HbA1c testing and also mention the importance of accuracy and precision and provide some data to document the device’s performance. There are specific criteria for HbA1c method evaluation and proficiency testing used by the National Glycohemoglobin Standardization Program and the College of American Pathologists. Chang and colleagues mention these criteria but chose wider performance limits for their evaluation of the A1cNow SELFCHECK. Given the available data on the relationship between HbA1c and risk for complications, assay method performance is a vital consideration when HbA1c results, including those from POC methods, are used in the management of patients with diabetes.     

Association between fat mass index,fat‐free mass index and hemoglobin A1c in a Japanese population: The Tohoku Medical Megabank Community‐based Cohort Study

Aims/IntroductionFat mass and fat‐free mass affect glycated hemoglobin A1c (HbA1c) levels and blood glucose levels, respectively. The aim of the present study was to examine the association between the fat mass index and fat‐free mass index with HbA1c.Materials and MethodsWe carried out a cross‐sectional study that included 3,731 men and 9,191 women aged ≥20 years, living in Miyagi Prefecture, Japan, who were not treated for diabetes. The fat mass index and fat‐free mass index were calculated as fat mass and fat‐free mass divided by the height squared, respectively. The indices were classified into sex‐specific quartiles and combined into 16 groups. An analysis of covariance was used to assess associations between the combined fat mass index and fat‐free mass index with HbA1c adjusted for potential confounders. The linear trend test was carried out by stratifying the fat mass index and fat‐free mass index, entering the number as a continuous term in the regression model.ResultsIn multivariable models, a higher fat mass index was related to higher HbA1c levels in men and women in all fat‐free mass index subgroups (P < 0.001 for linear trend). When we excluded the participants who had been identified as having diabetes, the fat‐free mass index was also related to higher HbA1c levels in most fat mass index subgroups (P < 0.05 for linear trend).ConclusionsFat mass index was positively related to HbA1c levels. The fat‐free mass index was also related to HbA1c levels when we excluded participants who had been identified as having have diabetes.     

Stability of haemoglobin A1c (HbA1c) measurements from frozen whole blood samples stored for over a decade.

OBJECTIVE: Haemoglobin A1c (HbA1c), a measure of long-term glycaemic control, is at the centre of the clinical management of diabetes mellitus. However, the reproducibility of HbA1c measurements from whole blood samples which have been in long-term storage is unknown. We undertook this study to assess the reproducibility of HbA1c measurements from whole blood samples that had been in storage at -70 degrees C for over a decade. RESEARCH DESIGN AND METHODS: Three hundred and thirty-six samples of frozen whole blood from the Atherosclerosis Risk in Communities (ARIC) Study, stored at -70 degrees C for 11-14 years assayed for HbA1c using a dedicated ion-exchange HPLC assay (Tosoh A1c 2.2 Plus HPLC) were compared with measurements on these same samples conducted prior to storage (in 1990-92) using a Diamat (Bio-Rad) HPLC instrument. RESULTS: HbA1c measurements from long-term stored samples were strongly correlated with values obtained prior to long-term storage (r=0.97). The difference between HbA1c from long- and short-term stored samples had a mean of 0.35% HbA1c (sd=0.35) and a CV of 5.8%, which was approximately three times that of duplicate assays (CV 1.3 to 2.5%). CONCLUSIONS: These data demonstrate that highly correlated but more variable and slightly higher HbA1c results were obtained from frozen whole blood samples that have been in storage for more than a decade. This highly reproducible assay performance would lead to comparable ranking of individuals and unbiased estimates of relative risks and odds ratios in epidemiological studies (case-control and cohort designs), but results should be realigned when the absolute value is of interest. These results have important implications for epidemiological studies and clinical trials which have stored whole blood specimens.     

The Impact of Point-of-Care Hemoglobin A1c Testing on Population Health-Based Onsite Testing Adherence: A Primary-Care Quality Improvement Study

Background:The hemoglobin A1c (HbA1c) is a gold-standard test to diagnose and monitor diabetes mellitus and has been incorporated into population health performance metrics for quality care. However, patients and practices remain challenged in completing timely HbA1c tests. Point-of-care testing (POCT) for HbA1c provides a quick, easy, reliable method for monitoring diabetes in the primary care office setting. The objectives of this quality improvement study were to evaluate the impact of HbA1c POCT on onsite HbA1c testing frequency as a component of population health performance, as well as to measure the utility of HbA1c POCT in identifying clinically meaningful change in disease.Method:Prospective quality improvement cohort study among sequentially scheduled adult patients with diabetes due for HbA1c testing across three primary care practices.Results:Practices with HbA1c POCT were 3.7 times less likely to miss HbA1c testing at the time of the visit compared with practices in which HbA1c POCT was not available (P < .001). Nearly one in four patients in each group were found to have clinically worsening diabetes (defined by an increase in HbA1c of ≥0.5% or 5.5 mmol/mol). Nearly half of those patients in the intervention group were identified by POCT.Conclusions:HbA1c POCT can improve population health-driven HbA1c testing adherence at office visits in primary care and may enable more timely intervention of diabetes management for patients with worsening disease.     

An Examination of the Glucose Management Indicator in Young Children with Type 1 Diabetes

Background:Previous studies utilizing glucose data from continuous glucose monitors (CGM) to estimate the Glucose Management Indicator (GMI) have not included young children or determined appropriate GMI formulas for young children with type 1 diabetes (T1D).Methods:We extracted CGM data for 215 children with T1D (0-6 years) from a repository. We defined sampling periods ranging from the 3-27 days prior to an HbA1c measurement and compared a previously established GMI formula to a young child-specific GMI equation based on the sample’s CGM data. We examined associations between HbA1c, GMI values, and other CGM metrics for each sampling period.Results:The young child-specific GMI formula and the published GMI formula did not evidence significant differences when using 21-27 days of CGM data. The young child-specific GMI formula demonstrated higher correlations to laboratory HbA1c when using 18 or fewer days of CGM data. Overall, the GMI estimate and HbA1c values demonstrate a strong relationship in young children with T1D.Conclusions:Future research studies may consider utilizing the young child-specific GMI formula if the data collection period for CGM values is under 18 days. Further, researchers and clinicians may consider changing the default number of days of data used to calculate glycemic metrics in order to maximize validity of CGM-derived metrics.     

Clinical Evaluation of a Novel On-Strip Calibration Method for Blood Glucose Measurement

Background:This study evaluated a novel technology for improving accuracy of self-monitoring of blood glucose (SMBG). The technology calibrates each and every test by measuring the response from a predetermined amount of glucose present in the sample chamber of each test strip.Method:SMBG test strips were modified to include a lid coated with a fast dissolving formulation containing glucose. These test strips were characterized for hematocrit (Hct) and temperature induced error response to develop a calibration algorithm. The modified test strips were used in a clinical evaluation involving fingerstick blood samples from 160 subjects.Results:Experiments involving Hct and temperature induced errors show that the technology generates a signal characteristic of the error conditions in any particular test, but independent of glucose concentration, allowing a correction algorithm to be derived. The approach substantially reduced Hct and temperature derived errors. Clinical evaluation using fingerstick blood directly applied to prototype strips showed the error (measured as MARD) was reduced from 11.1 to 5.9% by the on-strip correction approach and the number of outliers reduced by approximately 90%.Conclusion:This technology could improve the accuracy and precision of glucose monitoring systems and so reduce decision errors particularly in clinical situations where hematocrit and temperature may be significant confounders.     

Multimorbidity Among Adult Outpatients With Type 1 Diabetes in Germany

Aim:The aim of this cross-sectional retrospective study was to estimate the prevalence of different physical and psychiatric disorders as well as multimorbidity in outpatients with type 1 diabetes (T1D) in Germany.Methods:A total of 6967 adult patients with T1D from 958 general or diabetologist practices in Germany between January 2015 and December 2019 from the Disease Analyzer database (IQVIA) were included. The main outcome of the study was the prevalence of different diabetes-related and nondiabetes-related disorders within 12 months prior to the last outpatient visit. Multivariate logistic regression models were fitted with multimorbidity differently defined as >2, >3, >4, and >5 different disorders as a dependent variable and age, sex, glycated hemoglobin (HbA1c) values, and insulin pump therapy as impact variables.Results:Mean age (standard deviation [SD]) was 45.3 (16.7) years; 42.9% were women, the mean HbA1c was 7.9% (SD: 1.4%). The most frequent disorder was arterial hypertension (31.2%), followed by dyslipidemia (26.4%), dorsalgia (20.4%), diabetic neuropathy (17.3%), and depression (14.6%). The proportion of thyroid gland disorders, retinopathy, urethritis, iron deficiency anemia, and psychiatric disorders was higher in women than in men. Hypertension and mental and behavioral disorders due to the use of tobacco were higher in men. On average, each patient was diagnosed with 3.1 different disorders. Age had the strongest association with multimorbidity, followed by HbA1c value and female sex.Conclusion:In summary, patients with T1D are often multimorbid, and the multimorbidity is associated with higher gender, female sex, and high HbA1c values. Understanding all of these factors can help practitioners create a risk profile for every patient.     

HbA1c Is Disproportionately Higher in Women and Older People With Type 1 Diabetes Compared With Flash Glucose Monitoring Metrics of Glycemic Control

Aims:Discrepancy between HbA1c and glucose exposure may have significant clinical implications. We sought to assess predictors of disparity between HbA1c and flash monitoring metrics and how these relate to microvascular complications.Methods:We conducted a cross-sectional study of adults with type 1 diabetes (n = 518). We assessed the relationship between clinic HbA1c and flash monitoring metrics, predictors of discrepancy between these measurements, and whether discrepancy was associated with microvascular complications.Results:Actual HbA1c and estimated HbA1c were strongly correlated (r = .779, P < .001). The likelihood of having a higher actual HbA1c than estimated HbA1c was greater with increasing age (OR = 1.055 per year, P < .001) and lower in men (OR = .208, P < .001). HbA1c was significantly lower in men (58 mmol/mol [51-67]) (7.5% [6.8-8.3]) compared to women (61 mmol/mol [54-70], P = .021) (7.7% [7.1-8.6]), despite no significant differences in any flash monitoring metrics. Whereas HbA1c was not different between younger (≤39 years) and older individuals (>39 years) despite significantly higher glucose exposure, in younger people, based on multiple flash monitoring metrics. Having a lower estimated than actual HbA1c was independently associated with a lower prevalence of retinopathy (OR = .55, P = .004).Conclusions:HbA1c appears to overestimate glucose exposure in women and older people with type 1 diabetes. This has potentially important clinical implications, as is hinted at by the independent relationship with retinopathy prevalence. It may also be of relevance when considering the use of HbA1c for the diagnosis of diabetes.     

V-shaped relationship between HbA1c and all-cause mortality in the elderly with type 2 diabetes

PurposeThe optimal glycemic target for elderly patients with diabetes has not been established. The purpose of this study was to elucidate relationship between HbA1c and mortality in elderly patients with diabetes.SubjectsThree hundred consecutive elderly (≥ 65 yrs) patients with type 2 diabetes mellitus admitted for control of hyperglycemia between 2002 and 2010 were registered. Upon mortality survey at the end of 2012, 201 (70%) of them were traceable (men/women 121/80, mean age 71 yrs, duration of diabetes 11 yrs and HbA1c 9.9%). The analysis took account of the following baseline information: gender, age, duration of diabetes, HbA1c, body mass index, systolic blood pressure, eGFR, urinary albumin excretion, serum lipid levels and use of insulin and oral hypoglycemic agents. The follow-up HbA1c was also recorded.ResultsThe mean follow-up period was 5.7 yrs and 45 of the patients have died. The mortality hazard as a function of the baseline HbA1c quartile was significantly V-shaped with the nadir in quartile 2 (HbA1c 8.5–9.4%) (P = 0.02), and this relationship remained significant after adjustment for the confounders such as estimated glomerular filtration rate and insulin use. The follow-up HbA1c was 7.7 ± 1.6% and not significantly related to mortality.Discussion/ConclusionThere was a V-shaped relationship between baseline HbA1c and all-cause mortality in elderly patients with insufficiently controlled glycemia. The nadir was in Q2 in which the HbA1c value was 8.5–9.4%. No significant relationship was found between the follow-up HbA1c and mortality. Further studies are needed to clarify the relationship between HbA1c and mortality in the elderly.