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1.
medRxiv ; 2024 Apr 27.
Article En | MEDLINE | ID: mdl-38712131

Background and Aims: Identifying simple markers of risk for worsening glucose can allow care providers to target therapeutic interventions according to risk of worsening glycemic control. We aimed to determine which routine clinical measures herald near-term glycemic worsening in early type 2 diabetes(T2D). Methods: The Early Diabetes Intervention Program (EDIP) was a clinical trial in individuals with screendetected T2D [HbA1C 6.3+0.63%(45+5mmol/mol)]. During the trial some participants experienced worsening fasting blood glucose (FBG). We investigated the time course of FBG, HbA1c, weight, and other clinical factors to determine which might herald glycemic worsening over the next year. Results: Progressors (62/219, 28.5%) had higher FBG than non-progressors at baseline [118 vs 130mg/dL (6.6 vs 7.2 mmol/L), p=<0.001]. FBG was stable except in the year of progression, when progressors exhibited a large 1-year rise [mean change 14.2mg/dL(0.79 mmol/L)]. Current FBG and antecedent year change in FBG were associated with progression(p<0.01), although the magnitude of change was too small to be of clinical utility (0.19 mg/dL; 0.01 mmol/L). Current or antecedent year change in HbA1c, weight, TG or HDL were not associated with progression. In the year of glycemic worsening, rising glucose was strongly associated with a concurrent increase in weight (p<0.001). Conclusions: Elevated FBG but not HbA1c identified individuals at risk for imminent glycemic worsening; the subsequent large rise in glucose was associated with a short-term increase in weight. Glucose and weight surveillance provide actionable information for those caring for patients with early diabetes.

2.
Diabetes Care ; 2024 Mar 29.
Article En | MEDLINE | ID: mdl-38552140

Hemoglobin A1c (A1C) is widely used for the diagnosis and management of diabetes. Accurate measurement of A1C is necessary for optimal clinical value. Assay standardization has markedly improved the accuracy and consistency of A1C testing. Devices to measure A1C at point of care (POC) are commercially available, allowing rapid results when the patient is seen. In this review, we describe how standardization of A1C testing was achieved, leading to high-quality results in clinical laboratories. We address the use of POC A1C testing in clinical situations and summarize the advantages and disadvantages of POC A1C testing. We emphasize the importance of considering the limitations of these devices and following correct testing procedures to ensure that accurate A1C results are obtained for optimal care of patients.

3.
Diabetes Care ; 47(4): 594-602, 2024 Apr 01.
Article En | MEDLINE | ID: mdl-38194519

OBJECTIVE: In Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) (5,047 participants, mean follow-up 5.0 years), differences in glycemic control were demonstrated over time among four randomized therapies added to metformin. Weight gain and hypoglycemia are also important outcomes for people with type 2 diabetes. We compared the effects of the four randomized GRADE medications on a composite outcome incorporating glycemic deterioration, weight gain, and hypoglycemia. RESEARCH DESIGN AND METHODS: The composite outcome was time to first occurrence of any of the following: HbA1c >7.5%, confirmed; ≥5% weight gain; or severe or recurrent nonsevere hypoglycemia. Secondary analyses included examination of individual components of the composite outcome, subgroup effects and potential mediators, and treatment satisfaction. Cumulative incidence was estimated with the Kaplan-Meier estimator. Cox proportional hazards models were used to assess pairwise group differences in risk of an outcome. RESULTS: Risk of reaching the composite outcome (events per 100 participants per treatment year [PTYs]) was lowest with liraglutide (19 per 100 PTYs) followed by sitagliptin (26 per 100 PTYs), glargine (29 per 100 PTYs), and glimepiride (40 per 100 PTYs); all pairwise comparisons were statistically significant. The order was the same for risk of weight gain and hypoglycemia, but risk of glycemic deterioration was lowest with glargine, followed by liraglutide, glimepiride, and sitagliptin. No significant heterogeneity in risk of composite outcome was detected across prespecified covariates. Participants who reached the composite outcome had modestly but significantly lower treatment satisfaction. CONCLUSIONS: Among participants treated with common second-line drug classes for type 2 diabetes, the liraglutide group had the lowest and glimepiride the highest risk of reaching a composite outcome encompassing glycemic deterioration, weight gain, and hypoglycemia. These findings may inform decision-making regarding type 2 diabetes therapy.


Diabetes Mellitus, Type 2 , Hypoglycemia , Metformin , Sulfonylurea Compounds , Humans , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin Glargine , Liraglutide , Glycemic Control , Glycated Hemoglobin , Hypoglycemia/prevention & control , Hypoglycemia/drug therapy , Metformin/therapeutic use , Sitagliptin Phosphate/therapeutic use , Body Weight , Weight Gain , Treatment Outcome
4.
Diabetes Care ; 46(10): 1740-1746, 2023 10 01.
Article En | MEDLINE | ID: mdl-37471272

BACKGROUND: Numerous laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in patients with diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments in the full version of the guideline). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association for Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. CONTENT: Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c) in the blood. Glycemic control is monitored by the patients measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring devices and also by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring; genetic testing; and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. SUMMARY: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.


Blood Glucose , Diabetes Mellitus , Humans , Glycated Hemoglobin , Blood Glucose/analysis , Blood Glucose Self-Monitoring , Diabetes Mellitus/diagnosis , Diabetes Mellitus/therapy , Insulin
5.
Diabetes Care ; 46(10): e151-e199, 2023 10 01.
Article En | MEDLINE | ID: mdl-37471273

BACKGROUND: Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH: An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association for Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. CONTENT: Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c) in the blood. Glycemic control is monitored by the people with diabetes measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring (CGM) devices and also by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. SUMMARY: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.


Diabetes Mellitus, Type 1 , Diabetes Mellitus , Humans , Glycated Hemoglobin , Blood Glucose/analysis , Blood Glucose Self-Monitoring , Diabetes Mellitus/diagnosis , Diabetes Mellitus/therapy , Insulin , Diabetes Mellitus, Type 1/diagnosis
6.
Clin Chem ; 69(8): 808-868, 2023 08 02.
Article En | MEDLINE | ID: mdl-37473453

BACKGROUND: Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH: An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association of Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. CONTENT: Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (Hb A1c) in the blood. Glycemic control is monitored by the people with diabetes measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring (CGM) devices and also by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. SUMMARY: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.


Diabetes Mellitus, Type 1 , Diabetes Mellitus , Humans , Glycated Hemoglobin , Blood Glucose/analysis , Blood Glucose Self-Monitoring , Diabetes Mellitus/diagnosis , Diabetes Mellitus/therapy , Insulin
7.
Diabetes Obes Metab ; 25(3): 688-699, 2023 03.
Article En | MEDLINE | ID: mdl-36314293

AIMS: Co-management of weight and glycaemia is critical yet challenging in type 1 diabetes (T1D). We evaluated the effect of a hypocaloric low carbohydrate, hypocaloric moderate low fat, and Mediterranean diet without calorie restriction on weight and glycaemia in young adults with T1D and overweight or obesity. MATERIALS AND METHODS: We implemented a 9-month Sequential, Multiple Assignment, Randomized Trial pilot among adults aged 19-30 years with T1D for ≥1 year and body mass index 27-39.9 kg/m2 . Re-randomization occurred at 3 and 6 months if the assigned diet was not acceptable or not effective. We report results from the initial 3-month diet period and re-randomization statistics before shutdowns due to COVID-19 for primary [weight, haemoglobin A1c (HbA1c), percentage of time below range <70 mg/dl] and secondary outcomes [body fat percentage, percentage of time in range (70-180 mg/dl), and percentage of time below range <54 mg/dl]. Models adjusted for design, demographic and clinical covariates tested changes in outcomes and diet differences. RESULTS: Adjusted weight and HbA1c (n = 38) changed by -2.7 kg (95% CI -3.8, -1.5, P < .0001) and -0.91 percentage points (95% CI -1.5, -0.30, P = .005), respectively, while adjusted body fat percentage remained stable, on average (P = .21). Hypoglycaemia indices remained unchanged following adjustment (n = 28, P > .05). Variability in all outcomes, including weight change, was considerable (57.9% were re-randomized primarily due to loss of <2% body weight). No outcomes varied by diet. CONCLUSIONS: Three months of a diet, irrespective of macronutrient distribution or caloric restriction, resulted in weight loss while improving or maintaining HbA1c levels without increasing hypoglycaemia in adults with T1D.


Diabetes Mellitus, Type 1 , Hypoglycemia , Obesity , Overweight , Weight Loss , Humans , Young Adult , Diabetes Mellitus, Type 1/therapy , Diabetes Mellitus, Type 1/complications , Glycated Hemoglobin , Hypoglycemia/complications , Obesity/complications , Obesity/therapy , Overweight/complications , Overweight/therapy
8.
N Engl J Med ; 387(12): 1075-1088, 2022 09 22.
Article En | MEDLINE | ID: mdl-36129997

BACKGROUND: Data are lacking on the comparative effectiveness of commonly used glucose-lowering medications, when added to metformin, with respect to microvascular and cardiovascular disease outcomes in persons with type 2 diabetes. METHODS: We assessed the comparative effectiveness of four commonly used glucose-lowering medications, added to metformin, in achieving and maintaining a glycated hemoglobin level of less than 7.0% in participants with type 2 diabetes. The randomly assigned therapies were insulin glargine U-100 (hereafter, glargine), glimepiride, liraglutide, and sitagliptin. Prespecified secondary outcomes with respect to microvascular and cardiovascular disease included hypertension and dyslipidemia, confirmed moderately or severely increased albuminuria or an estimated glomerular filtration rate of less than 60 ml per minute per 1.73 m2 of body-surface area, diabetic peripheral neuropathy assessed with the Michigan Neuropathy Screening Instrument, cardiovascular events (major adverse cardiovascular events [MACE], hospitalization for heart failure, or an aggregate outcome of any cardiovascular event), and death. Hazard ratios are presented with 95% confidence limits that are not adjusted for multiple comparisons. RESULTS: During a mean 5.0 years of follow-up in 5047 participants, there were no material differences among the interventions with respect to the development of hypertension or dyslipidemia or with respect to microvascular outcomes; the mean overall rate (i.e., events per 100 participant-years) of moderately increased albuminuria levels was 2.6, of severely increased albuminuria levels 1.1, of renal impairment 2.9, and of diabetic peripheral neuropathy 16.7. The treatment groups did not differ with respect to MACE (overall rate, 1.0), hospitalization for heart failure (0.4), death from cardiovascular causes (0.3), or all deaths (0.6). There were small differences with respect to rates of any cardiovascular disease, with 1.9, 1.9, 1.4, and 2.0 in the glargine, glimepiride, liraglutide, and sitagliptin groups, respectively. When one treatment was compared with the combined results of the other three treatments, the hazard ratios for any cardiovascular disease were 1.1 (95% confidence interval [CI], 0.9 to 1.3) in the glargine group, 1.1 (95% CI, 0.9 to 1.4) in the glimepiride group, 0.7 (95% CI, 0.6 to 0.9) in the liraglutide group, and 1.2 (95% CI, 1.0 to 1.5) in the sitagliptin group. CONCLUSIONS: In participants with type 2 diabetes, the incidences of microvascular complications and death were not materially different among the four treatment groups. The findings indicated possible differences among the groups in the incidence of any cardiovascular disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; GRADE ClinicalTrials.gov number, NCT01794143.).


Cardiovascular Diseases , Diabetes Complications , Diabetes Mellitus, Type 2 , Glycated Hemoglobin , Hypoglycemic Agents , Metformin , Albuminuria/etiology , Albuminuria/prevention & control , Blood Glucose/analysis , Cardiovascular Diseases/etiology , Cardiovascular Diseases/prevention & control , Comparative Effectiveness Research , Diabetes Complications/etiology , Diabetes Complications/prevention & control , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Diabetic Neuropathies/diagnosis , Diabetic Neuropathies/etiology , Diabetic Neuropathies/prevention & control , Drug Therapy, Combination , Dyslipidemias/etiology , Dyslipidemias/prevention & control , Glomerular Filtration Rate , Glycated Hemoglobin/analysis , Heart Failure/etiology , Heart Failure/prevention & control , Humans , Hypertension/etiology , Hypertension/prevention & control , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Insulin Glargine/adverse effects , Insulin Glargine/therapeutic use , Liraglutide/adverse effects , Liraglutide/therapeutic use , Metformin/adverse effects , Metformin/therapeutic use , Microvessels/drug effects , Sitagliptin Phosphate/adverse effects , Sitagliptin Phosphate/therapeutic use , Sulfonylurea Compounds/adverse effects , Sulfonylurea Compounds/therapeutic use
10.
J Gen Intern Med ; 37(1): 15-22, 2022 01.
Article En | MEDLINE | ID: mdl-33826060

BACKGROUND: In 2015, the US Preventive Services Task Force (USPSTF) revised clinical recommendations to more broadly recommend abnormal blood glucose screening and more clearly recommend referral to behavioral interventions for adults with prediabetes. OBJECTIVE: To assess the effects of the 2015 USPSTF recommendation changes on abnormal blood glucose screening and referral to behavioral interventions, and to examine physicians' perceptions of the revised recommendation. DESIGN: We utilized a sequential, dependent mixed-methods triangulation design. PARTICIPANTS: A total of 33,444 patients meeting USPSTF abnormal blood glucose screening criteria within 15 health system-affiliated primary care practices and 20 primary care physicians in North Carolina. MAIN MEASURES: We assessed monthly abnormal blood glucose screening rate and monthly referral rate to behavioral interventions. To estimate trend changes in outcomes, we used segmented linear regression analysis of interrupted time-series data. We gathered physicians' perspectives on the 2015 USPSTF abnormal blood glucose recommendation including awareness of, agreement with, adoption of, and adherence to the recommendation. To analyze qualitative data, we used directed content analysis. KEY RESULTS: There was a slight significant change in trend in abnormal blood glucose screening rates post-recommendation. There was a slight, statistically significant decrease in referral rates to behavioral interventions post-recommendation. Physicians were generally unaware of the revisions to the 2015 USPSTF abnormal blood glucose recommendation; however, once the recommendations were described, physicians agreed with the screening recommendation but felt that the behavioral intervention referral recommendation was hard to implement. CONCLUSION: The 2015 USPSTF abnormal blood glucose guideline had little to no effect on abnormal blood glucose screening or referral to behavioral interventions in North Carolina practices. Potential interventions to improve these rates could include clinical decision tools embedded in the electronic health record and better referral systems for community-based diabetes prevention programs.


Blood Glucose , Prediabetic State , Adult , Advisory Committees , Attitude , Humans , Mass Screening , Prediabetic State/diagnosis , Prediabetic State/epidemiology , Prediabetic State/therapy , Preventive Health Services
12.
Diabetes Care ; 44(11): 2589-2625, 2021 11.
Article En | MEDLINE | ID: mdl-34593612

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycemia, behavioral considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management, and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors.


Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Adult , Blood Glucose , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/therapy , Diabetes Mellitus, Type 2/therapy , Humans , Insulin
13.
Diabetologia ; 64(12): 2609-2652, 2021 12.
Article En | MEDLINE | ID: mdl-34590174

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycaemia, behavioural considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that healthcare professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors. Graphical abstract.


Diabetes Mellitus, Type 1 , Adult , Blood Glucose , Blood Glucose Self-Monitoring , Consensus , Diabetes Mellitus, Type 1/therapy , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use
14.
Prev Med ; 148: 106587, 2021 07.
Article En | MEDLINE | ID: mdl-33930437

The projected three-fold increase in diabetes burden by 2060 in the United States will affect certain race and gender groups disproportionately. The objective of this mixed-methods study was to assess differences in prediabetes screening and clinician response to prediabetes by patient race and gender. We utilized data from 18,742 patients seen between 11/1/15 and 4/30/17 who met criteria for blood glucose screening by the 2015 US Preventive Service Task Force recommendation and had at least one visit to a primary care practice within a large, academic health system located in North Carolina. We utilized generalized estimating equations with logistic regression to assess race and gender differences in two outcomes: prediabetes screening and clinician response to prediabetes. We conducted twenty in-depth interviews (October 2018-May 2019) with physicians to assess their approach to screening for and treating prediabetes. Black patients had 11% higher odds (95% CI:1.02-1.20) of being screened for prediabetes than White patients. Men had 19% higher odds (95% CI:1.09-1.30) of being screened for prediabetes than women. There were no significant differences in clinician response to prediabetes by patient race or gender. Qualitatively, physicians reported a non-systematic approach to prediabetes screening and follow-up care related to: 1) System-level barriers to screening and treatment; 2) Implicit bias; 3) Patient factors; and 4) Physician preferences for prediabetes treatment. Targeted risk-based screening for prediabetes along with increased treatment for prediabetes are critical for preventing diabetes and reducing diabetes-related disparities.


Diabetes Mellitus , Prediabetic State , Blood Glucose , Diabetes Mellitus/diagnosis , Female , Humans , Male , North Carolina , Prediabetic State/diagnosis , Sex Characteristics , United States
15.
Diabetes Care ; 44(4): 960-968, 2021 04.
Article En | MEDLINE | ID: mdl-33622669

OBJECTIVE: Despite advances in exogenous insulin therapy, many patients with type 1 diabetes do not achieve acceptable glycemic control and remain at risk for ketosis and insulin-induced hypoglycemia. We conducted a randomized controlled trial to determine whether TTP399, a novel hepatoselective glucokinase activator, improved glycemic control in people with type 1 diabetes without increasing hypoglycemia or ketosis. RESEARCH DESIGN AND METHODS: SimpliciT1 was a phase 1b/2 adaptive study. Phase 2 activities were conducted in two parts. Part 1 randomly assigned 20 participants using continuous glucose monitors and continuous subcutaneous insulin infusion (CSII). Part 2 randomly assigned 85 participants receiving multiple daily injections of insulin or CSII. In both parts 1 and 2, participants were randomly assigned to 800 mg TTP399 or matched placebo (fully blinded) and treated for 12 weeks. The primary end point was change in HbA1c from baseline to week 12. RESULTS: The difference in change in HbA1c from baseline to week 12 between TTP399 and placebo was -0.7% (95% CI -1.3, -0.07) in part 1 and -0.21% (95% CI -0.39, -0.04) in part 2. Despite a greater decrease in HbA1c with TTP399, the frequency of severe or symptomatic hypoglycemia decreased by 40% relative to placebo in part 2. In both parts 1 and 2, plasma ß-hydroxybutyrate and urinary ketones were lower during treatment with TTP399 than placebo. CONCLUSIONS: TTP399 lowers HbA1c and reduces hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.


Diabetes Mellitus, Type 1 , Glucokinase , Diabetes Mellitus, Type 1/drug therapy , Double-Blind Method , Glycated Hemoglobin/analysis , Humans , Hypoglycemic Agents/adverse effects , Insulin , Organic Chemicals , Treatment Outcome
16.
Am J Physiol Endocrinol Metab ; 320(1): E169-E177, 2021 01 01.
Article En | MEDLINE | ID: mdl-33252253

The disposition index, calculated by multiplying measures of insulin secretion and insulin sensitivity, is widely applied as a sensitivity-adjusted measure of insulin secretion. We have recently shown that linearizing the underlying relationship uniquely permits identification of terms relating to maximal insulin secretion capacity and the secretion-coupling relationship, with both terms separately contributing to differences in the secretion-sensitivity relationship across gradations of glycemia. Here, we demonstrate the application of this linearized equation to the evaluation of treatment-induced changes in the insulin secretion-sensitivity relationship. We applied a combination of repeated-measures multivariate linear regression (evaluating treatment-induced changes in the joint relationship of insulin sensitivity and secretion) plus mixed-model repeated measures (evaluating treatment effects on maximal secretion capacity and on the secretion-sensitivity coupling slope) and compared against a usual application of the disposition index calculated from the same measurements. This novel approach allows a more informative description of treatment-induced changes compared with the usual disposition index, including isolating the source of change within the mutually adjusted relationship and identifying treatment-induced changes in the secretion-sensitivity coupling slope and in maximal insulin secretion. Application of this linearized approach provides an expanded understanding of treatment-induced changes in the insulin sensitivity-secretion relationship.NEW & NOTEWORTHY The linearized insulin secretion-sensitivity relationship allows separate evaluation of the secretion-sensitivity slope and of maximal insulin secretion. Here, we demonstrate the application of this methodology to the evaluation of clinical trial data, showing that it provides an expanded understanding of treatment-induced changes compared with the disposition index.


Algorithms , Diabetes Mellitus/therapy , Insulin Resistance , Insulin Secretion , Female , Glucose Clamp Technique , Glucose Tolerance Test , Humans , Linear Models , Male , Middle Aged , Multivariate Analysis
17.
J Clin Transl Endocrinol ; 21: 100231, 2020 Sep.
Article En | MEDLINE | ID: mdl-32695611

OBJECTIVES: Surveys for U.S. diabetes surveillance do not reliably distinguish between type 1 and type 2 diabetes, potentially obscuring trends in type 1 among adults. To validate survey-based algorithms for distinguishing diabetes type, we linked survey data collected from adult patients with diabetes to a gold standard diabetes type. RESEARCH DESIGN AND METHODS: We collected data through a telephone survey of 771 adults with diabetes receiving care in a large healthcare system in North Carolina. We tested 34 survey classification algorithms utilizing information on respondents' report of physician-diagnosed diabetes type, age at onset, diabetes drug use, and body mass index. Algorithms were evaluated by calculating type 1 and type 2 sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) relative to a gold standard diagnosis of diabetes type determined through analysis of EHR data and endocrinologist review of selected cases. RESULTS: Algorithms based on self-reported type outperformed those based solely on other data elements. The top-performing algorithm classified as type 1 all respondents who reported type 1 and were prescribed insulin, as "other diabetes type" all respondents who reported "other," and as type 2 the remaining respondents (type 1 sensitivity 91.6%, type 1 specificity 98.9%, type 1 PPV 82.5%, type 1 NPV 99.5%). This algorithm performed well in most demographic subpopulations. CONCLUSIONS: The major federal health surveys should consider including self-reported diabetes type if they do not already, as the gains in the accuracy of typing are substantial compared to classifications based on other data elements. This study provides much-needed guidance on the accuracy of survey-based diabetes typing algorithms.

18.
Diabetes Res Clin Pract ; 165: 108235, 2020 Jul.
Article En | MEDLINE | ID: mdl-32450102

AIMS: The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry. METHODS: Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications. RESULTS: We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean known T2D duration 4 years (all < 10 years); mean HbA1c 8.0% (∼64 mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥ 30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%. CONCLUSIONS: In the GRADE cohort with < 10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.


Diabetes Complications/epidemiology , Diabetes Mellitus, Type 2/complications , Cohort Studies , Female , Humans , Male , Middle Aged , Prevalence
19.
Diabetes Spectr ; 32(3): 277-283, 2019 Aug.
Article En | MEDLINE | ID: mdl-31462885

The National Diabetes Education Program (NDEP) implemented periodic deployment of the NDEP National Diabetes Survey (NNDS) in 2006 to collect data on diabetes-related knowledge, attitudes, and behaviors among U.S. adults with diabetes and on risk-reduction attitudes and behaviors among people at risk for type 2 diabetes. Because of similarities in the nationally representative samples of the past three surveys, trends between 2011 and 2016 can be assessed. We present key findings of the 2016 NNDS, focusing on areas of interest to diabetes educators. The 2016 NNDS identified both progress and gaps. Eighty-nine percent of people with diabetes are aware of the A1C test, and disparities by race and ethnicity are narrowing. Awareness of the link between cardiovascular disease and diabetes has plateaued at 75% of respondents. Most people with diabetes do not feel comfortable managing hyper- or hypoglycemia (65 and 60%, respectively), and 60-69% report some level of diabetes distress. Among people without diabetes, awareness of personal risk of type 2 diabetes has increased from 30% in 2011 to 45% in 2016. A diagnosis of prediabetes significantly increases awareness of personal risk of diabetes (65% of people with prediabetes vs. 45% of those at risk), likelihood of receiving counseling about reducing risk (45 vs. 11%), and likelihood of taking action to reduce risk (71 vs. 52%). However, 33% of people without diabetes report not planning to take action to lower their risk of type 2 diabetes. The 2016 NNDS results suggest that outreach and educational efforts have increased knowledge about diabetes and diabetes risk, but also point to the need for more education and support for people with diabetes and those at risk.

20.
J Med Educ Train ; 2(1)2018.
Article En | MEDLINE | ID: mdl-30035272

INTRODUCTION: Type 2 diabetes is a significant problem among uninsured patients. Shared medical appointments (SMA) have been shown to improve outcomes in type 2 diabetes. We hypothesized that the SMA model could be adapted for a non-profit clinic in North Carolina that serves uninsured patients with diabetes that have incomes at/below 150% of the federal poverty line. RESEARCH DESIGN AND METHODS: We implemented and sustained a patient-driven, student-led SMA model that incorporated the monthly rotations of students, physician assistant, and undergraduate students as well as pharmacy residents and an endocrinologist who collectively provide diabetes care at the free clinic. SMA groups are 'open' cohorts and include 4-12 patients scheduled for the monthly clinic. Teams of transdisciplinary trainees work together to perform triage, medication reconciliation, brief history, and physical exam, after which patients participate in the SMA. The endocrinologist evaluates SMA patients individually during and after the visit. RESULTS: Between November 2015 and January 2017, we enrolled 29 patients in SMA. There was high variability in HbA1c at baseline. Among eight type 2 diabetes patients seen in endocrine clinic and with complete data one year before and after SMA implementation, the mean (SD) HbA1c before SMA was 9.7% ± 1.7% (83±7 mmol/ mol); mean HbA1c after SMA was 9.2% ± 1.8% (77 ± 8mmol/mol). The median HbA1c before SMA was 9.5% (80 mmol/mol); median HbA1c after SMA was 8.9% (74 mmol/mol). Overall, 6/8 patients showed decreased HbA1c after SMA although there was variability between individuals in response of glycemic control to SMA. SMA increased clinic efficiency and offered an opportunity to integrate transdisciplinary trainees. Trainees gain experience with novel models of care and the complexities of the patient experience of diabetes. CONCLUSIONS: We hope this observation encourages others to implement such programs to enhance the evidence-base for SMA to address health disparities and increase the quality of free diabetes care.

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