Dataset Information

Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program.

ABSTRACT: The DIAMOND study demonstrated that the addition of real-time continuous glucose monitoring (rtCGM) effectively lowers glycated hemoglobin (HbA1c) in patients with type 1 (T1D) and type 2 diabetes (T2D), treated with multiple daily injections (MDI). This post hoc analysis investigated whether DIAMOND study participants at progressively higher baseline HbA1c levels benefit from using rtCGM. We examined outcomes data from a large, randomized, controlled trial of MDI-treated participants with T1D (N?=?158) and T2D (N?=?158), comparing monitoring by rtCGM versus self-monitoring of blood glucose (SMBG). The primary outcome was the magnitude of HbA1c reductions among study participants within elevated baseline HbA1c levels (?8.0%-10.0%, ?8.5%-10.0%, and ?9.0%-10.0%). Analyses were performed on three subgroups: T1D, T2D, and combined T1D/T2D. The full T1D analysis population had a mean baseline HbA1c value of 8.6?±?0.6% (range 7.5%-9.9%), randomized to rtCGM (n?=?105) or control (n?=?53). The full T2D analysis population had a mean baseline HbA1c value of 8.5?±?0.6% (range 7.5%-9.9%), randomized to rtCGM (n?=?79) or control (n?=?79). Participants had improvements in glycemic status regardless of monitoring method. In the three subgroups, the change in HbA1c was significantly greater in rtCGM participants compared to SMBG at all predefined baseline HbA1c levels at 12 and 24 weeks. Among the rtCGM participants, the change in HbA1c was numerically greatest at the highest baseline HbA1c subgroup (?9.0%). Participants with elevated baseline HbA1c had improvements in glycemic status regardless of monitoring method. However, the magnitudes of improvements appeared greater among participants using rtCGM.

SUBMITTER: Billings LK

PROVIDER: S-EPMC6080123 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program.

Billings Liana K LK Parkin Christopher G CG Price David D

Diabetes technology & therapeutics 20180725 8

The DIAMOND study demonstrated that the addition of real-time continuous glucose monitoring (rtCGM) effectively lowers glycated hemoglobin (HbA<sub>1c</sub>) in patients with type 1 (T1D) and type 2 diabetes (T2D), treated with multiple daily injections (MDI). This post hoc analysis investigated whether DIAMOND study participants at progressively higher baseline HbA<sub>1c</sub> levels benefit from using rtCGM. We examined outcomes data from a large, randomized, controlled trial of MDI-treated p ...[more]

PMID: 30044123

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Project description:Importance:Glycated hemoglobin (HbA1c) values are used to guide glycemic control, but in patients with type 2 diabetes and multivessel coronary artery disease (CAD), the association of the longitudinal values of HbA1c with cardiovascular outcomes is unclear. Objective:To assess whether longitudinal variation of HbA1c is associated with cardiovascular events in long-term follow-up among patients with diabetes and multivessel CAD. Design, Setting, and Participants:This cohort study included 888 patients with type 2 diabetes and multivessel CAD in the Medicine, Angioplasty, or Surgery Study (MASS) Registry of the Heart Institute of the University of São Paulo from January 2003 to December 2007. Data were analyzed from January 15, 2018, to October 15, 2019. Exposure:Longitudinal HbA1c values. Main Outcomes and Measures:The combined outcome of all-cause mortality, myocardial infarction, and ischemic stroke. Results:Of 888 patients with type 2 diabetes and multivessel CAD, 725 (81.6%; median [range] age, 62.4 [55.7-68.0] years; 467 [64.4%] men) had complete clinical and HbA1c information during a median (interquartile range) follow-up period of 10.0 (8.0-12.3) years, with a mean (SD) of 9.5 (3.8) HbA1c values for each patient. The composite end point of death, myocardial infarction, or ischemic stroke occurred in 262 patients (36.1%). A 1-point increase in the longitudinal value of HbA1c was significantly associated with a 14% higher risk of the combined end point of all-cause mortality, myocardial infarction, and ischemic stroke (hazard ratio, 1.14; 95% CI, 1.04-1.24; P = .002) in the unadjusted analysis. After adjusting for baseline factors (ie, age, sex, 2-vessel or 3-vessel CAD, initial CAD treatments, ejection fraction, and creatinine and low-density lipoprotein cholesterol levels), a 1-point increase in the longitudinal value of HbA1c was associated with a 22% higher risk of the combined end point (hazard ratio, 1.22; 95% CI, 1.12-1.35; P < .001). Conclusions and Relevance:Longitudinal increase of HbA1c was independently associated with higher rates of cardiovascular events in patients with type 2 diabetes and multivessel CAD.

Project description:BACKGROUND:Electronic, personalized clinical decision support tools to optimize glycated hemoglobin (HbA1c) screening are lacking. Current screening guidelines are based on simple, categorical rules developed for populations of patients. Although personalized diabetes risk calculators have been created, none are designed to predict current glycemic status using structured data commonly available in electronic health records (EHRs). OBJECTIVE:The goal of this project was to create a mathematical equation for predicting the probability of current elevations in HbA1c (≥5.7%) among patients with no history of hyperglycemia using readily available variables that will allow integration with EHR systems. METHODS:The reduced model was compared head-to-head with calculators created by Baan and Griffin. Ten-fold cross-validation was used to calculate the bias-adjusted prediction accuracy of the new model. Statistical analyses were performed in R version 3.2.5 (The R Foundation for Statistical Computing) using the rms (Regression Modeling Strategies) package. RESULTS:The final model to predict an elevated HbA1c based on 22,635 patient records contained the following variables in order from most to least importance according to their impact on the discriminating accuracy of the model: age, body mass index, random glucose, race, serum non-high-density lipoprotein, serum total cholesterol, estimated glomerular filtration rate, and smoking status. The new model achieved a concordance statistic of 0.77 which was statistically significantly better than prior models. The model appeared to be well calibrated according to a plot of the predicted probabilities versus the prevalence of the outcome at different probabilities. CONCLUSIONS:The calculator created for predicting the probability of having an elevated HbA1c significantly outperformed the existing calculators. The personalized prediction model presented in this paper could improve the efficiency of HbA1c screening initiatives.

Dataset Information

Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program.

Publications

Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program.

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