Improvements in Glycemic Control With a Digital Diabetes Logbook: Secondary Analysis of a Randomized Controlled Trial Enriched by Observational, Real-World Data.

Abstract

The treatment of diabetes requires substantial self-management. Digital tools can help reduce the burden of self-management and may improve glycemic control. This study aims to determine whether the use of a digital diabetes logbook increased the likelihood of achieving optimal glycemic control (glycated hemoglobin [HbA_1c] ≤6.5%) after 3 months, based on a secondary analysis of randomized controlled trial (RCT) data. A secondary objective was to evaluate the long-term impact of the logbook on mean blood glucose levels over 3 and 12 months using observational, real-world data (RWD). Data from 342 participants with type 1 or type 2 diabetes enrolled in the mySugr PRO-RCT were analyzed. A robust logistic regression was performed to examine the likelihood of achieving optimal glycemic control, defined as an HbA1c value ≤6.5% at the 3-month follow-up. The dependent variable was the dichotomous outcome indicating whether this threshold was met. The primary independent variable was group allocation, with baseline HbA1c included as a covariate. For the analysis of RWD, a total of 2861 participants with type 1 or type 2 diabetes were identified using propensity score matching to align their characteristics with those of the RCT participants closely. One-sample t tests were conducted to analyze changes in mean blood glucose separately for each diabetes type, from baseline to 3 months of app use, and from baseline to 12 months of app use (in a subcohort of 1176 participants). The RCT data showed that the likelihood of achieving optimal glycemic control was nearly doubled in the intervention group compared with the control group (odds ratio 2.24, 95% CI 1.12-4.47; P=.02). RWD indicated that mean blood glucose levels significantly improved over 3 months of app use in both groups (type 1: -16.3 mg/dL; 95% CI -20.6 to -12.4; P<.001 and type 2: -27.3 mg/dL, 95% CI -28.7 to -25.9; P<.001). Participants with an estimated HbA_1c>8.5% at baseline (before app use) showed the greatest reductions in mean blood glucose (type 1: -82.2 mg/dL; 95% CI -102.0 to -61.8; P<.001; type 2: -104.6 mg/dL, 95% CI -109.1 to -100.3; P<.001). Long-term analyses revealed a sustained reduction in mean blood glucose over a 12-month period, with a mean decrease of -19.8 mg/dL (95% CI -21.8 to -17.9; P<.001) after 12 months of app use in the total RWD sample. The secondary analysis of the RCT demonstrated a significant increase in the likelihood of achieving optimal glycemic control after 3 months of using the mySugr logbook. This finding was supported by observational, real-world data, which showed significant reductions in mean blood glucose after 3 and 12 months of app use-particularly among individuals with elevated baseline HbA1c levels. German Clinical Trials Register DRKS00022923; https://drks.de/search/en/trial/DRKS00022923/details.