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

Abstract

Background: The treatment of diabetes requires substantial self-management. Digital tools can help reduce the burden of self-management and may improve glycemic control.

Objective: 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).

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: German Clinical Trials Register DRKS00022923; https://drks.de/search/en/trial/DRKS00022923/details.