Observational studyJournal of medical Internet research2025
Improvements in Glycemic Control With a Digital Diabetes Logbook: Secondary Analysis of a Randomized Controlled Trial Enriched by Observational, Real-World Data.
Observational study in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe treatment of diabetes requires substantial self-management. Digital tools can help reduce the burden of self-management and may improve glycemic control.
objectiveThis study aims to determine whether the use of a digital diabetes logbook increased the likelihood of achieving optimal glycemic control (glycated hemoglobin [HbA
methodsData 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).
resultsThe 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
conclusionsThe 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 registrationGerman Clinical Trials Register DRKS00022923; https://drks.de/search/en/trial/DRKS00022923/details.
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