Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 16, 2025
Date Accepted: Apr 12, 2026
Date Submitted to PubMed: Apr 17, 2026
A Digital Diabetes Self-Management Education and Support Program Integrated With Continuous Glucose Monitoring Improves Glycemic Control: A Randomized Controlled Trial
ABSTRACT
Background:
Previous research has demonstrated that continuous glucose monitoring (CGM) use can improve glycemic control in people with type 2 diabetes when used regularly alongside an in-person digital diabetes self-management and education support (DSMES) program. However, to date there is limited evidence showing the benefits of a digitally-delivered DSMES program combined with real-time CGM for adults with type 2 diabetes.
Objective:
To evaluate the impact of a DSMES program coupled with CGM on hemoglobin A1c (HbA1c) and CGM-derived glycemic measures compared to usual care for adults with type 2 diabetes over 6 months.
Methods:
Participants with type 2 diabetes and HbA1c ≥8% not using mealtime bolus insulin (26–83 years old; mean HbA1c: 9.58% [81 mmol/mol]) were randomly assigned to a digital DSMES + CGM integrated solution (n=51) or usual care (n=49) for 6 months. The primary outcome was HbA1c. Secondary outcomes were CGM-derived glycemic measures, including glucose management indicator (GMI), percent time in range 70-180 mg/dL (TIR), above range (TAR), and below range (TBR), and mean glucose. Linear mixed effects models were used for intention-to-treat (ITT) and per-protocol (PP) analyses.
Results:
HbA1c was significantly lower among intervention versus usual care at 3 months (difference=-0.7% [-8.1 mmol/mol]; P=.03) in the ITT analysis and significantly lower among intervention versus usual care at both 3 months (difference=-1.0% [-10.5 mmol/mol]; P=.006) and 6 months (difference=-0.8% [-9.1 mmol/mol]; P=.046) in the PP analysis. CGM-derived glycemic measures, including GMI (difference=-1.1%; P=.01), TIR (difference=17.3%; P=.02), TAR (difference=17.6%; P=.02), and glucose (difference=-43.2 mg/dL; P=.01) were also significantly improved for intervention vs usual care at 3 and 6 months in both ITT and PP analyses (data reported represent 6-month PP results).
Conclusions:
The combination of digital DSMES + CGM is effective for type 2 diabetes management and has potential to reduce the risk of long-term health complications. Clinical Trial: The trial was registered on ClinicalTrials.gov (NCT05368454).
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