A Digital Diabetes Self-Management Education and Support Program Integrated With Continuous Glucose Monitoring Improves Glycemic Control: A Randomized Controlled Trial.

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% (64 mmol/mol) not using mealtime bolus insulin (26-83 years old; mean HbA1c: 9.6% [81.2 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; >180 mg/dL), and below range (TBR; <70 mg/dL), and mean glucose. Linear mixed effects models were used for intention-to-treat analyses. RESULTS: HbA1c was lower among intervention versus usual care at 3 months (difference=-0.7% [-8.1 mmol/mol]; P=.03) and at 6 months (difference=-0.6% [-6.9 mmol/mol]; P=.12) but only reached statistical significance at 3 months. CGM-derived glycemic measures, including GMI (difference=-0.9%; P=.03), TIR (difference=14.6%; P=.04), and TAR (difference=-14.9%; P=.04), and mean glucose (difference=-36.4 mg/dL; P=.03) were also significantly improved for intervention vs usual care at 6 months. CONCLUSIONS: The combination of digital DSMES + CGM is effective for supporting adults with type 2 diabetes in managing their condition and has potential to reduce the risk of long-term health complications. CLINICALTRIAL: The trial was registered on ClinicalTrials.gov (NCT05368454).