A Digital Diabetes Self-Management Education and Support Program Integrated With Continuous Glucose Monitoring for Type 2 Diabetes: Randomized Controlled Trial

Background: Previous research has demonstrated that the use of continuous glucose monitoring (CGM) can improve glycemic control in people with type 2 diabetes when used regularly alongside a digital diabetes self-management education and 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: The objective of this study is to evaluate the impact of a DSMES program coupled with CGM on hemoglobin A (HbA) 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 HbA of 8% or higher (64 mmol/mol) who were not using mealtime bolus insulin (aged 26‐83 y; mean HbA 9.6%, SD 1.4% [mean 81.2 mmol/mol, SD 15.8 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 HbA. The secondary outcomes were CGM-derived glycemic measures, including glucose management indicator, percent time in range 70 to 180 mg/dL, percent time above range (>180 mg/dL), percent time below range (<70 mg/dL), and mean glucose. Linear mixed effects models were used for intention-to-treat analyses. Results: HbA was lower among the intervention group versus the usual care group at 3 months (difference=−0.7%, 95% CI −1.4% to −0.1% or difference=−8.1 mmol/mol, 95% CI −15.5 to −0.7 mmol/mol; =.03) and at 6 months (difference=−0.6%, 95% CI −1.4% to 0.2% or difference=−6.9 mmol/mol, 95% CI −15.7 to 1.9 mmol/mol; =.12) but only reached statistical significance at 3 months. CGM-derived glycemic measures, including glucose management indicator (difference=−0.9%, 95% CI −1.7% to −0.1%; =.03), time in range (difference=14.6%, 95% CI 1.0% to 28.2%; =.04), time above range (difference=−14.9%, 95% CI −29.0% to −0.9%; =.04), and mean glucose (difference=−36.4 mg/dL, 95% CI −70.0 to −2.9 mg/dL; =.03), also significantly improved for the intervention group versus the usual care group 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 the potential to reduce the risk of long-term health complications. Trial Registration: ClinicalTrials.gov NCT05368454; https://clinicaltrials.gov/ct2/show/NCT05368454