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

Clinical Snapshot

Key Findings

• P Value: Statistically significant at 3 months (p=0.03) but not at 6 months (p=0.12) for HbA1c

• Effect Size: Moderate effect size for HbA1c reduction and large effect for time in range improvement

• Primary Outcome: HbA1c reduction of 0.7% (95% CI -1.4% to -0.1%) at 3 months (p=0.03), 0.6% (95% CI -1.4% to 0.2%) at 6 months (p=0.12)

• Nnt Or Sensitivity: Time in range improved by 14.6% (95% CI 1.0% to 28.2%, p=0.04), representing substantial clinical benefit

• Confidence Interval: Primary outcome 95% CI crossed null at 6 months but remained clinically meaningful

Clinical Application

Digital platform may be cost-effective and scalable, though requires patient engagement with technology and CGM access Relevant to Australian practice where CGM is increasingly PBS-subsidised for type 2 diabetes. Aligns with RACGP diabetes management guidelines emphasising self-management education Adults with type 2 diabetes and HbA1c ≥8% not on mealtime insulin, representing a significant proportion of Australian diabetes patients

Abstract

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 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 of 8% or higher (64 mmol/mol) who were not using mealtime bolus insulin (aged 26-83 y; mean HbA1c 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 HbA1c. 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: HbA1c 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; P=.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; P=.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%; P=.03), time in range (difference=14.6%, 95% CI 1.0% to 28.2%; P=.04), time above range (difference=-14.9%, 95% CI -29.0% to -0.9%; P=.04), and mean glucose (difference=-36.4 mg/dL, 95% CI -70.0 to -2.9 mg/dL; P=.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.