Abstract:
Objective: Prediabetes with obesity is a high-risk phenotype for progression to type 2 diabetes. Continuous glucose monitoring (CGM) may strengthen lifestyle intervention through real-time feedback, and intensive coaching may amplify behaviour change, yet comparative data in this population and the feasibility of fully online delivery are limited. This pilot randomised controlled trial was designed to compare real-time CGM with intensive coaching versus CGM with standard self-directed support, added to a fully online Diabetes Prevention Program–based lifestyle programme, and to estimate effect sizes and feasibility parameters for a future full-scale trial in adults with prediabetes and obesity.
Methods: This single-centre, open-label, two-arm parallel pilot randomised controlled trial is conducted entirely online in Thailand and registered in the Thai Clinical Trials Registry. Seventy adults aged 30–65 years with prediabetes (ADA criteria) and obesity (BMI ≥25 kg/m²) are randomised 1:1, stratified by sex and baseline HbA1c, to Arm A (real-time CGM plus weekly intensive coaching) or Arm B (CGM plus standard self-directed support). All participants receive the same video-delivered lifestyle programme (weight-loss goal 5–7%). The same CGM device is worn at weeks 4, 8 and 13 in Arm A and at week 13 in Arm B; total participation is 16 weeks (run-in weeks 1–2, intervention weeks 3–14, close-out weeks 15–16).
Outcomes and planned analysis: The primary outcome is the change in Glucose Management Indicator (GMI) derived from CGM. Secondary outcomes include body weight, waist circumference, time in range, glycaemic variability, physical activity, dietary intake, quality of life, diabetes distress, self-efficacy, CGM satisfaction, and feasibility (recruitment, retention, and CGM data completeness). Analyses will follow the intention-to-treat principle using mixed-effects models for repeated measures, emphasising effect sizes with 95% confidence intervals appropriate to the pilot design.
Conclusions: This trial will provide preliminary efficacy and feasibility evidence for a scalable, fully online CGM-based diabetes-prevention model with intensive coaching in adults with prediabetes and obesity. Results are forthcoming and will inform the design of a future adequately powered multicentre online trial. (Study completed; outcome analysis in progress.)
Keywords: Prediabetes; Obesity; Continuous Glucose Monitoring; Diabetes Prevention; Telehealth; Lifestyle Intervention
