An Active Health-Based Comprehensive Study on Diabetes Management

An Active Health-Based Comprehensive Study on Diabetes Management

This randomized, open-label, multicenter trial evaluates the efficacy and safety of the AI-based lifestyle guidance system (X-Life) compared to standard care in adults with type 2 diabetes. X-Life integrates glucose level, wearable devices, and AI-driven decision models to provide personalized lifestyle recommendations. The primary endpoint is the percentage of time in glucose target range (TIR).

Type 2 diabetes imposes a global health burden. Traditional care has limitations in accessibility, personalization, and long-term adherence. AI-driven digital therapeutics may overcome these barriers. X-Life is an innovative AI system providing individualized lifestyle guidance using glucose level and wearable data. User studies demonstrated usability and acceptability. This multicenter randomized controlled trial will rigorously test whether X-Life improves glycemic control compared with standard care, while also evaluating metabolic outcomes, patient-reported measures, and safety. The investigators designed this trial with the assistance of a digital twin-based clinical research system (termed X Town).

Inclusion Criteria:

• Age 18-70 years
• Diagnosed type 2 diabetes
• Stable medication regimen ≥ 3 months
• HbA1c 7-10%
• Smartphone access and ability to operate app
• Willing to wear CGM and activity tracker
• Able to provide informed consent

Exclusion Criteria:

• Insulin therapy
• Severe chronic/acute diabetic complications
• Early-onset diabetes (<40 years at diagnosis)
• Severe cardiovascular disease, uncontrolled hypertension, active liver disease, malignancy
• Severe psychiatric or cognitive disorders
• Allergy to CGM materials
• Planned surgery or long-term travel during study