Overview
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 CGM, 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).
Description
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 real-time CGM 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.
Eligibility
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