NCT07160998

An Active Health-Based Comprehensive Study on Diabetes Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Li Huating · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 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).

Conditions

• Diabetes

Interventions

Type	Name	Description
OTHER	Digital Lifestyle Therapeutic	Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data.
BEHAVIORAL	Standard Care	Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.

Timeline

• Start date: 2025-09-07
• Primary completion: 2025-11-28
• Completion: 2025-12-06
• First posted: 2025-09-08
• Last updated: 2026-02-12

Locations

1 site across 1 country: China