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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).
Age
40 - 70 years
Sex
ALL
Healthy Volunteers
No
Shanghai Sixth People's Hospital
Shanghai, China
Start Date
September 7, 2025
Primary Completion Date
November 28, 2025
Completion Date
December 6, 2025
Last Updated
February 12, 2026
124
ACTUAL participants
Digital Lifestyle Therapeutic
OTHER
Standard Care
BEHAVIORAL
Lead Sponsor
Li Huating
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07296484