Status:
RECRUITING
An Active Health-Based Comprehensive Study on Diabetes Management
Lead Sponsor:
Li Huating
Conditions:
Diabetes
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 int...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 26 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT07160998
Start Date
September 7 2025
End Date
October 26 2025
Last Update
September 12 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, China