An Active Health-Based Comprehensive Study on Diabetes Management (X Life)

Li Huating

Status: Enrolling

Conditions: Diabetes

Treatments: Other: Digital Lifestyle Therapeutic; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07160998

2025-122

Details and patient eligibility

About

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).

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

X Life AI Lifestyle Guidance

Experimental group

Description:

Personalized real-time lifestyle recommendations delivered via smartphone/tablet, integrating CGM and wearable data.

Treatment:

Other: Digital Lifestyle Therapeutic

Standard Care

Active Comparator group

Description:

Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.

Treatment:

Behavioral: Standard Care