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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X Life AI Lifestyle Guidance | Experimental | Personalized real-time lifestyle recommendations delivered via smartphone, tablet, etc., integrating glucose level and wearable data. |
|
| Standard Care | Active Comparator | Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Lifestyle Therapeutic | Other | Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range (TIR, %) | Percentage of glucose readings within 3.9-10 mmol/L measured by CGM | Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Other CGM metrics | mean glucose, SD, CV, TAR (>10 mmol/L), TBR (<3.9 and <3.0 mmol/L), daytime/nighttime TIR, MAGE, MODD, AUC, etc. | Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28) |
| Patient-reported outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Behavioral | Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines. |
|
Using DDS, DSCS, Self-Efficacy, WHO-5 scales, etc.
| Baseline and 28 days |
| User Experience Score | Evaluation in X Life group only. User experience will be assessed using a validated questionnaire covering usability, usefulness, satisfaction, and acceptability. Each item is rated on a 5-point Likert scale. Higher scores indicate better user experience. | At 28 days |
| Safety outcomes | Number of participants with CGM-recorded or symptomatic hypoglycemia (<3.9 mmol/L). Number of participants experiencing any AE/SAE. | Day 1-28 (intervention period) |
| OGTT Glucose Concentration | Plasma glucose at 0, 60, and 120 minutes during OGTT. | Baseline and 28 days |
| OGTT Insulin Concentration | Serum insulin at 0, 60, and 120 minutes during OGTT. | Baseline and 28 days |
| OGTT C-peptide Concentration | Serum C-peptide at 0, 60, and 120 minutes during OGTT. | Baseline and 28 days |
| Body Weight | Body weight (kg) measured using digital scale. | Baseline and 28 days |
| Body Mass Index (BMI) | Calculated as weight (kg) / height (m²). | Baseline and 28 days |
| Waist Circumference | Measured at the midpoint between the lowest rib and iliac crest. | Baseline and 28 days |
| Hip Circumference | Hip circumference measured at the widest part of the buttocks using a non-stretchable tape. | Baseline and 28 days |
| Thigh Circumference | Mid-thigh circumference measured at the midpoint between the inguinal crease and the proximal border of the patella. | Baseline and 28 days |
| Systolic Blood Pressure | Average of two seated measurements. | Baseline and 28 days |
| Diastolic Blood Pressure | Average of two seated measurements. | Baseline and 28 days |
| Resting Heart Rate | Measured by automated device after 5 minutes rest. | Baseline and 28 days |
| Blood Lipids | Total cholesterol, LDL-C, HDL-C, and triglycerides. | Baseline and 28 days |
| Liver Function | ALT, AST, GGT, etc. | Baseline and 28 days |
| Kidney Function | Serum creatinine, eGFR, etc. | Baseline and 28 days |
| Inflammatory Markers | C-reactive protein | Baseline and 28 days |
| Composite Psychological and Behavioral Outcomes | Psychological and behavioral outcomes will be assessed using multiple validated questionnaires. Each scale will be reported and analyzed separately: Diabetes Distress Scale (DDS): 17 items, scored 1-6; higher scores indicate greater distress; General Self-Efficacy Scale (GSES): 10 items, scored 1-4, total 10-40; higher scores indicate stronger self-efficacy; WHO-5 Well-Being Index: 5 items, raw score 0-25 transformed to 0-100; higher scores indicate better well-being; Summary of Diabetes Self-Care Activities (SDSCA): Items scored 0-7 days per week; higher scores indicate better diabetes self-management behaviors. | Run-in end (Day 0), Intervention end (Day 28), Follow-up end (Day 35) |