Diabetes
Conditions
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 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).
Interventions
OTHERDigital Lifestyle Therapeutic
Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data.
BEHAVIORALStandard Care
Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.
Sponsors
Li Huating
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR, %) | Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28) | Percentage of glucose readings within 3.9-10 mmol/L measured by CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other CGM metrics | Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28) | mean glucose, SD, CV, TAR (\>10 mmol/L), TBR (\<3.9 and \<3.0 mmol/L), daytime/nighttime TIR, MAGE, MODD, AUC, etc. |
| Patient-reported outcomes | Baseline and 28 days | Using DDS, DSCS, Self-Efficacy, WHO-5 scales, etc. |
| User Experience Score | At 28 days | 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. |
| Safety outcomes | Day 1-28 (intervention period) | Number of participants with CGM-recorded or symptomatic hypoglycemia (\<3.9 mmol/L). Number of participants experiencing any AE/SAE. |
| OGTT Glucose Concentration | Baseline and 28 days | Plasma glucose at 0, 60, and 120 minutes during OGTT. |
| OGTT Insulin Concentration | Baseline and 28 days | Serum insulin at 0, 60, and 120 minutes during OGTT. |
| OGTT C-peptide Concentration | Baseline and 28 days | Serum C-peptide at 0, 60, and 120 minutes during OGTT. |
| Body Weight | Baseline and 28 days | Body weight (kg) measured using digital scale. |
| Body Mass Index (BMI) | Baseline and 28 days | Calculated as weight (kg) / height (m²). |
| Waist Circumference | Baseline and 28 days | Measured at the midpoint between the lowest rib and iliac crest. |
| Hip Circumference | Baseline and 28 days | Hip circumference measured at the widest part of the buttocks using a non-stretchable tape. |
| Thigh Circumference | Baseline and 28 days | Mid-thigh circumference measured at the midpoint between the inguinal crease and the proximal border of the patella. |
| Systolic Blood Pressure | Baseline and 28 days | Average of two seated measurements. |
| Diastolic Blood Pressure | Baseline and 28 days | Average of two seated measurements. |
| Resting Heart Rate | Baseline and 28 days | Measured by automated device after 5 minutes rest. |
| Blood Lipids | Baseline and 28 days | Total cholesterol, LDL-C, HDL-C, and triglycerides. |
| Liver Function | Baseline and 28 days | ALT, AST, GGT, etc. |
| Kidney Function | Baseline and 28 days | Serum creatinine, eGFR, etc. |
| Inflammatory Markers | Baseline and 28 days | C-reactive protein |
| Composite Psychological and Behavioral Outcomes | Run-in end (Day 0), Intervention end (Day 28), Follow-up end (Day 35) | 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. |
Countries
China
Outcome results
None listed