An Active Health-Based Comprehensive Study on Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Time in Range (TIR, %)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
X Life AI Lifestyle Guidance
Personalized real-time lifestyle recommendations delivered via smartphone, tablet, etc., integrating glucose level and wearable data.
干预措施: Digital Lifestyle Therapeutic (Other)
Standard Care
Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Time in Range (TIR, %)
时间窗: 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
次要结局
- Other CGM metrics(Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28))
- Patient-reported outcomes(Baseline and 28 days)
- User Experience Score(At 28 days)
- Safety outcomes(Day 1-28 (intervention period))
- OGTT Glucose Concentration(Baseline and 28 days)
- OGTT Insulin Concentration(Baseline and 28 days)
- OGTT C-peptide Concentration(Baseline and 28 days)
- Body Weight(Baseline and 28 days)
- Body Mass Index (BMI)(Baseline and 28 days)
- Waist Circumference(Baseline and 28 days)
- Hip Circumference(Baseline and 28 days)
- Thigh Circumference(Baseline and 28 days)
- Systolic Blood Pressure(Baseline and 28 days)
- Diastolic Blood Pressure(Baseline and 28 days)
- Resting Heart Rate(Baseline and 28 days)
- Blood Lipids(Baseline and 28 days)
- Liver Function(Baseline and 28 days)
- Kidney Function(Baseline and 28 days)
- Inflammatory Markers(Baseline and 28 days)
- Composite Psychological and Behavioral Outcomes(Run-in end (Day 0), Intervention end (Day 28), Follow-up end (Day 35))
研究者
Li Huating
Shanghai 6th People's Hospital
Shanghai 6th People's Hospital