AI-Assisted Blood Glucose Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Change in OGTT Glucose Incremental Area Under the Curve (iAUC)
研究概览
简要总结
AI-driven health management tools can leverage continuous glucose monitoring (CGM), physical activity, and dietary data to provide real-time, individualized feedback, improving self-management and adherence. The X Life model integrates AI algorithms with wearable devices to dynamically adjust dietary and exercise recommendations. Preliminary user studies suggest good usability and user experience, with potential to promote positive behavior change.
This trial aims to preliminarily evaluate whether the X Life AI system can improve glucose tolerance (measured by oral glucose tolerance test [OGTT] incremental area under the curve [iAUC]) in adults with prediabetes, providing effect size and protocol design reference for a future confirmatory randomized controlled trial. 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
- 18 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
- •Prediabetes (per ADA or WHO criteria)
- •Stable lifestyle and body weight (±5%) for ≥3 months
- •Owns and can operate a smartphone
- •Able to understand and sign informed consent
排除标准
- •Current glucose-lowering medication use
- •Severe cardiovascular disease, liver/kidney dysfunction, or active malignancy
- •Psychiatric or cognitive disorders affecting participation
- •Planned major surgery or long-distance travel during the study
- •Allergy/intolerance to CGM sensor materials
研究组 & 干预措施
X Life Lifestyle Guidance
干预措施: AI-based Lifestyle Management (Other)
Standard Care
干预措施: Lifestyle Management (Other)
结局指标
主要结局
Change in OGTT Glucose Incremental Area Under the Curve (iAUC)
时间窗: Baseline and at the end of the 28-day intervention period.
Difference between groups in the incremental area under the curve for plasma glucose concentration during a 2-hour oral glucose tolerance test (OGTT), calculated from measurements at 0, 60, and 120 minutes, adjusting for baseline values.
次要结局
- Change in OGTT Plasma Glucose Levels(Baseline and at the end of the 28-day intervention period.)
- Change in Continuous Glucose Monitoring (CGM) Metrics(Baseline (7-day run-in period) and during the 28-day intervention period.)
- Change in OGTT Plasma Insulin Levels(Baseline and at the end of the 28-day intervention period.)
- Composite Body Composition Outcomes(Baseline and at the end of the 28-day intervention period.)
- Composite Metabolic Parameters(Baseline and at the end of the 28-day intervention period.)
- Composite Patient-Reported Outcomes(Baseline, at the end of the 28-day intervention period and at the end of the 7-day follow-up period.)
- User Experience Score with the X Life Model(At the end of the 28-day intervention period.)
- Safety and Tolerability(From baseline to the end of the 28-day intervention period.)
研究者
Li Huating
Professor
Shanghai 6th People's Hospital