AI-Based Lifestyle Guidance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- User Experience Score
研究概览
简要总结
The X Life model is an innovative AI-based lifestyle guidance system designed to provide tailored health management recommendations for individuals with T2DM or prediabetes, leveraging continuous glucose monitoring (CGM) data, wearable activity and sleep metrics, and baseline clinical information. Despite its potential, a lack of in-depth understanding of real-world user experiences remains a key barrier to clinical adoption.
This exploratory user study aims to systematically assess the usability, acceptability, and user experience of the X Life model in the target population, to identify facilitators and barriers to adoption, and to preliminarily explore the association between X Life use and changes in user-reported outcomes, behavior patterns, and device-monitored health metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Age 18-70 years.
- •Prediabetes or Type 2 diabetes mellitus (diagnosed according to recognized clinical criteria).
- •Owns and is proficient in using a smartphone with compatible applications.
- •Willing and able to wear study devices (CGM, activity tracker).
- •Willing to use the X Life model terminal and comply with study procedures.
- •Able to understand and provide written informed consent (including participation in interviews).
排除标准
- •Severe chronic diabetic complications or recent acute diabetic complications.
- •Early-onset adult T2DM.
- •Recent severe hypoglycemic events.
- •Cognitive impairment.
- •Pregnancy, severe hepatic/renal/thyroid disease, acute infection, psychiatric disorders affecting participation.
- •Planned major surgery or treatment likely to significantly impact glucose or weight during the study period.
- •Allergy to device materials (CGM sensor, activity tracker, AI terminal).
- •Any condition deemed unsuitable by the investigator.
研究组 & 干预措施
X Life Intervention
Participants will use the X Life system via AR glasses or mobile terminal (smartphone/tablet) for 7 days. The system provides personalized dietary and exercise recommendations at dynamic trigger points (before/after meals, before/after exercise, before bedtime) using baseline clinical data, real-time CGM readings, dietary images, activity data, and wearable monitoring (activity, sleep, heart rate). Standard care guidance will also be provided in accordance with national dietary and physical activity guidelines.
干预措施: Lifestyle Management (Other)
结局指标
主要结局
User Experience Score
时间窗: 7 days after intervention initiation
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.
次要结局
- Change in self-reported diabetes self-management behaviors(Baseline and 7 days after intervention initiation)
- Change in diabetes-related distress(Baseline and 7 days after intervention initiation)
- Change in self-efficacy(Baseline and 7 days after intervention initiation)
- Change in psychological well-being(Baseline and 7 days after intervention initiation)
- Composite Wearable Device Metrics(Baseline and 7 days after intervention initiation)
- Correlation between AI-predicted and actual CGM glucose values(From baseline to 7 days after intervention initiation)
- Composite Continuous Glucose Monitoring (CGM) Metrics(Baseline, 7 days after intervention initiation)
- Expert Panel Evaluation of AI-Generated Dietary Recommendations(7 days after intervention initiation)
- Expert Panel Evaluation of AI-Generated Exercise Recommendations(7 days after intervention initiation)
研究者
Li Huating
Professor
Shanghai 6th People's Hospital