An interventional study of Lifestyle Management in Diabetes, sponsored by Li Huating. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Li Huating · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Li Huating is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Lifestyle Management
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.
User Experience Score
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.
Time frame: 7 days after intervention initiation
Change in self-reported diabetes self-management behaviors
Diabetes self-care activities will be assessed using the SDSCA scale. Each item is rated on a scale of 0-7 days. Higher scores indicate better self-management behavior.
Time frame: Baseline and 7 days after intervention initiation
Change in diabetes-related distress
Diabetes distress will be assessed using the DDS. Each item is rated on a 6-point Likert scale. Higher scores indicate greater distress.
Time frame: Baseline and 7 days after intervention initiation
Change in self-efficacy
Self-efficacy will be assessed using the validated Self-Efficacy Scale. Each item is rated on a 10-point Likert scale. Higher scores indicate greater self-efficacy.
Time frame: Baseline and 7 days after intervention initiation
Composite Wearable Device Metrics
Physiological and behavioral data will be captured by wearable devices. Each metric will be reported and analyzed separately: Daily activity level: Steps/day; Sleep duration: Hours/night; Sleep architecture: % of light/deep/REM sleep; Resting heart rate: Beats per minute, etc.
Time frame: Baseline and 7 days after intervention initiation
Correlation between AI-predicted and actual CGM glucose values
intraclass correlation, mean absolute relative difference, RMSE, Bland-Altman analysis, etc.
Time frame: From baseline to 7 days after intervention initiation
Change in psychological well-being
Psychological well-being will be assessed using the WHO-5 Well-Being Index, a validated 5-item questionnaire. Each item is rated on a 6-point Likert scale (0 = at no time, 5 = all of the time). Raw scores range from 0 to 25, which are multiplied by 4 to yield a final score ranging from 0 to 100. Higher scores indicate better well-being.
Time frame: Baseline and 7 days after intervention initiation
Composite Continuous Glucose Monitoring (CGM) Metrics
Glycemic control and variability will be evaluated using multiple CGM-derived measures. Each metric will be reported and analyzed separately: Time in Range (TIR): % of glucose values within 3.9-7.8 (for individuals without diabetes) or 10.0 (for individuals with diabetes) mmol/L; Mean glucose: mmol/L; Coefficient of variation (CV): %; Time above range (TAR): % of glucose values \>10.0 mmol/L; Time below range (TBR): % of glucose values \<3.9 mmol/L, etc.
Time frame: Baseline, 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Dietary Recommendations
Independent nutrition experts will score the AI-generated dietary recommendations using two validated diet-quality indices. Each index will be reported and analyzed separately: AHEI-2010: Overall score 0-110, higher = better diet quality. Standard 11 components (each 0-10), summed to total; DQI-I: Overall score 0-100, higher = better diet quality. Standard four domains (variety, adequacy, moderation, overall balance), etc.
Time frame: 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Exercise Recommendations
Exercise recommendations generated by the system will be evaluated by an expert panel using a validated structured rating scale. The scale includes five dimensions (Timing, Glycemic Safety, Individualization, FITT principle and Feasibility \& Clarity), each scored independently, with a total score calculated as the weighted sum of all domains. Each domain scored 0-2 (0 = not met, 1 = partially met, 2 = fully met). Weighted composite score range: 0-10. Higher scores indicate better quality of exercise recommendations.
Time frame: 7 days after intervention initiation
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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