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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X Life Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days after intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 7 days after intervention initiation |
| Change in diabetes-related distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Diabetes distress will be assessed using the DDS. Each item is rated on a 6-point Likert scale. Higher scores indicate greater distress. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 7 days after intervention initiation |