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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
131
Participants will use the X Life system for 28 days, receiving real-time, personalized dietary and exercise recommendations triggered by glucose level and activity tracker data. Participants can interact with the system by uploading meal images, physical activity data, and wearable-derived metrics.
Participants will receive guideline-based lifestyle counseling according to national prediabetes prevention guidelines, delivered via mobile terminal, without AI-generated recommendations.
Shanghai Sixth People's Hospital
Shanghai, China
Change in OGTT Glucose Incremental Area Under the Curve (iAUC)
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.
Time frame: Baseline and at the end of the 28-day intervention period.
Change in OGTT Plasma Glucose Levels
Difference between groups in plasma glucose levels at 0, 60, and 120 minutes during OGTT, adjusting for baseline values.
Time frame: Baseline and at the end of the 28-day intervention period.
Change in Continuous Glucose Monitoring (CGM) Metrics
Difference between groups in CGM-derived metrics, including mean glucose, daytime TIR, nighttime TIR, glucose standard deviation (SD), coefficient of variation (CV), time above range (TAR \>10.0 mmol/L), and time below range (TBR \<3.9 mmol/L and \<3.0 mmol/L).
Time frame: Baseline (7-day run-in period) and during the 28-day intervention period.
Change in OGTT Plasma Insulin Levels
Difference between groups in plasma insulin concentrations at 0, 60, and 120 minutes during OGTT, adjusting for baseline values.
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Body Composition Outcomes
Body composition will be assessed and each measurement will be reported separately: Body weight, BMI (calculated from weight and height), Body fat percentage, Fat-free mass, Waist circumference, Hip circumference, Thigh circumference, Blood pressure (systolic and diastolic, reported separately).
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Metabolic Parameters
Metabolic outcomes will be assessed and each laboratory parameter will be reported separately: Blood lipids: Total cholesterol, LDL-C, HDL-C, triglycerides; Liver function tests: ALT, AST, GGT; Kidney function tests: Serum creatinine, eGFR, etc.
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Patient-Reported Outcomes
Patient-reported outcomes will be assessed using validated questionnaires. Each scale will be reported and analyzed separately: WHO-5 Well-being Index: 0-25, higher = better well-being; Self-Efficacy: 10 items, each rated 1-4. Total score range 10-40; higher scores indicate stronger self-efficacy, etc.
Time frame: 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
User experience will be assessed using a questionnaire covering Knowledge \& Awareness, Acceptability, Usability, Motivations \& Barriers, Perceived Benefits and Perceived Risks. Each item is rated on a 5-point Likert scale. Higher scores indicate better user experience.
Time frame: At the end of the 28-day intervention period.
Safety and Tolerability
Incidence and frequency of adverse events (AEs), serious adverse events (SAEs), symptomatic and asymptomatic hypoglycemia (\<3.9 mmol/L and \<3.0 mmol/L).
Time frame: From baseline to the end of the 28-day intervention period.
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