Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
123 participants
INTERVENTIONAL
2025-09-07
2025-10-26
Brief Summary
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This trial aims to preliminarily evaluate whether the X Life AI system combined with CGM management 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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X Life Lifestyle Guidance
AI-based Lifestyle Management
Participants will use the X Life model via smartphone/tablet for 28 days, receiving real-time, personalized dietary and exercise recommendations triggered by CGM and activity tracker data. Participants can interact with the system by uploading meal images, physical activity data, and wearable-derived metrics.
Standard Care
Lifestyle Management
Participants will receive guideline-based lifestyle counseling according to national prediabetes prevention guidelines, delivered via mobile terminal, without AI-generated recommendations.
Interventions
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AI-based Lifestyle Management
Participants will use the X Life model via smartphone/tablet for 28 days, receiving real-time, personalized dietary and exercise recommendations triggered by CGM and activity tracker data. Participants can interact with the system by uploading meal images, physical activity data, and wearable-derived metrics.
Lifestyle Management
Participants will receive guideline-based lifestyle counseling according to national prediabetes prevention guidelines, delivered via mobile terminal, without AI-generated recommendations.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Li Huating
OTHER
Responsible Party
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Li Huating
Professor
Locations
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Shanghai Sixth People's Hospital
Shanghai, , China
Countries
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Facility Contacts
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Other Identifiers
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2025-06
Identifier Type: -
Identifier Source: org_study_id
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