AI-Assisted Blood Glucose Management Study

Li Huating

Status: Enrolling

Conditions: Pre-diabetes

Treatments: Other: Lifestyle Management; Other: AI-based Lifestyle Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07160985

2025-06

Details and patient eligibility

About

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 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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years
• 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

• Current glucose-lowering medication use
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

X Life Lifestyle Guidance

Experimental group

Treatment:

Other: AI-based Lifestyle Management

Standard Care

Active Comparator group

Treatment:

Other: Lifestyle Management