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NOT YET RECRUITING
NCT07787403
NA

Pilot RCT of PIPE-AI for Prediabetes and Diabetes Self-Management

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

Summary

This pilot randomized controlled trial evaluates the feasibility, effectiveness, and acceptance of the Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) enhanced by DiabetesGPT among adults with prediabetes or diabetes in Hong Kong primary healthcare settings. Participants will be randomized in a 1:1 ratio to an intervention group receiving PIPE-AI or to a waitlist control group receiving usual care during the first 3 months. Both groups will complete baseline and 3-month assessments, including patient-reported outcome measures, clinical outcomes, healthcare service utilization, and intermittent continuous glucose monitoring using Abbott FreeStyle Libre 2 Plus sensors.

Official title: A Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) Enhanced by DiabetesGPT in Prediabetes and Diabetes Patients in Primary Healthcare Settings

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08-29

Completion Date

2026-11-29

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

PIPE-AI digital patient empowerment intervention

PIPE-AI is a personalized interactive patient empowerment artificial intelligence platform enhanced by DiabetesGPT. It integrates individualized risk assessment and a locally fine-tuned large language model to provide personalized health advice, diabetes self-management support, and patient empowerment during the 3-month follow-up period.

OTHER

Waitlist usual care control

Participants receive usual care during the first 3 months and are given access to the PIPE-AI app after completion of the 3-month follow-up assessment.