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

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07787403
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PIPE-AI digital patient empowerment intervention — BEHAVIORAL
    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.
  • Waitlist usual care control — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Aug 29, 2026
Status verified
Aug 2026
Primary completion
Nov 29, 2026
Completion
Nov 29, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PIPE-AI Intervention Group
    Participants assigned to the intervention group will install and use the PIPE-AI app. Research assistants will provide detailed instructions on app use. An individualized patient empowerment programme will be provided during the 3-month follow-up period. App login frequency will be monitored, and reminders may be sent by SMS, WhatsApp, or WeChat when needed. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the control group.
  • Active Comparator: Waitlist Control Group
    Participants assigned to the waitlist control group will receive usual care during the first 3 months. Depending on recruitment source, usual care may include group-based patient empowerment programmes provided by the District Health Centre, general guidance from the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings, or routine diabetes education and management services in their respective clinics. After the 3-month follow-up assessment, control group participants will be given access to the PIPE-AI app. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the intervention group.

Primary Outcome Measure

Change in Diabetes Self-Management Questionnaire total score from baseline to 3 months [ Time Frame: Baseline and 3-month follow-up ]

Central Contacts

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