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Blended Resources for Integrated Diabetes Guidance and Empowerment

NCT07373379 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-02-23

No results posted yet for this study

Summary

The goal of this cluster randomized clinical trial is to learn if an AI-enabled blended care model (the BRIDGE program) works to treat type 2 diabetes in adults. It will also learn about the cost-effectiveness and implementation feasibility of this model in primary care settings. The main questions it aims to answer are:

Does the AI-driven intervention lower HbA1c levels (blood sugar) compared to standard care?

Does this model improve participants' quality of life, self-management behaviors, and digital literacy?

Researchers will compare the "Diet-Medicine Companion" (Shi Yi Ban Lv) mini-program combined with family doctor support to standard community care to see if the blended care model works to manage diabetes.

Participants will:

Use the "Diet-Medicine Companion" mini-program to upload diet photos daily and receive AI feedback for 6 months

Receive periodic guidance and phone reminders from case administrators (family doctors)

Complete questionnaires and blood tests (HbA1c) at baseline, 3 months, and 6 months

Conditions

Interventions

DEVICE

AI-driven Dietary Management and Human-in-the-loop Support

The intervention consists of a 6-month AI-enabled blended care program using the "Diet-Medicine Companion" (Shi Yi Ban Lv) WeChat mini-program. Patient Component (AI Support): Participants are required to upload dietary photos and blood glucose records via the mini-program at least once daily. The system, powered by a Large Language Model (LLM), provides immediate, personalized dietary feedback and answers diabetes-related queries via an AI chatbot. Provider Component (Human Support): Case administrators (family doctors) monitor patient data through a provider dashboard. The protocol involves "human-in-the-loop" support, where doctors provide telephone reminders if participants are inactive (no uploads) for more than 7 days. Doctors also intervene to provide medical guidance or health education based on specific system alerts or patient needs.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-03-01
Completion
2026-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373379 on ClinicalTrials.gov