Blended Resources for Integrated Diabetes Guidance and Empowerment (BRIDGE)

Peking University

Status: Begins enrollment this month

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: AI-driven Dietary Management and Human-in-the-loop Support

Study type: Interventional

Funder types: Other

Identifiers

NCT07373379

IRB00001052-25198

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 65 years (inclusive).
• Glycosylated hemoglobin (HbA1c) level ≥ 7.0%.
• Resided in the local area for at least 6 months.
• Capable of using a smartphone to take photos and use the WeChat mini-program.
• Willing and able to provide informed consent.

Exclusion criteria

• Diagnosed with Type 1 diabetes, gestational diabetes, or secondary diabetes.
• Presence of severe diabetic complications.
• Received radiotherapy or chemotherapy within the past 6 months.
• Diagnosed with severe intellectual disabilities, Alzheimer's disease, or other serious psychiatric disorders.
• Current participation in other research projects that may affect the results of this study.
• Presence of other severe disabilities or medical conditions deemed unsuitable for participation by the investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants in this arm will receive the "Diet-Medicine Companion" (Shi Yi Ban Lv) intervention. This involves using an AI-powered WeChat mini-program for daily dietary logging and receiving real-time feedback. Participants also receive proactive monitoring and support from family doctors (case administrators), including telephone reminders if they are inactive for more than 7 days and targeted health guidance based on their data.

Treatment:

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

Control

No Intervention group

Description:

Participants in this arm will receive standard community care (usual care) for type 2 diabetes management provided by their local community health centers. They will complete the same schedule of assessments (HbA1c tests and questionnaires) at baseline, 3 months, and 6 months but will not receive the AI mini-program intervention or the specific case administrator support provided to the experimental group.