Blended Resources for Integrated Diabetes Guidance and Empowerment

NCT07373379 | Not Yet Recruiting

• 1 other identifier: IRB00001052-25198
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; digital health; AI; blended care

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Hemoglobin (HbA1c) Levels

  Glycosylated Hemoglobin (HbA1c) reflects the average plasma glucose concentration over the preceding 3 months. It serves as the gold standard biomarker for long-term glycemic control in diabetes management. Data will be obtained from venous blood samples collected at community health centers. A lower HbA1c percentage indicates better glycemic control.

  Baseline, Month 3, and Month 6

Secondary Outcomes (8)

• Change in Body Mass Index (BMI)

  Baseline, Month 3, and Month 6

• Change in Blood Pressure

  Baseline, Month 3, and Month 6

• Incidence of Diabetes Complications

  Baseline, Month 3, and Month 6

• Quality of Life (EQ-5D-5L)

  Baseline, Month 3, and Month 6

• Self-Management Behaviors (SDSCA)

  Baseline, Month 3, and Month 6

Other Outcomes (1)

• Frequency of Dietary Uploads (Adherence)

  Throughout the 6-month intervention period

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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.

Interventions

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

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years (inclusive).
• Glycosylated hemoglobin (HbA1c) level ≥ 6.5%.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Start Date: Within 6 months after publication of the primary manuscript End Date: 3 years after publication
• Access Criteria: De-identified individual participant data (IPD) that underlie the results reported in the article will be available to researchers who provide a methodologically sound proposal. Data will be available beginning 6 months and ending 3 years following article publication. Proposals should be directed to the Principal Investigator, Ping He (phe@pku.edu.cn) or the study contact. To gain access, data requestors will need to sign a data access agreement.