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NCT Number: NCT07373379

Blended Resources for Integrated Diabetes Guidance and Empowerment

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c) Levels

    Time frame: Baseline, Month 3, and Month 6

    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.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline, Month 3, and Month 6

    Calculated as weight in kilograms divided by the square of height in meters (kg/m^2). BMI is used as an indicator of body fatness and weight management status. A lower BMI (within the healthy range) generally indicates better weight control outcomes.

  2. Change in Blood Pressure

    Time frame: Baseline, Month 3, and Month 6

    Measured as Systolic and Diastolic Blood Pressure in mmHg using a standard sphygmomanometer. Lower blood pressure values (approaching the normal range) indicate better cardiovascular risk management.

  3. Incidence of Diabetes Complications

    Time frame: Baseline, Month 3, and Month 6

    The occurrence of new or worsening diabetes-related complications, including but not limited to neuropathy, retinopathy, nephropathy, and cardiovascular events. Data will be collected through medical record reviews and patient self-reports. A lower incidence rate indicates better disease management

  4. Quality of Life (EQ-5D-5L)

    Time frame: Baseline, Month 3, and Month 6

    Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. It covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single utility index score ranging from less than 0 to 1. Higher scores indicate better health-related quality of life.

  5. Self-Management Behaviors (SDSCA)

    Time frame: Baseline, Month 3, and Month 6

    Assessed using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. This instrument measures the frequency of self-care activities (including diet, exercise, blood sugar testing, and foot care) over the past 7 days. Higher scores indicate better adherence to diabetes self-management activities.

  6. Treatment Satisfaction (DTSQs)

    Time frame: Baseline, Month 3, and Month 6

    Assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQs). This tool evaluates the patient's satisfaction with their current treatment regimen, including perception of hyperglycemia/hypoglycemia and convenience. Higher scores indicate greater satisfaction with the treatment.

  7. Digital Literacy (C-eHEALS)

    Time frame: Baseline, Month 3, and Month 6

    Assessed using the Chinese eHealth Literacy Scale (C-eHEALS). This scale measures the participants' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Higher scores indicate higher levels of electronic health literacy.

  8. Medical Costs

    Time frame: Baseline, Month 3, and Month 6

    Total direct and indirect costs related to diabetes management. Direct costs include expenses for examinations, medications, outpatient/inpatient visits, transportation, and caregiver fees. Indirect costs include caregiver time costs. Data will be collected via patient questionnaires and healthcare utilization records. Lower costs indicate a reduced economic burden.

Other outcomes

  1. Frequency of Dietary Uploads (Adherence)

    Time frame: Throughout the 6-month intervention period

    Measured as the total count of dietary records (photos or text entries) uploaded by each participant via the "Diet-Medicine Companion" (Shi Yi Ban Lv) mini-program. Data is automatically logged by the system's backend server. This metric serves as a direct objective indicator of participant engagement and adherence to the intervention protocol (which requires daily uploads). Higher numbers indicate better adherence.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Effectiveness and Implementation of an AI-Driven Blended Care Model for Type 2 Diabetes Management in Primary Care: A Single-Blind, Cluster Randomized Controlled Trial in Zhangjiagang, China

Acronym: BRIDGE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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