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Type 2 Diabetes MellitusBRIDGENCT07373379

Blended Resources for Integrated Diabetes Guidance and Empowerment

A study testing AI-driven Dietary Management and Human-in-the-loop Support in people with Type 2 Diabetes Mellitus, run by Peking University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
AI-driven Dietary Management and Human-in-the-loop Support
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official 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

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?

Read more

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

Being tested
AI-driven Dietary Management and Human-in-the-loop Support
Keywords
Type 2 Diabetes Mellitus, digital health, AI, blended care
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-driven Dietary Management and Human-in-the-loop SupportDevice

    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.

Study groups in NCT07373379
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Device: AI-driven Dietary Management and Human-in-the-loop Support
ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 3, and Month 6

Secondary outcomes (8)

  1. Change in Body Mass Index (BMI)

    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.

    Measured: Baseline, Month 3, and Month 6

  2. Change in Blood Pressure

    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.

    Measured: Baseline, Month 3, and Month 6

  3. Incidence of Diabetes Complications

    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

    Measured: Baseline, Month 3, and Month 6

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

    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.

    Measured: Baseline, Month 3, and Month 6

  5. Self-Management Behaviors (SDSCA)

    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.

    Measured: Baseline, Month 3, and Month 6

  6. Treatment Satisfaction (DTSQs)

    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.

    Measured: Baseline, Month 3, and Month 6

  7. Digital Literacy (C-eHEALS)

    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.

    Measured: Baseline, Month 3, and Month 6

  8. Medical Costs

    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.

    Measured: Baseline, Month 3, and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373379
Sponsor's protocol ID
IRB00001052-25198
Acronym
BRIDGE
Status last verified
Jan 2026
First submitted
21 Jan 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing AI-driven Dietary Management and Human-in-the-loop Support in people with Type 2 Diabetes Mellitus, run by Peking University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Hemoglobin (HbA1c) Levels (time frame: Baseline, Month 3, and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07373379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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