Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, digital health, AI, blended care
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
Interventions
DEVICEAI-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
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | 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. |
| Incidence of Diabetes Complications | 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 |
| Quality of Life (EQ-5D-5L) | 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. |
| Self-Management Behaviors (SDSCA) | 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. |
| Treatment Satisfaction (DTSQs) | 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. |
| Digital Literacy (C-eHEALS) | 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. |
| Change in Body Mass Index (BMI) | 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. |
| Medical Costs | 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. |
Outcome results
None listed