Blended Resources for Integrated Diabetes Guidance and Empowerment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-driven Dietary Management and Human-in-the-loop Support.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device AI-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 adm
Primary outcome measures
- Change in Glycosylated Hemoglobin (HbA1c) Levels [Time frame: Baseline, Month 3, and Month 6]
Secondary outcome measures (8)
- Change in Body Mass Index (BMI) [Time frame: Baseline, Month 3, and Month 6]
- Change in Blood Pressure [Time frame: Baseline, Month 3, and Month 6]
- Incidence of Diabetes Complications [Time frame: Baseline, Month 3, and Month 6]
- Quality of Life (EQ-5D-5L) [Time frame: Baseline, Month 3, and Month 6]
- Self-Management Behaviors (SDSCA) [Time frame: Baseline, Month 3, and Month 6]
- Treatment Satisfaction (DTSQs) [Time frame: Baseline, Month 3, and Month 6]
- Digital Literacy (C-eHEALS) [Time frame: Baseline, Month 3, and Month 6]
- Medical Costs [Time frame: Baseline, Month 3, and Month 6]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07373379 · IRB00001052-25198