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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c) Levels
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
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.
干预措施: AI-driven Dietary Management and Human-in-the-loop Support (Device)
Control
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.
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c) Levels
时间窗: 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.
次要结局
- 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)
- Treatment Satisfaction (DTSQs)(Baseline, Month 3, and Month 6)
- Digital Literacy (C-eHEALS)(Baseline, Month 3, and Month 6)
- Medical Costs(Baseline, Month 3, and Month 6)