Blended Resources for Integrated Diabetes Guidance and Empowerment

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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

Первичные конечные точки

• Change in Glycosylated Hemoglobin (HbA1c) Levels [Срок оценки: Baseline, Month 3, and Month 6]

Вторичные конечные точки (8)

• Change in Body Mass Index (BMI) [Срок оценки: Baseline, Month 3, and Month 6]
• Change in Blood Pressure [Срок оценки: Baseline, Month 3, and Month 6]
• Incidence of Diabetes Complications [Срок оценки: Baseline, Month 3, and Month 6]
• Quality of Life (EQ-5D-5L) [Срок оценки: Baseline, Month 3, and Month 6]
• Self-Management Behaviors (SDSCA) [Срок оценки: Baseline, Month 3, and Month 6]
• Treatment Satisfaction (DTSQs) [Срок оценки: Baseline, Month 3, and Month 6]
• Digital Literacy (C-eHEALS) [Срок оценки: Baseline, Month 3, and Month 6]
• Medical Costs [Срок оценки: Baseline, Month 3, and Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07373379 · IRB00001052-25198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗