Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Type 2 Diabetes;
- •Aged ≥ 18 years;
- •Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
- •Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
- •Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.
排除标准
- •Having severe mental illness or language barriers;
- •Suffering from malignant tumors;
- •Pregnant or lactating women;
- •Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
- •Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase > 3 times the upper limit of normal; estimated glomerular filtration rate < 15 mL/min/1.73 m²);
- •A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
- •Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
- •Alcoholism or drug addiction;
- •Receiving insulin therapy;
- •Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
研究组 & 干预措施
Experimental:WeChat mini-program Smart Management
On the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management.
干预措施: Device: "Professor Tang" WeChat Mini-program (Other)
Experimental: Wearable Devices + Data Management Platform
On the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software.
干预措施: Device: CGM,CGM management platform (Other)
Control: Traditional Control
Adopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary.
干预措施: Device: No specific devices (Other)
Experimental:Wearable Devices + WeChat mini-program Management
On the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations.
干预措施: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program (Other)
结局指标
主要结局
HbA1c
时间窗: Baseline, 1 year
Between-group differences in HbA1c change (from Central Lab)
次要结局
未报告次要终点