Application and Effectiveness Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients of Community
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Change of HbA1c
研究概览
简要总结
The goal of this clinical trial is to learn about the application and effectiveness evaluation of artificial intelligence (AI) in lifestyle management of diabetic patients in community.
详细描述
To determine the effectiveness of lifestyle intervention through AI on diabetic patients, whether it can improve blood sugar/ blood pressure/ body weight/ blood lipid control in people with type 1 or type 2 diabetes? Then find related risk factors. Participants will complete the basic information, diet structure, use of dietary supplements, living habits, and exercise according to the AI scale (AI scale can be entered through we-chat mini program search), and provided personalized lifestyle intervention plan according to the survey result, while the control group received routine lifestyle guidance. All included patients would fill in the patient's medication information according to the information content of the machine reading card, and follow up whether the medication is adjusted. The patient was included in the diabetes management we-chat group, followed up for 3 months /6 months according to the visit plan. The experimental group filled in the lifestyle assessment scale again, and personalized lifestyle intervention programs were provided according to the survey results, while the control group received routine follow-up and lifestyle guidance. Researchers will compare the two groups to see if the control of blood glucose, blood pressure, blood lipids and BMI of the experimental group after 6 months of AI-based lifestyle intervention was better than the control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well informed of the procedures of this trial and informed consent is obtained
- •18-80 years old, gender is not limited
- •Diagnosed diabetes (according to WHO1999 diagnostic criteria)
- •Well compliance
排除标准
- •Pregnant or lactating
- •Poor blood glucose control (HbA1c>11%)
- •A history of malignant tumor
- •Abnormal liver or renal function [defined as alanine aminotransferase (ALT)>2.5 times higher than normal range, or eGFR<30 mL/min per 1.73 m2]
- •Poor blood pressure control [systolic blood pressure (SBP)>180mmHg, or diastolic blood pressure (DBP)>110mmHg
- •With severe heart disease, cardiac function worse than grade II, anemia (Hb<9.0g/d1)
- •Blood routine test indicates that the white blood cell count (WBC) <3*109/L
- •Body Mass Index (BMI)<18.5 or ≥35kg/m2
- •Drug or alcohol abuse
- •Accompanying mental disorder who can't collaborate
- •Abnormal digestion and absorption function
- •Other endocrine diseases
- •Other chronic diseases needed long-term glucocorticoid treatment
- •With severe infection, immune dysfunction
结局指标
主要结局
Change of HbA1c
时间窗: one year
Change of HbA1c from baseline to endpoint (1 year follow-up)
次要结局
- Change of systolic blood pressure(one year)
- Change of diastolic blood pressure(one year)
- Change of LDL-c(one year)
研究者
Qifu Li
Professor.
Chongqing Medical University