NCT04096794招募中不适用
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- changes in serum hemoglobin A1c level
研究概览
简要总结
The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.
详细描述
- Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.
- observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.
- Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.
- By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
- •Written informed consent from the patient or family representative;
- •Individuals who own smartphone and are capable of using wechat or apps
排除标准
- •Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease
- •With mental disorders
- •Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
结局指标
主要结局
changes in serum hemoglobin A1c level
时间窗: Baseline and every up to 12 weeks afterwards
A1c reflects the average blood glucose level in the past 3 months.
次要结局
- Systolic blood pressure(Baseline and every up to 12 weeks afterwards)
- Height in meters(Baseline and every up to 12 weeks afterwards)
- C-peptide(Baseline and every up to 12 weeks afterwards)
- changes in Time in range (TIR)(Baseline and every up to 12 weeks afterwards)
- Diastolic blood pressure(Baseline and every up to 12 weeks afterwards)
- Change in lipid profiles(Baseline and every up to 12 weeks afterwards)
- Weight in kilograms(Baseline and every every up to 12 weeks afterwards)
- Fasting blood glucose(Baseline and every up to 12 weeks afterwards)
- Stool samples(Baseline and every up to 12 weeks afterwards)
- Change in titer of autoantibodies(Baseline and every up to 12 weeks afterwards)
- Adverse effects(Baseline and every up to 12 weeks afterwards)
研究者
Zhiguang Zhou
Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases.
Second Xiangya Hospital of Central South University
研究点 (1)
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