China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 11
- 主要终点
- Arteriosclerotic cardiovascular diseases
研究概览
简要总结
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
CD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.
详细描述
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with T1D, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
- •Clinical diagnosis of type 1 diabetes by a specialist
- •Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
- •Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or
- •Children and adolescents with diabetes mellitus at age of onset <= 20 years, regardless of type and duration of disease.
排除标准
- •For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)
- •No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.
- •No DKA for 1 month off insulin for those with a history of diabetes > 1 year. ③ C-peptide > 800 pmol/L at any time point.
研究组 & 干预措施
Individuals diagnosed with type 1 diabetes
All patients diagnosed with type 1 diabetes of all ages.
干预措施: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center (Other)
Individuals with diabetes who had an age of onset <= 20 years.
All patients with diabetes who had an age of onset <= 20 years.
干预措施: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center (Other)
结局指标
主要结局
Arteriosclerotic cardiovascular diseases
时间窗: up to 10 years
Incident cases of cardiovascular diseases
PHQ-9
时间窗: up to 10 years
PHQ-9（a score between 0-27, ≥10 may indicate depression)
Change in serum hemoglobin A1c level
时间窗: Every year for up to 10 years
A1c reflects the average blood glucose level
Albumin-to-creatinine ratio in urine sample
时间窗: up to 10 years
Albumin-to-creatinine ratio in urine sample
Electromyography
时间窗: up to 10 years
value of nerve conduction velocity, F wave index, H-reflex
GAD-7
时间窗: up to 10 years
GAD-7(a score between 0-21, ≥5 may indicate general anxiety)
WHO-5
时间窗: up to 10 years
WHO-5 (a score between 0-100, higher score means better outcome)
PAID
时间窗: up to 10 years
PAID (a score between 0-100, ≥40 warrants special attention).
次要结局
- Change in C-peptide(Every year for up to 10 years)
- Fasting blood glucose(Every year for up to 10 years)
- Change in lipid profiles(Every year for up to 10 years)
- Systolic blood pressure(Every year for up to 10 years)
- Diastolic blood pressure(Every year for up to 10 years)
- Change in titer of autoantibodies(Every year for up to 10 years)
- Metabolomics(Every year for up to 10 years)
研究者
Zhiguang Zhou
Director, National Clinical Research Center for Metabolic Diseases
Second Xiangya Hospital of Central South University