Nationwide registry for type 1 diabetes in China
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
This study is creating a detailed registry for young people with type 1 diabetes in China to better understand their health and challenges.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 11 sites (Lanzhou, Gansu and 10 other locations) |
| Trial ID | NCT05498974 on ClinicalTrials.gov |
What this trial studies
The China Diabetes Type 1 Study (CD1S) aims to create a comprehensive registry for type 1 diabetes (T1D) patients across China, focusing on demographic characteristics, metabolic control, and complications. This observational study includes both retrospective data from hospitalized patients between 2016 and 2021 and prospective data collection starting in 2022. It specifically examines pediatric patients diagnosed with diabetes at or before the age of 20, assessing their clinical features and risk factors. The study is conducted under a standardized management model developed by the China Alliance for Type 1 Diabetes.
Who should consider this trial
Good fit: Ideal candidates include patients with type 1 diabetes of any duration and children or adolescents diagnosed with diabetes at age 20 or younger.
Not a fit: Patients who do not require insulin therapy or have a C-peptide level above 800 pmol/L may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of type 1 diabetes in young patients, leading to improved management and outcomes.
How similar studies have performed: Other studies have successfully established diabetes registries, indicating that this approach has potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1\. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
1. Clinical diagnosis of type 1 diabetes by a specialist
2. Age at onset \< 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide \< 200 pmol/L
3. Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset \<= 20 years, regardless of type and duration of disease.
Exclusion Criteria:
* 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.
Where this trial is running
Lanzhou, Gansu and 10 other locations
- Gansu Provincial People's Hospital — Lanzhou, Gansu, China (Recruiting)
- Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- Hainan General Hospital — Haikou, Hainan, China (Recruiting)
- the First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
- The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
- Heji Hospital Affiliated to Changzhi Medical College — Changzhi, Shanxi, China (Recruiting)
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
- The First People's Hospital of Yunnan — Kunming, Yunnan, China (Recruiting)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhiguang Zhou, MD, PhD — The Second Xiangya Hospital, Central South University
- Study coordinator: Zhiguang Zhou, MD, PhD
- Email: zhouzhiguang@csu.edu.cn
- Phone: +8673185292154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.