Nationwide registry for type 1 diabetes in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.