NCT05498974 China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
| NCT ID | NCT05498974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Type1diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2022-01-01 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Zhiguang Zhou, MD, PhD
PRINCIPAL INVESTIGATOR
The Second Xiangya Hospital, Central South University
Frequently Asked Questions
Who can join the NCT05498974 clinical trial?
This trial is open to participants of all sexes, studying Type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05498974 currently recruiting?
Yes, NCT05498974 is actively recruiting participants. Contact the research team at zhouzhiguang@csu.edu.cn for enrollment information.
Where is the NCT05498974 trial being conducted?
This trial is being conducted at Lanzhou, China, Shenzhen, China, Haikou, China, Harbin, China and 7 additional locations.
Who is sponsoring the NCT05498974 clinical trial?
NCT05498974 is sponsored by Second Xiangya Hospital of Central South University. The principal investigator is Zhiguang Zhou, MD, PhD at The Second Xiangya Hospital, Central South University. The trial plans to enroll 20,000 participants.
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