China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSecond Xiangya Hospital of Central South University
About this trial
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
Qualifiers
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 2. Children and adolescents with diabetes mellitus at age of onset <= 20 years, regardless of type and duration of disease.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Treatment groups
20,000 Participants
are divided into 2 treatment groupsLocations
11Gansu Provincial People's Hospital LanzhouGansu, China
Shenzhen Second People's Hospital ShenzhenGuangdong, China
Hainan General Hospital570311, HaikouHainan, China
the First Affiliated Hospital of Harbin Medical University HarbinHeilongjiang, China
Sponsors and collaborators
Second Xiangya Hospital of Central South University
Lead sponsor
Source ClinicalTrials.gov