China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Dec 31, 2035
  • participants needed
    20000
  • sponsor
    Second Xiangya Hospital of Central South University
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Updated on 22 February 2023
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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.

Description

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.

Details
Condition Type1diabetes, Diabetes
Treatment Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Clinical Study IdentifierNCT05498974
SponsorSecond Xiangya Hospital of Central South University
Last Modified on22 February 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

\. 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

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
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