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

Central South University

Status: Enrolling

Conditions: Diabetes; Type1diabetes

Treatments: Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

Study type: Observational

Funder types: Other

Identifiers

NCT05498974

CD1S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)

  2. Clinical diagnosis of type 1 diabetes by a specialist

  3. Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L

  4. 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.

Trial design

20,000 participants in 2 patient groups

Individuals diagnosed with type 1 diabetes

Description:

All patients diagnosed with type 1 diabetes of all ages.

Treatment:

Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

Individuals with diabetes who had an age of onset <= 20 years.

Description:

All patients with diabetes who had an age of onset \<= 20 years.

Treatment:

Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center