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Recruiting NCT05498974

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

— Observational Type1diabetes Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center.
Who it may be relevant to
Registry conditions: Type1diabetes, Diabetes. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Change in serum hemoglobin A1c level [Time frame: Every year for up to 10 years]
  • Albumin-to-creatinine ratio in urine sample [Time frame: up to 10 years]
  • Arteriosclerotic cardiovascular diseases [Time frame: up to 10 years]
  • Electromyography [Time frame: up to 10 years]
  • PHQ-9 [Time frame: up to 10 years]
  • GAD-7 [Time frame: up to 10 years]
  • WHO-5 [Time frame: up to 10 years]
  • PAID [Time frame: up to 10 years]
Secondary outcome measures (7)
  • Change in C-peptide [Time frame: Every year for up to 10 years]
  • Change in titer of autoantibodies [Time frame: Every year for up to 10 years]
  • Fasting blood glucose [Time frame: Every year for up to 10 years]
  • Systolic blood pressure [Time frame: Every year for up to 10 years]
  • Diastolic blood pressure [Time frame: Every year for up to 10 years]
  • Change in lipid profiles [Time frame: Every year for up to 10 years]
  • Metabolomics [Time frame: Every year for up to 10 years]

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)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 11 centers
  • Gansu Provincial People's Hospital — Lanzhou
  • Shenzhen Second People's Hospital — Shenzhen
  • Hainan General Hospital — Haikou
  • the First Affiliated Hospital of Harbin Medical University — Harbin
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
  • The Second Xiangya Hospital, Central South University — Changsha
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing
  • Heji Hospital Affiliated to Changzhi Medical College — Changzhi
  • … and 3 more centers

Publications

  • Deng C, Fan W, Xie Y, Tang X, Jiang H, Niu X, Yan D, Su H, Kuang H, Tian L, Liu J, Jiang S, Quan H, Xu J, Wu X, Tao N, Sun S, Li J, Guo R, Chen Y, He B, Fan L, Cao C, Huang F, Huang G, Zhou Z, Li X; CD1S Study Group. Health Inequities in Older Adults With Type 1 Diabetes: A Nationwide Registry Analysis of Sociodemographic and Clinical Profiles for Glycaemic Control and Complications. Diabetes Obes PMID 42152598

Identifiers

NCT: NCT05498974 · CD1S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗