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

NCT05498974 | Recruiting

• 1 other identifier: CD1S
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Diabetes; Type1diabetes

Keywords

Type 1 diabetes; Diabetes in Young

Outcome Measures

Primary Outcomes (8)

• Change in serum hemoglobin A1c level

  A1c reflects the average blood glucose level

  Every year for up to 10 years

• Albumin-to-creatinine ratio in urine sample

  Albumin-to-creatinine ratio in urine sample

  up to 10 years

• Arteriosclerotic cardiovascular diseases

  Incident cases of cardiovascular diseases

  up to 10 years

• Electromyography

  value of nerve conduction velocity, F wave index, H-reflex

  up to 10 years

• PHQ-9

  PHQ-9（a score between 0-27, ≥10 may indicate depression)

  up to 10 years

• GAD-7

  GAD-7(a score between 0-21, ≥5 may indicate general anxiety)

  up to 10 years

• WHO-5

  WHO-5 (a score between 0-100, higher score means better outcome)

  up to 10 years

• PAID

  PAID (a score between 0-100, ≥40 warrants special attention).

  up to 10 years

Secondary Outcomes (7)

• Change in C-peptide

  Every year for up to 10 years

• Change in titer of autoantibodies

  Every year for up to 10 years

• Fasting blood glucose

  Every year for up to 10 years

• Systolic blood pressure

  Every year for up to 10 years

• Diastolic blood pressure

  Every year for up to 10 years

Study Arms (2)

Individuals diagnosed with type 1 diabetes

All patients diagnosed with type 1 diabetes of all ages.

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.

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

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

Interventions

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

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

Individuals diagnosed with type 1 diabetes; Individuals with diabetes who had an age of onset <= 20 years.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes or children and adolescents with diabetes mellitus at age of onset \<= 20 years

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (11)

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, 570311, China

RECRUITING

the First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

Heji Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830017, China

RECRUITING

The First People's Hospital of Yunnan

Kunming, Yunnan, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zhiguang Zhou, MD, PhD

  The Second Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguang Zhou, MD, PhD

CONTACT

+8673185292154; zhouzhiguang@csu.edu.cn

Xia Li, MD, PhD

CONTACT

lixia@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, National Clinical Research Center for Metabolic Diseases

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: August 12, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)