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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Type1diabetes
• Intervention / Treatment: Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

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.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Zhiguang Zhou, MD, PhD; Phone Number: +8673185292154; Email: zhouzhiguang@csu.edu.cn
• Study Contact Backup: Name: Xia Li, MD, PhD; Email: lixia@csu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Provincial People's Hospital
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: Dewen Yan
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Hongyu Kuang
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Hongwei Jiang
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The Second Xiangya Hospital, Central South University
      • Contact: Xia Li, MD, PhD; Email: lixia@csu.edu.cn
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Tao Yang
  • Shanxi
    • Changzhi, Shanxi, China
      • Recruiting
      • Heji Hospital Affiliated to Changzhi Medical College
      • Contact: Xiaohong Niu
  • Xinjiang
    • Urumqi, Xinjiang, China, 830017
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
      • Contact: Sheng Jiang
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • The First People's Hospital of Yunnan
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

  1. Clinical diagnosis of type 1 diabetes by a specialist
  2. Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
  3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-peptide	C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study	Every year for up to 10 years
Change in titer of autoantibodies	Glutamic acid decarboxylase antibody	Every year for up to 10 years
Fasting blood glucose	the blood sugar level after fasting for eight hours	Every year for up to 10 years
Systolic blood pressure	Systolic blood pressure	Every year for up to 10 years
Diastolic blood pressure	Diastolic blood pressure	Every year for up to 10 years
Change in lipid profiles	Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol	Every year for up to 10 years
Metabolomics	un-targeted metabolomics	Every year for up to 10 years

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Zhiguang Zhou, MD, PhD, The Second Xiangya Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2035
• Study Completion (ANTICIPATED): December 31, 2035

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Diabetes in Young
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CD1S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No