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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498974
• Other study ID #: CD1S
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2035

Study information

• Verified date: August 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: Zhiguang Zhou, MD, PhD
• Phone: +8673185292154
• Email: zhouzhiguang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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. ? C-peptide > 800 pmol/L at any time point.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
China	The Second Xiangya Hospital, Central South University	Changsha	Hunan
China	Heji Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	Hainan General Hospital	Haikou	Hainan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	the First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First People's Hospital of Yunnan	Kunming	Yunnan
China	Gansu Provincial People's Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum hemoglobin A1c level	A1c reflects the average blood glucose level	Every year for up to 10 years
Primary	Albumin-to-creatinine ratio in urine sample	Albumin-to-creatinine ratio in urine sample	up to 10 years
Primary	Arteriosclerotic cardiovascular diseases	Incident cases of cardiovascular diseases	up to 10 years
Primary	Electromyography	value of nerve conduction velocity, F wave index, H-reflex	up to 10 years
Primary	PHQ-9	PHQ-9(a score between 0-27, =10 may indicate depression)	up to 10 years
Primary	GAD-7	GAD-7(a score between 0-21, =5 may indicate general anxiety)	up to 10 years
Primary	WHO-5	WHO-5 (a score between 0-100, higher score means better outcome)	up to 10 years
Primary	PAID	PAID (a score between 0-100, =40 warrants special attention).	up to 10 years
Secondary	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
Secondary	Change in titer of autoantibodies	Glutamic acid decarboxylase antibody	Every year for up to 10 years
Secondary	Fasting blood glucose	the blood sugar level after fasting for eight hours	Every year for up to 10 years
Secondary	Systolic blood pressure	Systolic blood pressure	Every year for up to 10 years
Secondary	Diastolic blood pressure	Diastolic blood pressure	Every year for up to 10 years
Secondary	Change in lipid profiles	Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol	Every year for up to 10 years
Secondary	Metabolomics	un-targeted metabolomics	Every year for up to 10 years