China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
- Conditions
- Type1diabetesDiabetes
- Interventions
- Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
- Registration Number
- NCT05498974
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
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Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
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Clinical diagnosis of type 1 diabetes by a specialist
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Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
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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.
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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)
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals diagnosed with type 1 diabetes Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center All patients diagnosed with type 1 diabetes of all ages. Individuals with diabetes who had an age of onset <= 20 years. Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center All patients with diabetes who had an age of onset \<= 20 years.
- Primary Outcome Measures
Name Time Method Arteriosclerotic cardiovascular diseases up to 10 years Incident cases of cardiovascular diseases
PHQ-9 up to 10 years PHQ-9（a score between 0-27, ≥10 may indicate depression)
Change in serum hemoglobin A1c level Every year for up to 10 years A1c reflects the average blood glucose level
Albumin-to-creatinine ratio in urine sample up to 10 years Albumin-to-creatinine ratio in urine sample
Electromyography up to 10 years value of nerve conduction velocity, F wave index, H-reflex
GAD-7 up to 10 years GAD-7(a score between 0-21, ≥5 may indicate general anxiety)
WHO-5 up to 10 years WHO-5 (a score between 0-100, higher score means better outcome)
PAID up to 10 years PAID (a score between 0-100, ≥40 warrants special attention).
- Secondary Outcome Measures
Name Time Method Change in C-peptide Every year for up to 10 years C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study
Fasting blood glucose Every year for up to 10 years the blood sugar level after fasting for eight hours
Change in lipid profiles Every year for up to 10 years Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Metabolomics Every year for up to 10 years un-targeted metabolomics
Systolic blood pressure Every year for up to 10 years Systolic blood pressure
Change in titer of autoantibodies Every year for up to 10 years Glutamic acid decarboxylase antibody
Diastolic blood pressure Every year for up to 10 years Diastolic blood pressure
Trial Locations
- Locations (11)
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Gansu Provincial People's Hospital
🇨🇳Lanzhou, Gansu, China
the First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Heji Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First People's Hospital of Yunnan
🇨🇳Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China