Clinical Trials in China / NCT05498974
Recruiting
Observational
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
NCT05498974 · tracked via the Priya Life Science China tracker
Condition(s) studied
Type1diabetesDiabetes
Investigational drug(s) / intervention(s)
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: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Study 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.
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. ③ C-peptide \> 800 pmol/L at any time point.
Primary outcome measure(s)
- 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 - Arteriosclerotic cardiovascular diseases — up to 10 years
Incident cases of cardiovascular diseases - Electromyography — up to 10 years
value of nerve conduction velocity, F wave index, H-reflex - PHQ-9 — up to 10 years
PHQ-9（a score between 0-27, ≥10 may indicate depression) - 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).
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Gansu Provincial People's Hospital | Lanzhou | Gansu | Recruiting |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | Recruiting |
| Hainan General Hospital | Haikou | Hainan | Recruiting |
| the First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| The Second Xiangya Hospital, Central South University | Changsha | Hunan | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Not Yet Recruiting |
| Heji Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | Recruiting |
| The First People's Hospital of Yunnan | Kunming | Yunnan | Recruiting |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | Recruiting |
More Second Xiangya Hospital of Central South University trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05498974 on ClinicalTrials.gov ↗ ← All trials in China