Clinical trial NCT05498974: China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
Official title: China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Diabetes
Keywords: Type 1 diabetes; Diabetes in Young
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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

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.

Eligibility criteria: 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 outcomes:
measure: Change in serum hemoglobin A1c level
timeFrame: Every year for up to 10 years
measure: Albumin-to-creatinine ratio in urine sample
timeFrame: up to 10 years
measure: Arteriosclerotic cardiovascular diseases
timeFrame: up to 10 years
measure: Electromyography
timeFrame: up to 10 years
measure: PHQ-9
timeFrame: up to 10 years
measure: GAD-7
timeFrame: up to 10 years
measure: WHO-5
timeFrame: up to 10 years
measure: PAID
timeFrame: up to 10 years
Secondary outcomes:
measure: Change in C-peptide
timeFrame: Every year for up to 10 years
measure: Change in titer of autoantibodies
timeFrame: Every year for up to 10 years
measure: Fasting blood glucose
timeFrame: Every year for up to 10 years
measure: Systolic blood pressure
timeFrame: Every year for up to 10 years
measure: Diastolic blood pressure
timeFrame: Every year for up to 10 years
measure: Change in lipid profiles
timeFrame: Every year for up to 10 years
measure: Metabolomics
timeFrame: Every year for up to 10 years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Harbin
country: China
facility: the First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Changzhi
country: China
facility: Heji Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First People's Hospital of Yunnan
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: The Second Xiangya Hospital, Central South University
name: Zhiguang Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: