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

NCT ID: NCT05498974

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Type1diabetes Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Individuals diagnosed with type 1 diabetes

All patients diagnosed with type 1 diabetes of all ages.

Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

Intervention Type OTHER

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.

Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

Intervention Type OTHER

Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Zhiguang Zhou

Director, National Clinical Research Center for Metabolic Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiguang Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Xiangya Hospital, Central South University

Locations

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Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Hainan General Hospital

Haikou, Hainan, China

Site Status RECRUITING

the First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Heji Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

The First People's Hospital of Yunnan

Kunming, Yunnan, China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiguang Zhou, MD, PhD

Role: CONTACT

+8673185292154

Xia Li, MD, PhD

Role: CONTACT

Facility Contacts

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Jing Liu

Role: primary

Dewen Yan

Role: primary

Huibiao Quan

Role: primary

Hongyu Kuang

Role: primary

Hongwei Jiang

Role: primary

Xia Li, MD, PhD

Role: primary

Tao Yang

Role: primary

Xiaohong Niu

Role: primary

Sheng Jiang

Role: primary

Heng Su

Role: primary

Xiaohong Wu

Role: primary

Other Identifiers

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CD1S

Identifier Type: -

Identifier Source: org_study_id

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