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Type1diabetesNCT05498974

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

An observational study of Type1diabetes and Diabetes, run by Second Xiangya Hospital of Central South University at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Type1diabetes, Diabetes
What is being tested?
Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
How many people
20,000 participants
Where
11 sitesChina
Study dates
1 Jan 2022to 31 Dec 2035
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with type 1 diabetes or children and adolescents with diabetes mellitus at age of onset <= 20 years

Who may be able to join

  • 1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
  • Clinical diagnosis of type 1 diabetes by a specialist
  • Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhiguang Zhou, MD, PhD contact

+8673185292154

zhouzhiguang@csu.edu.cn

Xia Li, MD, PhD contact

lixia@csu.edu.cn

11 sites in 1 country

China11 sites, 11 recruiting

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

    Xia Li, MD, PhD, lixia@csu.edu.cn

    Recruiting

  • Heji Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi

    Xiaohong Niu

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan, 570311

    Huibiao Quan

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Xiaohong Wu

    Recruiting

  • the First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Hongyu Kuang

    Recruiting

  • The First People's Hospital of Yunnan

    Kunming, Yunnan

    Heng Su

    Recruiting

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu

    Jing Liu

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

    Hongwei Jiang

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Tao Yang

    Not yet recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

    Dewen Yan

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830017

    Sheng Jiang

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Keywords
Type 1 diabetes; Diabetes in Young
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05498974
Study groupRoleWhat they receive
Individuals diagnosed with type 1 diabetesAll patients diagnosed with type 1 diabetes of all ages.
Receives: 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.
Receives: Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum hemoglobin A1c level

    A1c reflects the average blood glucose level

    Measured: Every year for up to 10 years

  2. Albumin-to-creatinine ratio in urine sample

    Albumin-to-creatinine ratio in urine sample

    Measured: up to 10 years

  3. Arteriosclerotic cardiovascular diseases

    Incident cases of cardiovascular diseases

    Measured: up to 10 years

  4. Electromyography

    value of nerve conduction velocity, F wave index, H-reflex

    Measured: up to 10 years

  5. PHQ-9

    PHQ-9（a score between 0-27, ≥10 may indicate depression)

    Measured: up to 10 years

  6. GAD-7

    GAD-7(a score between 0-21, ≥5 may indicate general anxiety)

    Measured: up to 10 years

  7. WHO-5

    WHO-5 (a score between 0-100, higher score means better outcome)

    Measured: up to 10 years

  8. PAID

    PAID (a score between 0-100, ≥40 warrants special attention).

    Measured: up to 10 years

Secondary outcomes (7)

  1. 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

    Measured: Every year for up to 10 years

  2. Change in titer of autoantibodies

    Glutamic acid decarboxylase antibody using radioligand binding assay method

    Measured: Every year for up to 10 years

  3. Fasting blood glucose

    the blood sugar level after fasting for eight hours

    Measured: Every year for up to 10 years

  4. Systolic blood pressure

    Systolic blood pressure

    Measured: Every year for up to 10 years

  5. Diastolic blood pressure

    Diastolic blood pressure

    Measured: Every year for up to 10 years

  6. Change in lipid profiles

    Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol

    Measured: Every year for up to 10 years

  7. Metabolomics

    un-targeted metabolomics using the LC-MS/MS system

    Measured: Every year for up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2035 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
20,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498974
Sponsor's protocol ID
CD1S
Status last verified
May 2025
First submitted
2 Jul 2022
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deng C, Fan W, Xie Y, Tang X, Jiang H, Niu X, Yan D, Su H, Kuang H, Tian L, Liu J, Jiang S, Quan H, Xu J, Wu X, Tao N, Sun S, Li J, Guo R, Chen Y, He B, Fan L, Cao C, Huang F, Huang G, Zhou Z, Li X; CD1S Study Group. Health Inequities in Older Adults With Type 1 Diabetes: A Nationwide Registry Analysis of Sociodemographic and Clinical Profiles for Glycaemic Control and Complications. Diabetes Obes Metab. 2026 Aug;28(8):6850-6860. doi: 10.1111/dom.70833. Epub 2026 May 18.

    PubMed 42152598

Questions about this trial

What is this clinical trial studying?

An observational study of Type1diabetes and Diabetes, run by Second Xiangya Hospital of Central South University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhiguang Zhou, MD, PhD (+8673185292154, zhouzhiguang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum hemoglobin A1c level (time frame: Every year for up to 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05498974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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