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NCT Number: NCT05498974

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Gansu Provincial People's Hospital, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Change in serum hemoglobin A1c level

    Time frame: Every year for up to 10 years

    A1c reflects the average blood glucose level

  2. Albumin-to-creatinine ratio in urine sample

    Time frame: up to 10 years

    Albumin-to-creatinine ratio in urine sample

  3. Arteriosclerotic cardiovascular diseases

    Time frame: up to 10 years

    Incident cases of cardiovascular diseases

  4. Electromyography

    Time frame: up to 10 years

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

  5. PHQ-9

    Time frame: up to 10 years

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

  6. GAD-7

    Time frame: up to 10 years

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

  7. WHO-5

    Time frame: up to 10 years

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

  8. PAID

    Time frame: up to 10 years

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

Secondary outcomes

  1. Change in C-peptide

    Time frame: 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

  2. Change in titer of autoantibodies

    Time frame: Every year for up to 10 years

    Glutamic acid decarboxylase antibody using radioligand binding assay method

  3. Fasting blood glucose

    Time frame: Every year for up to 10 years

    the blood sugar level after fasting for eight hours

  4. Systolic blood pressure

    Time frame: Every year for up to 10 years

    Systolic blood pressure

  5. Diastolic blood pressure

    Time frame: Every year for up to 10 years

    Diastolic blood pressure

  6. Change in lipid profiles

    Time frame: Every year for up to 10 years

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

  7. Metabolomics

    Time frame: Every year for up to 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xia Li, MD, PhD

CONTACT

[email protected]

Zhiguang Zhou, MD, PhD

CONTACT

[email protected]

+8673185292154

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2022
Primary completion
2035
Study completion
2035
First posted
Aug 12, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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