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NCT Number: NCT04096794

Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location status: Recruiting

Location contact

Zhiguang Zhou, MD/PhD

CONTACT

[email protected]

86-731-85292154

About this study

  • Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.
  • observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.
  • Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.
  • By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
  • Written informed consent from the patient or family representative;
  • Individuals who own smartphone and are capable of using wechat or apps

Exclusion criteria

  • Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease
  • With mental disorders
  • Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial

Treatment and study plan

Primary outcomes

  1. changes in serum hemoglobin A1c level

    Time frame: Baseline and every up to 12 weeks afterwards

    A1c reflects the average blood glucose level in the past 3 months.

Secondary outcomes

  1. changes in Time in range (TIR)

    Time frame: Baseline and every up to 12 weeks afterwards

    TIR measures the time where the blood glucose remains within the proposed target range.

  2. C-peptide

    Time frame: Baseline and every up to 12 weeks afterwards

    C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study

  3. Change in titer of autoantibodies

    Time frame: Baseline and every up to 12 weeks afterwards

  4. Fasting blood glucose

    Time frame: Baseline and every up to 12 weeks afterwards

    the blood sugar level after fasting for eight hours

  5. Systolic blood pressure

    Time frame: Baseline and every up to 12 weeks afterwards

    Systolic blood pressure

  6. Diastolic blood pressure

    Time frame: Baseline and every up to 12 weeks afterwards

    Diastolic blood pressure

  7. Change in lipid profiles

    Time frame: Baseline and every up to 12 weeks afterwards

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

  8. Height in meters

    Time frame: Baseline and every up to 12 weeks afterwards

    Height in meters will be measured

  9. Weight in kilograms

    Time frame: Baseline and every every up to 12 weeks afterwards

    Weight in kilograms will be measured

  10. Stool samples

    Time frame: Baseline and every up to 12 weeks afterwards

  11. Adverse effects

    Time frame: Baseline and every up to 12 weeks afterwards

    Adverse effects are recorded at each time-point of the follow-up

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2019
Registry last updated
Apr 21, 2023

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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