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Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

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ClinicalTrials.gov Identifier: NCT04096794
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

Brief Summary:
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.

Condition or disease
Type 1 Diabetes Mellitus

Detailed Description:
  1. 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.
  2. 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.
  3. 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.
  4. 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  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 Outcome Measures :
  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. Total cholesterol [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    serum total cholesterol level

  8. High-density lipoprotein (HDL) cholesterol [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    serum HDL level

  9. Low-density lipoprotein (LDL) cholesterol [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    serum LDL level

  10. Triglycerides [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    serum triglycerides level

  11. Height in meters [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    Height in meters will be measured

  12. Weight in kilograms [ Time Frame: Baseline and every every up to 12 weeks afterwards ]
    Weight in kilograms will be measured

  13. Stool samples [ Time Frame: Baseline and every up to 12 weeks afterwards ]
  14. Adverse effects [ Time Frame: Baseline and every up to 12 weeks afterwards ]
    Adverse effects are recorded at each time-point of the follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 1 diabetes patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096794


Locations
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China, Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Zhiguang Zhou, MD/PhD    86-731-85292154    zhouzg@hotmail.com   
Sponsors and Collaborators
Second Xiangya Hospital of Central South University

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Responsible Party: Zhiguang Zhou, Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases., Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT04096794     History of Changes
Other Study ID Numbers: CAT1D2019CS0011
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases