Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- changes in serum hemoglobin A1c level [Time frame: Baseline and every up to 12 weeks afterwards]
Secondary outcome measures (11)
- changes in Time in range (TIR) [Time frame: Baseline and every up to 12 weeks afterwards]
- C-peptide [Time frame: Baseline and every up to 12 weeks afterwards]
- Change in titer of autoantibodies [Time frame: Baseline and every up to 12 weeks afterwards]
- Fasting blood glucose [Time frame: Baseline and every up to 12 weeks afterwards]
- Systolic blood pressure [Time frame: Baseline and every up to 12 weeks afterwards]
- Diastolic blood pressure [Time frame: Baseline and every up to 12 weeks afterwards]
- Change in lipid profiles [Time frame: Baseline and every up to 12 weeks afterwards]
- Height in meters [Time frame: Baseline and every up to 12 weeks afterwards]
- Weight in kilograms [Time frame: Baseline and every every up to 12 weeks afterwards]
- Stool samples [Time frame: Baseline and every up to 12 weeks afterwards]
- Adverse effects [Time frame: Baseline and every up to 12 weeks afterwards]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South Universi — Changsha
Identifiers
NCT: NCT04096794 · CAT1D2019CS0011