Type 1 Diabetes Mellitus
Conditions
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.
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.
Interventions
None listed
Sponsors
Second Xiangya Hospital of Central South University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in serum hemoglobin A1c level | Baseline and every up to 12 weeks afterwards | A1c reflects the average blood glucose level in the past 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool samples | Baseline and every up to 12 weeks afterwards | — |
| changes in Time in range (TIR) | Baseline and every up to 12 weeks afterwards | TIR measures the time where the blood glucose remains within the proposed target range. |
| C-peptide | 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 |
| Change in titer of autoantibodies | Baseline and every up to 12 weeks afterwards | — |
| Fasting blood glucose | Baseline and every up to 12 weeks afterwards | the blood sugar level after fasting for eight hours |
| Systolic blood pressure | Baseline and every up to 12 weeks afterwards | Systolic blood pressure |
| Diastolic blood pressure | Baseline and every up to 12 weeks afterwards | Diastolic blood pressure |
| Change in lipid profiles | Baseline and every up to 12 weeks afterwards | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol |
| Height in meters | Baseline and every up to 12 weeks afterwards | Height in meters will be measured |
| Weight in kilograms | Baseline and every every up to 12 weeks afterwards | Weight in kilograms will be measured |
| Adverse effects | Baseline and every up to 12 weeks afterwards | Adverse effects are recorded at each time-point of the follow-up |
Countries
China
Outcome results
None listed