Clinical trial NCT04096794: Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Official title: Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 1 diabetes patients

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.

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

Primary outcomes:
measure: changes in serum hemoglobin A1c level
timeFrame: Baseline and every up to 12 weeks afterwards
Secondary outcomes:
measure: changes in Time in range (TIR)
timeFrame: Baseline and every up to 12 weeks afterwards
measure: C-peptide
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Change in titer of autoantibodies
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Fasting blood glucose
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Systolic blood pressure
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Diastolic blood pressure
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Change in lipid profiles
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Height in meters
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Weight in kilograms
timeFrame: Baseline and every every up to 12 weeks afterwards
measure: Stool samples
timeFrame: Baseline and every up to 12 weeks afterwards
measure: Adverse effects
timeFrame: Baseline and every up to 12 weeks afterwards
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: