Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096794
• Other study ID #: CAT1D2019CS0011
• Status: Recruiting
• Start date: September 2016
• Est. completion date: September 2027

Study information

• Verified date: April 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in serum hemoglobin A1c level	A1c reflects the average blood glucose level in the past 3 months.	Baseline and every up to 12 weeks afterwards
Secondary	changes in Time in range (TIR)	TIR measures the time where the blood glucose remains within the proposed target range.	Baseline and every up to 12 weeks afterwards
Secondary	C-peptide	C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study	Baseline and every up to 12 weeks afterwards
Secondary	Change in titer of autoantibodies		Baseline and every up to 12 weeks afterwards
Secondary	Fasting blood glucose	the blood sugar level after fasting for eight hours	Baseline and every up to 12 weeks afterwards
Secondary	Systolic blood pressure	Systolic blood pressure	Baseline and every up to 12 weeks afterwards
Secondary	Diastolic blood pressure	Diastolic blood pressure	Baseline and every up to 12 weeks afterwards
Secondary	Change in lipid profiles	Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol	Baseline and every up to 12 weeks afterwards
Secondary	Height in meters	Height in meters will be measured	Baseline and every up to 12 weeks afterwards
Secondary	Weight in kilograms	Weight in kilograms will be measured	Baseline and every every up to 12 weeks afterwards
Secondary	Stool samples		Baseline and every up to 12 weeks afterwards
Secondary	Adverse effects	Adverse effects are recorded at each time-point of the follow-up	Baseline and every up to 12 weeks afterwards