Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

type 1 diabetes patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in titer of autoantibodies		Baseline and every up to 12 weeks afterwards
Fasting blood glucose	the blood sugar level after fasting for eight hours	Baseline and every up to 12 weeks afterwards
Systolic blood pressure	Systolic blood pressure	Baseline and every up to 12 weeks afterwards
Diastolic blood pressure	Diastolic blood pressure	Baseline and every up to 12 weeks afterwards
Change in lipid profiles	Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol	Baseline and every up to 12 weeks afterwards
Height in meters	Height in meters will be measured	Baseline and every up to 12 weeks afterwards
Weight in kilograms	Weight in kilograms will be measured	Baseline and every every up to 12 weeks afterwards
Stool samples		Baseline and every up to 12 weeks afterwards
Adverse effects	Adverse effects are recorded at each time-point of the follow-up	Baseline and every up to 12 weeks afterwards

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2027
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CAT1D2019CS0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No