NCT04096794

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2016Sep 2027

Study Start

First participant enrolled

September 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

11 years

First QC Date

September 2, 2019

Last Update Submit

April 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • changes in Time in range (TIR)

    Baseline and every up to 12 weeks afterwards

  • C-peptide

    Baseline and every up to 12 weeks afterwards

  • Change in titer of autoantibodies

    Baseline and every up to 12 weeks afterwards

  • Fasting blood glucose

    Baseline and every up to 12 weeks afterwards

  • Systolic blood pressure

    Baseline and every up to 12 weeks afterwards

  • +6 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

type 1 diabetes patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases.

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 20, 2019

Study Start

September 1, 2016

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations