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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00097292




Registration number
NCT00097292
Ethics application status
Date submitted
19/11/2004
Date registered
22/11/2004
Date last updated
21/12/2023

Titles & IDs
Public title
TrialNet Pathway to Prevention of T1D
Scientific title
TrialNet Pathway to Prevention of T1D
Secondary ID [1] 0 0
UC4DK117009
Secondary ID [2] 0 0
NHStudy (IND)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Annual Re-Testing/Annual Metabolic Monitoring - Participants will be monitored annually for risk of type 1 diabetes.

Semi-Annual Metabolic Monitoring - Participants will be monitored every six months for risk of type 1 diabetes
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of type 1 diabetes
Timepoint [1] 0 0
Monitoring is provided once or twice annually depending on risk level
Secondary outcome [1] 0 0
Metabolic and Autoantibody Assessments
Timepoint [1] 0 0
Metabolic and Autoantibody assessments are provided once or twice annually depending on risk level

Eligibility
Key inclusion criteria
* Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
* Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
* Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.
Minimum age
30 Months
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To be eligible a person must not:

* Have diabetes already
* Have a previous history of being treated with insulin or oral diabetes medications.
* Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
* Have any known serious diseases

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
75000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Walter and Eliza Hall Institute - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Finland
State/province [16] 0 0
Turku
Country [17] 0 0
Italy
State/province [17] 0 0
Milan
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Florida
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
American Diabetes Association
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Center for Research Resources (NCRR)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kevan Herold, M.D.
Address 0 0
Yale School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
TrialNet Central Information Center general info
Address 0 0
Country 0 0
Phone 0 0
1-800-425-8361
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00097292