Type 1 Diabetes Extension Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-35
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D).
This observational study will:
* follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin.
This information could help design better therapies for type 1 diabetes in the future.
Eligibility criteria
Qualifiers
Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
Ability to sign informed consent/assent (as applicable for children).
Disqualifiers
Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
Inability to comply with the study visit schedule and required assessments.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
111 Participants
are grouped into 2 trial groupsLocations
12California
UCSF School of Medicine94143, San Francisco United States
Stanford University94305, Stanford United States
Colorado
University of Colorado School of Medicine: Barbara Davis Center for Diabetes80045, Aurora United States
Connecticut
Yale University06519, New Haven United States
Sponsors and collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Immune Tolerance Network (ITN)
Collaborator
Source ClinicalTrials.gov