Type 1 Diabetes Extension Study
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Description
Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include: * Overall health assessments * Blood and urine collections * Mixed meal tolerance test (MMTTs) for certain participants, per protocol.
Eligibility
- Age range
- 8–35 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study. * Ability to sign informed consent/assent (as applicable for children). Exclusion Criteria: * 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.
Locations (12)
- UCSF School of MedicineSan Francisco, California
- Stanford UniversityStanford, California
- University of Colorado School of Medicine: Barbara Davis Center for DiabetesAurora, Colorado
- Yale UniversityNew Haven, Connecticut
- Emory UniversityAtlanta, Georgia
- Indiana University Riley Hospital for ChildrenIndianapolis, Indiana