Overview
This is a multi-center, prospective, non-interventional study that focuses on the longterm 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
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.