Type 1 Diabetes Extension Study

Type 1 Diabetes Extension Study

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.

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.

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.