Type 1 Diabetes Extension Study

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. This means that the immune system
(the part of the body that helps fight infections) mistakenly attacks the cells that produce
insulin (beta cells in the pancreas). As beta cells are destroyed by the immune cells, the
ability to produce insulin is decreased and diabetes develops. Insulin helps keep blood
glucose levels normal.

People with diabetes who have the ability to produce some of their own insulin (even though
they still need to take insulin) may be able to achieve better glucose control than people
who produce no insulin at all. Better glucose control has been shown to reduce the long-term
complications of diabetes.

Several Immune Tolerance Network (ITN) drug treatment studies have been completed and have
shown that some participants with new onset T1DM had partial disease remissions with therapy.
Prior participants in these trials, had measured insulin secretion, at six month intervals,
up to two years after diabetes diagnosis. It is unclear, however, if any of the interventions
have produced a continuing disease remission in patients. For persons who have completed drug
treatment trials, longer term follow-up is important for continued evaluation for effect of
therapy on insulin production.

Inclusion Criteria:

- Prior participation in protocol ITN027AI AbATE(NCT00129259) or protocol ITN045AI
T1DAL(NCT00965458) studies; and

- 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.