Type 1 Diabetes Recurrence in Pancreas Transplants

To identify the factors associated with recurrence of diabetes in subjects who received a
simultaneous pancreas-kidney (SPK) or pancreas transplant. The study will see if there are
changes in the participant's blood that will help the investigator know whether diabetes has
returned after the transplant.

SPK patients will be retrospectively analyzed to determine frequency, levels and time course
of autoantibody recurrence and predictive value of autoantibodies for recurrence of the
disease.

This study will prospectively follow our existing and our new pancreas transplant recipients
to monitor autoantibody levels, monitor and phenotype autoreactive T cells in peripheral
blood. This will happen monthly for 24 months.

This study will assess the presence or absence of insulitis in the transplanted pancreas from
biopsies performed in recipients with consistent recurrence of multiple autoantibodies.

It will also monitor and phenotype autoreactive T cells from the pancreatic infiltrate
obtained by pancreatic transplant biopsies.

Inclusion Criteria:

- Patient has been fully informed and has signed a dated IRB approval informed consent
form and is willing to follow study procedures for the extent of the study (24
months). Parent or legal guardian must provide written consent for patients <18 years
of age.

- Age 18-75 years.

- Recipient of simultaneous pancreas and kidney transplant

- Primary or secondary renal allograft: living or deceased

Exclusion Criteria:

- Patient has previously received or is receiving an organ transplant other than a
pancreas-kidney.