At 75 ± 7 and 365 ± 14 days following the islet transplant, and at two years following the final islet transplant: the incidence and severity of AEs related to the islet transplant procedure including: bleeding (>2 g/dL decrease in hemoglobin concentration); wound complication (infection or subsequent hernia); torsion of omentum; gastrointestinal obstruction; abscess; cysts; need for surgical intervention. The incidence and severity of AEs related to the immunosuppression including: allergy; reduction in GFR; addition or intensification of antihyperlipidemic therapy; gastrointestinal toxicity; neutropenia, anemia, or thrombocytopenia; viral, bacterial, or fungal infections; and benign or malignant neoplasms. The incidence of immune sensitization defined by presence of anti-HLA antibodies absent prior to transplantation. The incidence of discontinuation of immunosuppression.