Prior to enrollment in the study, patients who have been identified for islet transplantation will also be screened immediately prior to transplant procedure for the inclusion/exclusion criteria. The patient's eligibility will be documented on a set of case report forms. The following baseline evaluations must be completed prior to study enrollment:

• Obtain signed and dated informed consent.
• Record donor and recipient serological status for Hepatitis B and C and Human Immunodeficiency Virus (HIV), Cytomegalovirus (CMV), and Epstein-Barr virus, Varicella-zoster, syphilis, toxoplasmosis.
• Perform urine or serum pregnancy test (on admission to hospital or within 7 days prior to transplant) on women who

are of childbearing potential.

• Obtain medical history within 48 hours prior to transplant. Include diagnosis for transplant, secondary diagnoses, and

pre-study medications taken up to 7 days prior to transplant.

• Obtain weight.
• Ophthalmological evaluation.
• Autonomic, cardiovascular and quality of life evaluations
• Perform the following evaluations:
• CBC (hemoglobin, hematocrit, WBC with differential and platelet count).
• Serum Chemistries: serum creatinine, BUN, Mg, Na, K, and glucose.
• Hepatic Profile: total bilirubin, AST, ALT, and alkaline phosphatase.
• OGTT (Appendix D).
• Glucose and C-Peptide levels before and 90 minutes after a standard mixed-meal test
• MAGE (mean of the differences in the major fluctuations in glucose concentrations during two 24-hour periods; a minimum of seven measurements of capillary glucose will be obtained (before a meal, two hours after a meal, at bedtime, and at 3 a.m.).
• IVGTT and Arginine stimulation test (Appendix D).
• Glycosylated hemoglobin levels
• Thyroid function test
• Lipid profile
• Total proteins in urine
• HLA determination
• Anti-ICA and Anti-Gad antibodies
• Men > 40 years: prostate-specific antigen
• Women > 40 years: mammogram
• Chest X-ray
• Dental examination
• Electrocardiogram (further cardiac test only if required)