Islet transplants show promise in stopping dangerous blood sugar crashes

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Male and female patients age 18-65 years of age at consent 2. Ability to provide written informed consent 3. Mentally stable and able to comply with the procedures of the study protocol 4. Patients with T1D and insulin-dependent for at least 5 years fulfilling the following criteria: 1. Absent stimulated c-peptide (\<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption 2. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months 3. At least one episode of severe hypoglycemia in the past 12 months 4. A Clarke score of 4 or more defining reduced awareness of hypoglycemia 5. Or, previous islet cell transplant recipients who have returned to partial or full insulin usage and are taking maintenance immunosuppression medications. Exclusion Criteria 1. Body mass index (BMI) \> 30 2. Insulin requirement of \> 1.0 IU/kg/day 3. HbA1c \> 10% 4. Calculated glomerular filtration rate (GFR) \< 80mL/min for transplant-naïve patients (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation CKD-EPI) or 50mL/min for previously transplanted patients currently on immunosuppression 5. Macroalbuminuria \>300 mg/g creatinine 6. Panel reactive anti-HLA antibodies\> 50% by flow cytometry 7. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study. 8. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB) 9. Negative Epstein-Barr Virus (EBV) by IgG 10. Any history of malignancy except resected squamous or basal cell carcinoma 11. Alcohol or substance abuse 12. Baseline Hb below the lower limit of normal 13. International normalized ratio \>1.5 and long term anticoagulant therapy 14. Clinically significant coronary artery disease 15. Elevated liver function tests \>1.5 times upper limit of normal 16. Symptomatic cholecystolithiasis 17. Gastrointestinal disorders interfering with ability to absorb oral medications 18. Uncontrolled hyperlipidemia (LDL cholesterol \>130 mg/dL and/or triglycerides \>200 mg/dL) 19. Chronic corticosteroid use