| Outcome Measures: |
Primary: The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets., Insulin Independence examined 75 days after 1st infusion; subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window at Day 75 (Day 70-80) and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window (Day 63-87); 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; (6) at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL, Day 75 | Secondary: The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions, Subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window of time frame, noted below, and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window; 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; 6. at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL, 1 year after the first islet infusion, 1 year after the last islet infusion, 2 years after the first islet infusion, 2 years after the last islet infusion|The Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events, Number of subjects with both an HbA1c \</= 6.5% and no severe hypoglycemic events at specified timepoints; data utilized for measure were HbA1c levels and number of severe hypoglycemic events., From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.|The Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events, Subjects with an HbA1c \<7.0% and free of severe hypoglycemic events at specified timepoints; data utilized were HbA1c levels and number/absence of severe hypoglycemic events, From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.|The Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia, Subjects with a reduction in HbA1c of 1 point and no severe hypoglycemia at specific timepoints. Data utilized were HbA1c numbers at specified timepoints and absence of any severe hypoglycemic events, From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.|The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects, Clarke Score is a 7 question patient report of hypoglycemia awareness. Answers provide a rating of either A (aware) or R (reduced). Four or more R ratings suggest impaired hypoglycaemia awareness; \< or equal to 2 = normal awareness, 3=borderline. A higher Clarke Score indicates reduced awarness., 1 year and 2 years after the first islet transplant|The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects, Subjects requiring a 2nd islet infusion at specified timepoints; data utilized were the number of patients who were not successful at gaining and maintaining insulin independence following the 1st infusion and required a 2nd infusion/transplant of islets., 1 year and 2 years following the first and last islet transplant(s)|The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects, Number of subjects requiring a 3rd islet infusion. Data utilized were the number of patients require a 3rd transplant/infusion of islets due to continued requirement of insulin during study participation., 1 year and 2 years following the first and last islet transplant(s)|Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects, Subjects experience of cardiovascular events and changes in atherogenic profile were examined for the timepoints listed below. Data utilized were baseline lipid labs (triglycerides, total cholesterol, HDL, LDL, and Non-HDL Cholesterol) and lipid labs taken at specified timepoints. An improvement would be an overall improvement of the lipid profile (e.g. reduction in non-HDL cholesterol/overall cholesterol, decrease in LDL, increase in HDL, etc.). Due to the COVID-19 pandemic and increased risk faced by transplant/immunosuppressed individuals, some lipid labs were not collected and data has been indicated as NA due to reduction in sample collection/prioritizing safety labs for subjects., 1 year and 2 years following the first and last islet transplant(s)
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