Clinical Trial Search

Primary: Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. — 44; 14; 17; 14…

Primary: Insulin Independence. — 2 Participants

Primary: Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point…

Primary: The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation — 5 participants

Primary: Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year — 71 Percentage of patients

Primary: Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation — 4; 5 participants

Primary: Achievement of Insulin Independence at 12-month Post Transplant — 1 participant

Primary: A1c </= 6.5% and no Severe Hypoglycemia — 0.667 Proportion of participants

Primary: The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation — 4; 1 participants

Primary: Percentage Time in Range 70-180 mg/dL by CGM — 77 percentage of CGM readings 70-180mg/dL

Primary: Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia — 3 participants

Primary: The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy. — 0.25 proportion of participants — p=< 0.05

Primary: Number of Participants Who Experienced Adverse Events — 1; 7 participants

Primary: Insulin Independence — 42; 45 percentage of participants

Primary: Study Period: Average Serum BG — 130; 111 mg/dL — p=0.003

Primary: The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation — 3; 1 Participants — p=0.87

Primary: The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion — 4 participants

Primary: Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit — 0.834; 0.775 nmol/L — p=0.048

Primary: Islet Graft Function — 233; 354 ng/ml*min

Primary: Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. — 1.8; 3.1 ng/mL

Primary: The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. — 0; 2; 2; 1 Participants

Primary: Maximal Acute C-peptide Response to Glucose (ACRmax) — 1.06; 1.52; 1.29 ng/mL*min

Primary: Subjects With Full Islet Function. — 3 Participants

Primary: Percentage of Patients Who Were Insulin Independent After Islet Autotransplantation (IAT) at Day 365±14 Days After Transplant. — 20.0; 21.2 Percentage of participants…

Primary: Delayed Graft Function — 8; 12 participants

Primary: The Percentage of Insulin-independent Patients Following Single Infusion Islet Cell Transplantation at Day 75 +/- 5 — 0; 0 percentage of patients

Primary: C-PEPTIDE Suppression During Hyperinsulinemia Euglycemia. — 0.51; 0.56; 0.59 ng/mL

Primary: Change in Metabolic Function Baseline to 12 Months. — 0.74; 0.43 nmol/L/min — p=0.017

Primary: Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo — 0.088; 0.102 Proportion with diabetes/year

Primary: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year — 0.58; 0.429 pmol per mL — p=0.05