Defining Outcomes For -Cell Replacement Therapy In The Treatment Of Diabetes: A Consensus Report On The Igls Criteria From The Ipita/Epita Opinion Leaders Workshop

beta-cell replacement therapy, available currently as pancreas or islet transplantation, has developed without a clear definition of graft functional and clinical outcomes. The International Pancreas & Islet Transplant Association (IPITA) and European Pancreas & Islet Transplantation Association (EPITA) held a workshop to develop consensus for an IPITA/EPITA Statement on the definition of function and failure of current and future forms of -cell replacement therapy. There was consensus that -cell replacement therapy could be considered as a treatment for -cell failure, regardless of etiology and without requiring undetectable C-peptide, accompanied by glycemic instability with either problematic hypoglycemia or hyperglycemia. Glycemic control should be assessed at a minimum by glycated hemoglobin (HbA(1c)) and the occurrence of severe hypoglycemia. Optimal -cell graft function is defined by near-normal glycemic control [HbA(1c)6.5% (48mmol/mol)] without severe hypoglycemia or requirement for insulin or other antihyperglycemic therapy, and with an increase over pretransplant measurement of C-peptide. Good -cell graft function requires HbA(1c)<7.0% (53mmol/mol) without severe hypoglycemia and with a significant (>50%) reduction in insulin requirements and restoration of clinically significant C-peptide production. Marginal -cell graft function is defined by failure to achieve HbA(1c)<7.0% (53mmol/mol), the occurrence of any severe hypoglycemia, or less than 50% reduction in insulin requirements when there is restoration of clinically significant C-peptide production documented by improvement in hypoglycemia awareness/severity, or glycemic variability/lability. A failed -cell graft is defined by the absence of any evidence for clinically significant C-peptide production. Optimal and good functional outcomes are considered successful clinical outcomes.