Abstract
Summary
β‐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 β‐cell replacement therapy. There was consensus that β‐cell replacement therapy could be considered as a treatment for β‐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 (HbA1c) and the occurrence of severe hypoglycemia. Optimal β‐cell graft function is defined by near‐normal glycemic control [HbA1c ≤ 6.5% (48 mmol/mol)] without severe hypoglycemia or requirement for insulin or other antihyperglycemic therapy, and with an increase over pretransplant measurement of C‐peptide. Good β‐cell graft function requires HbA1c < 7.0% (53 mmol/mol) without severe hypoglycemia and with a significant (>50%) reduction in insulin requirements and restoration of clinically significant C‐peptide production. Marginal β‐cell graft function is defined by failure to achieve HbA1c < 7.0% (53 mmol/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 β‐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.
