Open AccessDefining outcomes for β‐cell replacement therapy in the treatment of diabetes: a consensus report on the Igls criteria from the IPITA / EPITA opinion leaders workshop
Author(s) -
Rickels Michael R.,
Stock Peter G.,
Koning Eelco J. P.,
Piemonti Lorenzo,
Pratschke Johann,
Alejandro Rodolfo,
Bellin Melena D.,
Berney Thierry,
Choudhary Pratik,
Johnson Paul R.,
Kandaswamy Raja,
Kay Thomas W. H.,
Keymeulen Bart,
Kudva Yogish C.,
Latres Esther,
Langer Robert M.,
Lehmann Roger,
Ludwig Barbara,
Markmann James F.,
Marinac Marjana,
Odorico Jon S.,
Pattou François,
Senior Peter A.,
Shaw James A. M.,
Vantyghem MarieChristine,
White Steven
Publication year - 2018
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/tri.13138
Subject(s) - medicine , hypoglycemia , glycemic , islet cell transplantation , islet , transplantation , insulin , diabetes mellitus , c peptide , intensive care medicine , gastroenterology , endocrinology , surgery
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 (HbA 1c ) and the occurrence of severe hypoglycemia. Optimal β‐cell graft function is defined by near‐normal glycemic control [HbA 1c ≤ 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 HbA 1c < 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 HbA 1c < 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.