Defining 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

Michael R. Rickels, Peter G. Stock, Eelco J.P. de Koning, Lorenzo Piemonti, Johann Pratschke, Rodolfo Alejandro, Melena D. Bellin, Thierry Berney, Pratik Choudhary, Paul R. Johnson, Raja Kandaswamy, Thomas W.H. Kay, Bart Keymeulen, Yogish C. Kudva, Esther Latres, Robert M. Langer, Roger Lehmann, Barbara Ludwig, James F. Markmann, Marjana MarinacJon S. Odorico, François Pattou, Peter A. Senior, James A.M. Shaw, Marie Christine Vantyghem, Steven White

Research output: Contribution to journalReview articlepeer-review

27 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)343-352
Number of pages10
JournalTransplant International
Volume31
Issue number4
DOIs
StatePublished - Apr 2018

Bibliographical note

Funding Information:
The workshop was supported in part by educational grants received from The Transplantation Society and JDRF International. M.R.R. is supported in part by U.S. Public Health Services research grants R01 DK091331, R01 DK97830, and U01 DK070430. Y.C.K. is supported in part by U.S. Public Health Services research grant UC4 DK108483.

Funding Information:
The workshop was supported in part by educational grants received from The Transplantation Society and JDRF International. M.R.R. is supported in part by U.S. Public Health Services research grants R01 DK091331, R01 DK97830, and U01 DK070430. Y.C.K. is supported in part by U.S. Public Health Services research grant UC4 DK108483. The authors thank Sondra Livingston of The Transplantation Society and Chiara Parisotto and Giovanna Rossi of the European Society for Organ Transplantation for their assistance with organization of the workshop, and Aristea Slikas of the University of Pennsylvania Institute for Diabetes, Obesity & Metabolism for assistance with preparation of the manuscript.

Publisher Copyright:
© 2018 Steunstichting ESOT

Keywords

  • Outcome
  • islet clinical
  • pancreas clinical

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