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 journal/periodicalArticleScientificpeer-review

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
Pages (from-to)343-352
Number of pages10
JournalTransplant international : official journal of the European Society for Organ Transplantation
Volume31
Issue number4
DOIs
Publication statusPublished - Apr 2018

Keywords

  • Blood Glucose
  • Diabetes Mellitus/blood
  • Glycated Hemoglobin A/metabolism
  • Humans
  • Islets of Langerhans Transplantation
  • Outcome Assessment (Health Care)

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