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

MR Rickels, PG Stock, EJP de Koning, L Piemonti, J Pratschke, R Alejandro, MD Bellin, T Berney, P Choudhary, PR Johnson, R Kandaswamy, TWH Kay, B Keymeulen, YC Kudva, E Latres, RM Langer, R Lehmann, B Ludwig, JF Markmann, M MarinacJS Odorico, F Pattou, PA Senior, JAM Shaw, MC Vantyghem, S White

Research output: Contribution to journalArticle

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 (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. © 2018 Steunstichting ESOT
Original languageEnglish
Pages (from-to)343-352
Number of pages10
JournalTransplant International
Volume31
Issue number4
DOIs
Publication statusPublished - 2018

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    Rickels, MR., Stock, PG., de Koning, EJP., Piemonti, L., Pratschke, J., Alejandro, R., Bellin, MD., Berney, T., Choudhary, P., Johnson, PR., Kandaswamy, R., Kay, TWH., Keymeulen, B., Kudva, YC., Latres, E., Langer, RM., Lehmann, R., Ludwig, B., Markmann, JF., ... White, S. (2018). 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. Transplant International, 31(4), 343-352. https://doi.org/10.1111/tri.13138