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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

2018; Springer Science+Business Media; Volume: 31; Issue: 4 Linguagem: Inglês

10.1111/tri.13138

1432-2277

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 Johnson, Raja Kandaswamy, Thomas W. H. Kay, Bart Keymeulen, Yogish C. Kudva, Esther Latres, R.M. Langer, Roger Lehmann, Barbara Ludwig, James F. Markmann, Marjana Marinac, Jon S. Odorico, François Pattou, Peter Senior, James Shaw, Marie‐Christine Vantyghem, Steven White,

Diabetes and associated disorders

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 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 function are considered successful clinical outcomes.