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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

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, Marie‐Christine ; White, Steven

Transplant International, April 2018, Vol.31(4), pp.343-352 [Periódico revisado por pares]

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  • Título:
    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
  • Autor: 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, Marie‐Christine ; White, Steven
  • Assuntos: Outcome ; Islet Clinical ; Pancreas Clinical
  • É parte de: Transplant International, April 2018, Vol.31(4), pp.343-352
  • Descrição: 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 () and European Pancreas & Islet Transplantation Association () held a workshop to develop consensus for an / 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) and the occurrence of severe hypoglycemia. Optimal β‐cell graft function is defined by near‐normal glycemic control [HbA ≤ 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 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 < 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.

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