Defining outcomes for -cell replacement therapy in the treatment of diabetes: a consensus report on the Igls criteria from the IPITA/EPITA opinion leaders workshop
In: Rickels, M. R., Stock, P. G., de Koning, E. J. P., Piemonti, L., Pratschke, 2018
Online
academicJournal
Zugriff:
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.
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Defining outcomes for -cell replacement therapy in the treatment of diabetes: a consensus report on the Igls criteria from the IPITA/EPITA opinion leaders workshop
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Autor/in / Beteiligte Person: | 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 ; Marinac, M ; Odorico, JS ; Pattou, F ; Senior, PA ; Shaw, JAM ; Vantyghem, M-C ; White, S |
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Zeitschrift: | Rickels, M. R., Stock, P. G., de Koning, E. J. P., Piemonti, L., Pratschke, 2018 |
Veröffentlichung: | WILEY, 2018 |
Medientyp: | academicJournal |
ISSN: | 0934-0874 (print) ; 1432-2277 (print) |
DOI: | 10.1111/tri.13138. |
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