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Title

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

Authors
Rickels, Michael R
Stock, Peter G
de Koning, Eelco J P
Piemonti, Lorenzo
Pratschke, Johann
Alejandro, Rodolfo
Bellin, Melena D
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Published in Transplant International. 2018, vol. 31, p. 343-352
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 pre-transplant 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. This article is protected by copyright. All rights reserved.
Identifiers
PMID: 29453879
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Article (Author postprint) (208 Kb) - document accessible for UNIGE members only Limited access to UNIGE (until 2019-03-19)
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Research group La transplantation d'îlots de Langerhans (623)
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RICKELS, Michael R et al. 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. In: Transplant International, 2018, vol. 31, p. 343-352. https://archive-ouverte.unige.ch/unige:103526

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Deposited on : 2018-04-13

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