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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
Authors: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 R. Johnson  Raja Kandaswamy  Thomas W. H. Kay  Bart Keymeulen  Yogish C. Kudva  Esther Latres  Robert M. Langer  Roger Lehmann  Barbara Ludwig  James F. Markmann  Marjana Marinac  Jon S. Odorico  François Pattou  Peter A. Senior  James A. M. Shaw  Marie‐Christine Vantyghem  Steven White
Affiliation:1. Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Institute for Diabetes, Obesity & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;2. Department of Surgery, Division of Transplantation, University of California at San Francisco, San Francisco, CA, USA;3. Department of Medicine, Leiden University Medical Center, Leiden, The Netherlands;4. Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy;5. Department of Surgery, Charité Medical School, Berlin, Germany;6. Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, USA;7. Department of Pediatrics, Division of Endocrinology, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN, USA;8. Department of Surgery, Division of Transplantation and Visceral Surgery, Geneva University Hospital, Geneva, Switzerland;9. Diabetes Research Group, King's College London, London, UK;10. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK;11. Department of Surgery, Division of Transplantation, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN, USA;12. Department of Medicine, St. Vincent's Hospital, St. Vincent's Institute of Medical Research, University of Melbourne, Melbourne, Vic., Australia;13. Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium;14. Department of Internal Medicine, Division of Endocrinology, Diabetes, Metabolism & Nutrition, Mayo Clinic, Rochester, MN, USA;15. JDRF International, New York, NY, USA;16. Ordensklinikum Elisabethinin Hospital, Linz, Austria;17. Department of Endocrinology and Diabetology, University Hospital Zurich, Zurich, Switzerland;18. Department of Medicine III, Division of Endocrinology and Diabetes, University Hospital Carl Gustav Carus at the Technische Universit?t Dresden, Dresden, Germany;19. Department of Surgery, Division of Transplantation, Massachusetts General Hospital, Boston, MA, USA;20. Department of Surgery, Division of Transplantation, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA;21. Department of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, Inserm, Université de Lille, Lille, France;22. Department of Medicine, Division of Endocrinology & Metabolism, University of Alberta, Edmonton, AB, Canada;23. Institute of Transplantation, The Freeman Hospital, Newcastle University, Newcastle upon Tyne, UK;24. Department of Endocrinology, Diabetology and Metabolism, Centre Hospitalier Universitaire de Lille, Inserm, Université de Lille, Lille, France
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 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.
Keywords:Outcome  islet clinical  pancreas clinical
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