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Transplantation. 2018 Sep;102(9):1479-1486. doi: 10.1097/TP.0000000000002158.

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.

Author information

1
Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
2
Division of Transplantation, Department of Surgery, University of California at San Francisco, San Francisco, CA.
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, Berlin, Germany.
6
Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.
7
Division of Endocrinology, Department of Pediatrics, and the Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
8
Division of Transplantation and Visceral Surgery, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
9
Diabetes Research Group, King's College London, London, United Kingdom.
10
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
11
Division of Transplantation, Department of Surgery, and the Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
12
Department of Medicine, St. Vincent's Hospital, and St. Vincent's Institute of Medical Research, University of Melbourne, Melbourne, Victoria, Australia.
13
Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.
14
Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
15
Juvenile Diabetes Research Foundation International, New York, NY.
16
Ordensklinikum Elisabethinin Hospital, Linz, Austria.
17
Department of Endocrinology and Diabetology, University Hospital Zurich, Zurich, Switzerland.
18
Division of Endocrinology and Diabetes, Department of Medicine III, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.
19
Division of Transplantation, Department of Surgery, Massachusetts General Hospital, Boston, MA.
20
Division of Transplantation, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI.
21
Department of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, and Inserm, Université de Lille, Lille, France.
22
Division of Endocrinology and Metabolism, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
23
Institute of Transplantation, The Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom.
24
Department of Endocrinology, Diabetology and Metabolism, Centre Hospitalier Universitaire de Lille, and 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 and Islet Transplant Association and European Pancreas and Islet Transplantation Association held a workshop to develop consensus for an International Pancreas and Islet Transplant Association and European Pancreas and Islet Transplant Association 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 less than 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 less than 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.

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