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

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 MarinacJon S. Odorico, François Pattou, Peter A. Senior, James A.M. Shaw, Marie Christine Vantyghem, Steven White

Research output: Contribution to journalReview article

7 Citations (Scopus)

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 (HbA 1c ) and the occurrence of severe hypoglycemia. Optimal β-cell graft function is defined by near-normal glycemic control (HbA 1c ≤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 1c 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 HbA 1c 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.

Original languageEnglish (US)
Pages (from-to)1479-1486
Number of pages8
JournalTransplantation
Volume102
Issue number9
DOIs
StatePublished - Sep 1 2018

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Cell- and Tissue-Based Therapy
Hypoglycemia
C-Peptide
Transplants
Education
Pancreas
Pancreas Transplantation
Islets of Langerhans Transplantation
Therapeutics
Insulin
Glycosylated Hemoglobin A
Treatment Failure
Hypoglycemic Agents
Hyperglycemia

PubMed: MeSH publication types

  • Consensus Development Conference
  • Journal Article
  • Practice Guideline
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

Cite this

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.; De 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.

In: Transplantation, Vol. 102, No. 9, 01.09.2018, p. 1479-1486.

Research output: Contribution to journalReview article

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, MC & White, S 2018, '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', Transplantation, vol. 102, no. 9, pp. 1479-1486. https://doi.org/10.1097/TP.0000000000002158
Rickels, Michael R. ; Stock, Peter G. ; De 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. / 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: Transplantation. 2018 ; Vol. 102, No. 9. pp. 1479-1486.
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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 (HbA 1c ) and the occurrence of severe hypoglycemia. Optimal β-cell graft function is defined by near-normal glycemic control (HbA 1c ≤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 1c 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 HbA 1c 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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AU - Stock, Peter G.

AU - De Koning, Eelco J.P.

AU - Piemonti, Lorenzo

AU - Pratschke, Johann

AU - Alejandro, Rodolfo

AU - Bellin, Melena D

AU - Berney, Thierry

AU - Choudhary, Pratik

AU - Johnson, Paul R.

AU - Kandaswamy, Raja

AU - Kay, Thomas W.H.

AU - Keymeulen, Bart

AU - Kudva, Yogish C.

AU - Latres, Esther

AU - Langer, Robert M.

AU - Lehmann, Roger

AU - Ludwig, Barbara

AU - Markmann, James F.

AU - Marinac, Marjana

AU - Odorico, Jon S.

AU - Pattou, François

AU - Senior, Peter A.

AU - Shaw, James A.M.

AU - Vantyghem, Marie Christine

AU - White, Steven

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N2 - 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 (HbA 1c ) and the occurrence of severe hypoglycemia. Optimal β-cell graft function is defined by near-normal glycemic control (HbA 1c ≤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 1c 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 HbA 1c 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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