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

10 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 & 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.

Original languageEnglish (US)
Pages (from-to)343-352
Number of pages10
JournalTransplant International
Volume31
Issue number4
DOIs
StatePublished - Apr 1 2018

Fingerprint

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

Keywords

  • islet clinical
  • Outcome
  • pancreas clinical

ASJC Scopus subject areas

  • Transplantation

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: Transplant International, Vol. 31, No. 4, 01.04.2018, p. 343-352.

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', Transplant International, vol. 31, no. 4, pp. 343-352. https://doi.org/10.1111/tri.13138
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: Transplant International. 2018 ; Vol. 31, No. 4. pp. 343-352.
@article{29d4efb2a28f46cf9444611e9472c5b5,
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",
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 = "islet clinical, Outcome, pancreas clinical",
author = "Rickels, {Michael R.} and Stock, {Peter G.} and {de Koning}, {Eelco J.P.} and Lorenzo Piemonti and Johann Pratschke and Rodolfo Alejandro and Bellin, {Melena D.} and Thierry Berney and Pratik Choudhary and Johnson, {Paul R.} and Raja Kandaswamy and Kay, {Thomas W.H.} and Bart Keymeulen and Kudva, {Yogish C} and Esther Latres and Langer, {Robert M.} and Roger Lehmann and Barbara Ludwig and Markmann, {James F.} and Marjana Marinac and Odorico, {Jon S.} and Fran{\cc}ois Pattou and Senior, {Peter A.} and Shaw, {James A.M.} and Vantyghem, {Marie Christine} and Steven White",
year = "2018",
month = "4",
day = "1",
doi = "10.1111/tri.13138",
language = "English (US)",
volume = "31",
pages = "343--352",
journal = "Transplant International",
issn = "0934-0874",
publisher = "Wiley-Blackwell",
number = "4",

}

TY - JOUR

T1 - Defining outcomes for β-cell replacement therapy in the treatment of diabetes

T2 - a consensus report on the Igls criteria from the IPITA/EPITA opinion leaders workshop

AU - Rickels, Michael R.

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

PY - 2018/4/1

Y1 - 2018/4/1

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 & 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.

AB - 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.

KW - islet clinical

KW - Outcome

KW - pancreas clinical

UR - http://www.scopus.com/inward/record.url?scp=85044360650&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044360650&partnerID=8YFLogxK

U2 - 10.1111/tri.13138

DO - 10.1111/tri.13138

M3 - Review article

C2 - 29453879

AN - SCOPUS:85044360650

VL - 31

SP - 343

EP - 352

JO - Transplant International

JF - Transplant International

SN - 0934-0874

IS - 4

ER -