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

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

N1 - © 2018 Steunstichting ESOT.

PY - 2018/4

Y1 - 2018/4

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 - Blood Glucose

KW - Diabetes Mellitus/blood

KW - Glycated Hemoglobin A/metabolism

KW - Humans

KW - Islets of Langerhans Transplantation

KW - Outcome Assessment (Health Care)

U2 - 10.1111/tri.13138

DO - 10.1111/tri.13138

M3 - Article

C2 - 29453879

SN - 0934-0874

VL - 31

SP - 343

EP - 352

JO - Transplant International

JF - Transplant International

IS - 4

ER -