Examination of the Igls Criteria for Defining Functional Outcomes of β-Cell Replacement Therapy: IPITA symposium report.

Abstract

CONTEXT\nThe Igls criteria were developed to provide a consensus definition for outcomes of β-cell replacement therapy in the treatment of diabetes during a January 2017 workshop sponsored by the International Pancreas & Islet Transplant Association (IPITA) and the European Pancreas & Islet Transplant Association (EPITA). In July 2019, a symposium at the 17 th IPITA World Congress was held to examine the Igls criteria after two years in clinical practice, including validation against continuous glucose monitoring (CGM)-derived glucose targets, and to propose future refinements that would allow for comparison of outcomes with artificial pancreas system approaches.\n\n\nEVIDENCE ACQUISITION\nUtilization of the criteria in various clinical and research settings were illustrated by population as well as individual outcome data of four islet and/or pancreas transplant centers. Validation against CGM metrics was conducted in 55 islet transplant recipients followed-up to 10 years from a fifth center.\n\n\nEVIDENCE SYNTHESIS\nThe Igls criteria provided meaningful clinical assessment on an individual patient and treatment group level, allowing for comparison both within and between different β-cell replacement modalities. Important limitations include the need to account for changes in insulin requirements and C-peptide levels relative to baseline. In islet transplant recipients, CGM glucose time-in-range improved with each category of increasing β-cell graft function.\n\n\nCONCLUSIONS\nFuture Igls 2.0 criteria should consider absolute rather than relative levels of insulin use and C-peptide as qualifiers with treatment success based on glucose assessment using CGM-metrics on par with assessment of HbA1c and severe hypoglycemia events.