Examination of the Igls Criteria for Defining Functional Outcomes of β-cell Replacement Therapy: IPITA Symposium Report

Cyril P. Landstra, Axel Andres, Mikael Chetboun, Caterina Conte, Yvonne Kelly, Thierry Berney, Eelco J.P. De Koning, Lorenzo Piemonti, Peter G. Stock, Francois Pattou, Marie Christine Vantyghem, Melena D. Bellin, Michael R. Rickels

Research output: Contribution to journalArticlepeer-review

Abstract

CONTEXT: The 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. In July 2019, a symposium at the 17th IPITA World Congress was held to examine the Igls criteria after 2 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.

EVIDENCE ACQUISITION: Utilization of the criteria in various clinical and research settings was illustrated by population as well as individual outcome data of 4 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.

EVIDENCE SYNTHESIS: The 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.

CONCLUSIONS: Future 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 glycated hemoglobin and severe hypoglycemia events.

Original languageEnglish (US)
Pages (from-to)3049-3059
Number of pages11
JournalJournal of Clinical Endocrinology and Metabolism
Volume106
Issue number10
DOIs
StatePublished - Oct 1 2021

Bibliographical note

Publisher Copyright:
© 2021 The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Keywords

  • continuous glucose monitoring
  • islet transplantation
  • pancreas transplantation
  • type 1 diabetes
  • β-cell replacement

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