Defining outcomes for beta cell replacement therapy: a work in progress
Defined outcomes for beta cell replacement therapy in the treatment of diabetes are critically needed. Progress towards the clinical acceptance of pancreas and islet transplantation has been hampered by the lack of clear definitions of functional and efficacy outcomes, as well as a lack of consistently applied glycaemic control metrics, together with poor alignment with the field of artificial insulin delivery/artificial pancreas development. To address this problem, the International Pancreas & Islet Transplant Association (IPITA) collaborated with the European Pancreas and Islet Transplant Association (EPITA) to develop a consensus for a joint statement on the definition of function and failure of beta cell replacement therapies, which is summarised in this commentary.
KeywordsIslet transplantation Outcomes Pancreas transplantation
Continuous glucose monitoring
European Pancreas and Islet Transplant Association
International Pancreas & Islet Transplant Association
Self-monitoring of blood glucose
The authors thank S. Livingston of The Transplantation Society and C. Parisotto and G. Rossi of the European Society for Organ Transplantation for their assistance with organisation of the workshop.
All authors were responsible for drafting the article and revising it critically for important intellectual content. All authors approved the version to be published.
Duality of interest
The authors declare that there is no duality of interest associated with this manuscript.
- 3.Rickels MR, Stock PG, de Koning EJP et al (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. Transpl Int https://doi.org/10.1111/tri.13138
- 4.Rickels MR, Stock PG, de Koning EJP, et al. (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: in pressGoogle Scholar
- 8.International Hypoglycaemia Study Group (2017) Glucose concentrations of less than 3.0 mmol/l (54 mg/dl) should be reported in clinical trials: a joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 60: 3–6Google Scholar
- 9.Senior PA, Bellin MD, Alejandro R et al (2015) Consistency of quantitative scores of hypoglycemia severity and glycemic lability and comparison with continuous glucose monitoring system measures in long-standing type 1 diabetes. Diabetes Technol Ther 17:235–242CrossRefPubMedPubMedCentralGoogle Scholar
- 16.Agiostratidou G, Anhalt H, Ball D et al (2017) Standardizing clinically meaningful outcome measures beyond HbA1c for type 1 diabetes: a consensus report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 40:1622–1630CrossRefPubMedGoogle Scholar
- 22.Skyler JS (2018) Hope vs hype: where are we in type 1 diabetes? Diabetologia 61:509–516Google Scholar
- 26.(1998) Effect of intensive therapy on residual beta-cell function in patients with type 1 diabetes in the diabetes control and complications trial. A randomized, controlled trial. The Diabetes Control and Complications Trial Research Group. Ann Intern Med 128: 517–523Google Scholar