American Diabetes Association, EASD Publish Joint Consensus Report on Automated Insulin Delivery

Jennifer Sherr, MD, PhD

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have released a new consensus report aimed at providing evidence-based recommendations as well as an overview of the benefits and challenges with automated insulin delivery (AID).

Published on October 6, the document reflects the rapid advancement of AID technology in recent years and was composed by a joint Diabetes Technology Working Group, the same group that wrote the organizations’ first consensus report on insulin pumps in 2015.

“The report addresses the clinical usage of AID systems from a practical point of view rather than as a meta-analysis or a review of all relevant clinical studies,” explains lead author Jennifer Sherr, MD, PhD, professor of pediatrics, Pediatric Endocrinology, Yale University, in a statement from the ADA. “As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”

At more than 15 pages in length and citing 109 references, the consensus report represents the fourth report from the joint Diabetes Technology Group. The international writing group responsible for the report includes Sherr, as well as Lutz Heinemann, PhD, G. Alexander Fleming, MD, Richard M. Bergenstal, MD, Daniela Bruttomesso, MD, PhD, Helene Hanaire, MD, PhD, Reinhard W. Holl, MD, PhD, John R. Petrie, MBChB, PhD,Anne L. Peters, MD, and Mark Evans, PhD.

With a particular focus on the safety of AID systems, the consensus report provides a table outlining the limitations of AID systems, with these limitations broken down into physiological, technological, and behavior. Altogether, the report lists 20 specific limitations of AID systems: 2 pertaining to physiological limitations, 11 pertaining to technological limitations, and 7 pertaining to behavioral limitations. Among these were concerns over the suboptimal analytical accuracy of CGM system in low glucose range, the need to bolus prandial insulin, overtreatment of hypoglycemia, time lag in sensor glucose values, and cybersecurity risks.

The specific recommendations made by the joint Diabetes Technology Working Group within the report are grouped by the parties they are intended for, with these parties defined as regulatory agencies, manufacturing companies, International and national professional societies and advocacy organizations, researchers and academics, and, lastly, health care professionals, and consumers of AID. The recommendations for healthcare professionals are highlighted below:

• Be knowledgeable of AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with people with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number, or method by which a person with diabetes can access support from an HCP, at the practice to be available at all times including weekends and nights. This will allow for support for patients with diabetes in critical situations. Protocols may be implemented on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

“We are excited to share this report to guide health care professionals globally on these technological advances for people with diabetes,” added Robert Gabbay, MD, PhD chief scientific and medical officer of the ADA.

The writing committee also provides recommendations for evidence-based access policies for AID systems.

“Most other publications about AID systems are sponsored by the manufacturers of the systems. Our report is independent and endorsed by the ADA and the EASD,” added Mark Evans, MD, FRCP, professor of diabetic medicine, University of Cambridge, UK. “Many clinically relevant aspects, including safety, are addressed in this report. The aim of this report is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it.”

This document, “Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association,” was simultaneously published in Diabetes Care and Diabetologia.