Leading Diabetes Organizations Publish Joint Consensus Report on Benefits, Challenges, and Recommendations for Automated Insulin Delivery
A new consensus report addressing the benefits, challenges, and recommendations related to automated insulin delivery (AID) is being launched today by two leading diabetes organizations - the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA).
The joint Diabetes Technology Working Group of the EASD and ADA created this consensus report to provide
a review of the current landscape of AID systems as well as recommended targeted actions.
“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.
- As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
The report is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dieticians. - Colleagues working in regulatory agencies, healthcare organizations, and related media might also benefit from reading this report.
“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, United Kingdom. “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.”
Read the full report here
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A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care.
Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data.
Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care.
Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialised for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report.
We provide a review of the current landscape of AID systems, with a particular focus on their safety.
We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organisations to write the first statement on insulin pumps, which was published in 2015.
The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise.
Each organisation has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonisation of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organisations for confirmation.
From the article
A biological cure for type 1 diabetes is not realistic in the near future [1,2,3,4]. However, a ‘technical’ solution for diabetes management has developed under the umbrella of automated insulin delivery (AID) systems . These AID systems integrate data from a continuous glucose monitoring (CGM) system, a control algorithm, and an insulin pump to automate subcutaneous insulin delivery.
Many different terms for AID systems are in use; however, all describe the same fundamental approach (Table 1). Overall, the term ‘AID’ is becoming standard and is also used by regulatory agencies like the US Food and Drug Administration (FDA).
Current, commercially available AID systems require user input for optimal prandial insulin dosing with a mix of manual and/or automated insulin correction dosing, yet these systems represent a significant movement toward optimising glucose management for individuals with diabetes. However, expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.
The use of AID systems does not mean that diabetes is ‘cured’; instead, when integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care by adjusting basal insulin delivery and providing automatic correction doses. However, issues seen with medical products like CGM systems and insulin pumps (e.g., regarding skin irritations induced by adhesives, occlusion of insulin infusion sets [IIS], inaccurate sensor readings and early sensor failure, and adequacy of the adjustment algorithm for individual users) are also of relevance when these devices are combined to build AID systems. Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (i.e., non-automated subcutaneous insulin delivery by pump or injections) in case the AID system fails.
They should be able to independently troubleshoot and have access to their healthcare provider (HCP), if needed (see below). In addition, their HCP should have easy remote access to their AID system data. Simply giving a person with diabetes an AID system without support and adequate training presents safety issues without improving outcomes. Presently, AID systems are not available to all people with diabetes due to the high costs associated with this advanced version of diabetes therapy. It is hoped that all parts of AID systems (including insulin and digital access to the data) will become more affordable in the future.
We provide a short overview on the benefits, limitations, and challenges of current AID systems, followed by a review of a number of critical safety aspects. Finally, we make a series of consensus recommendations for all concerned parties to further enhance and refine the safe use of these systems.
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