A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.
"Automated insulin delivery systems" is becoming the standard terminology — including by the US Food and Drug Administration — to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. "Hybrid AID" or "hybrid closed-loop" refer to the current status of these systems, which still require some degree of user input to control glucose levels.
The term "artificial pancreas" was used interchangeably with AID in the past, but it doesn't take into account exocrine pancreatic function. The term "bionic pancreas" refers to a specific system in development that would ultimately include glucagon along with insulin.
The new consensus report, entitled, "Automated insulin delivery: Benefits, challenges, and recommendations," was published online October 6 in Diabetes Care and Diabetologia.
The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dieticians. Colleagues working at regulatory agencies, healthcare organizations, and related media might also benefit from reading it.
It is endorsed by two professional societies — the European Association for the Study of Diabetes and American Diabetes Association — and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, UK, in a statement.
"Many clinically relevant aspects, including safety, are addressed in this report. The aim...is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it," Evans said.
Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Connecticut, commented that 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...As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology."
AID Systems Do Not Mean Diabetes Is "Cured"
Separate recommendations provided at the end of the document are aimed at specific stakeholders, including healthcare providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.
The authors make clear in the introduction that, while representing "a significant movement toward optimizing glucose management for individuals with diabetes," the use of AID systems doesn't mean that diabetes is "cured." Rather, "expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do."
In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.
"When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care," the authors write.
The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.
"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 (ie, nonautomated 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 if needed."
To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.
Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.
Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
Recommendations for Healthcare Professionals
A table near the end of the document provides specific recommendations for healthcare professionals, included the following:
Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
Inform patients with diabetes about AID systems, include 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 patients 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 always access support from a healthcare provider at the practice, including weekends and nights.
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.
Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Evans from the National Health Service.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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Cite this: New Advice on Artificial Pancreas Insulin Delivery Systems - Medscape - Oct 06, 2022.