The European Association for the Study of Diseases and the American Diabetes Association jointly published a consensus report on the benefits, challenges, and recommendations for use of automated insulin delivery (AID) systems.

The term AID is an umbrella term that refers to administration systems that incorporate continuous glucose monitoring (CGM), insulin dose adjustment algorithms, and an insulin pump to automate subcutaneous insulin delivery. These device systems take many forms, from sensor-augmented pumps to artificial pancreases to “do-it-yourself" AID systems.

Unlike a quarterly hemoglobin A1C level to assess glycemic control, AIDs can determine time-in-range (TIR) and provide visualization of data through standardized reports, such as the Ambulatory Glucose Profile.

While there are numerous benefits associated with the use of AIDs, such as improvement in TIR and enhanced quality of life because of improved sleep, reductions in anxiety, and a sense of relief from daily diabetes management, there are also limitations to the technology. These include physiological (e.g., lag time associated with sensor glucose values, delayed insulin absorption from the subcutaneous depot) and technological limitations (e.g., inaccurate assessment of low glucose levels, false readings for hypoglycemia due to tissue compression around the sensor insertion lead site, missing sensor glucose data, infusion set or pump failure, issues with data uploading, battery life, communication between the AID and the cloud storage, server malfunctions, cybersecurity/data privacy issues, need for software updates, and the impact of work or the environment on the functioning of the AID). Limitations also include behavioral (e.g., patient improperly administering insulin boluses or correction doses, inability to problem solve reasons for hyper- or hypoglycemia, overcorrecting hyper- or hypoglycemia, failure of the AID to adjust insulin doses following exercise, and the need for backup supplies in the event of AID failure or inability to use the device).

The document stresses the importance of education both for the patient and for the provider so that that they can help the patient troubleshoot any clinical issues that may arise as the landscape associated with AIDs is rapidly evolving.

The report identifies patient issues that can affect care, such as setting realistic expectations for the device; need for meal boluses (especially with older devices); loss of insulin dosing skills due to overreliance on technology; problems associated with the disruption with supply chains as during the COVID-19 pandemic; handling problems with defective devices or lack of internet or charging access while traveling; medical imaging that requires removal of the pump, CGM systems, and/or sensors; overcorrecting hypoglycemia; and the need for education about the AID. Provider issues are also addressed.

Concerns were identified for special populations, as study patients in clinical trials may not necessarily be representative of the population using AIDs in real-world situations. Since these devices are typically used in young patients with type 1 diabetes, there is concern during the transition adulthood, when former children need to be knowledgeable enough to assume responsibility for their care. Patients undergoing acute metabolic events and pregnant women are other groups of concern.

AIDs may be most ideally suited for those who are technically able to use an insulin pump; those with realistic expectations about the device; those who are properly educated about the AID and have a good support system; and those who are mentally and psychologically prepared to deal with the new technology.

Safety concerns such as device malfunction, bypassing safeguards, adverse skin reactions, liability issues, data privacy issues and cybersecurity, as well as concerns about the functionality of “do-it-yourself” AIDs were raised. It is important for both patients and providers to report any device issues to the manufacturer and FDA. The issue of access to these device systems was also addressed.

The consensus report concludes with recommendations for regulatory agencies, manufacturers of these devices, international and national professional societies or advocacy organizations, researchers/academicians, healthcare professionals, consumers, and evidence-based access policies.

This consensus report provides retail pharmacists with valuable information about the benefits and challenges associated with the use of AIDs so that they can better assist their patients who utilize these devices.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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