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Along with its position statement in Diabetologia, the group outlined recommendations that seek greater structure and consistency for automated insulin delivery (AID) manufacturers as they develop products for use by persons with type 1 and type 2 diabetes.
An international task force last week called on regulatory agencies across the globe to prioritize safety and patient privacy for automated insulin delivery (AID) systems and “harmonize” standards as AID expands.
Along with its position statement in Diabetologia, the group outlined recommendations that seek greater structure and consistency for manufacturers as they develop products for use by persons with type 1 (T1D) and type 2 diabetes (T2D). They called on all stakeholders—including patients—to understand their role as technology promises to play a greater role in management of blood glucose levels, particularly the percentage of time a person’s glucose stays within a recommended range.
The consensus statement, the fourth in a series, comes from the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. The group notes that the first AID system has been approved and more are in development, while a community of people with T1D has developed its own “do-it-yourself” system using existing commercial components.
The working group offers an overview of the AID landscape, drawing on experience from the last decade of advances in diabetes technology, when continuous glucose monitoring became standard of care for those with T1D and has emerged as a more common tool for those with T2D.
Many issues remain, the authors note, including uneven access to the technology itself, as well as the infrastructure needed for devices to operate properly. Notably, the authors state, although studies have demonstrated the value of AID systems for individuals—by improving sleep and reducing burdens of daily disease management—more work is needed to show whether these benefits translate at the population level. And more customization is likely needed.
“Future AID systems might use artificial intelligence to adjust responses of the system to the needs of the individual with diabetes,” they write.
And because AID systems rely on power, they have their limitations. Authors warn that many systems still require patients and caregivers to manually transmit data and that systems can be affected by things like low batteries on smart phones, operating system upgrades, or loss of connectivity or power. Backup methods for delivering insulin are still needed.
The authors offer 8 sets of recommendations for regulatory agencies, manufacturing companies, professional societies, and policy leaders to guide future AID development:
Reference
Sherr JL, Heinemann L, Fleming GA, et al. 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. Diabetologia. Published online October 6, 2022. doi:10.1007/s00125-022-05744-z