Task Force Calls for Prioritizing Safety, Privacy in AID Use; Seeks Harmony Among Regulators

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:

• Regulatory agencies should harmonize activities through creation of standards and clear pathways for approval of future AID systems. This includes guidelines for clinical trials and postmarketing requirements; the authors said regulators should “encourage” randomized, not single-arm trials. Rules should require manufacturers to publish any updated data annually from real-world studies that may show “who would derive the most benefit from the product.”
• Manufacturing companies should “comply with regulations, industry standards, and best practices established for AID systems.” Companies should perform studies longer than 1 year to collect real-world data, create accessible training modules, and offer 24/7 technical support. Interfaces should be individualized and user-friendly for all demographic groups, and safety data must be promptly and transparently reported to regulators.
• Professional societies and advocacy groups should engage all stakeholders on how to advance AID while prioritizing the safety and privacy of those with diabetes, encourage large-scale clinical trials with diverse populations, provide evidence-based guidelines on AID systems, and recommend education requirements for health care providers to support patients.
• International and national research funding groups should provide for well-designed independent studies on “safety, effectiveness, outcomes, and use of AID systems in real-world settings,” which may include registry sponsorship.
• Researchers and academics should “share patient-level data only in accordance with local law” and develop appropriate patient-related outcome measures.
• Health care professionals (HCPs) should understand differences and nuances among the different systems, and they should be able to explain strengths and weaknesses of various products to patients. HCPs should involve patients in shared decision-making when selecting an AID system. They should also discuss when an AID system should and should not be used and provide an on-call number to support patients with diabetes in critical situations.
• Patients, families, and caregivers of those using AID systems should have realistic expectations of what AID can do and understand systems are a tool, not a replacement for being engaged in one’s own care. Patients or caregivers should submit data to health care providers as appropriate to aid in diabetes care.
• Evidence-based access policies for AID should reflect the science—these standards should be set by policy makers to reflect the challenges seen in rapid advances of the product cycle, consider health inequalities, and include patient-reported outcomes.

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