During a session aimed at enhancing home healthcare for diabetes patients, Arianna Gehan, co-founder and CEO of Daia Diabetes, described the daily challenges of managing her Type 1 diabetes, emphasizing the overwhelming experience of alarm fatigue from numerous notifications on her insulin pump and continuous glucose monitor. This session was part of the Food and Drug Administration’s (FDA) new initiative called “Home as a Health Care Hub”, launched by Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health. This initiative seeks to cater to diverse living conditions during device development by partnering with the architecture firm HKS to create virtual prototypes of various living spaces.
Key stakeholders including diabetes patients and medical device companies gathered to discuss necessary improvements in diabetes management devices. Former CDRH Director Jeff Shuren pointed out that diabetes was chosen as the initial focus due to its wide prevalence in the U.S., affecting over 38 million people. The shift towards a home-centered healthcare model underscores the need for better device integration into daily lives, reducing the burden on individuals managing this complex condition.
Gehan shared insights into her personal regimen which includes maintaining a three-month supply of necessities and acquiring a backup generator to avoid insulin spoilage during power outages. She highlighted the critical role of virtual care, particularly during the COVID-19 pandemic, noting that such services are becoming less accessible, especially across state lines.
Courtney Lias, acting director of CDRH’s office of in-vitro diagnostic devices, discussed regulatory improvements influenced by community feedback. These include advancements such as wireless data transmission and app integration that have significantly improved user experience by removing cumbersome cords and separate receivers for continuous glucose monitoring data. Furthermore, community feedback led to the FDA’s approval of automated insulin dosing systems in 2016, enhancing treatment accuracy.
Despite these advancements, concerns about the safety, costs, and accessibility of these home devices persist. Julianne Lally, associate director for Breakthrough T1D, stressed the importance of making cost a primary consideration from the development stage. She warned that adoption rates of new technologies might lag despite their recognized benefits, as highlighted by the low adoption rates of CGMs among patients, owing to socio-demographic disparities.
René Quashie, vice president of digital health at the Consumer Technology Association, further brought attention to the financial aspects, emphasizing the role of insurance and reimbursement in enabling equal access to advanced technologies. Quashie warned that without thoughtful insurance coverage, advanced tools might become inaccessible to those unable to afford high costs out-of-pocket.
Scott Lucas, vice president for device safety at ECRI, criticized the design of complex medical devices which are often not user-friendly for non-professionals. He urged device companies to consider factors such as power supply, internet access, space availability, and language barriers to improve usability at home. Lucas also highlighted a significant gap in direct communication from manufacturers to patients about device recalls, pointing out a general lack of awareness among users about such critical updates.
These discussions underscore a broader need for device designs that are not only technically efficient but also user-centered and equitable in terms of access and cost. By considering these elements, the FDA’s “Home as a Health Care Hub” initiative aims to foster a more inclusive, practical, and sustainable healthcare environment for individuals managing diabetes at home.
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