Patient shares his day with diabetes at first FDA Home Health Hub meeting

Arianna Gehan often starts her day by waking up to alerts from the devices she uses to manage her diabetes.

“A few days ago, I got over 60 notifications on my phone from my insulin pump and continuous glucose monitor,” Gehan said at a session convened by regulators seeking input on ways to improve home health care for diabetes patients.

“Alarm fatigue is real, and diabetes burnout is a serious problem,” said Gehan, co-founder and CEO of Daia Diabetes, which makes it possible to share critical blood sugar information with emergency contacts.

Last Thursday, Food and Drug Administration officials heard stories from patients like Gehan and medical device companies to launch the agency’s Home as a Healthcare Center initiative.

Michelle Tarver, the new acting director of the FDA’s Center for Devices and Radiological Health, launched the initiative in April to advance health equity, starting with a focus on diabetes. The agency will work with architecture firm HKS to create virtual prototypes of different living spaces — a single-family home, an apartment and an accessory dwelling unit — to help health technology developers consider people’s living conditions as part of the device design.

“Conscious development that includes members from different geographies, different resources, different cultures, different generations, different genders and different life experiences helps us ensure that the solutions we develop can meet the needs of everyone,” Tarver said during the event.

Former CDRH Director Jeff Shuren, who announced his retirement last weekThe FDA started with diabetes because it affects more than 38 million people in the U.S. and the number is growing, he said. The initiative stems from the agency’s efforts to improve access to care and facilitate diversity in clinical trials.

“The healthcare model that focuses on the healthcare system and providers increasingly places the burden of care and care coordination, screening for complications and preventing poor outcomes on the shoulders of the person who already has a complex condition,” Shuren said.

A day in the life

During the meeting, Gehan shared her daily experiences of living with type 1 diabetes.

At home, Gehan often keeps a three-month supply, plus emergency supplies. She bought a backup generator for her home to make sure her insulin is kept cool, even if the power goes out. Gehan explained that insulin can spoil if not stored at the right temperature, which can create a life-threatening situation.

Gehan also told regulators that access to virtual care is an important innovation in diabetes care. At the height of the COVID-19 pandemic, she was able to have telehealth visits with an endocrinologist, but that access has declined, especially between states.

Courtney Lias, acting director of the CDRH Office of In Vitro Diagnostic Devices, shared how feedback from the diabetes community has helped regulators make earlier decisions. For example, the FDA encouraged manufacturers to develop wireless data transmission, eliminating the need for users to “go through a tangle of tangled cables” to manually download glucose data. It also encouraged integration with mobile apps, eliminating the need to wear a separate receiver to get CGM readings.

“As we learned, we realized that the regulatory landscape can be simply actionable, working with patients, physicians and device developers to improve the lives of these patients through simple technology solutions,” Lias said.

Feedback from the diabetes community was also key to the FDA’s 2016 approval of the first automated insulin dosing systems. These systems allow CGM devices and pumps to communicate and deliver insulin when needed.

Concerns about cost and access remain

Other meeting participants supported the initiative but also noted challenges related to the safety and costs of home equipment.

“For this initiative to have the impact on public health that it does, cost definitely needs to be a consideration from the very beginning,” said Julianne Lally, deputy director of community screening and clinical trials education at the diabetes nonprofit Breakthrough T1D, formerly known as JDRF.

Lally cautioned that it could take longer than expected for new devices to be introduced, even if their benefits are “widely known and common,” citing CGMs as an example.

The devices are recommended by the American Diabetes Association when patients start insulin therapy, but studies estimate that fewer than half of people with type 1 diabetes use CGM, Lally said, and there are significant sociodemographic differences.

René Quashie, vice president of digital health at the Consumer Technology Association, echoed Lally’s concerns about costs, focusing on the role of insurance and concerns about lack of reimbursement.

“I think we need to rethink this because we could be in a situation where a lot of these amazing tools, especially as they become more advanced, only end up in the hands of those who can afford the out-of-pocket costs,” Quashie said.

Scott Lucas, vice president of device security at the nonprofit ECRI, said sophisticated medical devices are often designed for health care workers, not home users. Device companies need to think about the user interface, as well as power, internet access, space, literacy and language barriers, he said.

Lucas also raised concerns about communication gaps about recalls, noting that device manufacturers rarely communicate directly with patients. For these reasons, ECRI cited usability challenges for home devices as biggest technological threat in 2024.