Expert Weighs In: FDA Alert Highlights Hidden Risks in Diabetes Apps

Last week, the U.S. Food and Drug Administration (FDA) issued a safety alert for patients using diabetes devices, including continuous glucose monitors (CGMs), to ensure the settings in their phones were configured correctly to deliver critical alerts.

Some users may miss important notifications from their diabetes management apps due to software settings, hardware changes (such as connecting to headphones or car audio) and operating system updates. These issues can lead to severe health risks, including hypoglycemia, hyperglycemia, diabetic ketoacidosis and even death.

In an interview with The Educated Patient, Linda Parks, RN, highlights that while smartphones were never originally intended to be medical devices, they have become essential tools for diabetes management due to the rise of apps for insulin pumps and CGMs. However, since phones were not designed for this purpose, users must be vigilant about their settings.

Can you discuss the importance of ensuring CGM settings are configured on smartphone apps to deliver these critical alerts?

Linda Parks, RN: I think the evolution of technology often dictates the devices we use. The phone was never originally intended to be part of a medical system or device. However, as insulin pumps and continuous glucose monitors (CGMs) started integrating with apps, and as apps became more popular, it made sense to have them on smartphones. People already carry their phones everywhere, so using an app for diabetes management helps make life more convenient.

That said, smartphones were not designed as medical devices, yet they still serve as the "brains" of these systems. For example, if someone enables Do Not Disturb on their phone while relying on a CGM app to receive blood sugar alerts, those alerts may not come through. This means users must be mindful of their phone’s overall settings and how they've configured their diabetes management apps to ensure they receive critical alerts.

Configuration is crucial when setting up these apps, but it doesn't end there. Apps are software, and software updates happen frequently. If Apple or another phone manufacturer releases an update, it can disrupt previous settings, potentially affecting how an app functions. People using their phones for diabetes management need to regularly check that everything is working as expected.

As for the recent FDA alert, this isn't a new issue. The FDA has simply received enough complaints to issue an official warning. While app labeling now includes these considerations, I think it's important for people living with diabetes to take an active role in managing their devices. A good habit would be checking their app configurations at least once a month to ensure everything is set up correctly and functioning properly.

This transcript was edited for clarity.