FDA Warns of Missed Alerts with Smartphone-Connected Diabetes Devices

The U.S. Food and Drug Administration (FDA) issued an alert about continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing (AID) systems that rely on a smartphone to deliver critical safety alerts.

The agency said it received reports where users say the alerts aren’t being delivered or heard, in cases where they thought they had configured the alerts to be delivered. In some cases, the FDA reported, missing these alerts might have contributed to serious harm including hypoglycemia, hyperglycemia, diabetic ketoacidosis, and death.

Specific problems include software configuration issues like app notification permissions, using “do not disturb” or “focus mode”, or the app entering “deep sleep” after a period of not being used. Connecting new hardware to the smartphone was also identified as an issued, like connecting to car audio or using wireless earphones, which can change the default volume of alerts of prevent alert delivery.

Another issue is smartphone operating system updates that aren’t supported by the medical device application.

“Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected,” said Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health. “Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”

The agency’s safety communication recommends turning turn off automatic operating system (OS) updates to the smartphone and not updating the phone’s OS until confirming the diabetes device app is compatible with the new OS version. After updating the phone’s OS or adding a new accessory, such as wireless headphones, users should confirm that alert settings, then carefully monitor the medical device app to make sure alerts are received and can be heard as expected.

At least once a month, users should check that the smartphone alerts are configured as expected. If alerts are not being received as expected from the mobile medical app, or cannot be heard, the FDA advised calling the technical support number for the medical device for assistance.