In order to provide vital safety alerts, the U.S. Food and Drug Administration is warning patients about a safety issue with diabetic devices that rely on smartphones, including insulin pumps, continuous glucose monitors (CGMs), and automated insulin dosing systems. Through the app on their phone, users of these diabetic devices that work with smartphones can customize alert settings, including which notifications they want to receive, how frequently they must be sent, and how they are delivered (e.g., text alone, vibration, or audio).
The FDA has received reports from users of medical devices stating that these notifications are not being heard or delivered, even though the users believed they had set them up to do so. Serious consequences, such as severe hypoglycemia (low blood sugar), severe hyperglycemia (high blood sugar), diabetic ketoacidosis (when the body does not have enough insulin to use blood sugar for energy), and even death, may have resulted from ignoring these warnings in certain instances.
The following hardware and software modifications, updates, and configurations have been identified by the FDA as potentially causing crucial alerts to not be received as expected:
- software configuration issues, such as 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, such as connecting to car audio or using wireless earphones, that can change the default volume of alerts or prevent delivery of alerts; and
- smartphone operating system updates that are not supported by the medical device application.
The FDA’s safety communication provides recommendations, such as the following, for users of these devices:
- Carefully follow the instructions provided by diabetes device manufacturers when installing, setting up or updating mobile medical apps on the smartphone;
- turn off automatic operating system (OS) updates to the smartphone and do not update 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, confirm 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, 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, call the technical support number for the medical device for assistance; and
- report any problems with the diabetes device to the FDA.
The FDA is working with diabetes-related medical device producers to ensure that their devices' smartphone alert options are thoroughly tested before being used by patients. The FDA is also working with manufacturers to ensure that settings in smartphones and mobile medical apps that may affect safety alerts are constantly checked, and that any changes to recommended configurations are conveyed to consumers in a timely and clear manner.
