The U.S. Food and Drug Administration (FDA) is alerting patients with diabetes and their caregivers about the potential risks associated with missed alerts from continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems and other mobile-connected diabetes devices.

A failure to receive critical alerts could result in severe health issues, including hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), diabetic ketoacidosis or even death.

Mobile apps for diabetes devices allow users to customize their alert settings, including volume, frequency, and method of delivery (audible, vibration, or text). However, if a smartphone is not properly configured, users may miss these critical notifications. This could occur if alerts aren't delivered or if the volume is too low to hear the audible signals.

The FDA has identified several factors that may lead to missed alerts, such as:

• Software issues: App notification settings, "Do Not Disturb," "Focus Mode" or the app entering "deep sleep" after inactivity could prevent alerts from being received.
• New hardware: Connecting devices like wireless earphones or car audio systems can change alert volumes or prevent their delivery altogether.
• Operating system (OS) updates: New updates to a smartphone's OS may not be supported by the diabetes device app, causing alert failures.

The FDA recommends that patients and caregivers take several precautions to ensure alerts are received as expected. These include carefully following manufacturer instructions when setting up or updating medical apps, turning off automatic OS updates, and verifying alert settings after updating the OS or connecting new accessories. Patients should also check their alert configurations at least once a month and contact technical support if problems persist.

Health care providers are encouraged to inform patients about the importance of periodically verifying their smartphone settings to ensure critical alerts are properly configured. Providers should also ensure that patients' devices continue to provide alerts after hardware or software updates.

Mobile medical apps, which control many diabetes-related devices, rely on proper smartphone configurations to deliver essential safety alerts. These apps may offer customizable alert options, but if the app or smartphone settings are not correctly configured, alerts may not be received or heard.

The FDA is collaborating with diabetes device manufacturers to evaluate the smartphone alert configurations of their products and ensure safety. The agency will continue to monitor developments and provide updates if new information arises.

Patients who experience issues with their diabetes devices are encouraged to report them using the MedWatch Voluntary Reporting Form on the FDA website.

For more information, visit the FDA's website at www.fda.gov for detailed guidance on device configurations and alert settings.