The U.S. Food and Drug Administration (FDA) is urging users of continuous glucose monitors (CGMs), insulin pumps, and other diabetes devices to routinely verify their smartphone alert settings. The agency has received reports of patients missing critical safety alerts due to smartphone configurations, potentially leading to severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, or even death.

Key Issues Identified

• Software and OS Changes: Updates may prevent alerts from being delivered or alter volume settings.
• Phone Settings: Features like "Do Not Disturb," "Focus Mode," and "Battery Saver" can interfere with notifications.
• Connected Devices: Wireless headphones and car audio systems may suppress or redirect alert sounds.

Recommendations

• Verify alert settings after installing app updates, OS upgrades, or connecting new accessories.
• Disable automatic OS updates until compatibility with diabetes apps is confirmed.
• Check alert functionality at least once a month.
• Contact device manufacturers for assistance if alerts are not received as expected.

The FDA continues working with manufacturers to ensure smartphone and app settings are optimized for patient safety. More details are available on the FDA website.