FDA Warns About Diabetes Device Smartphone Alert Settings

The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood glucose level alerts from diabetes-related smartphone devices due to improper setting configurations, particularly following software or hardware updates.

On February 5, 2025, the FDA issued an alert it has received reports of missed alarms for patients who use continuous glucose monitors (CGMs), insulin pumps, or automated insulin delivery systems. Whether the alarm didn’t occur or wasn’t heard, the result can lead to harm from extremes of hypoglycemia or hyperglycemia. 

Diabetes device apps allow users to configure most alert settings, including which alerts they receive, how often, and the delivery mode, ie, audible, vibration, or push notification.

Healthcare providers are advised to inform patients and their caregivers who rely on smartphone-connected diabetes devices to periodically check the smartphone settings to ensure critical alerts can be delivered. Such checks should also be conducted following any hardware or software updates or connecting any external software to make sure the device can still issue alerts.

Specific problems cited by the FDA include use of app “do not disturb” or “focus mode” configurations that prevent alarms, or the app entering a “deep sleep” after a period of disuse. In addition, connecting new hardware such as wireless earphones or car audio can change default alert volumes. 

Another common problem occurs when operating system (OS) updates aren’t supported by the medical device app. The FDA advises patients to carefully follow instructions from diabetes device manufacturers when installing, setting up, or updating mobile medical apps on smartphones. Automatic OS updates should be disabled and updates should not be initiated until system compatibility is confirmed. 

Patients who aren’t receiving alerts as expected or can’t hear them should call the device manufacturer’s technical support number. Problems with diabetes devices should also be reported to the FDA. 

In a statement, the FDA said it is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations are carefully evaluated before patient use. In addition, the agency is working to ensure continuous testing of smartphone app alert settings and to communicate any configuration updates to users.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.