Smartphone Settings May Block Critical Diabetes Device Alerts, FDA Warns

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The U.S. Food and Drug Administration (FDA) has issued a safety alert regarding diabetes devices, including continuous glucose monitors (CGMs) and insulin pumps, that rely on smartphones to deliver critical alerts.

Users can configure these settings through the app on their phone. However, in some cases these results are not being delivered or not being heard. Reports indicate that some users are not receiving or hearing these alerts due to software settings (such as enabling “do not disturb” and “focus mode” or entering “deep sleep” after a period of inactivity), hardware changes (when connecting to headphones or car audio), or operating system updates, which may contribute to severe health risks, including low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), diabetic ketoacidosis and death.

The FDA offered some recommendations for patients using these applications:

• When installing mobile medical apps, be sure to follow the instructions provided by the diabetes device manufacturer.
• Turn off automatic operating system updates in your system settings.
• Do not update the phone’s operating system until you confirm the app is compatible with the new version.
• Confirm alert settings when updating or adding a new accessory, including wireless headphones, and ensure alerts can be received and heard as expected. This includes volume, vibration, notifications and other relevant settings.
• Check the alert settings monthly.
• Reach out to technical support if necessary.
• Report any problems with the medical app to the FDA.

The FDA is collaborating with diabetes-related device manufacturers to improve safety measures and ensure reliable alert delivery.