Date Issued: February 5, 2025
The U.S. Food and Drug Administration (FDA) is alerting patients who use diabetes devices and their caregivers of reports where users of continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices did not receive or did not hear alerts from their smartphones. A missed alert for a diabetes-related safety issue may lead to serious harm, including 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 death.
Apps for diabetes devices allow users to configure alert settings, such as which alerts to receive, how often and how the alerts are delivered (audible, vibration, or text only). If a user’s smartphone is not configured correctly, critical safety alerts that the user expects to receive may be missed. They might not be delivered, or the volume might be too low to notice audible alerts.
The FDA has identified the following hardware and software configurations, changes, and updates that may lead to critical alerts not being received as expected, including:
- 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, such as wireless earphones or car audio, that can change default volume of alerts or prevent delivery of alerts.
- Operating system (OS) updates that are not supported by the medical device app.
Recommendations for Patients and Caregivers
- Carefully follow the instructions provided by diabetes device manufacturers when installing, setting up, or updating mobile medical apps on your smartphone.
- Turn off automatic OS updates and do not update your phone’s OS until you check your diabetes device manufacturer’s website to verify that the medical apps you use are compatible with the new OS version. Turn off automatic OS updates by navigating to your system settings, usually accessible through a gear icon, and find the "software update" option; within this section, look for a toggle switch labeled "automatic updates" or similar, and disable it.
- After updating your OS or adding a new accessory such as wireless headphones, confirm alert settings and then carefully monitor your medical device app to make sure you can receive and hear alerts as expected.
- At least once a month, check that your smartphone alerts are configured as expected. Ensure your volume, vibration, notifications, and other relevant settings still work.
- If you are not receiving alerts as expected from your mobile medical app, or you cannot hear them, call the technical support number for your medical device for assistance.
- Report any problems with your diabetes device to the FDA.
Recommendations for Health Care Providers
Inform patients and their caregivers that people who rely on smartphone-compatible diabetes devices that connect to their smartphones should:
- Periodically check smartphone settings to ensure that they can receive critical alerts.
- Confirm that diabetes devices still provide alerts as expected through their smartphones after making any hardware or software updates or connecting external hardware.
Device Description
Many diabetes-related devices use mobile medical apps as part of the medical device system. These mobile medical apps run on smartphones and manage or provide information from diabetes-related devices.
Many types of diabetes devices can use a mobile medical app installed on a smartphone to deliver safety alerts, including CGMs, insulin pumps, automated insulin dosing systems, and others. The settings within the mobile medical app, as well as the settings in the smartphone itself, must be configured correctly for alerts to be delivered as users expect. Users may be able to choose how some alerts are delivered, such as by push notifications, vibration alerts, or audible alerts.
Medical device manufacturers provide instructions on how to configure these apps and smartphones so users can receive the alerts they want according to their preferred delivery method. For example, medical device manufacturers may instruct users to disable smartphone features like “Focus mode,” which includes such options as “Do Not Disturb” and “Sleep Focus.” They may also suggest disabling “Low Power Mode,” “Adaptive Battery,” “Standby mode,” “Assistive Access,” or others to ensure that the mobile medical app can deliver alerts. Users may also be instructed to grant certain permissions to mobile medical apps such as Bluetooth, location, notifications, background usage, or others.
During normal use of a smartphone, many things can happen that could change how alerts are delivered. For example:
- Updates to smartphone operating systems may introduce new features or change existing settings in the diabetes mobile medical app.
- OS updates for cybersecurity issues may change existing alert settings.
- When new audio devices are connected to a smartphone -- such as wireless headphones, Bluetooth speakers, or car audio -- the volume settings for notifications including critical alerts may change.
- Users may enable smartphone features such as battery saver, focus mode, or others and later forget to disable these features.
FDA Actions
The FDA is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated before use by patients.
The FDA is also working with manufacturers to ensure that settings in smartphones and mobile medical apps that may impact safety alerts are continuously tested, and any updates to recommended configurations are communicated quickly and clearly to users.
The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with your diabetes-related device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).
