Diabetes device data may fail to deliver based on smartphone settings

Diabetes device data may fail to deliver based on smartphone settings | Image Credit: © KRISTINA KUPTSEVICH - © KRISTINA KUPTSEVICH - stock.adobe.com.

In a new FDA alert, the agency is warning diabetes patients who use devices such as smartphones, continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, that smartphone settings could hinder delivery of critical safety alerts that come from such devices.

Many diabetes devices depend on smartphone connectivity to delivery safety alerts to the patients using them. Smartphone settings determine which alerts to receive, how often, and how alerts are delivered to the smartphone, such as via text, vibration, or with an audible sound. This is typically done through the device's app on the phone.

The federal agency has received medical device reports that stated alerts are not being delivered or not being heard, in cases where the users thought they had configured the settings correctly. In some cases, the FDA stated, these missed alerts could have contributed to serious harm such as hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death.

In the announcement, Courtney Lias, who is the director of the Office of In Vitro Diagnostic Products within the FDA's Center for Devices and Radiological Health, said a regular monitor of these settings can help mitigate missed alerts.

"Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected," said Lias.

It is important to remind patients that even routine smartphone updates can have a potential impact on notification delivery.

"Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected," added Lias.

The FDA identified the following hardware and software changes and updates, among other reasons, that could lead to critical alerts not being delivered as intended:

• 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 to the smartphone, such as connecting to car audio or using wireless earphones, that can change the default volume of alerts or prevent delivery of alerts; and
• Smartphone operating system updates that are not supported by the medical device application.

Recommendations, from the FDA's safety communication guide, for users of these devices include:

• Carefully follow the instructions provided by diabetes device manufacturers when installing, setting up or updating mobile medical apps on the smartphone;
• Turn off automatic operating system (OS) updates to the smartphone and do not update the phone’s OS until confirming the diabetes device app is compatible with the new OS version;
• After updating the phone’s OS or adding a new accessory, such as wireless headphones, confirm alert settings then carefully monitor the medical device app to make sure alerts are received and can be heard as expected;
• At least once a month, check that the smartphone alerts are configured as expected;
• If alerts are not being received as expected from the mobile medical app, or cannot be heard, call the technical support number for the medical device for assistance; and
• Report any problems with the diabetes device to the FDA.

The federal agency stated in the alert that it is working with diabetes-related medical device manufacturers "to ensure that smartphone alert configurations of their devices are carefully evaluated prior to use by patients. The agency 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."

Reference:

FDA alerts patients of potential to miss critical safety alerts due to phone settings when using smartphone-compatible diabetes devices. FDA. Press release. February 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-potential-miss-critical-safety-alerts-due-phone-settings-when-using-smartphone