Diabetes Smartphone Alerts May Be Impacted by Hardware, Software Updates: FDA Warns

Smartphone diabetes alerts could become disabled inadvertently, increasing the risk of dangerous blood sugar levels, diabetic ketoacidosis injuries and death.

Federal regulators are warning that cellphone updates may disable diabetes monitoring software, preventing users from receiving critical alerts about dangerous drops in blood glucose levels.

Diabetes apps enable users to customize their alerts, allowing them to choose the types of notifications they receive about their condition, the frequency of these alerts, and the delivery method, whether through sounds, vibrations or text messages.

However, according to a U.S. Food and Drug Administration (FDA) safety alert published on February 5, after smartphone users download and install new cell phone updates, diabetes devices and apps may not work properly, potentially failing to alert the user of critical blood sugar problems.

Officials are warning this may lead to serious and potentially life threatening health conditions like hypoglycemia (low blood sugar), hyperglycemia (high blood sugar) and diabetic ketoacidosis (lack of insulin in the blood).

The FDA indicates that devices and apps that could be impacted by these updates include continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems and other diabetic devices. Many of these diabetes monitoring devices work with smartphones and health apps, to monitor a person’s blood sugar levels. When operating correctly, the devices send data to smartphones that alert the user via push notification, sound, vibration or text.

Federal regulators are now cautioning that improperly configured smartphones may cause users to miss critical diabetes safety alerts. For instance, recent updates to iPhone Operating Systems (iOS) could introduce features that are incompatible with older software used by diabetic monitors, resulting in missed notifications.

The FDA has identified multiple incidents where users of continuous glucose monitors and other diabetic devices failed to receive smartphone alerts. The agency warns that delays in receiving critical alerts can lead to severe consequences, such as dangerously low or high blood sugar levels, shock, ketoacidosis requiring urgent treatment, or even death.

Smartphone Update Recommendations

According to the agency, patients should regularly check their smartphone device alert settings, especially after phone software and hardware updates. They should pay special attention to app notification permissions, including “Do not disturb,” “Focus mode” and “Deep sleep” modes, which can cause alerts not to come through.

Users should also be aware after connecting new hardware, like wireless earbuds or car audio, that can change settings and default volume levels. In addition, some operating system updates may not be supported by the diabetic device manufacturer, the agency warned.

The FDA offered these recommendations for patients:

• Follow the instructions by the manufacturers when installing, setting up, or updating mobile medical apps on your smartphone.
• Turn off automatic iOS updates and do not update the OS until you check the diabetes device manufacturer’s website to verify the apps you use are compatible with the OS version.
• Check that the alerts are configured as expected at least once a month. Ensure the volume, vibration, notifications and other settings work as expected.
• If alerts aren’t functioning as they should be, contact customer support for the medical device.

App developers may also suggest disabling “Low Power Mode,” “Adaptable Battery” and “Assistive Access.” Users may also need to enable Bluetooth and location access to the medical apps.

Any problems with diabetic devices or with the functionality of the devices and smartphone apps should be reported to the FDA’s MedWatch Adverse Event Reporting Program.