The Food and Drug Administration (FDA) has released a notice to users of diabetes-related smartphone devices, such as continuous glucose monitors (CGMs) and insulin pumps, to review alert settings regularly, particularly after software or hardware changes. FDA advises that missing alarms can lead to serious health conditions, such as severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, or death.

Key Highlights:
Missed Alerts Have Serious Implications:

• Reports indicate that users of diabetes devices are missing critical alerts because their smartphones are not configured correctly.

• Life-threatening conditions, such as low/high blood glucose or diabetic ketoacidosis, can be the outcome of missing alerts.

Causes of Missing Alerts:

• Software configuration errors such as notification privileges, Do Not Disturb/Focus Mode, or apps being in deep sleep.

• Plugging in new hardware (such as wireless earpieces or car sound) may alter alert volumes or stop delivery.

• Incompatible updates in OS not supported by medical devices, impacting application compatibility.

Recommendations of the FDA to the Patient and the Caregiver:

• Use manufacturer instructions to install or update applications.

• Enable automatic OS updates only after device compatibility with diabetes app is verified.

• After updating devices or plugging in new accessories, verify that the alert settings work.

• Check settings for alerts at least once a month to ensure proper functionality.

• Check with device support if the alarm is not coming through as anticipated and report a problem to FDA.

Recommendations for Health Care Providers:
Inform the patient of the need to review frequently the smartphone configuration for important alerts regarding the diabetes device.
Ensure the patients review alert performance after device or hardware updates.

FDA Statements:
"Missing reminders from diabetes devices can lead to serious health problems. We urge patients and caregivers to check their smartphone and app settings regularly to make sure important reminders are delivered as expected."The FDA is working with diabetes device manufacturers to make sure smartphone alert settings are fully tested and updated to avoid missed reminders. The agency stresses the need for frequent patient education and encourages users to stay alert to their device settings, especially after phone updates or adding new hardware. The FDA will keep an eye on the situation and issue updates as needed to safeguard patients.