FDA Warns Users of Continuous Glucose Monitors That Some May Fail to Deliver Critical Safety Alerts

The FDA is alerting patients of a “safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts.”

The FDA has received reports in which “users report these alerts are not being delivered or not being heard, in cases where the users thought they had configured the alerts to be delivered. In some cases, missing these alerts may have contributed 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.”

The FDA has identified certain issues that may lead to critical alerts not being received as expected. These issues include “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;” and “smartphone operating system updates that are not supported by the medical device application.”

Certain recommendations have been outlined by the FDA for users of these devices. These include “carefully following the instructions provided by diabetes device manufacturers when installing, setting up, or updating mobile medical apps on the smartphone;” “turn off automatic operating system updates to the smartphone;” and “at least once a month, check that the smartphone alerts are configured as expected.”