Patients who use smartphone apps to manage their diabetes could face serious health problems if they miss notifications needed to control their blood sugar, U.S. health officials warned.
The Food and Drug Administration (FDA) said Wednesday it has received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low blood sugar and even death.
The agency's warning applies to a growing field of wearable devices that track patients’ sugar levels or automatically deliver insulin, the hormone that helps manage glucose in the blood and break it down into energy.
These days, many devices are programmed through apps on patients’ phones. But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical updates. In other cases, connecting the phone to a new audio source, such as a car stereo, could change the volume of the alerts users are accustomed to hearing.
"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,” said Courtney Lias, a division director in the FDA's device center, in a release.
Roughly 37 million Americans have diabetes. People with the disease either don’t produce enough insulin or they have become resistant to it.
Continuous glucose monitors are small devices that use a sensor under the skin to measure blood sugar, sending regular readings to a smartphone or smartwatch. Automated insulin pumps deliver the hormone through a catheter attached to the abdomen and can be programmed to deliver extra insulin before meals.
FDA regulators recommend turning off automatic updates on your smartphone until you’ve confirmed the new operating system is compatible with your diabetes app. After connecting your smartphone to a new accessory, such as Bluetooth headphones, confirm that app alerts are still being delivered and can be heard clearly. Once a month, double check that your smartphone’s notification settings haven’t changed.
Since the introduction of iPhone and Android devices, thousands of apps have been launched claiming to help users manage their health, from calorie counters to mental health apps.
The FDA doesn’t regulate the vast majority of them because they don’t pose much risk to consumers if they malfunction, according to regulators. The agency mostly enforces safety requirements on apps that turn smartphones into the equivalent of devices, for example, by monitoring heart rhythms or other critical medical readings.
The FDA said Wednesday it is talking to "manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated prior to use by patients.”
