WASHINGTON (news agencies) — 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 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 make 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.
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