Health experts have issued a warning that patients who rely on smartphone apps for managing their diabetes could face severe health consequences if they miss critical alerts related to blood sugar control.
The U.S. Food and Drug Administration (FDA) announced on Wednesday that it has received numerous reports of patients failing to receive important medical notifications from their diabetes management apps, leading to dangerously low blood sugar levels and, in some cases, fatalities.
This caution pertains to the increasing number of wearable devices that monitor blood glucose levels or automatically administer insulin, the hormone responsible for regulating glucose in the bloodstream and converting it into energy. Many of these devices are synced with mobile applications that allow users to track their health data. However, the FDA has warned that certain phone settings, such as silencing notifications, can prevent users from receiving these vital updates.
In other cases, users have inadvertently altered the volume or settings of their alerts when connecting their phones to new audio devices, such as car stereo systems. The FDA emphasized that even if devices are configured correctly, software or hardware changes could disrupt their normal functioning, potentially resulting in harm if not detected in time.
Courtney Lias, director of the FDA’s Division of Neurology and General Hospital Devices, explained in a statement: “Even if set up correctly, changes to hardware or software can interfere with the intended operation of these crucial devices, potentially putting patients at risk.”
The warning is particularly concerning given the widespread prevalence of diabetes in the United States, affecting roughly 37 million Americans. Those with the condition either do not produce enough insulin or have developed resistance to the hormone.
Continuous glucose monitors (CGMs) are small devices equipped with sensors placed under the skin to measure blood sugar levels. These devices send readings to a smartphone or smartwatch, which then delivers alerts. Automated insulin pumps, which are often paired with CGMs, deliver insulin through a catheter attached to the abdomen, and can be programmed to provide extra doses before meals.
To ensure the proper functioning of glucose-monitoring apps, the FDA advises the following precautions:
Disable automatic updates on your smartphone until you verify that the new operating system is compatible with your diabetes app.
After connecting your phone to new accessories like Bluetooth headphones, check that the alerts are still being received and are clearly audible.
Monthly, review your phone’s notification settings to ensure they remain configured correctly.
While thousands of health-related apps are available for download on devices like iPhones and Android phones, the FDA only regulates a small subset of them, primarily those with significant risks to user health, such as those used for monitoring heart rhythms or other vital medical data. Apps designed for general wellness, such as calorie counters or mental health trackers, are generally not subject to FDA oversight.
The FDA also stated that it is in discussions with manufacturers to ensure that app alert configurations are thoroughly evaluated before they are made available to patients.
As the use of smartphone-connected health devices continues to rise, regulators urge users to remain vigilant about the settings and compatibility of their apps, particularly those critical to managing chronic conditions like diabetes.
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