WASHINGTON — Health authorities have issued a warning regarding the potential health risks for individuals using smartphone applications to manage their diabetes, particularly concerning missed notifications essential for blood sugar control. The Food and Drug Administration (FDA) highlighted concerns on Wednesday following several reports indicating that patients have failed to receive critical medical alerts, which has sometimes resulted in dangerously low blood sugar levels or even fatalities.
This advisory specifically addresses a rising trend in wearable technology designed to monitor glucose levels or administer insulin automatically, which is vital for glucose regulation. Nowadays, most of these devices connect with mobile applications on patients’ smartphones; however, the FDA cautions that certain settings on these devices, such as silencing notifications, might lead to significant health risks if users do not remain vigilant. Furthermore, changing audio output settings, like connecting to a car stereo, may inadvertently reduce the volume of crucial alerts, impacting a patient’s ability to respond adequately.
Courtney Lias, a director at the FDA’s device center, stated, “Even if these devices are properly set up, modifications to hardware or software can disrupt their expected performance. This can result in serious health consequences if the issues remain unnoticed.” With approximately 37 million individuals in the United States living with diabetes, it’s crucial to recognize that the condition arises from either insufficient insulin production or a resistance to insulin, both leading to complications in glucose management.
Continuous glucose monitors represent a key component in diabetes management. These compact devices place a sensor just beneath the skin to consistently gather blood sugar data, relaying that information to a smartphone or smartwatch. Similarly, automated insulin pumps are programmed to administer insulin through a catheter attached to the abdomen and can dispense additional insulin doses around meal times.
To ensure that glucose-monitoring applications function correctly, the FDA has suggested several precautions for users. They advise turning off automatic updates on smartphones until there is confirmation that the latest operating system is compatible with the diabetes management app. Additionally, once a smartphone is connected to new accessories, such as Bluetooth headphones, users should check that app notifications are still active and clearly audible. Lastly, it is recommended to verify the smartphone’s notification settings monthly to ensure there have been no unintentional changes.
It’s also noteworthy that the FDA only regulates specific functionalities within health applications. Since the popularization of smartphones, countless apps have emerged promoting various health management features, including calorie tracking and mental health support. However, the FDA does not oversee most of these applications as they typically do not pose significant risk if they malfunction. Their regulatory focus is primarily on applications transforming smartphones into medical devices, such as those that monitor heart rhythms or other vital health indicators.
In response to these potential issues, the FDA has been in discussions with manufacturers to enhance the scrutiny of smartphone alert configurations before their devices are released for patient use.
