ARE SMARTPHONE DIABETES DEVICES PUTTING LIVES IN DANGER? US FDA SOUNDS ALARM

The U.S. Food and Drug Administration (US FDA) has said patients using diabetes devices that rely on smartphones, sometimes fail to receive alerts critical for their health.

Users of smartphone compatible devices like continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems often configure their settings so that they receive timely updates about their health. The growing popularity of these devices is driven by the convenience and improved disease management they offer. These devices, such as continuous glucose monitors (CGMs) seamlessly sync with smartphone apps, allowing users to track glucose levels in real time, set alerts, and analyze trends. Enhanced connectivity enables data sharing with healthcare providers and caregivers, improving treatment decisions. Advancements in wearable technology, AI-driven insights, and user-friendly mobile apps make diabetes management more accessible. The increasing focus on digital health solutions and the demand for remote monitoring further contribute to their widespread adoption.

"The FDA has received medical device 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," the US FDA has said.

" 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 US FDA announcement alarms.

According to Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, "modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected.”

"“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," she added.

Here's what such individuals can do to ensure they receive updates and alerts on time.

Software configuration issues can impact app notifications due to permission settings; check for “Do Not Disturb” or “Focus Mode,” or the app entering “deep sleep” after prolonged inactivity. When connecting new hardware, such as car audio systems or wireless earphones, default alert volumes or notifications get activated. Smartphone operating system updates that are incompatible with certain medical device applications may prevent proper functionality. These factors can disrupt critical alerts, making it essential to regularly review notification settings, ensure hardware connections do not interfere with alerts, and verify software compatibility with medical applications after system updates.

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