The Food and Drug Administration (FDA) has issued a safety alert regarding potential notification failures on smartphone-connected diabetes management devices, including continuous glucose monitors, insulin pumps, and automated insulin dosing systems.
According to the FDA’s February 5 announcement, some users have reported instances where alerts—intended to notify them of critical blood sugar levels—were either not received or not heard, despite being configured. In certain cases, these failures have led to severe medical emergencies, including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and even death.
The agency is working closely with manufacturers to evaluate smartphone alert settings before use and to ensure that mobile medical applications are rigorously tested for reliability. Additionally, the FDA is urging manufacturers to provide clear and timely updates to users regarding any changes that may impact the effectiveness of these alerts.
Related topics:
Record Number of UK Adults Affected by Diabetes or Pre-Diabetes, New Data Reveals
Sisters Combine Passion for Skiing with Fundraising to Battle Cancer and Diabetes
Top in Endocrinology: Novel GLP-1 Lowers Weight; Osteoporosis Detection with CT plus AI
