FDA Approves First Wearable Device to Monitor Glucose, Ketone Levels

The FDA has authorized the first wearable in the U.S. to continuously monitor ketone levels and the first device globally to track both ketones and glucose together in a single system. From a report: [Abbott’s] Libre Duo 10 Day continuously measures both glucose and ketone levels in the fluid just beneath the skin every minute, day and night. Readings are transmitted wirelessly to a compatible smartphone, where users can view current glucose and ketone levels and whether those values are trending up or down. The device also can send automatic alerts if ketone levels reach a concerning threshold. The FDA noted that ketone information should be interpreted in the context of glucose readings and symptoms.

Ketones are produced when the body uses fat instead of glucose for energy. When ketone levels rise too high, patients with diabetes can develop diabetic ketoacidosis (DKA), a serious complication that can progress quickly and become life-threatening without prompt treatment. Until now, patients who needed ketone monitoring had to test separately using methods that provided a single measurement at one point in time. Those tests could not show whether ketone levels were rising or falling. For patients with diabetes — particularly those at higher risk for DKA — continuous glucose and ketone monitoring may provide earlier warning of metabolic deterioration and support timelier sick-day management, hydration, insulin adjustment, and escalation of care when clinically appropriate.