FDA Approves First Wearable Device to Monitor Glucose and Ketone Levels
The FDA has authorized the first wearable device that continuously monitors ketone levels, and the first to track both glucose and ketones together in a single system.
The device measures 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 levels and whether those values are trending up or down. The device can also 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, according to the report from Slashdot. 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.