The Food and Drug Administration authorized the first wearable medical device that continuously monitors both ketone levels and blood glucose simultaneously on Aug. 25, offering diabetic patients a more complete real-time picture of their metabolic health.
The dual-sensor device is particularly significant for diabetics at risk for diabetic ketoacidosis, a life-threatening complication that occurs when dangerously high ketone levels build up in the blood. Existing continuous glucose monitors do not track ketones.
Approximately 38 million Americans have diabetes, according to the CDC, giving the device a broad potential market. The FDA’s clearance means the device can now be sold commercially in the United States.
Diabetic ketoacidosis, or DKA, results in roughly 150,000 hospitalizations annually in the United States and can be fatal if untreated. The ability to detect rising ketone levels in real time could enable earlier intervention and potentially prevent emergency hospitalizations, the FDA said.
The device combines two sensor technologies into a single wearable platform, eliminating the need for separate blood tests to check ketone levels, according to the FDA announcement. Current ketone testing methods require finger-prick blood samples or urine test strips that provide only intermittent readings.
The authorization was issued through the FDA’s Center for Devices and Radiological Health. The agency evaluated clinical data demonstrating the device’s accuracy and safety in continuously measuring both analytes.
For patients with Type 1 diabetes, who face the highest DKA risk, the device could represent a significant advance in daily disease management by providing continuous dual monitoring without additional equipment.