The U.S. Food and Drug Administration (FDA) has approved the first wearable sensor that continuously monitors ketone and glucose levels in the body, HealthDay reports.
The device could help people with diabetes detect diabetic ketoacidosis (DKA), a potentially life-threatening complication, before it becomes severe.
The Libre Duo 10 Day sensor is worn on the skin and measures glucose and ketone levels in the fluid beneath the skin every minute. The data are transmitted to a smartphone, where an app displays current readings and tracks changes over time. If ketone levels rise to a potentially dangerous level, the system issues an alert.
Ketones are produced when the body begins using fat instead of glucose as its primary source of energy. Excessive ketone accumulation can lead to diabetic ketoacidosis, a dangerous condition that can develop within hours and, without treatment, may result in coma or death.
Before the new device became available, ketone levels had to be checked separately using blood or urine tests. These tests provide a measurement only at a specific point in time and cannot continuously track changes in ketone levels.
“Knowing that ketone levels are rising and receiving that information in real time, around the clock, could be the difference between early intervention and a life-threatening condition,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health.
The FDA’s decision was based on the results of six studies involving more than 600 people. The studies showed that the sensor accurately tracked changes in ketone levels throughout the 10-day wear period and could detect rising ketone levels before diabetic ketoacidosis developed.
The device is authorized for use by people with diabetes aged two and older. Manufacturer Abbott plans to begin selling the sensor in the United States later this year.
The FDA emphasized, however, that ketone readings should be interpreted together with blood glucose levels and the patient’s symptoms.
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