WASHINGTON (WDNews) — The U.S. Food and Drug Administration has authorized a first-of-its-kind wearable device designed to help people with diabetes continuously monitor both ketone levels and blood sugar.
According to the FDA, the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System is authorized for people ages 2 and older living with diabetes. It is the first wearable device in the U.S. to continuously monitor ketone levels and the first in the world to continuously monitor both ketones and glucose in a single device.
The device measures ketone and glucose levels in fluid just beneath the skin every minute, day and night. Readings are sent wirelessly to a compatible smartphone, allowing users to see their current levels and whether they are rising or falling.
The device can also send automatic alerts when ketone levels reach a concerning threshold.
Rising ketone levels can be an early warning sign of diabetic ketoacidosis, or DKA, a serious complication that can develop quickly and become life-threatening if left untreated.
“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”
According to the FDA, about 40.1 million Americans are living with diabetes, including an estimated 2.1 million people with type 1 diabetes.
Until now, people who needed to monitor ketones had to test them separately, providing a measurement from only one point in time. The new wearable allows users and caregivers to follow changes continuously.
The FDA said its authorization was based on clinical and performance data from six studies involving more than 600 participants ages 2 and older. The studies evaluated the accuracy of both the ketone and glucose monitoring functions.
The Libre Duo 10 Day was granted marketing authorization to Abbott Diabetes Care through the FDA’s De Novo premarket review pathway.
Image Source – FDA
