FDA Authorizes a Diabetes Wearable That Tracks Ketones as Well as Blood Sugar
The U.S. Food and Drug Administration said on Aug. 25 that it has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, a wearable sensor for people aged 2 and older living with diabetes. Authorization went to Abbott Diabetes Care through the De Novo pathway, which the agency uses for low- to moderate-risk devices of a new type.
The device measures both ketones and blood sugar in the fluid just beneath the skin, every minute, according to the FDA. Readings go wirelessly to a compatible smartphone, which can alert the user when ketone levels reach a concerning threshold. The agency describes it as the first wearable in the U.S. that continuously monitors ketones, and the first anywhere to monitor ketones and glucose together in one device.
Ketones are produced when the body burns fat instead of glucose for energy. Too many can lead to diabetic ketoacidosis, which the FDA describes as a serious complication that can develop quickly and become life-threatening. Until now, the agency says, people tracking ketones used tests that gave a single reading and could not show whether levels were rising or falling.
The authorization rests on sponsor data from six clinical studies that enrolled more than 600 participants aged 2 and over, the FDA says. The agency states the results showed the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketones before ketoacidosis began, an accuracy result, not a trial of whether earlier warning changes what happens to patients.
"Today's authorization is a breakthrough for the safety of children and adults living with diabetes," said Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.
Alongside the authorization the FDA is setting special controls for the new device type, covering labeling and performance testing. The device had earlier been granted Breakthrough Device designation. The agency cites Centers for Disease Control and Prevention estimates of 40.1 million Americans living with diabetes, 2.1 million of them with type 1. The announcement gives no price and no on-sale date.
