WASHINGTON, D.C. — U.S. regulators authorized Abbott Diabetes Care’s Libre Duo 10 Day for people with diabetes aged 2 and older, introducing the first U.S. wearable capable of continuously monitoring ketones and the first device globally designed to continuously track ketones and glucose together.
The Food and Drug Administration granted marketing authorization through its De Novo pathway for new low- to moderate-risk devices, following clinical testing involving more than 600 participants across six studies.
The device measures glucose and ketone levels every minute in fluid beneath the skin during a 10-day wear period. Results are transmitted wirelessly to a compatible smartphone, allowing users to track current levels and whether they are rising or falling.
It can also automatically alert users when ketones reach a concerning threshold, potentially providing an earlier warning of diabetic ketoacidosis, or DKA, a potentially life-threatening complication of diabetes.
“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,” Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated.
Until now, patients monitoring ketones separately have generally relied on tests providing a measurement at a single point in time. Continuous monitoring can instead show the direction of changes, although the FDA cautioned that ketone readings should be interpreted alongside glucose levels and symptoms.
The clinical studies evaluated the accuracy of both ketone and glucose monitoring across different concentrations. According to the FDA, the device tracked clinically meaningful differences in ketone levels throughout its 10-day wear period and identified elevated levels before the onset of DKA.
The authorization potentially has particular relevance for people with type 1 diabetes, who face the risk of excessive ketone production when the body uses fat rather than glucose for energy. The Centers for Disease Control and Prevention estimates about 2.1 million Americans have type 1 diabetes, while roughly 40.1 million Americans overall are living with diabetes.
The FDA previously granted the Libre Duo 10 Day Breakthrough Device designation, a program intended to expedite development and regulatory review of certain technologies addressing life-threatening or irreversibly debilitating conditions.
As part of the De Novo authorization, the agency established requirements covering areas including labeling and performance testing. The decision also falls under the FDA’s Home as a Health Care Hub initiative, which seeks to expand the use of medical technology in home settings.
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