Abbott (NYSE: ABT) said it received U.S. Food and Drug Administration authorization for its Libre Duo 10 Day system, which the company claims is the first device to continuously monitor both glucose and ketone levels in people with diabetes.

The device received De Novo authorization after securing FDA breakthrough device designation. Abbott said it is the first system to meet both the FDA's integrated continuous glucose monitoring standard and a newly established integrated continuous glucose and ketone monitoring standard for the United States. The company plans to launch the product in the U.S. later this year. Abbott also received CE Mark for Libre Duo systems earlier in 2026.

The wearable sensor is designed for people with Type 1 or Type 2 diabetes who use insulin or other glucose-lowering medications, including SGLT2 inhibitors, and is approved for ages 2 and older. It provides up to 10 days of wear and integrates with Abbott's existing Libre app ecosystem, including LibreView for health care providers and LibreLinkUp for caregivers.

Diabetic ketoacidosis, or DKA, is described by the American Diabetes Association as a condition that can progress within hours and, if untreated, can lead to coma or death. Hospital admissions for DKA have increased 55% over the past decade, according to a 2024 study cited in the press release.

"As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed," said Jennifer Sherr, M.D., Ph.D., pediatric endocrinologist at Yale School of Medicine.

Abbott said it is working with several pump manufacturers to enable automated insulin delivery system compatibility. The company expects Libre Duo 10 Day to work with Beta Bionics' iLet and Sequel Med Tech's twiist systems by the end of 2026, with Insulet and Tandem devices following in 2027. An exclusive integration with MiniMed smart dosing systems is also expected in 2027.

The Libre platform currently has more than 8 million users across 60 countries, according to Abbott.