FDA authorizes Abbott's Libre Duo to continuously track glucose and ketones
The prescription sensor reads both markers every minute and is due in the U.S. later in 2026, with insulin-pump integrations starting by year-end.
By Ryan Merket · Published
Primary source: U.S. Food and Drug Administration
Why it matters
Libre Duo turns ketone testing from an occasional manual check into a continuous data stream, while giving Abbott an early lead in a new FDA device category and another route into insulin-pump systems.
The Food and Drug Administration on August 25th authorized Abbott's Libre Duo 10 Day, the first U.S. wearable that continuously monitors ketones and the first device globally to combine continuous ketone and glucose readings in one sensor.
The prescription-only device is authorized for people with diabetes aged 2 and older. It measures both markers in fluid beneath the skin every minute, sends readings to a compatible smartphone and can alert users when ketones reach a concerning level. Abbott plans to launch Libre Duo 10 Day in the U.S. later in 2026.
The added ketone channel addresses a dangerous blind spot in diabetes monitoring. Continuous glucose monitors show whether blood sugar is rising or falling, while ketone testing has generally required a separate blood or urine test that captures one moment. A buildup of ketones can lead to diabetic ketoacidosis, or DKA, which can progress quickly when the body lacks enough insulin.
The Centers for Disease Control and Prevention estimates that 40.1 million people in the U.S. have diabetes, including 2.1 million with diagnosed type 1 diabetes. People with type 1 diabetes face the clearest DKA risk, though Abbott is also targeting insulin users with type 2 diabetes and people taking glucose-lowering drugs known as SGLT2 inhibitors.
Six studies supported the authorization
The FDA reviewed clinical and performance data from six studies involving more than 600 participants aged 2 and older. According to the regulator, the device tracked clinically meaningful changes in ketone levels across its 10-day wear period and identified elevated ketones before the onset of DKA.
The authorization came through the FDA's De Novo pathway for new types of low- to moderate-risk devices. That decision establishes a new regulatory classification, including special requirements for labeling and performance testing. Under the FDA's De Novo framework, an authorized device can also serve as a predicate for future 510(k) submissions from manufacturers building similar products.
Libre Duo therefore gives Abbott an early commercial position while defining part of the regulatory path that competitors may follow. Abbott said the device is the first system to meet a new integrated continuous glucose and ketone monitoring standard, or iCGK, alongside the existing integrated continuous glucose monitoring standard.
Abbott's product materials also spell out limits that matter for a sensor intended to provide an early warning. In Abbott's wear-duration study, 84.1% of adult sensors and 68.8% of pediatric sensors lasted the full 10 days. That means about 16% of adult sensors and 31% of pediatric sensors may stop short of the advertised duration when used according to the labeling.
Abbott also warns that urgent alarms may not detect every instance of glucose below 55 mg/dL or ketones above 3.0 mmol/L. Users are instructed to consider ketone and glucose readings together and to use a fingerstick glucose test when sensor data does not match symptoms or expectations.
Abbott is building Libre Duo into insulin-pump workflows
The sensor feeds readings into Abbott's Libre app and is designed to share data through LibreView for clinicians and LibreLinkUp for caregivers. The larger commercial play is integration with automated insulin-delivery systems, where a second continuous biomarker could give pump makers another input for safety warnings and future dosing features.
In its August 25th announcement, Abbott said it expects Libre Duo to connect with Beta Bionics' iLet and Sequel Med Tech's twiist systems by the end of 2026. Abbott expects integrations with Insulet and Tandem devices in 2027. A separate, exclusive integration between Abbott-made dual glucose-ketone sensors and MiniMed dosing systems is also planned for 2027.
The U.S. authorization follows a European CE Mark secured in May. Abbott received that mark for the pediatric-focused 10-day sensor and a 15-day version intended for adults.
Sensor accuracy remains the execution test
Libre Duo is arriving after regulatory scrutiny of manufacturing controls elsewhere in Abbott's glucose-monitoring portfolio. In January, the FDA issued a warning letter citing quality-system violations tied to Libre 3 manufacturing and product-release controls. The agency said Abbott had not adequately ensured that finished devices met validated accuracy requirements before distribution.
A separate medical device correction covered roughly 3 million Libre 3 and Libre 3 Plus sensors that could produce incorrect low-glucose readings. Abbott said the issue was limited to one production line and that it had identified and resolved the cause.
Libre Duo's usefulness rests on reliable minute-by-minute readings from two analytes, making manufacturing performance central to the launch. FDA authorization clears the regulatory gate. Abbott's next job is delivering the sensor at scale, keeping it attached for the promised wear period and proving that the added ketone stream produces warnings patients and caregivers can trust.