The Food and Drug Administration has authorized the first wearable device in the United States capable of continuously monitoring ketone levels, giving patients a potential early warning of a life-threatening diabetes complication.
Abbott’s Libre Duo 10 Day system measures glucose and ketones simultaneously through a single sensor and sends updated readings to a compatible smartphone every minute. Abbott plans to introduce the prescription device in the United States later this year.
One Sensor Tracks Two Warning Signs
The Libre Duo is authorized for adults and children ages 2 and older with diabetes, according to the FDA’s August 25 announcement.
The agency described it as the first wearable device authorized in the United States to continuously monitor ketones and the first device in the world to track glucose and ketones together with a single sensor.
Continuous glucose monitors have become common tools for people with diabetes, providing readings throughout the day without requiring repeated finger sticks. Ketone monitoring, however, has generally required separate blood or urine tests to be performed after symptoms appear or when glucose readings become concerning.
Abbott’s new system measures glucose and ketones in the interstitial fluid beneath the skin. The disposable sensor is worn on the back of the upper arm for up to 10 days.
Readings are transmitted to Abbott’s Libre smartphone application, which displays current measurements and trends. The system can issue an automatic alert when ketones reach a concerning threshold.
“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” FDA Center for Devices and Radiological Health Director Michelle Tarver said in the agency’s announcement.
Rising Ketones Can Signal an Emergency
Ketones are chemicals produced when the body breaks down fat for energy. They can accumulate when a person does not have enough insulin to move glucose from the bloodstream into cells.
High ketone levels can lead to diabetic ketoacidosis, commonly called DKA. The condition can cause dehydration, nausea, vomiting, abdominal pain, difficulty breathing, confusion, loss of consciousness, and death if it is not treated promptly.
People with Type 1 diabetes face the greatest risk, although DKA can also affect people with Type 2 diabetes. The risk may increase during illness, disruptions in insulin delivery, or treatment with certain medications, including sodium-glucose cotransporter-2 inhibitors, commonly known as SGLT2 inhibitors.
DKA can sometimes develop without an exceptionally high glucose reading. Continuous ketone monitoring could therefore provide information that glucose measurements alone may not reveal.
The device is intended to help patients identify rising ketones before the condition becomes an emergency. However, the FDA said users must consider ketone readings alongside glucose levels, symptoms, and medical guidance.
More Than 600 People Participated in Testing
The FDA reviewed six clinical studies involving more than 600 adults and children with diabetes before authorizing the device.
Participants wore the system for 10 days while researchers compared its readings with reference measurements. The agency said the studies demonstrated that the device could detect meaningful differences in ketone levels, including elevations occurring before the onset of DKA.
The FDA granted the Libre Duo marketing authorization through its De Novo pathway, which is used for certain new medical devices with no legally marketed equivalent. The agency had previously designated the technology as a Breakthrough Device, a status intended to expedite the development and review of products that may offer significant advantages over existing options.
The authorization also establishes a new regulatory category for integrated continuous ketone-monitoring systems.
U.S. Launch Planned for Later in 2026
Abbott said it expects to launch the Libre Duo in the United States later in 2026. The company has not announced the device’s price or detailed whether it will be covered by Medicare, Medicaid, or private insurance plans.
The system is designed for people at higher risk of developing elevated ketone levels, including patients with Type 1 diabetes and insulin-treated Type 2 diabetes, according to Abbott’s product announcement.
Abbott also plans to connect the Libre Duo with automated insulin-delivery systems. The company said compatibility with the Beta Bionics iLet and Sequel Med Tech twiist systems is expected by the end of 2026. Integrations with systems from Insulet, Tandem Diabetes Care, and MiniMed are expected in 2027.
Abbott cautions that not every sensor lasts the full advertised wear period. Company data show that 84.1% of sensors used by adults and 68.8% of those used by pediatric patients remained operational for the complete 10 days, according to the Libre Duo product information.
The device is not yet commercially available. Abbott said additional information about distribution and access will be released closer to its U.S. introduction.
