FDA grants Abbott's De Novo request for the Libre Duo 10 Day glucose-ketone sensor

On August 25, 2026, the FDA granted Abbott Diabetes Care's De Novo request for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, a single sensor that measures both glucose and ketones.[1] The FDA had received the request on September 29, 2025.[1] Abbott announced the authorization the same day and said it planned to launch the system in the United States later in 2026.[3]

What a De Novo grant means

Under a 510(k), a company shows that its device is substantially equivalent to one already sold legally. That comparison device is called a predicate. The De Novo route is for something new: a company that finds no legally marketed device to compare against can ask the FDA to classify the device based on its risks instead.[2]

Granting the request did more than authorize one product. The FDA's order created a new generic device type, the "integrated continuous glucose ketone monitoring system," placed it in Class II, and wrote a new regulation for it, 21 CFR 862.1354, with product code SJD.[2] Class II devices carry special controls on top of the general rules. For this type, the order requires clinical accuracy studies for both glucose and ketones, testing against interfering substances, a usability study, and labeling that reports how often sensor data drops out.[2] Any company that later wants to sell a device of this type has to file a 510(k) first, and the Libre Duo can now serve as its predicate.[2]

One detail surprised us. The order letter posted with the record is dated August 26, 2026, and says it corrects the original August 25 order to fix an inconsistency in one labeling requirement.[2]

What the FDA authorized

The order describes a prescription device for managing diabetes in people age 2 and older. It monitors glucose and ketones (specifically beta-hydroxybutyrate) in real time, provides alarms and tracks trends.[2] The indication says the system replaces blood glucose testing for diabetes treatment decisions unless otherwise indicated, and that ketone readings should be used together with glucose levels and symptoms.[2] The system is also intended to send its data on its own to digitally connected devices, such as automated insulin dosing systems.[2]

Abbott said the sensor is worn for up to 10 days and works with the latest-generation Libre app available in the US.[3] The company also said the Libre Duo had received breakthrough device designation, an FDA program designed to help people get faster access to new medical technologies.[3] Abbott's US page reports that in clinical studies, 84.1% of sensors worn by adults and 68.8% worn by children lasted the full 10 days.[4]

Pump connections Abbott described

In its August 25 release, Abbott said it expected the sensor to work with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by the end of 2026. It said it expected connections with devices from Insulet and Tandem in 2027, and an exclusive integration with MiniMed smart dosing systems that same year.[3] These were company expectations on that date, not completed integrations.

What this means for you

As of October 15, 2026, Abbott's US page said the FDA has authorized the Libre Duo 10 Day system and that it "is coming soon."[4] The page gave no launch date. Abbott's release lists 855-632-8658 as its customer service number for more information.[3] The FDA order says the device requires a prescription.[2] Whether a combined glucose and ketone sensor fits your diabetes care is a question to raise with your care team or pharmacist.

We will add a dated update when Abbott announces that the Libre Duo 10 Day is available in the US.