Abbott has secured FDA De Novo authorization for its Libre Duo 10 Day system, introducing the world’s first continuous sensor capable of tracking both glucose and ketone levels at the same time.
- Early DKA Warning System: Diabetic Ketoacidosis (DKA) is a dangerous complication that can progress rapidly within hours. The sensor acts like a "check engine light" by continuously monitoring ketones in the background, alerting users to rising levels even when glucose numbers appear normal.
- Device Details: Approved for adults and children aged 2 and older with Type 1 or Type 2 diabetes. Each sensor offers up to 10 days of continuous wear and syncs directly with the existing Libre app ecosystem, including LibreView for doctors and LibreLinkUp for caregivers.
- Launch & Pump Integrations: Abbott plans to launch the device in the U.S. later this year, with automated insulin delivery (AID) pump integrations (such as Beta Bionics, Insulet, and Tandem) rolling out through 2027.
Source: Abbott