Abbott Secures CE Mark for Libre Duo Dual Glucose-Ketone Sensor Targeting DKA Detection

Abbott's CE Mark approval for Libre Duo and Libre Duo 10 Day positions the company to enter European markets with a continuous monitoring device that simultaneously tracks glucose and ketone levels from a single wearable sensor — a configuration with direct implications for device manufacturers, clinical integration teams, and regulatory affairs leads preparing for analogous submissions in other jurisdictions.

The two cleared systems measure both analytes every minute, replacing episodic blood or urine ketone tests with a continuous data stream. Libre Duo is approved for adults 18 and older with up to 15 days of wear; Libre Duo 10 Day covers ages 2 and older with a 10-day wear period, a distinction driven by clinical data showing improved wear completion in active pediatric users. Both systems integrate with Abbott's existing Libre digital health ecosystem, enabling data sharing with caregivers and healthcare providers.

For QA and regulatory leads tracking combination product frameworks, the dual-analyte architecture raises questions around analytical validation scope, sensor drift characterization across two simultaneous biomarkers, and how notified body review was structured for a device with no direct predicate. Abbott has not disclosed the specific notified body or the technical file structure, but the approval signals that EU MDR pathways can accommodate novel multi-analyte continuous monitoring configurations when supported by clinical accuracy data.

Abbott is also working with pump manufacturers to enable compatibility with automated insulin delivery (AID) systems, a development that will require interoperability agreements and likely additional regulatory touchpoints as AID system labeling is updated to reflect the new data inputs. The company has not announced specific AID partners or a timeline for those integrations.

The clinical rationale is grounded in a consensus paper from Breakthrough T1D describing continuous ketone monitoring as part of standard diabetes management, providing a published clinical framework that regulatory submissions in non-CE jurisdictions — including FDA 510(k) or De Novo pathways — may reference when Abbott pursues U.S. clearance. No U.S. submission timeline has been disclosed.

Abbott plans to begin a phased European commercial launch in select countries later in 2026, with broader rollout details pending.

Source: Abbott MediaRoom via PRNewswire, 27 May 2026.