The Food and Drug Administration announced on August 25 that Abbott’s Libre Duo 10‑Day system received its first-ever authorization for a wearable that continuously monitors ketone levels alongside glucose. The approval marks a significant step for people living with diabetes, offering a potential early alert for diabetic ketoacidosis (DKA), a life‑threatening complication.
How the device works
Libre Duo combines a single, disposable sensor placed on the back of the upper arm with a smartphone app. The sensor measures glucose and ketones in the interstitial fluid beneath the skin and transmits updated readings to the app every minute. Users can wear the sensor for up to ten days, and the app can issue an automatic alert when ketone levels cross a preset threshold.
Who can use it
The FDA clearance covers adults and children ages two and older who have diabetes. Continuous glucose monitors are already common, but ketone monitoring has traditionally required separate blood or urine tests performed after symptoms appear. By integrating both measurements, the Libre Duo gives patients and caregivers more comprehensive data to manage insulin therapy.
Clinical evidence
The agency reviewed six clinical studies involving more than 600 participants. In the trials, users wore the system for ten days while researchers compared its readings to standard laboratory measurements. The studies demonstrated that the device reliably detected meaningful changes in ketone levels, including elevations that occurred before the onset of DKA.
Potential impact on safety
DKA can develop rapidly, sometimes even when glucose readings are not exceptionally high. Early detection of rising ketones could allow patients to intervene—adjusting insulin, seeking medical care, or addressing illness—before the condition becomes an emergency. FDA Director Michelle Tarver called the authorization “a breakthrough for the safety of children and adults living with diabetes.”
Future plans and availability
Abbott plans to launch the Libre Duo in the United States later in 2026. Pricing and insurance coverage details have not yet been released. The company also intends to integrate the sensor with automated insulin‑delivery systems, including Beta Bionics iLet and Sequel Med Tech twiist by the end of 2026, with additional partnerships slated for 2027.
Considerations for users
While the device offers continuous monitoring, the FDA advises users to interpret ketone readings alongside glucose levels, symptoms, and medical guidance. Abbott reports that 84.1% of adult sensors and 68.8% of pediatric sensors remained functional for the full ten‑day wear period.
What this means for the diabetes community
For families managing Type 1 diabetes or insulin‑treated Type 2 diabetes, the Libre Duo could reduce the need for separate finger‑stick tests and urine strips, simplifying daily care. By providing real‑time insight into both glucose and ketone trends, the technology supports proactive health management and aligns with broader efforts to improve outcomes for diabetics nationwide.
Original reporting: WBAP News/Talk (Dallas-Fort Worth) — read the source article.
