FDA authorises the first wearable that reads ketones continuously

The FDA authorised Abbott’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System on 25 August 2026 for people aged 2 years and older living with diabetes. It is the first wearable in the United States to monitor ketones continuously, and the first anywhere to read ketones and glucose from the same sensor. Both are sampled in interstitial fluid just beneath the skin, once a minute, day and night.

The clinical case rests on warning time. Ketones accumulate when the body burns fat instead of glucose, and a rise can progress to diabetic ketoacidosis within hours. Until now ketones were checked by blood or urine test, which means checked only when someone thought to check. The device raises an automatic alert when ketone levels cross a set threshold.

The agency cleared it through the De Novo premarket pathway, used for devices with no substantially equivalent predicate. Abbott’s submission drew on six clinical studies enrolling more than 600 participants aged 2 and over, testing accuracy across a range of glucose and ketone concentrations.

Abbott secured a CE mark for the same sensing technology in Europe on 27 May 2026. The company says the US launch will follow later in 2026.