Abbott has received FDA clearance for its Libre Duo 10 Day system, a pioneering wearable that continuously monitors both glucose and ketone levels, aiming to improve early detection of diabetic ketoacidosis for people with diabetes aged two and above.
Abbott said on Tuesday that the US Food and Drug Administration had authorised its Libre Duo 10 Day system, a wearable device the company describes as the first in the US to monitor glucose and ketone levels continuously in one sensor. The device is intended for people with diabetes aged two and above and is designed to alert users when ketone levels are rising, which can be a warning sign of diabetic ketoacidosis, or DKA, a potentially life-threatening emergency.
According to the FDA, the device is the first wearable cleared in the United States to track both measures at the same time, and it can send readings to a compatible smartphone while sounding alerts if ketone levels reach concerning thresholds. The regulator said the authorisation was supported by clinical data on accuracy over the sensor’s 10-day wear period. Abbott said it plans to launch the product in the US later this year.
The company is pitching the system as a response to a gap in current diabetes care, since ketones are often checked only when someone feels unwell or has high glucose. Abbott cited medical experts and diabetes advocates who argued that continuous ketone monitoring could help people spot danger earlier, especially because DKA can develop quickly and symptoms may be mistaken for common illness. The device is aimed particularly at people with type 1 or type 2 diabetes who use insulin or certain glucose-lowering medicines, including SGLT2 inhibitors.
The FDA authorisation follows Abbott’s earlier CE Mark clearance in Europe for the Libre Duo family, which the company said includes both the 10-day version and a longer-wear adult model. Abbott also said it is working with insulin pump makers on future compatibility with automated insulin delivery systems, with some integrations expected by the end of this year and others in 2027.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
