The US Food and Drug Administration has authorised Abbott’s Libre Duo 10 Day system, a groundbreaking device that continuously tracks ketones and blood glucose levels, potentially alerting users to diabetic ketoacidosis earlier than ever before.
The US Food and Drug Administration has authorised the first wearable sensor that continuously tracks ketones as well as blood sugar, a move that could give people with diabetes earlier warning of diabetic ketoacidosis, or DKA, a rapid-onset complication that can become life-threatening if untreated. Abbott’s Libre Duo 10 Day system is also the first device in the United States approved to monitor both measures at the same time, according to the FDA.
The sensor adheres to the skin and measures ketones and glucose in the fluid just beneath it every minute, sending the data to a smartphone app that shows levels and trends and issues an alert when ketones rise to a concerning point. Until now, people have generally relied on separate blood or urine tests, which provide only a snapshot rather than a continuous picture of whether ketones are climbing. The FDA said the device is authorised for people aged two and older with diabetes.
The agency’s decision was based on six studies involving more than 600 participants, which found that the system could track meaningful changes in ketone levels across the full 10-day wear period and detect elevated ketones before DKA developed. Dr Michelle Tarver, who leads the FDA’s Centre for Devices and Radiological Health, said real-time knowledge of rising ketones can be critical. Dr Jennifer Sherr, a paediatric endocrinologist at Yale School of Medicine, said she regularly sees how quickly DKA can develop and how often early checks are missed.
Abbott said the device is aimed especially at people at higher risk of elevated ketones, including those using insulin or glucose-lowering drugs. The company plans to launch it in the US later this year and says it is working on links with automated insulin delivery systems. The FDA cautioned that ketone readings should always be interpreted alongside glucose levels and symptoms.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
