Ketone tracking joins CGM in first-of-its-kind wearable

Clinical takeaway: Consider continuous ketone monitoring as an emerging option for patients with diabetes at risk for diabetic ketoacidosis (DKA), particularly those with type 1 diabetes and others using insulin or sodium-glucose cotransporter 2 (SGLT2) inhibitors. The newly authorized Libre Duo 10 Day system provides real-time ketone trend data alongside glucose readings and may help identify rising ketone levels before DKA becomes a medical emergency.

DKA can develop rapidly and become life-threatening if not recognized and treated early. Until now, ketone monitoring has relied on periodic blood or urine testing that offers only a single point-in-time measurement, limiting clinicians' and patients' ability to track whether ketone levels are rising or falling.

FDA has authorized Abbott’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older with diabetes, making it the first wearable device in the US to continuously monitor ketones and the first device worldwide to continuously track both ketones and glucose in a single sensor.

The sensor measures glucose and ketone levels in interstitial fluid every minute and wirelessly transmits results to a compatible smartphone app. Users can view current values and trend information and receive alerts when ketone levels reach concerning thresholds, potentially enabling earlier recognition of impending DKA. FDA officials noted that ketone data should be interpreted alongside glucose readings and clinical symptoms.

Authorization was supported by six clinical studies involving more than 600 participants aged 2 years and older. According to FDA, the device accurately tracked clinically meaningful differences in ketone levels throughout its 10-day wear period, including identification of elevated ketones before the onset of DKA. The device received Breakthrough Device designation and was authorized through the De Novo pathway.

“Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health.

Sources: U.S. Food and Drug Administration. (2026 Aug 25). FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar; Abbott. (2026 Aug 25). Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes