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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has authorized Abbott's Libre Duo 10 Day system — the world's first wearable device to continuously track both glucose and ketone levels in real time. Cleared for patients with diabetes aged 2 and older, it's designed to catch rising ketones before they spiral into life-threatening diabetic ketoacidosis (DKA). Abbott plans to launch the device in the U.S. later in 2026.
The FDA has given the green light to Abbott's Libre Duo 10 Day system — a wearable device that simultaneously monitors both glucose and ketone levels every minute via interstitial fluid. It's the first device of its kind in the world, and the first in the U.S. authorized for continuous ketone monitoring. The device is cleared for people with diabetes aged 2 and older, wirelessly transmitting readings to a smartphone and issuing alerts when levels rise.
The system is specifically aimed at patients at elevated DKA risk — including those with type 1 or type 2 diabetes on insulin or SGLT2 inhibitors, which can cause ketone buildup even when glucose appears normal. Authorization was based on six clinical studies involving over 600 participants, with data showing the device accurately tracked clinically meaningful ketone changes across its 10-day wear period — including detecting elevated ketones before DKA onset.
Key Takeaways:
Why it matters: DKA remains a leading cause of diabetes-related morbidity and mortality worldwide. A continuous, passive ketone monitor could shift care from reactive emergency treatment to proactive prevention — particularly for high-risk patients who may not recognize early warning signs.
