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FDA approves wearable ketone monitor
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The gist
FDA authorized Abbott's Libre Duo 10 Day, the first wearable monitoring both ketones and glucose. It can alert diabetics to rising ketones before a dangerous DKA emergency.
Background
The FDA approved the Libre Duo 10 Day on August 25, 2026, for people aged 2 and older with diabetes. It is the first wearable device in the U.S. to continuously monitor ketone levels, and the first to combine ketone and blood sugar monitoring in a single device. The approval was based on six clinical studies with over 600 participants, showing accurate tracking of ketone levels over a 10-day wear period, including detecting elevated ketones before the onset of diabetic ketoacidosis (DKA).
How it unfolded
- Aug 25, 2026FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable to monitor both ketones and glucose.
- Aug 25, 2026Abbott announced the FDA authorization, highlighting the device's ability to alert users to rising ketones that can lead to DKA.
- Aug 26, 2026Media coverage emphasized the device's significance for diabetes management, with FDA official Dr. Michelle Tarver calling it a breakthrough for safety.
Who’s saying what
- FDA
- FDA's Dr. Michelle Tarver called the authorization a breakthrough for safety, noting real-time ketone information can be the difference between early intervention and a life-threatening emergency.
- Abbott
- Abbott touted the device as the world's first dual glucose-ketone sensing technology, designed to address a critical gap in ketone monitoring without adding burden.
- Analysts
- Pharmacy Times noted the device introduces real-time ketone trends into diabetes monitoring, with direct implications for patients at risk of DKA.