FDA authorizes first wearable device that monitors ketone and blood sugar levels

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FDA authorized the first wearable device that continuously monitors both ketone and glucose levels.

The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2+ with diabetes. It is the first wearable in the U.S. to continuously monitor ketones, and the first globally to monitor both ketones and glucose in one device. The device sends readings wirelessly to a smartphone and can alert users to rising ketone levels, potentially preventing diabetic ketoacidosis. Authorization was based on six clinical studies with over 600 participants.

What commenters are saying

Commenters split on whether the device is useful outside diabetes. Some predicted marathoners and ultra runners would use it to monitor glucose and ketones for performance, but others countered that high-level endurance athletes maximize carb intake and are never in ketosis during events. A few noted that non-diabetics likely get no actionable information from a CGM. One commenter cited a study showing fit cyclists appear glucose intolerant on a CGM. Another noted that non-invasive optical sensors have struggled with accuracy across skin tones.