FDA authorizes continuous ketone monitor

Patients aged 2 years and older with diabetes are eligible to use the wearable.

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The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for continuous monitoring of glucose and ketone levels.
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This device measures glucose and ketone levels at 1-minute intervals and displays data on a compatible smartphone.
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Users receive notifications when ketone levels reach concerning thresholds, helping to prevent diabetic ketoacidosis.
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The authorization was based on clinical data from over 600 participants, demonstrating accurate tracking of ketone levels.
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The device received Breakthrough Device designation and was authorized through the FDA's De Novo premarket review pathway.

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