FDA Authorizes First Wearable Device That Monitors Ketone and Glucose Levels

The FDA has granted approval for the first wearable device in the United States capable of continuously monitoring both glucose and ketone levels. This marks the first globally to track these two metrics simultaneously in a single system. Abbott's Libre Duo 10 Day device measures glucose and ketone levels in the fluid beneath the skin every minute, day and night.

The readings are wirelessly transmitted to a compatible smartphone, displaying current levels and whether they are increasing or decreasing. The device can also automatically alert users if ketone levels reach dangerous thresholds. However, ketone information must be considered alongside glucose readings and symptoms. Ketones are produced when the body relies on fat for energy instead of glucose.

Elevated ketone levels can lead to diabetic ketoacidosis (DKA), a serious and potentially life-threatening complication for diabetics. Previously, separate tests were required to monitor ketone levels, providing a single snapshot rather than continuous tracking. This new device could offer earlier warnings of metabolic deterioration for high-risk diabetics, aiding in timely management of sick days, hydration, insulin adjustments, and escalation of care as needed.