Health
FDA authorizes first wearable continuous monitor for both ketones and glucose
The Abbott Diabetes Care device measures both metrics every minute to help prevent diabetic ketoacidosis.
The short version
- The FDA authorized Abbott Diabetes Care's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for patients aged two and older with diabetes.
- The wearable sensor measures ketone and blood sugar levels in fluid beneath the skin every minute, sending real-time readings and alerts to smartphones.
- The device is designed to give early warning of rising ketone levels to help prevent diabetic ketoacidosis, a potentially life-threatening complication.
Key facts
- The FDA granted marketing authorization via the De Novo pathway for Abbott Diabetes Care's dual ketone and glucose monitoring system.[Hacker News]
- It is the first wearable device in the U.S. to offer continuous ketone tracking and the first globally to track both ketones and blood sugar simultaneously in one system.[Hacker News]
- The system monitors ketone and glucose levels every minute from interstitial fluid under the skin for up to 10 days.[Hacker News]
- FDA authorization was based on evaluation data from six clinical studies involving over 600 participants aged two and older.[Hacker News]
What remains uncertain
- The release date and retail pricing for the system have not been detailed.[Hacker News]