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FDA Authorizes First Wearable Device for Continuous Ketone and Glucose Monitoring
Key points
- FDA authorized Libre Duo 10 Day for diabetes patients aged 2 and older.
- First wearable in U.S. for continuous ketone monitoring.
- First globally to continuously monitor both ketones and glucose.
- Helps prevent diabetic ketoacidosis by providing real-time data.
FDA Authorization for Dual Monitoring Device
The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System. This device is approved for use by individuals aged 2 years and older who have diabetes. It represents the first wearable technology in the United States capable of continuously monitoring ketone levels and the first worldwide to continuously track both ketone and blood sugar (glucose) levels using a single device.
Addressing Diabetic Ketoacidosis Risk
For the estimated 2.1 million Americans with type 1 diabetes, managing blood sugar is only one aspect of their care. High ketone levels, produced when the body uses fat for energy instead of glucose, can lead to diabetic ketoacidosis (DKA), a severe and potentially life-threatening complication if not treated promptly. The Libre Duo 10 Day provides continuous, real-time data on both ketone and glucose levels, which can help in early detection of rising ketones before DKA becomes critical.
Continuous Monitoring Capabilities
Previously, ketone monitoring relied on single-point-in-time tests, which could not indicate whether levels were increasing or decreasing. The Libre Duo 10 Day addresses this limitation by continuously measuring both ketone and glucose levels in the fluid beneath the skin, every minute, day and night. Readings are transmitted wirelessly to a compatible smartphone, allowing users to view current levels and trends. The device can also send automatic alerts if ketone levels reach a concerning threshold, aiding in timely intervention.
Clinical Validation
The FDA's authorization followed a comprehensive review of clinical and performance data submitted by the device sponsor. The clinical program included data from six studies involving over 600 participants aged 2 years and older, supporting the device's safety and efficacy.
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Reporting from
The U.S. Food and Drug Administration (FDA) authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable device in the U.S. to continuously monitor ketone levels and the first globally to continuously monitor both ketones and blood sugar in a single device. This authorization provides a new tool for individuals with diabetes to manage their condition and prevent serious complications like diabetic ketoacidosis.