FDA Approves FreeStyle Libre 14 Day Flash Glucose Monitoring System
Abbott announced that the Food and Drug Administration (FDA) has approved the FreeStyle Libre 14 Day Flash Glucose Monitoring System, making it the longest-lasting self-applied personal glucose sensor available for patients with diabetes.
The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear. The FreeStyle Libre System consists of a handheld reader and a sensor that is applied on the back of the upper arm; the sensor is inserted just under the skin and measures glucose every minute. Users can view real-time glucose readings with a quick scan and monitor glucose trends with 8 hours of logged history.
Moreover, the 14 Day system was found to have greater accuracy compared to the FreeStyle Libre System (10 day) (mean absolute relative difference [MARD] 9.4 vs 9.7). Jared Watkin, senior vice president, Diabetes Care, Abbott, stated, "With the new FreeStyle Libre 14 day system, people with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition."
The Freestyle Libre 14 Day Flash Glucose Monitoring System will be available by prescription in the coming months.
For more information call (855) 632-8658 or visit freestylelibre.us.