The FDA approved the FreeStyle Libre Flash Glucose Monitoring System, a small sensor wire inserted below the skin’s surface on the back of the upper arm that continuously monitors glucose levels.
For decades, the daily routine of diabetics involved painful needles, finger-pricking lancets and imprecise glucose meters. Studies have shown that a majority of people test less than three times per day because of the pain and hassles associated with finger sticks. Without comprehensive glucose data, significant glucose fluctuations may be missed, which can lead to major health consequences. Now, for many American diabetics, a wearable sensor the size of a bottle cap will soon replace finger pricks.
The Food and Drug Administration (FDA) approved the FreeStyle Libre Flash Glucose Monitoring System, a small sensor wire inserted below the skin’s surface on the back of the upper arm that continuously monitors glucose levels — eliminating the need for daily finger pricks. The FDA evaluated the new device by looking at a clinical study of participants 18 and older, comparing readings obtained by the FreeStyle Libre to those obtained by an established lab method for analyzing blood glucose levels.
Developed by Abbot Laboratories, the new sensor will be a “game-changer” for diabetic adults. In July 2016, a similar product from DexCom was approved, but it still required twice daily finger pricks.
The cost of the FreeStyle Libre will be similar to its price in Europe — where the device is sold for the equivalent $140 for a sensor and a reader. The sensor must be swapped for a new one every 10 days, amounting to a total of about $1,900 a year in Europe, including one reader and 26 sensors. FreeStyle Libre will be available by prescription in U.S. pharmacies by the end of 2017 or early 2018.
The Libre includes a small hand-held reader that scans the sensor, receives real-time glucose readings and reviews eight hours of blood glucose history. The sensor is water-resistant and can be worn in the shower and while swimming. It can also be scanned over clothing. Experts believe this will truly be life-altering for those suffering from diabetes and in many cases will improve treatment with more accurate data.
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