The US Food and Drug Administration has given the green light for the FreeStyle Libre Flash Glucose Monitoring System to be used by adults suffering from diabetes. This is the first glucose monitoring system that does not require patients to stick their fingers to draw blood.
The FDA approved the professional version of the device last year, for use by clinicians to monitor glucose levels in diabetic patients, Medscape reports. Both manufactured by pharmaceutical giant Abbott, these new methods reduces fingerstick testing.
The Freestyle Libre system measures glucose levels with a small sensor that is placed into the back of the upper arm for as long as 14 days. Users can then wave a mobile scanner over the sensor to get readings. It is intended for use in patients 18 years or older.
The system is similar to traditional continuous glucose monitors (CGMs) that measure interstitial fluid glucose levels. But the FreeStyle Libre has advantages such as longer wear, no calibration required, and lower costs. Also, the device is pre-calibrated, so there is no need for fingerstick blood glucose measurements.
On the downside, it does not warn users of low and high glucose numbers, which the CGMs do with an alarm.
Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said,
The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable.
He added, “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes — with a wave of the mobile reader.”
The system was licensed in Europe in 2014 and is already being used outside of the USA in over 30 countries, by over 250,000 diabetics.