FreeStyle Libre Flash Gets FDA Approval
Update: July 27, 2018, FDA approves use of Freestyle Libre 14 Day System in the USA, extending wear from previously approved 10. The 14 Day System will have a warm up time of only one hour, compared to previously approved 12.
Getting a read on your blood glucose levels (BGLs) just got easier and less painful for millions of Americans as the days of constant finger prick testing may be drawing to a close.
On Wednesday the U.S. Food and Drug Administration approved Abbott Diabetes Care’s FreeStyle Libre Flash Glucose Monitoring System for public use in the United States, making it the first-FDA approved monitoring device that does not require a fingerstick test for calibration.
That’s right. No finger stick test required.
Late last year the FDA approved the Dexcom G5 Mobile system for sole use by patients in making treatment and insulin dosing decision. This approval goes a step further, with the FDA specifically eliminating the need for a finger prick with the Libre.
“This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful,” said 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, in an agency press release, “but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”
While patients typically use the results of fingerstick tests to calibrate their meters and confirm their continuous glucose monitor (CGM) readings, the Libre comes factory calibrated. “Fingerstick testing is not needed to inform appropriate care choices or to calibrate blood glucose levels with this system,” the FDA stated in its press release.
The Libre consists of a blood glucose monitor and a small round sensor you wear on your upper arm. Similarities to traditional CGMs, however, mostly end there. Libre users move a handheld reader over the sensor, which is a little larger than a quarter, to obtain real-time blood glucose readings. A small wire comes off the sensor and is inserted into the skin to continually measure blood glucose levels (BGLs).
The handheld mobile reader itself looks similar to the ones paired with Abbott’s traditional blood glucose monitors. The reader works quickly and can take readings though layers of clothing. Micro-USB is used for recharging. While the monitor can store up to 90 days of information, the sensor can only hold up to eight hours of data, making multiple daily scans a requirement.
Additionally, while the mobile reader shows trend data like lows and highs with a directional arrow, and allows used to review eight hours of data, it does not, however, include high or low alarms like most traditional CGMs. Also, data can’t currently be streamed to mobile devices like smartphones or tablets either.
Last years a physician version of the Freestyle Libre was approved for United States use. That device is nearly identical to the one that received approval on Wednesday, but only a healthcare provider could scan it and view the blood glucose data. With the new approval, users can now view that data themselves.
According to the FDA, the system is intended for use in people 18 years of age and older. Globally the Libre sensors can be worn for and replaced after 14 days. Wednesday’s ruling approves the sensor for 10 days of wear in the U.S.
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