FDA Approves 14-Day Freestyle Libre Glucose Monitoring System

JULY 30, 2018
Kevin Kunzmann
The US Food and Drug Administration has approved the FreeStyle Libre 14-day Flash Glucose Monitoring system, now the longest-lasting self-applied continuous glucose monitor (CGM) in the US market.

The CGM, from Abbott, supplants the company’s 10-day Libre system, which was approved in September 2017 as the first CGM capable of providing adult diabetes patient feedback from a fingertip blood sample.

The FreeStyle Libre system was first launched in Europe in 2014, with clinical and real-world data support showing patients who more frequently scanned blood samples spent less time in hypoglycemia or hyperglycemia while also reporting improved average glucose levels and overall control.

The 14-day system requires a one-hour warmup phase, but with greater accuracy compared to its 10-day preceding model. In clinical trials, patients provided the new CGM reported a mean absolute relative difference (MARD) of 9.4, versus a MARD of 9.7 in those administered the 10-day CGM.

Constant improvement of its own devices and of those currently in the diabetes market is a targeted goal from Abbott, Jared Watkin, senior vice president of Diabetes Care for the company, said in a statement.

"At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes," Watkins said. "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."

While presenting new Freestyle Libre data at the American Diabetes Association’s 78th Annual Scientific Session in Orlando, FL, this June, Tim Dunn, PhD, director of clinical and computational research for Abbott Diabetes Care, emphasized capabilities such as the device’s 90-day memory storage and daily summary reports in an interview with MD Magazine®.



“The focus from the beginning has been ease of use for the patient, and the big step forward has been the factory calibration of the device,” Dunn said. “The sensor does not require calibration of the fingerstick, [patients] just simply place it—it's very easy to use insert, it's a 1-step process for putting it on—and then they're able to check the glucose without doing routine a fingerstick.”

Dunn noted that, on average, patients with diabetes using the CGM are checking their levels 13 times per day. The improved personability—and duration—of the CGM system promotes that consistent use.

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