FDA approves 14-day FreeStyle Libre CGM sensor for diabetes

The FDA on Friday approved the FreeStyle Libre flash glucose monitoring system, which allows patients with diabetes to wear the sensor up to 14 days with high accuracy, Abbott announced in a press release.

The approval makes Abbott’s continuous glucose monitor the longest-lasting self-applied personal glucose sensor available on the market, with improved accuracy and reduced warmup time, according to the company.

“At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes,” Jared Watkin, senior vice president of diabetes care at Abbott, said in the release. “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 flash CGM system, which first launched in Europe in 2014 with a 14-day wear time, was the first to eliminate the need for finger sticks, and is designed to be an easier-to-use, streamlined and more affordable system vs. other available CGMs on the market.

As Endocrine Today previously reported, FDA approved a 10-day version of the CGM system in September, making it the first CGM system in the U.S. that did not require finger-stick calibration for adults with diabetes. Both the 10- and 14-day systems use a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels without the need for finger-stick testing. Glucose levels can be determined by users waving a mobile reader above the sensor wire, which will let the reader know if levels are too high or too low as well as their trajectory. The 10-day system can be worn after a 12-hour start-up period.

The 14-day CGM system has a 1-hour warmup and greater accuracy vs. the 10-day system, with a mean absolute relative difference of 9.4 compared with 9.7, respectively, according to the release.

In data presented at the American Diabetes Association Scientific Sessions in June and reported by Endocrine Today, patients with type 1 and type 2 diabetes prescribed multiple daily injection therapy experienced lower health care costs and improved adherence with the use of CGM vs. self-monitoring blood glucose.

“Based on U.S. acquisition costs and ADA-recommended testing frequencies, flash monitoring is overall cost-saving compared with SMBG in people with [type 1 diabetes] or [type 2 diabetes] using [multiple daily injection] therapy,” the researchers wrote in a poster presentation at ADA. “In this population, flash monitoring has been shown to be associated with changes in behavior leading to improved adherence to ADA Standards of Care for glucose monitoring frequency.”

The 14-day CGM system is supported by both clinical data and real-world evidence that show that people who scan more frequently spend less time in hypoglycemia or hyperglycemia while having improved average glucose levels, demonstrating improved glucose control overall. The CGM system will be available via prescription in the coming months at participating pharmacies and durable medical equipment suppliers in the U.S. – by Regina Schaffer

Disclosure: Watkin reports he is senior vice president of diabetes care at Abbott.