Flash glucose monitoring system now approved in the US

1st August 2018

Enaie Azambuja

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Datasheet

Abbott has announced that the FDA has approved the FreeStyle Libre 14 day Flash Glucose Monitoring system, which allows people with diabetes to wear the sensor up to 14 days with high accuracy. This approval makes Abbott's revolutionary continuous glucose monitor (CGM) the longest lasting self-applied personal glucose sensor available on the market.

"At Abbott, we are continuously pushing for new innovations that minimise the daily burden of managing diabetes," said Jared Watkin, senior vice president, Diabetes Care, Abbott.

"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 FreeStyle Libre system, which first launched in Europe in 2014, with a 14-day wear time, was the first to eliminate the need for fingersticks, and is designed to be an easier-to-use, streamlined and more affordable system compared with other available CGMs on the market.

In the U.S., the FreeStyle Libre system (10 day) is approved for replacement of blood glucose monitoring (BGM) for adults with diabetes. With just a quick, one-second scan, users can see real-time glucose readings, as well as identify glucose trends with a directional arrow and review eight hours of glucose history. The sensor is worn on the back of the upper arm and is the size of two stacked quarters.

The FreeStyle Libre system is supported by both clinical data and real-world evidence that show that people who scan more frequently spend less time in hypoglycemia (low-glucose levels) or hyperglycemia (high-glucose levels) while having improved average glucose levels, demonstrating improved glucose control overall.

The FreeStyle Libre 14 day system has a 1-hour warmup and greater accuracy compared to the FreeStyle Libre system (10 day) with a mean absolute relative difference (MARD) of 9.4 compared to 9.7, respectively. The FreeStyle Libre system (10 day) was approved by the FDA in September 2017.

The FreeStyle Libre 14 day system will be available via prescription in the coming months at participating pharmacies and durable medical equipment suppliers (DMEs) in the U.S.

FreeStyle Libre system is now being used by more than 800,000 people across more than 43 countries8 and is the #1 CGM worldwide9. Additionally, Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 30 countries, including France, Japan, the United Kingdom and the U.S.