Abbott’s FreeStyle® Libre 14 Day Flash Glucose Monitoring System Now Approved in the U.S.

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According to a recent press release from Abbott, “the U.S. Food and Drug Administration (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.”

Here’s what our analysts have to say about this new update in the U.S. diabetes market: 

After leaving the continuous glucose monitoring (CGM) market in 2011, when it discontinued its FreeStyle Navigator product line, Abbott re-entered the market in 2016 with the launch of the FreeStyle Libre Pro professional CGM system and the popular FreeStyle Libre 10 day flash glucose monitoring (FGM) system in 2017. The FreeStyle Libre competes directly against CGM devices manufactured by Dexcom and Medtronic, as well as the numerous companies active in the traditional blood glucose monitoring (BGM) market.

On July 27, 2018, Abbott received FDA approval for the FreeStyle Libre 14 day FGM system, which also features several improvements in accuracy compared to the 10 day system. Dexcom’s G5 and G6 sensors have a 10 day lifespan, while Medtronic’s MiniMed 670G and Guardian Sensor 3 have a 7 day lifespan. Continued innovation and development within the CGM and FGM space is expected to drive growth within the overall diabetes care market, as companies continue to strive to launch the first commercial artificial pancreas.

Read the full press release from Abbott below:

“At Abbott, we are continuously pushing for new innovations that minimize 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 countries and is the #1 CGM worldwide. 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.


For Further Information

More on the diabetes device market in the US can be found in a series of reports published by iData Research entitled the US Market Report Suite for Diabetes Devices . The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, insulin pens, insulin syringes and insulin pumps.

The iData report series on diabetes devices covers the US and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at for a US Market Report Suite for Diabetes Devices brochure and synopsis.

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