"As our capacity expands, we’ll put even more effort behind the expansion with type 2 patients. Two-thirds of the total Libre population has type 1 diabetes, but White said the company's intent with the device has been to serve the entire diabetic community and not niche it because the product has mass-market potential worldwide. "I think this is a very big, long-term, sustainable growth product for the company," White said. With FDA approval last September, patients and their doctors can now make treatment decisions based on information from the FreeStyle Libre system, without the need for routine finger sticks, which were the standard of glucose testing for more than 40 years. That's almost equivalent to the entire user base of the number two competitor in the space. "We did add 300,000 patients last quarter. "First of all, it's going extremely well," CEO Miles White said during the company's fourth-quarter earnings call Wednesday, as transcribed by Seeking Alpha. Additionally, Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 30 countries, including France, Japan, the United Kingdom and the US.It's been about four months since FDA approved Abbott’s FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring (BGM) for adults and it's safe to say the Libre system has been a blockbuster product for the company. 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 US.įreeStyle Libre system is now being used by more than 800,000 people across more than 43 countries and is the #1 CGM worldwide. The FreeStyle Libre system (10 day) was approved by the FDA in September 2017. 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 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 sensor is worn on the back of the upper arm and is the size of two stacked quarters. 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. In the US, the FreeStyle Libre system (10 day) is approved for replacement of blood glucose monitoring (BGM) for adults with diabetes. 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 fingersticks10, and is designed to be an easier-to-use, streamlined and more affordable system compared with other available CGMs on the market. "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." "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. This approval makes Abbott's revolutionary continuous glucose monitor (CGM) the longest lasting self-applied personal glucose sensor available on the market. Click hereĪbbott's FreeStyle Libre 14 day flash glucose monitoring system gets US FDA nodĪbbott has announced that the US 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. You can get e-magazine links on WhatsApp.
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