![]() ![]() Seek medical attention when appropriate and contact Abbott Toll Free (85) or visit * for detailed indications for use and safety information. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. ![]() Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.* Indications and Important Safety Information 4 Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S. ![]() and worldwide 8, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across 50 countries 5 by providing breakthrough technology that is accessible and affordable. We set a global price for our sensing technology that's closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs, because we wanted to make sure our life-changing technology was accessible to as many people as possible."Īs the #1 sensor-based glucose monitoring system used in the U.S. "From the start, Abbott designed FreeStyle Libre technology with affordability in mind. "Managing diabetes is expensive, even for those with insurance coverage," said Watkin. Abbott will offer the new system at the same price as the currently available FreeStyle Libre 14 day system, which was approved by the FDA in July 2018. The FreeStyle Libre 2 system will be available in the coming weeks at participating pharmacies and durable medical equipment suppliers (DMEs) across the U.S. It is also designed for use with a mobile app, which Abbott is working to bring to the U.S. With a one-second scan using a handheld reader, users can see their glucose reading, trend arrow and eight-hour history. The FreeStyle Libre 2 next-generation sensor, which is a third less bulky than other CGM sensors, 1 is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. This can allow people to tailor and potentially simplify how they manage their diabetes. The system is designed to digitally connect and communicate with other devices. The FreeStyle Libre 2 system met or exceeded the FDA's rigorous iCGM special control standards. The alarms are a bonus because they provide parents a level of reassurance." "Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child's glucose levels are doing without having to disrupt their play or sleep with painful fingersticks. "Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children," said Larry Kurt Midyett, M.D., pediatric endocrinologist, Midwest Women's and Children's Specialty Group. 7 The system has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3% (9.2% for adults and 9.7% for pediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days. Users also have the option of turning off the customizable, real-time alarms. Using Bluetooth technology, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor. "With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other CGMs, Abbott's FreeStyle Libre 2 system will change the future of diabetes care in the U.S. ![]() "We're thrilled to bring our next generation technology on our world-leading sensing platform to both children and adults with diabetes in the U.S.," said Jared Watkin, senior vice president, Diabetes Care, Abbott. ![]()
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