Abbott

Approved by FDA! FreeStyle Libre 2 Cleared as iCGM

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Abbott's FreeStyle Libre 2 has been approved for use in the U.S. for adults and children (ages four and older) with diabetes. In Abbott's June 15, 2020 press release, Jared Watkin, senior vice president, Diabetes Care, Abbott commented: "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. 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. the same way it has around the globe."

Highlights of the new iCGM system include:

  • FreeStyle Libre 2 is the only integrated continuous glucose monitoring (iCGM) system available that continuously transmits glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high or low without scanning.

  • Now for children and adults with diabetes, this latest technology is the first and only iCGM that sustains performance for up to 14 days, providing trends, insights and actionable data.

  • The FreeStyle Libre 2 system includes a self-applied sensor (the size of two-stacked quarters) that is easy to apply and worn on the back of the upper arm, eliminating the need for painful fingersticks to test glucose levels.

The FreeStyle Libre 2 has already launched in several European countries and is coming to others soon. It is not yet known when the FreeStyle Libre 2 will officially roll out in the United States, though Abbott says it will be in the coming weeks.

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In the News: Hospitals Try Glucose Monitors to Reduce Contact With Covid-19 Patients

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Many hospitals are beginning to use remote readings via CGM to monitor blood glucose levels for Covid-19 patients with diabetes. Through the resulting reduced clinician contact, this is helping to curb virus transmission and to preserve scarce protective gear. The entire article can be found in the Wall Street Journal. By using CGM, manual finger-stick or blood draw methods performed by nurses in patients' rooms can be cut back dramatically.

This month, the FDA told DexCom and Abbott Laboratories that they could provide their remote continuous glucose monitors to hospitals to support care of Covid-19 patients. Previously, the companies didn’t ship them to hospitals because they weren’t FDA-approved for inpatient use, though doctors had discretion to allow patients who already had them to continue using them.

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Abbott Donating FreeStyle Libre for Hospitalized Patients with Diabetes During COVID Pandemic

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Abbott has made the generous and mindful decision to make the FreeStyle Libre 14 Day system available in the U.S. for hospitalized patients with diabetes during the COVID-19 pandemic. Read the full press release here.

Key details from the press release include:

-- More than 50% of people with diabetes who have been diagnosed with COVID-19 are hospitalized, according to a report from the Centers for Disease Control and Prevention (CDC).

-- FreeStyle Libre 14 day system can be used by frontline healthcare workers in hospitals to remotely monitor patients with diabetes who can scan to minimize exposure to COVID-19 and preserve use of personal protective equipment (PPE).

-- In partnership with the American Diabetes Association (ADA), Abbott will donate 25,000 FreeStyle Libre 14 day sensors to U.S. hospitals and medical centers in outbreak hotspots to help accelerate access to technology.

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OmniPod and Abbott FreeStyle Libre Approved for Coverage by Medicare

The Abbott Freestyle Libre flash glucose monitoring system.

The Abbott Freestyle Libre flash glucose monitoring system.

Great news was announced earlier this month to start the New Year off strong for the diabetes community! Medicare is allowing coverage of the Omnipod tubeless insulin pump and the new FreeStyle Libre flash glucose monitoring system. And as Diabetes Mine notes, "since CMS typically sets the stage for what private insurers will cover, this is a big win for PWDs (people with diabetes) of all ages!"

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