Abbott’s Freestyle Libre 2 iCGM system now available to Medicare patients

Integrated continuous glucose monitoring (iCGM) system

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FreeStyle Libre
The FreeStyle Libre 2 technology is the integrated continuous glucose monitoring (iCGM) system available that continuously measures glucose data every minute without the need for painful fingersticks

Abbott announced its next-generation FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system is now available to Medicare patients. Having met the codes for therapeutic CGM systems used for coverage by the US Centers for Medicare and Medicaid Services (CMS), the FreeStyle Libre 2 system is now accessible to all Medicare patients with diabetes who meet the eligibility criteria.

“Abbott designed the FreeStyle Libre portfolio for performance, access and affordability to make it broadly available to people with diabetes who need it,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “By securing reimbursement, Abbott is making sure our latest life-changing technology can get to everyone who needs it, whether they’re children, adults or seniors eligible for Medicare.”

The FreeStyle Libre 2 system includes a sensor that is the easiest to apply and is worn on the upper arm’s back for up to 14 days, measuring glucose every minute. With a one-second scan using a handheld reader over the sensor, the system provides users with a real-time glucose reading, trend arrow, and eight-hour history to help them and their healthcare providers make more informed treatment decisions.

The FreeStyle Libre 2 system includes optional real-time alarms and measures glucose levels every minute, meeting the highest accuracy standards over 14 days, including superior day one accuracy compared to the other iCGM and excellent accuracy alarm performance at low-end glucose levels. With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied iCGM sensor currently available, eliminating the need for fingersticks – and priced at a third of the cost of other CGM systems.

The pandemic changes the way healthcare is delivered with greater acceptance of telehealth and medical technologies with remote monitoring capabilities such as CGMs. For instance, during the public health emergency, CMS gives healthcare professionals more flexibility to prescribe CGMs to those who qualify. Additionally, the US Food and Drug Administration (FDA) allows the FreeStyle Libre system to be used in hospital settings during the pandemic, making Abbott’s diabetes technology more easily accessible.

Abbott’s FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries6 by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre portfolio in 37 countries, including Canada, France, Germany, Japan, the United Kingdom, and the US.

Indications and important safety information

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 four and older.

According to the company, the system must not be used with automated insulin dosing (AID) systems, including closed-loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your sensor readings. Failure to use the System according to the instructions for use may result in missing severe low blood glucose or high blood glucose event and making a treatment decision that may result in injury. 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.

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