Medicare patients have gained access to a device that allows people with diabetes to keep tabs on their glucose levels without having to routinely prick their fingers, Abbott Laboratories announced January 4th.

Abbott’s FreeStyle Libre System, which was approved by the U.S. Food and Drug Administration in September and launched in U.S. pharmacies in November, has met the criteria for therapeutic continuous glucose monitoring used for coverage by the U.S. Centers for Medicare & Medicaid Services, Abbott said.

It is the first Medicare-covered continuous glucose monitor that requires no regular finger-stick or manual data entry for calibration, the company said. It is meant to reduce the intrusion and inconvenience of pausing one’s life multiple times a day to get a blood sample.

The Freestyle Libre is a flash glucose monitoring system that includes a sensor worn on the back of the upper arm and a handheld reader. The sensor uses a thin filament that’s inserted underneath the skin to measure glucose levels every minute. The handheld reader is used to scan the sensor. The factory-calibrated FreeStyle Libre system is the only CGM system recognized by Medicare that requires no user calibration whatsoever (either by fingerstick or manual data entry). The high accuracy of the FreeStyle Libre system allows for patients to dose insulin based on the results.

Designed to be approachable, accessible and affordable for the 30 million people with diabetes in the United States, the FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days, making it the longest lasting personal glucose sensor available in the U.S.

Key differences between the FreeStyle Libre system and other CGM technology include:

• FreeStyle Libre system is factory calibrated so it requires no user calibrations for accuracy, including any manual data entry or the need for routine fingersticks–therefore removing the additional costs and burden of blood glucose monitoring to the patient
• FreeStyle Libre system includes only two pieces (sensor, reader) vs. three for alternative systems (sensor, reader, transmitter), making it much less cumbersome to use
• For non-Medicare patients, FreeStyle Libre system is available at major U.S. retail pharmacies, removing the barrier of complicated paperwork necessary for commercial insurance coverage and making it more readily accessible to patients

Last year, CMS announced coverage for therapeutic CGM for certain beneficiaries who have either Type 1 or Type 2 diabetes and intensively manage their insulin. To be included in this category, the device must be approved by the U.S. Food & Drug Administration (FDA) for use in place of a blood glucose monitor (BGM), enabling patients to make treatment decisions based on the information provided. With the recent approval by the FDA, the FreeStyle Libre system can be used as a replacement for BGM.

With the FreeStyle Libre system, people with diabetes can:

• Self-apply the sensor, which is approximately the size of two stacked quarters, to the back of the upper arm.
• Capture real-time glucose readings with one-second painless scans of a small hand-held reader over the sensor.
• Identify glucose level trends (high, low, stable) with a directional arrow and review eight hours of glucose history.
• Receive glucose readings through clothing, making testing more convenient and discreet. The FreeStyle Libre sensor is also water-resistant and can be worn in the shower and during swimming.
• Avoid interference with acetaminophen, an active ingredient in more than 500 common over-the-counter medications, which can falsely raise reported glucose levels in certain CGMs to appear as if they are at dangerously high levels.

Medicare patients can access the FreeStyle Libre system by prescription through Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now and Mini Pharmacy in the U.S.

For non-Medicare patients, the FreeStyle Libre system is also available at five major retail pharmacies in the country (CVS, Walgreens, RiteAid, Walmart and Kroger).
The FreeStyle Libre system is now being used by more than 400,000 people across more than 40 countries. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 21 countries, including France, Japan, the United Kingdom and now the U.S. For more information, please visit: www.freestylelibre.us

Original Article by Alexa Elejade-Ruiz