Abbott readies U.S. pharmacy rollout of FreeStyle Libre

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Continuous glucose monitor doesn't require finger sticks

ABBOTT PARK, Ill. — Abbott plans to make its FreeStyle Libre flash glucose monitoring system available at major U.S. retail pharmacies before the end of the year.

Approved last week by the Food and Drug Administration as a replacement for blood glucose monitoring (BGM) for adults with diabetes, the FreeStyle Libre uses new glucose sensing technology that eliminates the need for routine finger sticks. Abbott said the device is currently the only personal continuous glucose monitor (CGM) that doesn’t require finger stick calibration.

FreeStyle Libre_Abbott

FreeStyle Libre

“Today, we are celebrating a breakthrough moment for people with diabetes in the U.S. — an end to the worry and hassles associated with routine finger sticks, which have been the standard of glucose testing for more than 40 years,” according to Jared Watkin, senior vice president of diabetes care at Abbott. “We believe that FreeStyle Libre will transform diabetes management, and we’re proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives.”

The FreeStyle Libre system reads glucose levels via a sensor worn on the back of the upper arm for up to 10 days. Abbott said that capability makes the device the longest-lasting personal glucose sensor available in the United States, where 30 million people have diabetes. The company noted that the BGM replacement indication means that people living with diabetes and their doctors can now make treatment decisions based on information from the FreeStyle Libre system, without the need for painful routine finger sticks and at a fraction of the cost of other CGM systems now available.

Abbott said data from the FreeStyle Libre provide a visual snapshot of a person’s glucose fluctuations in a typical day, known as an Ambulatory Glucose Profile (AGP). The AGP can reveal hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) trends to aid diabetes management. Continuous measuring, capturing and storing of glucose level data enables patients and their doctors to see patterns over time and make adjustments to lifestyle, diet or treatment.

With the FreeStyle Libre system, people with diabetes can self-apply the sensor (about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with one-second scans of a small handheld reader over the sensor. Glucose level trends (high, low or stable) are identified with a directional arrow, and users can review eight hours of glucose history.

The FreeStyle Libre also allows users to get glucose readings through clothing, and the water-resistant sensor can be worn in the shower and while swimming, according to Abbott. The company added that the monitor also enables users to 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.

Abbott FreeStyle Libre

The FreeStyle Libre system reads glucose levels via a sensor that users wear on the back of the upper arm.

Currently, the FreeStyle Libre is being used by more than 400,000 people in about 40 countries, Abbott said. To ensure accessibility to the product, the company has secured partial or full reimbursement in 17 countries, including France, Japan and the United Kingdom.

Two published clinical trials and real-world evidence from more than 50,000 FreeStyle Libre users show that people who use the system test their glucose levels an average of at least 15 times per day, Abbott reported. The studies show that people who scan more often spend less time in hypoglycemia or hyperglycemia and have improved average glucose levels, the company said.

With traditional BGM, some people with diabetes may have to finger-stick up to 12 times per day to test their glucose levels, which only provides readings at distinct points in time, according to Abbott. Studies have shown that most people test less than three times daily because of the pain and hassles related to finger sticks. And even with current CGM devices, people still must finger-stick at least twice a day, based on their system, to calibrate their devices for accuracy, Abbott added. The FreeStyle Libre system is factory-calibrated so daily calibration is not required, which the company called another first in the personal glucose monitoring industry.

“Diabetes management requires active participation by the patient. Regular monitoring of glucose levels is especially crucial among patients being treated with insulin,” stated Maria Tulpan, M.D. at Lenox Hill Hospital in Manhattan. “What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.”


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