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Abbott’s CGM Libre Approved by FDA

First Continuous Glucose Monitor that doesn’t require routine finger pricks.

The FDA has approved the Libre Flash System, which already is sold in 41 other countries, for sale to adults in the U.S. It’s the first continuous glucose monitor (CGM) that does not require fingersticks in order to check glucose levels. Abbott is also seeking approval for use by children.

The device consists of a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days.

The system currently doesn’t communicate with an insulin pump as other continuous glucose monitors do, but Abbott is looking to implement such a feature in the future.

In a news release Abbott announced pricing will be “very similar” to the price in Europe, where the reader costs about $69, and each sensor also costs about $69, before insurance. In the U.S., the sensor will last about 10 days.

In the U.S., continuous glucose monitors are often covered by insurance, and Abbott is planning discussions about coverage with insurers in the U.S. Regional and national health insurance systems in 18 countries — including the United Kingdom, France, Germany and Japan — already have agreed to fully or partially cover the devices.

The device will not eliminate all need for fingersticks. Patients may still need them to confirm the device’s readings in some cases.

Dr. Rasa Kazlauskaite, director of the diabetes technology Initiative at Rush University Medical Center, noted in an interview with the Chicago Tribune that the new device could be an exciting development for patients, but cautioned that its usefulness will depend on its accuracy. While she’s a fan of CGMs, Kazlauskaite said continuous glucose monitors can sometimes give inaccurate readings, necessitating traditional finger sticks. “No technology is entirely perfect,” she said.

The FDA warned in a news release that patients could experience abnormally high or low glucose levels in cases where information provided by the device is inaccurate, and that information is used to make treatment decisions.

Abbott’s Kazemi, however, said Abbott is confident in the device’s accuracy. Patients using the devices check their glucose levels an average of 16 times a day in Europe, where the devices already are available, he said.

“It allows people to finally do what we’ve been asking them to do all along,” he said, referring to asking patients to regularly check their glucose levels.

Practice Pearls:

  • The FDA approved the Libre Flash System in the U.S. which already is sold in 41 other countries.
  • The first continuous glucose monitor that does not require people with diabetes to routinely prick their fingers.
  • The device also does not alert patients of low glucose levels without a patient waving the reader over his arm.

Abbott News Release 9-28-2017