FDA Approves FreeStyle Libre Glucose Monitoring System

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FDA Approves FreeStyle Libre Glucose Monitoring System

Many people with diabetes want to test their blood sugar levels regularly but don’t. The reason that most of them give is that they just don’t want to go through the unpleasant business of sticking their finger to draw blood. However, the U.S. Food and Drug Administration (FDA) has just approved a new technology that its manufacturer advertises as a breakthrough that “eliminates the need for routine fingersticks.”

The device is called the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre for short), and it’s the creation of Abbott, a global health-care company based in Illinois. The system checks blood glucose levels through a sensor that’s about the size of two stacked quarters. The user applies the waterproof sensor to the back of the upper arm. Once it’s in place, the user is able to scan it with a small handheld reader. The scan is painless and takes about a second. Because the scanner can make readings through clothing, the wearer doesn’t have to uncover the upper arm to get a reading.

The scan identifies glucose levels as high, low, or stable and provides an 8-hour history of fluctuations — in other words, the FreeStyle Libre essentially works as a continuous glucose monitor (CGM). The manufacturer says that the FreeStyle Libre is calibrated at the factory and therefore doesn’t require daily calibration by the user through fingersticks, as some other CGMs do. The device is especially recommended for people being treated with insulin, because these are the ones who require the most careful and frequent monitoring.

Although it has just been approved in the United States, the FreeStyle Libre has already been used by more than 400,000 people in about 40 countries. The manufacturer says reports indicate that users test their glucose levels at an average of at least 15 times a day, a frequency that leads to better overall glucose control. Abbott expects that the device will be available at U.S. pharmacies before the end of the year. To get one, a user will need a doctor’s prescription.

Want to learn more about CGMs? Read “Making More Effective Use of Your Continuous Glucose Monitor” and watch “Continuous Glucose Monitoring.”

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