The FDA Just Approved the First Completely Poke-Free Continuous Glucose Monitor | The Diabetes Site Blog

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The FDA Just Approved the First Completely Poke-Free Continuous Glucose Monitor

Elizabeth Nelson

Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System is officially the first and only continuous glucose monitor that doesn't require any finger pricking at all and is approved by the FDA. The Dexcom G5, which eliminated a large number of finger pricks, was approved in 2016, but it still required them for calibration. With the Libre Flash, however, they're a thing of the past.

The system is fully disposable and involves placing a tiny sensor wire under the skin. Then a patch about the size of a quarter is worn on the user's arm. This patch checks blood glucose levels every 15 minutes and only has to be changed about every 10 days, before which time it can be scanned as many times as desired for an updated reading using a special reader or an Android phone with RFID or NFC technology. The patch holds 8 hours of memory to allow users to see recent trends in their blood glucose levels. The device is meant for people with diabetes who are over the age of 18.

Photo: Adobe Stock/ratmaner

The device is already available in 39 other countries and was used by doctors in America, but FDA approval was the roadblock that kept it off the market in the United States—until now. The Abbott company is excited to finally be able to sell their product to people with diabetes in their own country, as diabetes is an issue of personal significance to many of Abbott's staff members.

As the device is still new, users are cautioned to watch out for signs of hyperglycemia and hypoglycemia. The monitor may also cause slight skin irritation around the insertion site, and it is unable to provide alerts or alarms when the user's blood glucose level falls too low or spikes too high.

Photo: Adobe Stock/Photographee.eu

In some countries, the patches can be worn up to 14 days, according to safety regulations. This may be something to look forward to in the U.S. soon as well. But that's not the only thing to look forward to, Abbott assures us.

"We've got a long pipeline of innovations that are coming," said Christopher Thomas, Abbott research fellow and director of biosensor technology. "Stay tuned for different changes to that, smartphone editions, it's all part of the exciting pipeline that we're working on right now."