Abbott's Freestyle Libre system becomes first CGM to be FDA cleared for use without fingersticks

By Jonah Comstock
06:37 pm

Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA. As well as finally bringing the system, which is already available in 39 other countries, home to the US where Abbott is based, the approval also represents a first for continuous glucose monitoring, as it doesn't require the user to use a fingerstick, even for calibration.

"From an emotional perspective, it’s especially important to us because Abbott’s an American company, this is a product that was designed in California, and diabetes is personal to many of us," Abbott Research Fellow and Director of Biosensor Technology Christopher Thomas told MobiHealthNews. "Every part of the design we come to with an incredible amount of passion ... so to be able to make that available in America is one of the most satisfying things that we could work for ever."

Abbot's Freestyle Libre fully disposable system consists of a tiny insertable sensor and a patch about the size of a quarter worn on the arm for up to 10 days (though it's cleared for 14 in other countries). The patch records glucose data every 15 minutes. Using a special reader, the wearer can scan the patch with NFC technology, checking their glucose painlessly as often as they want. In addition to the current reading, a scan gives eight hours of historical data and trend information. 

"You get where you are, where you’ve been, and where you’re going, all in that painless, one second scan," Thomas said. "You can scan it as many times as you want per day. What we’ve done at Abbott, is we want to help this revolutionary technology to blend seamlessly into your life."

The device is factory calibrated, which means it allows the user to eschew pricking their finger entirely. The Dexcom G5 was cleared last year for use without fingersticks, but still required them for calibration. Freestyle Libre also becomes the second CGM, after the G5, to be approved for non-adjunctive insulin dosing claims.

“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”

Abbot saw a professional version of Freestyle Libre cleared one year ago. That device was nearly identical, but only a healthcare provider could scan it and view the glucose data. The newest clearance allows users to view data themselves, something that research shows they're keen to do often -- an average of 16 times per day.

Looking to Europe, where the device has been available for some time, we can make some predictions about next steps for Freestyle Libre in the US. For one thing, the sensor will likely be expanded from 10 to 14 days of wear. 

Also in Europe, Abbott has incorporated smartphone apps into the operation of the system. Users with Android phones that have RFID or NFC technology can leave the reader at home and scan the sensor directly with their phones. There are also monitoring apps for both care providers and parents to see someone else's data remotely. 

"We’ve got a long pipeline of innovations that are coming," Thomas said. "Stay tuned for different changes to that, smartphone editions, it’s all part of the exciting pipeline that we’re working on right now."


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