Abbott notches FDA nod for first fingerprick-free CGM

Patients wear a sensor on their upper arm for up to 10 days and use a hand-held sensor to capture glucose data. The hand-held device also displays glucose patterns, including whether glucose is trending upward or downward. (Abbott)

The FDA greenlighted Abbott’s FreeStyle Libre Flash glucose-monitoring system, the first FDA-approved CGM that allows patients and their physicians to make treatment decisions without requiring fingerpricks.

The FreeStyle Libre system includes a sensor that may be worn for up to 10 days at a time, as well as a hand-held reader, which captures and displays glucose data. The sensor, like other CGMs, measures glucose levels in the interstitial fluid just under the skin. But whereas other CGMs—such as Dexcom’s G5 device—require regular fingersticks to calibrate the system, the FreeStyle Libre does not.

The system is approved as a replacement for blood glucose monitoring (BGM) in adults with diabetes. With traditional BGM, patients may need to prick their finger as many as 12 times a day to check on their glucose levels. But, as each reading is a static data point on a continuous timeline, even testing blood glucose this frequently paints an incomplete picture.

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“With the FreeStyle Libre, I could watch what was going on in real time,” said Mike Kendall, a patient from the U.K. who has used the system several times for two weeks at a time. “I don’t need to wait [a certain period after eating] to check—I check when I want to.”

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By providing continuous data, the device plugs gaps that existed with traditional BGM to help physicians and patients make treatment, diet or lifestyle changes that will improve diabetes management.

Eden Miller, DO, who specializes in diabetes care, likens continuous glucose monitoring to checking a speedometer while driving. Miller uses the professional version of the FreeStyle Libre at her practice in Sisters, Oregon.

“Imagine if you were in a vehicle and only looked at the speedometer once a day. How much do you think you’d be protected against speeding?” Miller said. Using a CGM like the FreeStyle Libre is like looking at the speedometer all the time, she said. Having continuous data can uncover issues that traditional BGM misses.

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Abbott plans to roll the device out by the end of the year, the company said in a statement. Patients will be able to obtain one with a prescription at major retail pharmacies. It will be sold at a price similar to what Abbott charges for the system in Europe—about $140 for a sensor and reader, Bloomberg reported.

The devicemaker markets the FreeStyle Libre system in about 40 countries, including the professional version, which was FDA-approved for clinical use in September last year. A physician inserts the sensor into the back of a patient’s arm, where it is worn for up to 14 days. At the end of the treatment period, the physician scans the sensor with the hand-held reader to look at the patient’s glucose data.

The professional version has some advantages over the consumer device—a physician’s office needs only one reader to treat multiple patients, and patients take no equipment other than the sensor home with them.