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September 29, 2017

FDA approves first finger-prick-free blood sugar test for diabetes patients

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FDA on Thursday approved Abbott Laboratories' FreeStyle Libre Flash, the first glucose monitoring device to allow diabetes patients in the United States to test their blood sugar without having to prick their fingers.

How it works

The device is a bottle-cap-sized sensor containing a small wire that is inserted just beneath the skin on the upper arm. Patients can use a hand-held receiver to scan the sensor to check their current glucose levels, as well as trends and patterns.

The device does not, however, alert patients of low glucose levels unless the patient uses the hand-held receiver. It also does not communicate with insulin pumps, as other continuous glucose readers do, although Abbott has said that they are working on that functionality.

Abbott has not disclosed pricing information for the United States, the device's cost likely will be similar to its pricing in Europe, where it's currently sold for the equivalent of $140 for both the sensor and the reader. The sensor has to be replaced every 10 days, leading to an annual cost of roughly $1,900.

Jared Watkin, Abbott senior vice president of diabetes care, said his company is in the process of talking to insurers about covering the device.

No more pricking your finger

According to analysts from Jefferies, this sensor will be a "game-changer," as it will allow patients to check their blood glucose levels without pricking their finger, something that has been shown to prevent people from testing their blood sugar as frequently as recommended.

According to Reuters, diabetes patients typically should measure their glucose levels almost 12 times a day. Studies have shown, however, that the majority of diabetes patients test their glucose levels fewer than three times a day.

However, according to Mahmood Kazemi, the senior director of global medical and scientific affairs for Abbott, the device may not eliminate all finger-pricking for diabetes patients. Patients may still have to stick their fingers to confirm the accuracy of the readings from the device, especially if the readings are particularly low or rapidly changing, or if their symptoms don't match the readings.

Experts urge caution around accuracy

Rasa Kazlauskaite, director of the diabetes technology initiative at Rush University Medical Center, who is unaffiliated with Abbott, expressed excitement about the potential of the device, but also cautioned that its usefulness will be contingent on its accuracy.

She called continuous glucose monitors the "second greatest invention" in the history of diabetes management after the invention of insulin, but did say that these monitors can sometimes give inaccurate readings. "No technology is entirely perfect," she said.

"Eliminating finger sticks is a huge paradigm shift for managing diabetes," said David Ahn, an endocrinologist and diabetes technology expert at the University of California, Los Angeles. "But the accuracy, reliability, and the economics will dictate how transformative it will actually be to our patients' lives" (Grover/Mukhopadhyay, Reuters, 9/27; Rausch, Bloomberg, 9/27; Schencker, Chicago Tribune, 9/27; FDA release, 9/27; Nelson/Tucker, Medscape, 9/27).

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