Abbott glucose monitor eliminates finger sticks, receives CE mark

Abbott's FreeStyle Libre Flash glucose monitoring system--Courtesy of Abbott

Some European diabetics may soon find they no longer need finger sticks to manage their disease. That's because Abbott's ($ABT) FreeStyle Libre Flash has received a CE mark. The system uses a small sensor attached to the back of the arm to detect glucose levels via a tiny filament. And, unlike other continuous glucose monitors, this one doesn't require a twice-daily finger-stick blood glucose measurement for calibration.

Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.

"The FreeStyle Libre System fulfills a major need for people living with diabetes," Robert Ford, Abbott's SVP of Diabetes Care, said in a statement. "Our customers told us that the pain, inconvenience and indiscretion of finger pricking were the key reasons they weren't managing their diabetes as well as they should."

The system includes a small sensor--about the size of a quarter or a two-euro coin--that can be worn on the back of the upper arm for up to 14 days. It has a small filament (5 mm long and 0.4 mm wide) that is inserted just under the skin and is held in place by an adhesive pad.

A handheld reader is then scanned within 1 cm to 4 cm over the sensor each time to get a glucose result. Scanning takes about one second and can be done over clothing. The reader holds up to 90 days of glucose level data. With each reading, the user receives a current glucose reading, an 8-hour history and information on the direction the glucose levels are headed.

There are 382 million diabetics globally, 56 million of whom live in Europe. The number of diabetics is expected to grow by more than 20% by 2035, according to the International Diabetes Federation.

The system will be available for sale "in the coming weeks" in France, Germany, Italy, Netherlands, Spain, Sweden and the U.K., including through online sites. Abbott will provide detailed data on it at the European Association for the Study of Diabetes conference on Sept. 15.

Freestyle Libre is headed to the U.S., but the company had declined to disclose a timeline. And there are high expectations for its sales potential. About the system, Abbott chairman and CEO Miles White said on a July earnings call, "That, we believe, will be a significant growth driver for this business here over time, and it will come to the U.S. and it will be a global product."

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