No More Finger Pricks? EU Okays New Glucose Monitoring System

Miriam E. Tucker

September 05, 2014

A novel glucose monitoring system, Abbott's Freestyle Libre, has been licensed for use in the European Union.

The system measures interstitial tissue glucose levels every minute via a disposable round sensor about the size of a €2 coin, with a small catheter inserted under the skin, worn on the back of the upper arm for up to 14 days. The wearer scans the sensor with a reader, which generates a real-time glucose test, an 8-hour trend history, and the direction glucose is heading.

The Libre received the CE Mark on September 3 and will soon be available in France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom (and also available for purchase online in those countries).

While the system has several features in common with currently available continuous glucose monitoring (CGM) devices, the company is not classifying it as such.

"The FreeStyle Libre System is not a CGM device — with FreeStyle Libre Abbott has developed a new category, of flash glucose monitoring," a company spokesperson told Medscape Medical News.

Indeed, unlike current CGM devices, the Libre is approved as an alternative to routine blood glucose monitoring, and diabetes patients can use the results to guide therapeutic decisions.

However, finger-stick measurements are still required when blood glucose levels are rapidly changing, since interstitial fluid glucose levels may not accurately reflect the current blood level.

Finger-stick testing is also advised when the system reports hypoglycemia or impending hypoglycemia or when the patient's symptoms don't match the device's readings.

But also in contrast to current CGMs, the Libre is factory-calibrated so it doesn't require finger-stick blood glucose measurements for calibration.

"The FreeStyle Libre System is clinically proven to be accurate, stable, and consistent over 14 days without the need for finger-prick calibration," the spokesperson added.

These data on the new system will be presented during a symposium at the upcoming European Association for the Study of Diabetes (EASD) meeting on September 15, she said.

The system's software enables the figures to be presented in a visual chart for healthcare professionals and patients. More information on that is available at http://www.AbbottNextFrontier.com.

The spokesperson told Medscape Medical News that Abbott is not currently projecting a time line for the system in the United States, but "we have had positive discussions with the [Food and Drug Administration], [with] more to come in the next few months."

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