European authorities have issued the CE Mark to Abbott to market its FreeStyle Libre Flash Glucose Monitoring System. The continuous glucometer consists of a water resistant sensor that is attached to the back of the upper arm and a device that copies and displays the readings from the sensor.
The sensor records blood glucose levels every minute, sampling the interstitial fluid using a 5mm long and .4 mm wide filament that penetrates the skin. It doesn’t require any finger prick calibration, unlike all other currently available continuous glucose monitors. The display device takes only a second to copy the readings from the sensor and shows up to 90 days of historical trends.
More from the announcement:
The majority of people with diabetes are not at their target glucose levels often because the data generated by their glucose meters don’t provide a clear picture of where their glucose has been in the past or how their actions impact their glucose levels. The FreeStyle Libre System provides users and their physicians with the Ambulatory Glucose Profile (AGP), a report providing a visual snapshot of a person′s typical day by utilizing dense glucose data revealing hypoglycemic and hyperglycemic trends to facilitate better patient therapy and education. The data are presented in a single, user-friendly, visual chart providing health care professionals the vantage point to link glucose trends to clinical decision-making, enabling a more productive discussion between health care provider and patient. For more information, go to www.AbbottNextFrontier.com.
A recent study conducted by Abbott7 has shown that the FreeStyle Libre System is clinically proven to be accurate, stable and consistent over 14 days without the need for finger prick calibration. More details on this study will be made available during the Abbott Symposium at the European Association for the Study of Diabetes (EASD) medical conference September 15.