The Libre system gathers blood glucose data every minute via a coin-sized sensor worn on the back of the upper arm. The device doesn’t even require preliminary finger-prick-based calibration, Abbott said.
Libre analyzes glucose levels in the interstitial fluid with a filament inserted and held just under the skin. The system includes a scanner that collects results when in close proximity, even when the sensor is beneath clothing. The sensor is water-resistant and disposable after being worn for up to 14 days as it constantly takes measurements that can then be captured and recorded by the handheld scanner.
"The FreeStyle Libre System fulfills a major need for people living with diabetes," Abbott Diabetes Care senior vice president Robert Ford said in prepared remarks. "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. Addressing these concerns has guided the development of FreeStyle Libre – a transformational product designed to not only remove the pain of finger pricking but also seamlessly integrate into their daily lives."
Libre is the 1st device of its kind coming out of Abbott’s Flash glucose monitoring development initiative and the company is still enrolling patients in a randomized clinical trial evaluating the wearable sensor in comparison with standard blood glucose monitoring with finger-pricks, according to a note from Wells Fargo analysts Larry Biegelsen, Lei Huang, Craig Bijou and Dr. David Brill. Good results could give Abbott a leg up over its European competition and justify a price boost for the Libre system, the analysts wrote prior to news of the CE Mark.
In addition to capturing near-constant blood glucose levels, each scan also collects 8-hour history and maps the direction that blood glucose is heading in order to "help people determine how to modify food and other behaviors to better manage their diabetes in consultation with their healthcare professionals."
Abbott is a major player in the diabetes market and its FreeStyle line of devices includes glucose testing strips and meters as well as insulin syringes. Around this time last year the company won CE Mark approval for its FreeStyle Optium Neo combined glucose and ketone monitor.