Abbott receives Australian nod for FreeStyle Libre Flash Glucose Monitoring System for diabetics
Abbott announced that it has received approval from the Therapeutic Goods Administration (TGA) in Australia for its FreeStyle Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for insulin-using Australians with diabetes. The system eliminates the need for routine finger pricks, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed -- a key differentiator from current continuous glucose monitoring systems.
Abbott's FreeStyle Libre System consists of a small, round sensor -- approximately the size of two stacked Australian 20-cent coins -- worn on the back of the upper arm; the system measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A handheld reader is scanned over the sensor to get a glucose result painlessly in less than one second, without the need to draw blood routinely. Each scan displays a real-time glucose result, a historical trend and the direction the glucose is heading. The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. The FreeStyle Libre System software enables the data to be presented in a user-friendly, visual chart driving a more productive discussion with health care professionals around treatment and any necessary modification to it.
"We know through our research that pain, inconvenience and indiscretion of finger pricking were the key reasons people with diabetes aren't managing their diabetes as well as they should," said Jared Watkin, senior vice president, Diabetes Care, Abbott.
"Addressing these concerns has guided the development of FreeStyle Libre - a transformational product designed to not only remove the pain of routine finger pricking1 but also seamlessly integrate into daily lives - empowering people with diabetes to make better-informed treatment decisions and live their best lives through better health."
According to the International Diabetes Federation, there are 415 million people around the globe living with diabetes, and that number is projected to increase to 642 million by the year 2040--215 million of which will be in the Western Pacific region. The FreeStyle Libre System eliminates the challenges of routine finger pricking for insulin-using adults with diabetes aged 18 years and older, enabling them to maintain a better understanding of their glucose levels.
"People with diabetes find finger pricking to be painful and inconvenient and in turn, they often test glucose levels less frequently, which can then lead to suboptimal diabetes management," said Prof. Stephen Twigg, head of the Department of Endocrinology, RPA Hospital and Kellion Professor of Endocrinology at the University of Sydney.
"The FreeStyle Libre System will significantly advance the field of glucose monitoring, by offering not only a convenient and painless way to acquire more frequent glucose readings, but also in enabling detailed actionable glucose profiles, to help both healthcare professionals and their patients to better manage diabetes and people to live healthier lives."
The FreeStyle Libre System is currently available in several countries in Europe, and will be available in Australia in the coming months.