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News breaking: 2017-09-13

FreeStyle® Libre Flash Glucose Monitoring Technology Gains Reimburs..

ABBOTT PARK, Ill., Sept. 13, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the FreeStyle® Libre system is now available for reimbursement in the United Kingdom (UK). The National Health Service (NHS) Business Services Authority has approved the listing on the Drug Tariff for the FreeStyle Libre system for people with diabetes using insulin. This means that from Nov. 1, 2017 it will be available for reimbursementiii via the NHS across England and Wales, NHS Scotland, and the Health and Social Care in Northern Ireland.

"The FreeStyle Libre system has been shown to offer life-changing improvements for people with diabetes to help them live healthier and fuller lives," said Neil Harris, general manager of Abbott's UK diabetes care business. "We are delighted with the NHS decision, and we look forward to partnering with them to provide people with diabetes our innovative technology to help manage their condition."

Abbott's FreeStyle Libre system is designed to change how people with diabetes measure their glucose levels and ultimately help them achieve better health outcomes. The system automatically reads glucose levels through a sensor, approximately the size of a U.S. quarter, that is worn on the back of the upper arm for up to 14 days, eliminating the need for calibration and routine finger sticksi.

"FreeStyle Libre has allowed me to properly track my glucose – it's finally connected the dots when it comes to managing my diabetes," said Dave Sowerby, a 42-year old living with Type 1 diabetes from Lancashire, UK. "FreeStyle Libre more easily allows you to track how your glucose is changing versus using the finger stick method, as you can just scan on the go. This decision will allow people to finally take control of their condition, and understand it in a way they've never been able to before."

Two published clinical trialsiv,v, including one published in The Lancet, together with real-world evidence from more than 50,000 usersvi show that people with diabetes who use the FreeStyle Libre system scan their glucose levels an average of 15 times per day. The studies show that people who scan more frequently spend less time in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) and demonstrate improved glucose control overall. As such, use of the FreeStyle Libre system leads to improved diabetes management.

With the data from the FreeStyle Libre system, people can have a better understanding of their glucose levels through the Ambulatory Glucose Profile (AGP), a chart generated by the software that provides a visual snapshot of glucose levels, trends and patterns over time. It also provides doctors with deeper insights to make more informed treatment decisions.

Abbott's FreeStyle Libre system was introduced across Europe in 2014, and is now available in 41 countries and used by more than 300,000vii people with diabetes around the world. The UK now joins a group of 17 partially or fully reimbursed countries including France, Germany and Japan.

Diabetes in the UKApproximately 6 percent of the UK population, about 3.5 million people, are diagnosed with diabetes.viii It is predicted that up to 549,000 people in the UK have diabetes that is yet to be diagnosed.ix

About the FreeStyle Libre SystemAbbott's FreeStyle Libre system is designed to change how people with diabetes measure their glucose levels and ultimately help them achieve better health outcomes. The system reads glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days, eliminating the need for routine finger sticksi. In addition, no finger stick calibration is needed—a key differentiator from current consumer continuous glucose monitoring systems. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration.x

About AbbottAt Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @FreeStyleDiabet, @AbbottNews and @AbbottGlobal.

i A finger stick test using a glucometer is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels; or if hypoglycemia or impending hypoglycemia is reported by the system; or when symptoms do not match the system readings ii Data on File, Abbott Diabetes Care Inc, Clinical Report: Evaluation of the Accuracy of the Abbott Sensor-Based Interstitial Glucose Monitoring System 2014  iii Pending local health economy approval through the UK Clinical Commissioning Groups iv Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11 v Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial [published online September 12, 2016]. The Lancet. 2016; Haak, T., Hanaire, H., Ajjan, R., Hermanns, N., Riveline, J., & Rayman, G. (2016, February) vi Dunn TC, Xu Y, Hayter G. "Evidence of a strong association between frequency of flash glucose monitoring and glucose control measures during real-world usage." Diabetes Technology & Therapeutics, Volume 19, Supplement 1, 2017 vii Data on file, Abbott Diabetes Care, Inc viii DiabetesUK.org, https://www.diabetes.org.uk/Professionals/Position-statements-reports/Statistics/Diabetes-prevalence-2016/ ix Diabetes Facts and Stats: 2015 - Diabetes UK, published 2015 x Pending FDA approval. Not available for sale in the United States