PARIS, May 8, 2017 /PRNewswire/ -- Abbott today announced that the French Health Ministry has granted national reimbursement across France for FreeStyle® Libre—Abbott's revolutionary glucose monitoring technology that removes the need for routine finger sticks1 for people with diabetes. This reimbursement decision will mean access to the FreeStyle Libre system for hundreds of thousands of people from age four3 across France with both Type 1 and Type 2 diabetes who use insulin multiple times per day.
As part of the evaluation published in July 2016, the French Health Technology Assessment (HTA) body – Haute Autorité de Santé (HAS) – issued a positive opinion stating that FreeStyle Libre provides added clinical value (category of ASAIII) over the current standard of care for people with diabetes who use insulin multiple times per day. Unlike older continuous glucose monitoring (CGM) technology, FreeStyle Libre is now the first glucose sensing product to obtain the ASAIII category leading to a reimbursement agreement.
"Our goal is to develop breakthrough technologies that improve people's lives, and we thank the HAS and the French Health Ministry for recognizing the great benefit FreeStyle Libre has and for ensuring that people in France have wide access to this innovation," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "We share a common goal—to make the best technology available to people with diabetes so that they have access to the information that they need to live healthier lives."
The FreeStyle Libre system eliminates the challenges of routine finger sticking1 for people with diabetes. With the data from the device, they 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.
"People with diabetes find finger sticking painful and cumbersome so they often don't test as frequently as they should," said Hélène Hanaire, M.D., University Hospital Center of Toulouse, Toulouse, France. "Having easier access to technology like FreeStyle Libre is going to increase freedom for individual patients on a larger scale, and ultimately change how they—and we—manage diabetes going forward."
Abbott's FreeStyle Libre system was introduced across Europe in 2014, and is now available in more than 30 countries and used by more than 300,0004 people with diabetes around the world. Two published clinical trials5 and real-world evidence from more than 50,000 users6 show that people who use FreeStyle Libre system test their glucose levels an average of at least 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) while having improved average glucose levels, demonstrating improved glucose control overall.
About the FreeStyle Libre System
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 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 sticks1. In addition, no finger stick calibration is needed—a key differentiator from current continuous glucose monitoring systems. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration7.
At 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.
1 A fingerstick 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
2 Data on file, Abbott Diabetes Care, Inc.
3 A caregiver at least 18 years old is responsible for supervising, managing, and assisting the child or young person ages 4-17 years old in using the FreeStyle Libre system and interpreting its readings
4 Data on file, Abbott Diabetes Care, Inc.
5 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]. Lancet. 2016
6 Data on file. Dunn T, Xu Y, Hayter G; Evidence of a Strong Association Between Frequency of Flash Glucose Monitoring and Glucose Control Measures During Real-World Usage
7 Pending FDA approval. Not available for sale in the United States