Abbott has 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 sticks for people with diabetes. This reimbursement decision will mean access to the FreeStyle Libre system for hundreds of thousands of people from age four 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 sticking 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 trials and real-world evidence from more than 50,000 users 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.
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 sticks. In addition, no finger stick calibration is needed—a key differentiator from current continuous glucose monitoring systems. In the US, the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration.