NEW YORK (360Dx) – Abbott said today that the French Health Ministry has granted national reimbursement for its FreeStyle Libre glucose monitoring technology that removes the need for routine finger sticks for people with diabetes.
As a result, hundreds of thousands of people from age 4 and up throughout France who have type 1 or type 2 diabetes, and who use insulin multiple times per day, will have access to the system, Abbott said.
The firm noted that according to an evaluation published in July 2016 by a French health technology assessment body, Haute Autorité de Santé, FreeStyle Libre provides added clinical value over the current standard of care, making it the first glucose sensing product to obtain the ASAIII category.
"People with diabetes find finger sticking painful and cumbersome, so they often don't test as frequently as they should," Hélène Hanaire, a doctor at the University Hospital Center of Toulouse, France, said in a statement. "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."
Two published clinical trials and evidence from more than 50,000 users show that people who use the FreeStyle Libre system test their glucose levels an average of at least 15 times per day, Abbott said.
The studies show that people who scan more frequently spend less time in hypoglycemia, with low blood sugar, or hyperglycemia, with high blood sugar; exhibit improved average glucose levels; and demonstrate improved glucose control overall, Abbott said.
Diabetes patients usually use a glucometer and finger-stick test to keep track of glucose levels that are rapidly changing. Abbott noted that its system not only eliminates the challenges of routine finger sticking, but it also provides patients with "a better understanding of their glucose levels through the Ambulatory Glucose Profile," a chart generated by software that provides a visual snapshot of glucose levels, trends, and patterns over time, and provides doctors with "deeper insights to make more informed treatment decisions."
Abbott introduced the system in Europe in 2014. It’s available in more than 30 countries and used by more than 300,000 people globally, the firm said, and it now has either full or part reimbursement in 13 European countries, including Austria, Germany, Italy, and Sweden. France is the second-largest market globally for the system, the firm added. The system is pending US Food and Drug Administration approval and, therefore, not available for sale in the US.