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