ABBOTT PARK, Ill., Feb. 4, 2016
/PRNewswire/ -- Today, Abbott (NYSE: ABT) announced that it has
obtained CE Mark (Conformité Européenne) for the FreeStyle Libre
flash glucose monitoring system indicated for children and teens
with diabetes aged 4-17 years old.ii This means that
children and young people with diabetes living in Europe are able to experience the liberation
from the pain and hassle of routine finger pricks.i
A person with diabetes typically self-monitors their glucose by
pricking their fingers routinely to check their glucose level,
enabling appropriate adjustments to insulin, diet, and activity
based on their health care professionals' recommendations to help
achieve good glycemic control. However, according to
researchiii, there is often reluctance from people with
diabetes, especially children and adolescents, to perform this
task, based in part on the discomfort and pain of finger
pricking.
"I still wake up in the night to check my daughter's blood
glucose level with a [finger prick]. I'm very much looking forward
to the day that I can use a FreeStyle Libre instead, so that I
don't have to wake her up to check her levels," said Joanne Blackham, mother to a Type 1 person with
diabetes Madeleine, aged 13.
Abbott's FreeStyle Libre flash glucose monitoring system, which
is available in several European countries, 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 is worn on the back of
the upper arm for up to 14 days, eliminating the need for routine
finger pricks.ii In addition, no finger prick
calibration is needed—a key differentiator from current continuous
glucose monitoring systems.
"Children and teens with diabetes and their families have to
navigate many challenges in their daily lives as they care for this
complex condition," said Jared
Watkin, senior vice president, diabetes care, Abbott. "The
scientists and engineers at Abbott have made it their life's work
to provide the most innovative technology to help people with
diabetes improve their diabetes management and ultimately, live
happier and healthier lives."
In a recent accuracy study, Abbott's FreeStyle Libre flash
glucose monitoring system was clinically proven to be accurate,
stable and consistent for up to 14 days without the need for finger
prick calibration, for children and teens aged 4-17 years old. In
addition, more than 97 percent of these children and teens said
that the FreeStyle Libre system is easier to use than finger prick
testing.iv
According to the International Diabetes Federation (IDF), the
Europe region has the highest
number of children—ages 0-14—with type 1 diabetes compared with the
other IDF regions* – approximately 140,000. Within that region, the
United Kingdom, the Russia
Federation, and Germany have the
highest population of children with type 1
diabetes.v
"The availability of FreeStyle Libre for children is a critical
milestone for children living with diabetes," said Dr. Emanuele Bosi, associate professor, Department
of Endocrinology and Diabetology, Università Vita-Salute, San
Raffaele Hospital in Milan,
Italy." The technology in Abbott's FreeStyle Libre is
transformative because it changes how self-monitoring has been done
for decades—and is proven to be accurate and stable. I look
forward to seeing my young patients achieve better diabetes
management, while giving their parents and caretakers more peace of
mind."
Caregivers of children with diabetes also can be challenged as
they worry about such things as night-time hypoglycemia (a low
glucose level), which is the number one concern of parents of
children with diabetes, and a potentially life-threatening
condition. Authors of a 2013 study published in the journal Quality
of Life Research noted that people with diabetes — type 1 or type 2
— experience hypoglycemia while sleeping more frequently than many
doctors realize.vi A parent or caregiver often has
to wake their child up during the night to test glucose—now with
FreeStyle Libre flash glucose monitoring system that can be done
quickly, painlessly and without disturbing sleep.
Abbott's FreeStyle Libre system is currently available in
Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden
and the United Kingdom.
About Abbott:
At Abbott, we're committed to helping you live your 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, 74,000 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 @AbbottNews and
@AbbottGlobal.
i A finger prick test using a blood glucose
meter is required during times of rapidly changing glucose levels
when interstitial fluid glucose levels may not accurately reflect
blood glucose levels or if hypoglycaemia or impending hypoglycaemia
is reported by the system or when symptoms do not match the system
readings.
ii 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.
iii http://adc.bmj.com/content/89/6/516.full.pdf
iv Data on file, Abbott Diabetes Care, Inc., Evaluation
of the Accuracy of the Abbott Sensor Based Glucose Monitoring
System-Paediatric Label Extension Study (CE) (2015)
v 7th Edition of the IDF Diabetes Atlas,
chapter 4, http://www.diabetesatlas.org/
* IDF regions include Africa,
Europe, Middle East and North Africa, North American and Caribbean, South and Central America, South East Asia, and Western Pacific
vi Quality of Life Research, June 2013, Volume
22, Issue 5, pp 997-1004,
http://link.springer.com/article/10.1007/s11136-012-0234-3
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SOURCE Abbott