ABBOTT PARK, Ill., Sept. 28, 2016
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the
U.S. Food and Drug Administration (FDA) has approved the company's
FreeStyle Libre Pro system, a revolutionary continuous glucose
monitoring (CGM) system for healthcare professionals to use with
their patients with diabetes.
FreeStyle Libre Pro system is
designed to empower healthcare professionals to provide better
diabetes management for diabetes patients. The system provides
healthcare professionals with a visual snapshot of glucose data,
known as the Ambulatory Glucose Profile (AGP), giving a more
simplified and clear overview of not only glucose levels, but also
patterns and trends within those levels. This valuable information
helps healthcare professionals make better, customized treatment
decisions for their patients – and for a significantly lower cost
than other professional CGM products availablei.
On nearly a daily basis, Eugene E. Wright, Jr., M.D. of
Duke Southern Regional Area Health Education Center in
Fayetteville, N.C., finds it
challenging to effectively treat his patients with diabetes when it
comes to decisions around insulin, nutrition and medication.
"My patients are often out of range, due to inconsistent
self-monitoring and insufficient data from traditional glucose
meters that are unable to provide a full view of their glucose
levels."
"FreeStyle Libre Pro transforms how doctors assess their
patients' diabetes," said Jared
Watkin, senior vice president, Diabetes Care, Abbott. "This
novel technology provides a solution to the ongoing challenge of
the need for complete and dependable glucose data. This data is
imperative for not only the doctor, but also for the patient to
help them achieve optimal health."
The FreeStyle Libre Pro System—How it Works
Abbott's
FreeStyle Libre Pro system is applied to patients by healthcare
professionals in a clinic setting. A healthcare professional
applies a small, round sensor on the back of the patient's upper
arm. The water-resistantii and disposable sensor is held
in place with a self-adhesive pad and remains on the back of the
arm for up to 14 days, requiring no patient interaction with the
device or the need for the patient to draw blood via a fingerstick
to calibrate the sensor.
The sensor continuously measures glucose in interstitial fluid
through a small (5mm long, 0.4mm wide) filament that is inserted
just under the skin. It records glucose levels every 15 minutes,
capturing up to 1340 glucose results for up to 14 days, giving the
treating doctor comprehensive data for a complete glycemic profile
of their patient. After 14 days, the patient returns to the
doctor's office, where the doctor uses a FreeStyle Libre Pro reader
to scan the sensor and download the 14-days' worth of glucose
results that are stored in the sensor – in as little as
five seconds.
Abbott's FreeStyle Libre Pro system has a number of key
advantages compared to other professional CGM systems,
including:
- Convenient for both the doctor and the patient. With the
FreeStyle Libre Pro system there is no requirement for fingerstick
calibration so patients do not need to be trained by their
healthcare professional on calibration. After the sensor is applied
to the patient, there is no requirement for the patient to interact
with the system.
- Provides reliable glucose data. Healthcare professionals
receive up to 14 days of continuous glucose data based on
uninterrupted, normal daily routines of their patients.
- Reduce equipment costs, maintenance and time. FreeStyle
Libre Pro system costs significantly
less than other professional CGM products on the
marketi. The doctor's office only needs to purchase one
FreeStyle Libre Pro reader for multiple patients without having to
spend on extra recorders, receivers and transmitters, or devote
time to routine disinfecting or recharging patient use components.
In addition to the glucose sensor, other professional CGM systems
require reusable hardware components, such as receivers,
transmitters, and recorders that must go home with each patient to
perform the professional CGM assessment.
Ambulatory Glucose Profile—a Complete Glycemic
Profile
The FreeStyle Libre Pro system provides patients
and their physicians with an Ambulatory Glucose Profile (AGP), a
report developed by the International Diabetes Center that is
presented in a single, user-friendly, visual chart providing
healthcare professionals a complete glycemic view of their
patients' glucose trends for up to 14 days.
The AGP report helps identify when a patient is out of glucose
range, and provides hypoglycemic and hyperglycemic trends and
patterns. These insights help facilitate more meaningful
discussions between a doctor and the patient.
Dr. Wright added, "This technology is groundbreaking because
continuous glucose monitoring systems for professional use have
been long considered a niche, cumbersome, and expensive technology
for mostly Type 1 patients. The FreeStyle Libre Pro system changes
this paradigm not only because of the unique technology but because
it doesn't require fingerstick calibration, is easier to use, more
affordable, and is more accessible to people with diabetes."
The FreeStyle Libre Pro system is part of Abbott's FreeStyle
family of products including the sensing technology for consumers,
the FreeStyle Libre system.
Abbott recently submitted the consumer version of the FreeStyle
Libre system for review by the U.S. Food and Drug Administration.
The consumer version of the FreeStyle Libre system is designed to
be a continuous glucose monitoring system that does not require
fingerstick calibration, and measures glucose levels through a
small sensor on the back of the upper arm for up to 14 days.
Patients can self-monitor their glucose levels by scanning a reader
over the sensor as often as desired to get a reading.
About Diabetes and Diabetes Monitoring
According to
the International Diabetes Federation, the U.S. has one of the
highest prevalence rates for diabetes, with 29.1 million people (or
9 percent of the U.S. population) who have diabetes. A recent
survey of 1,527 people with Type 2 diabetes found that 40 percent
do not test glucose levels as frequently as recommended by their
doctors. Reasons for testing less often than recommended include
expense of testing strips (31 percent), dislike of pricking fingers
to draw blood for testing (29 percent), and forgetting to test
because they feel fine (26 percent).iii
Traditionally, continuous glucose monitoring devices have
primarily been used by people with Type 1 diabetes whom are
required to take insulin. However, both Type 1 and Type 2 diabetes
patients can experience conditions such as hypoglycemia (low blood
sugar) which can be life-threatening, especially when not detected.
Because the FreeStyle Libre Pro system provides rich, insightful
data, patterns that might otherwise be missed—such as nighttime
hypoglycemia—glucose levels excursions can be detected and
therefore managed.
Abbott's FreeStyle Libre Pro system will be available to U.S.
healthcare professionals in the coming weeks. For more
information, including important safety information, please go to
www.FreeStyleLibrePro.us.
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 Dexcom and Medtronic Professional CGM Order Forms,
2015
ii Sensor is water-resistant in up to 1 metre of water.
Do not immerse longer than 30 minutes.
iii These are findings from an Ipsos poll conducted
August 19-September 1, 2016. For the
survey, a sample of roughly 2,679 adults age 18+ from the
continental U.S., Alaska and
Hawaii was interviewed online in
English. The sample includes 1,152 adults with Type I diabetes and
1,527 adults with Type 2 diabetes. The poll also has a credibility
interval plus or minus 3.3 percentage points for those with Type 1
diabetes and plus or minus 2.9 percentage points for those with
Type 2 diabetes. Data on file.
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