- The FreeStyle Libre 3 system is the most accurate 14-day
continuous glucose monitor1, with readings sent directly
to a smartphone every minute.2
- Designed for access and affordability, the FreeStyle Libre 3
system will be available at the same price as previous versions,
which is one-third the cost of other competing continuous glucose
monitoring systems available today.3,4
ABBOTT
PARK, Ill., May 31, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) today announced the
U.S. Food and Drug Administration (FDA) cleared its next-generation
FreeStyle Libre 3 system for use by people four years and
older6 living with diabetes.
"The FreeStyle Libre 3 system is a direct result of listening to
our customers – and giving them the innovation and sensing
technology they've been looking for," said Jared Watkin, senior vice president of Abbott's
diabetes care business. "It's a game changer for the millions
of people living with diabetes. They'll be able to manage their
health minute-by-minute with the world's smallest and thinnest
sensor and most accurate 14-day continuous glucose monitoring
system."
FreeStyle Libre 3 System Features:
- Greatest accuracy – with a 7.9% overall mean absolute
relative difference (MARD), the FreeStyle Libre 3 system is the
most accurate 14-day continuous glucose monitor (CGM) with readings
sent directly to a smartphone every minute.6 It's the
first CGM to demonstrate a sub-8% MARD1,6 – which is the
standard way to measure continuous glucose accuracy – the lower
percentage, the better.
- Smallest and thinnest – at the size of two stacked U.S.
pennies (worn inconspicuously on the back of one's upper arm),
it's the smallest and thinnest4,7 CGM sensor in the
world.
- Even easier to use – with a one-piece applicator the
sensor is uncomplicated to apply.4
- Strongest Bluetooth® integration with a range
of up to 33 feet – 50% further range than other
CGMs.4,8
Priced for Access and Affordability
Abbott will price
the FreeStyle Libre 3 system the same as previous
versions9 with the goal of enabling the greatest number
of people living with diabetes to benefit from the next-generation
technology.
"We continue to disrupt the notion that CGMs have to sacrifice
quality or accuracy for affordability," said Watkin. "Access
to breakthrough diabetes technologies should not be out of reach
for the people who can benefit most from them. Innovation for
access and affordability is a core pillar in Abbott's business and
sustainability strategy."
There is a vast and growing need for new innovations in diabetes
care. There are now more than 133 million Americans living with
diabetes or prediabetes (nearly half of the U.S. population),
according to the American Diabetes Association.10 The
organization also notes that diabetes is the most common underlying
chronic condition in the U.S. and 1.4 million Americans aged 18
years or older are newly diagnosed with diabetes each year, which
equates to one every 23 seconds.10
"I have seen real-world evidence that diabetes technologies like
CGMs have helped my patients safely achieve improved glycemic
control," said Dr. Eugene E. Wright,
Jr., consulting associate at Duke
University's department of medicine. "I applaud Abbott
for making their CGM system the most affordable and addressing
disparities in care so patients living with diabetes can avoid
complications and optimize their quality of life."
Digital Health Tools
The FreeStyle Libre 3 system was
cleared for use with the FreeStyle Libre 3 iOS and Android mobile
apps, which enable users to view their glucose levels in real time,
track their glucose history and trends, and set up optional alarms
plus notifications to help them be alerted of serious medical
events like hypoglycemia.11
The mobile app integrates with the FreeStyle Libre digital
ecosystem, including LibreView and LibreLinkUp,12,13,14
enabling caregivers and healthcare professionals to remotely
monitor loved ones and patients as needed.
Availability
The FreeStyle Libre 3 sensor will be
available at participating pharmacies later this
year.15
Recognized Health Tech Innovator
Over the last year,
the FreeStyle Libre 3 system has been recognized multiple
times16 as a top health tech innovation by:
- Consumer Technology Association's 2022 Consumer Electronics
Show (CES) Best Health & Wellness Innovation
- The Edison 2022 Gold Award for Science & Medical,
Technology & Tools
- Business Intelligence Group's 2022 Healthcare Innovation
Award
- Medical Device and Diagnostic Industry's 2022 Medical Design
Excellence Bronze Award for Digital Health Products and Mobile
Medical Apps; and
- Lucintel's 2021 Product Innovation Award in the Biosensors
Market
The FreeStyle Libre portfolio is the most widely used continuous
glucose monitoring system in the U.S. and worldwide and has changed
the lives of approximately four million people across more than 60
countries.17 Abbott has secured partial or full
reimbursement for the FreeStyle Libre system in over 40 countries,
including Canada, France, Germany, Japan, the United
Kingdom, and the U.S.5 For more information visit
FreeStyleLibre.com.
Indications and Important Safety Information
Failure
to use FreeStyle Libre 3 system as instructed in labeling may
result in missing a severe low or high glucose event and/or making
a treatment decision, resulting in injury. If glucose alarms and
readings do not match symptoms or expectations, use a fingerstick
value from a blood glucose meter for treatment decisions. Seek
medical attention when appropriate or contact Abbott at
855-632-8658 or FreeStyleLibre.us safety info.
About Abbott Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
113,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews.
- Data on File, Abbott Diabetes Care. Comparison based on
publicly available information.
- The FreeStyle Libre 3 app is only compatible with certain
mobile devices and operating systems. Please check our website for
more information about device compatibility before using the app.
Use of the FreeStyle Libre 3 app requires registration with
LibreView.
- Notifications will only be received when alarms are turned on
and the sensor is within 33 feet unobstructed of the reading
device. You must enable the appropriate settings on your smartphone
to receive alarms and alerts, see the FreeStyle Libre 3 User's
Manual for more information.
- Data on file, Abbott Diabetes Care.
- Based on a comparison of list prices of FreeStyle Libre 3
system versus competitors' CGM systems. The actual cost to
patients may or may not be lower than other CGM systems, depending
on the amount covered by insurance, if any. Does not include
Medicare, Medicaid, and uninsured patients. At this time,
FreeStyle Libre 3 is not currently eligible for Medicare
reimbursement, and Medicaid eligibility may vary by state. Abbott
provides this information as a courtesy, it is subject to change
and interpretation. The customer is ultimately responsible for
determining the appropriate codes, coverage, and payment policies
for individual patients. Abbott does not guarantee third party
coverage or payment for our products or reimburse customers for
claims that are denied by third party payers.
- FreeStyle Libre 3 User's Manual.
- Among patient-applied sensors.
- Based on the signal range in Dexcom G6 CGM User Guide and
Medtronic Guardian Connect System User Guide.
- Based on a comparison of list prices of the FreeStyle Libre 3
system versus previous generations of FreeStyle Libre Personal CGM
systems.
- American Diabetes Association, Fast Facts: Data and Statistics
about Diabetes, from the National Diabetes Statistics Report,
2022.
- Notifications will only be received when alarms are turned on
and the sensor is within 33 feet unobstructed of the reading
device. You must enable the appropriate settings on your smartphone
to receive alarms and alerts, see the FreeStyle Libre 3 User's
Manual for more information.
- The user's device must have internet connectivity for glucose
data to automatically upload to LibreView and to transfer to
connected LibreLinkUp app users.
- LibreView is ISO27001/27018/27701 certified and HITRUST CSF
Certified.
- The LibreView data management software is intended for use by
both patients and healthcare professionals to assist people with
diabetes and their healthcare professionals in the review, analysis
and evaluation of historical glucose meter data to support
effective diabetes management. The LibreView software is not
intended to provide treatment decisions or to be used as a
substitute for professional healthcare advice.
- At this time, FreeStyle Libre 3 is not currently eligible for
Medicare reimbursement, and Medicaid eligibility may vary by
state.
- CES Innovation Award; Edison Awards; BIG Innovation Awards;
Medical Design Excellence Awards; and Lucintel Award of
Excellence.
- Data on file, Abbott Diabetes Care. Data based on the number of
users worldwide for the FreeStyle Libre portfolio compared to the
number of users for other leading personal use, sensor-based
glucose monitoring systems.
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SOURCE Abbott