ABBOTT PARK, Ill., Jan. 4, 2018
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the
FreeStyle® Libre System, the company's revolutionary new
continuous glucose monitoring (CGM) system, is now available to
Medicare patients, having met the codes for therapeutic CGM systems
used for coverage by the U.S. Centers for Medicare & Medicaid
Services (CMS). Coverage includes all Medicare patients with
diabetes who use insulin and who meet the eligibility
criteria2.
The factory-calibrated FreeStyle Libre system is the only CGM
system recognized by Medicare that requires no user calibration
whatsoever (either by fingerstick or manual data entry). The system
also does not require the need for routine
fingersticks1. The high accuracy of the FreeStyle Libre
system allows for patients to dose insulin based on the
results1.
"At Abbott, we are continuously challenging ourselves to ensure
our innovative technology is accessible to the majority of people
who need it," said Jared Watkin,
senior vice president, Diabetes Care, Abbott. "CMS's recognition of
this revolutionary health technology, which removes the need for
any user calibration, is ultimately going to empower Medicare
beneficiaries with diabetes to live better, healthier lives."
Designed to be approachable, accessible and affordable for the
30 million people with diabetes in the
United States3, the FreeStyle Libre system reads
glucose levels through a sensor that is worn on the back of the
upper arm for up to 10 days, making it the longest lasting personal
glucose sensor available in the U.S.
FREESTYLE LIBRE AND OTHER CGM TECHNOLOGY
Key differences between the FreeStyle Libre system and other CGM
technology include:
- FreeStyle Libre system is factory calibrated so it requires no
user calibrations for accuracy, including any manual data entry or
the need for routine fingersticks1 –therefore removing
the additional costs and burden of blood glucose monitoring to the
patient
- FreeStyle Libre system includes only two pieces (sensor,
reader) vs. three for alternative systems (sensor, reader,
transmitter), making it much less cumbersome to use
- For non-Medicare patients, FreeStyle Libre system is available
at major U.S. retail pharmacies, removing the barrier of
complicated paperwork necessary for commercial insurance coverage
and making it more readily accessible to patients
"The accessibility and affordability of this CGM technology is
unprecedented, and this is a huge step forward for the diabetes
community—both Type 1 and Type 2," said George Grunberger, M.D., chairman, Grunberger
Diabetes Institute. "More importantly, the evidence of FreeStyle
Libre being used in the real-world shows how people are getting
better insights into their glucose levels with this product and
achieving better glycemic control – that's something that you can't
put a price to."
Last year, CMS announced coverage for therapeutic
CGM4 for certain beneficiaries who have either Type 1 or
Type 2 diabetes and intensively manage their insulin. To be
included in this category, the device must be approved by the U.S.
Food & Drug Administration (FDA) for use in place of a blood
glucose monitor (BGM), enabling patients to make treatment
decisions based on the information provided. With the recent
approval by the FDA, the FreeStyle Libre system can be used as a
replacement for BGM1.
HOW THE FREESTYLE LIBRE SYSTEM WORKS
With the FreeStyle Libre system, people with diabetes can:
- Self-apply the sensor, which is approximately the size
of two stacked quarters, to the back of the upper arm.
- Capture real-time glucose readings with one-second
painless scans of a small hand-held reader over the sensor.
- Identify glucose level trends (high, low, stable) with a
directional arrow and review eight hours of glucose history.
- Receive glucose readings through clothing,5 making
testing more convenient and discreet6. The
FreeStyle Libre sensor is also water-resistant7, and can
be worn in the shower and during swimming.
- Avoid interference with acetaminophen, an active
ingredient in more than 500 common over-the-counter medications,
which can falsely raise reported glucose levels in certain CGMs to
appear as if they are at dangerously high levels8.
WHERE YOU CAN FIND THE FREESTYLE LIBRE SYSTEM
- Medicare patients can access the FreeStyle Libre system by
prescription through Edgepark Medical Supplies, Byram Healthcare,
Solara Medical Supplies, Edwards Health Care Services, Better
Living Now and Mini Pharmacy in the U.S.
- For non-Medicare patients, the FreeStyle Libre system is also
available at five major retail pharmacies in the country (CVS,
Walgreens, RiteAid, Walmart and Kroger).
The FreeStyle Libre system is now being used by more than
400,000 people across more than 40 countries9. Abbott
has secured partial or full reimbursement for the FreeStyle Libre
system in 21 countries, including France, Japan, the United
Kingdom and now the U.S. For more information, please visit:
www.freestylelibre.us.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
The FreeStyle Libre Flash Glucose Monitoring system is a
continuous glucose monitoring (CGM) device indicated for replacing
blood glucose testing and detecting trends and tracking patterns
aiding in the detection of episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term therapy
adjustments in persons (age 18 and older) with diabetes. The system
is intended for single patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan,
X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be
due to low or high blood glucose, hypoglycemic unawareness, or
dehydration. Check sensor glucose readings with a blood glucose
meter when Check Blood Glucose symbol appears, when symptoms do not
match system readings, or when readings are suspected to be
inaccurate. The FreeStyle Libre system does not have alarms unless
the sensor is scanned, and the system contains small parts that may
be dangerous if swallowed. The FreeStyle Libre system is not
approved for pregnant women, persons on dialysis, or critically-ill
population. Sensor placement is not approved for sites other than
the back of the arm and standard precautions for transmission of
blood borne pathogens should be taken. The built-in blood glucose
meter is not for use on dehydrated, hypotensive, in shock,
hyperglycemic-hyperosmolar state, with or without ketosis,
neonates, critically-ill patients, or for diagnosis or screening of
diabetes. Review all product information before use or contact
Abbott Toll Free (855-632-8658) or
visit www.freestylelibre.us for detailed indications for use and
safety information.
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 Fingersticks are required for treatment decisions
when you see Check Blood Glucose symbol, when symptoms do not match
system readings, when you suspect readings may be inaccurate, or
when you experience symptoms that may be due to high or low blood
glucose
2 Local Coverage Article: Glucose Monitor Policy Article
(A52464), May 2017
3 Center for Disease Control,
https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html
4 Centers for Medicare & Medicaid Services Ruling
CMS-1682-R: "Classification of Therapeutic Continuous Glucose
Monitors as 'Durable Medical Equipment' under Medicare Part B,"
January 12, 2017
5 The reader can capture data from the sensor when it is
within 1cm to 4cm of the sensor.
6 Data on file. Abbott Diabetes Care
7 Sensor is water-resistant in up to 1 meter (3 feet) of
water. Do not immerse longer than 30 minutes
8 Data on file, Abbott Diabetes Care
9 Data on file, Abbott Diabetes Care
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SOURCE Abbott