- Abbott's world's leading1 and affordable2
integrated continuous glucose monitoring (iCGM) sensors are cleared
for connectivity with automated insulin delivery (AID) systems in
- Sensors also cleared for use by children as young as two years
old, for use by women with diabetes who are pregnant, and for wear
time up to 15 days
PARK, Ill., March 6,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated
continuous glucose monitoring (iCGM) system sensors for integration
with automated insulin delivery (AID) systems. Abbott modified the
sensors to enable integration with AID systems.
"Our goal is to make diabetes care as easy as possible," said
Jared Watkin, senior vice president
for Abbott's diabetes care business. "The FreeStyle Libre portfolio
is already the most prescribed CGM in the United States³ and, with
the integration of automated insulin delivery systems, people in
the U.S. will soon have an affordable2 option to pair
with insulin pumps. This means less time thinking about diabetes
and more time living."
AID systems help people manage daily diabetes care by
automatically adjusting and administering the insulin delivered by
an insulin pump based on real-time glucose data from their
FreeStyle Libre 2 or FreeStyle Libre 3 sensors.
Abbott is working with leading insulin pump manufacturers to
integrate their systems with the FreeStyle Libre 2 and FreeStyle
Libre 3 sensors as soon as possible. The company is partnering with
Insulet and Tandem for future integrations in multiple countries,
including the U.S. Outside the U.S., Abbott's FreeStyle
Libre 3 sensor is already authorized to work with the mylife™
Loop solution from Ypsomed and CamDiab in Germany, with additional launches in the UK,
Switzerland and the Netherlands planned for the first half of
The modified sensors were also cleared for use by children as
young as two years old and for wear time up to 15 days. Current
FreeStyle Libre 2 and FreeStyle Libre 3 sensors available today in
the U.S. are approved for people four years and older and have a
wear time of up to 14 days.
Additionally, the clearance allows for FreeStyle Libre 2 and
FreeStyle Libre 3 sensors – both those available today and the
modified sensors available in the future – to be used by women with
all types of diabetes (Type 1, Type 2 and gestational) who are
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors
will be available in the U.S. later this year. Over time, the
modified sensors will replace the current FreeStyle Libre 2 and
FreeStyle Libre 3 sensors available today in the U.S.
The FreeStyle Libre portfolio is the number one sensor-based
glucose monitoring system in the world1, having changed
the lives of 4.5 million people across more than 60
countries4 by providing breakthrough technology
that is accessible and affordable.2
Important Safety Information
Failure to use FreeStyle
Libre 2 or FreeStyle Libre 3 systems 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.
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 115,000 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 based on the number of users worldwide for FreeStyle Libre
family of personal CGMs compared to the number of users for other
leading personal CGM brands and based on CGM sales dollars compared
to other leading personal CGM brands.
- Based on a comparison of list prices of the FreeStyle Libre 2
and FreeStyle Libre 3 systems versus competitors' CGM systems,
assuming annual use of one receiver (or equivalent hardware) and
quantity of transmitters and/or sensors according to use life. The
actual cost to patients may or may not be lower than other CGM
systems, depending on the amount covered by insurance, if any.
- Data on file, Abbott Diabetes Care. Based on the number of
patients assigned to each manufacturer based on last filed
prescription in US Retail Pharmacy and DME.
- Data on file, Abbott Diabetes Care.
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