- Abbott's consumer biowearable, Lingo™, is designed for general
consumers who are looking to improve their overall health and
wellness
- Libre Rio™ is designed for adults with Type 2 diabetes who do
not use insulin and typically manage their diabetes through
lifestyle modifications
- Both products are based on FreeStyle Libre® sensing
technology, the world's most widely used1 continuous
glucose monitoring (CGM) systems, pioneered by Abbott and used by
about 6 million people globally2
ABBOTT
PARK, Ill., June 10,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced U.S. Food and Drug Administration (FDA) clearance
for two new over-the-counter continuous glucose monitoring (CGM)
systems – Lingo™ and Libre Rio™, which are based on Abbott's
world-leading FreeStyle Libre® continuous glucose monitoring
technology1, now used by about 6 million people
globally2. The newly cleared systems have been
intentionally designed to meet different needs – Lingo for
consumers who want to better understand and improve their health
and wellness, and Libre Rio for
adults with Type 2 diabetes who do not use insulin and typically
manage their diabetes through lifestyle modifications.
"There is no one-size-fits all approach for glucose monitoring,
which is why we've designed different products for different people
– all based on the same world-leading biowearable
technology1," said Lisa
Earnhardt, executive vice president and group president of
Abbott's medical devices business. "People living with diabetes
need certain features like tracking medications or sharing data
with a healthcare provider. People without diabetes need different
features to manage their metabolic health, including personalized
coaching to promote actionable lifestyle changes."
Lingo
Abbott's consumer biowearable, Lingo, is
designed for consumers 18 years and older who are looking to
improve their overall health and wellness. Lingo will track glucose
and provide personalized insights and customized coaching to help
people create healthy habits, retrain their metabolism and improve
their overall well-being.
According to a University of North
Carolina study, only 12 percent of Americans are
metabolically healthy3 based on five key indicators of
metabolic health, including glucose levels, indicating that most of
the U.S. population has room to improve their metabolism. In
addition, in a recent online consumer survey conducted by The
Harris Poll on behalf of Abbott, 82 percent of Americans say they
would change their habits if a biowearable provided actionable,
personalized coaching to help them manage their
health.4
The Lingo system combines a biosensor that is worn on the upper
arm for 14 days5 and continuously streams glucose data
to a coaching application on a smart phone – translating the body's
language and giving insights on the person's reaction to food,
exercise and life's daily stressors.
"Continuous glucose monitors are a tool I recommend to my
patients to raise their overall awareness of factors that affect
their glucose and are an invaluable holistic wellness solution,"
said Fred St. Goar, M.D.,
cardiologist and medical director of El Camino Health Heart and
Vascular Institute. "Research has shown that overall lower glucose
exposure in the general population is associated with reduced
long-term risk to developing cardiovascular disease, diabetes,
Alzheimer's and certain cancers. Making continuous glucose monitors
widely available will undoubtedly have a dramatic effect on the
overall health and well-being of the broader population."
Visit www.hellolingo.com and sign up to be notified as soon
as Lingo is available in the U.S. Lingo is also available in the
UK.
Libre Rio
Libre Rio will be Abbott's first
over-the-counter CGM system for people with diabetes in the U.S. It
is designed for people ages 18 and older with Type 2 diabetes who
do not use insulin and typically manage their diabetes through
lifestyle modifications. Libre Rio
is the first over-the-counter CGM system with a measurement range
of 40-400 mg/dL, allowing for measurement of extremely low or high
glucose events.
Diabetes is among the top public health challenges in the U.S.,
with approximately 38.4 million people living with the
condition6. FreeStyle Libre systems have been available
over-the-counter in more than 50 countries over the last decade;
however, in the U.S., they have only been available through
prescription.
Libre Rio will join Abbott's
overall Libre portfolio of CGM systems, now used by about 6
million people across more than 60 countries2. The Libre
portfolio in the U.S. consists of the FreeStyle Libre 2 and
FreeStyle Libre 3 systems for people with all types of diabetes –
Type 1, Type 2 and gestational. FreeStyle Libre systems require a
prescription and have wide reimbursement by most major insurers in
the U.S.2 Libre Rio may
make it easier for Americans with diabetes to try a CGM and begin
to see progress toward their health goals, empowering them with
information to discuss with their healthcare provider at their next
visit.
Clinical and real-world data from the millions of people that
use FreeStyle Libre systems show that the technology helps
people improve their glucose control, lower their HbA1c, decrease
diabetes-related hospital admissions, and improve their quality of
life7,8. Libre systems consist of a biosensor
placed on the back of the arm for up to 15 days, and a reader or a
compatible smartphone app9, which displays glucose
measurements.
Abbott continues to invest in its world-leading innovation for
people with diabetes, including expanding manufacturing capacity
and developing a first-of-its-kind sensor that is designed to
measure both glucose and ketone in the same sensor.
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 114,000 colleagues
serve people in more than 160 countries. Connect with us
at www.abbott.com and
on LinkedIn, Facebook, Instagram, X and YouTube.
About Lingo:
The Lingo Glucose System is intended for users 18 years and older
not on insulin. It is not intended for diagnosis of diseases,
including diabetes.
The Lingo program does not guarantee that everyone will achieve the
same results as individual responses may vary. Consult your
healthcare professional before making changes to your diet or
exercise regimen or if you have an eating disorder or a history of
eating disorders.
About Libre
Rio:
Libre Rio is an
over-the-counter integrated continuous glucose monitoring (iCGM)
device indicated for non-insulin using persons ages 18 and older.
Failure to use Libre Rio as
instructed in labeling may result in missing a severe low or high
glucose event. If readings do not match symptoms or expectations,
use a fingerstick value from a blood glucose meter for treatment
decisions.
Important Safety Information about FreeStyle Libre
systems:
For Important Safety Information, please visit
https://www.freestyle.abbott/us-en/safety-information.html.
- Data on file. Abbott Diabetes Care. Data based on the number of
patients assigned to each manufacturer.
- Data on file. Abbott Diabetes Care.
- Prevalence of Optimal Metabolic Health in American Adults:
National Health and Nutrition Examination Survey 2009-2016.
- This survey was conducted online within the United States by The Harris Poll on behalf
of Abbott from March 7 - 11, 2024
among 2,060 adults ages 18 and older. The sampling precision
of Harris online polls is measured by using a Bayesian credible
interval. For this study, the sample data is accurate to
within +/- 2.5 percentage points using a 95% confidence level.
- A study was conducted to assess the biosensor life where 77.1%
of biosensors lasted the full 14 days. In other words, when using
the product per the package labeling, approximately 22.9% of
biosensors may not last for the full 14 days. 14.7% of biosensors
may last less than 11 days.
- American Diabetes Association, Statistics About Diabetes,
accessed March 20, 2024.
- The American Journal of Managed Care, Flash CGM Associated
With Event Reduction in Nonintensive Diabetes Therapy, 2021.
- American Diabetes Association, Continuous Glucose
Monitors, accessed March 20,
2024.
- The FreeStyle Libre systems are only compatible with
certain mobile devices and operating systems. Please check
our compatibility guide for more information about device
compatibility before using the app.
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SOURCE Abbott