- Data at the American Diabetes Association 82nd
Scientific Sessions show Abbott's FreeStyle Libre 3 system is first
and only 14-day continuous glucose monitor (CGM) system to achieve
a mean absolute relative difference (MARD) of less than 8%
- Additional data show the positive impact of the FreeStyle
Libre system and LibreView app in helping healthcare
professionals make earlier treatment decisions and detecting
hypoglycemic events
ABBOTT
PARK, Ill., June 5, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) today announced late-breaking
clinical data that demonstrate the FreeStyle Libre® 3
system has an overall mean absolute relative difference (MARD)
of 7.9%,1 making it the first and only 14-day continuous
glucose monitoring (CGM) system to achieve a sub-8% overall MARD.
The results were presented at the American Diabetes
Association® (ADA)
82nd Scientific Sessions, June
3-7, 2022, in New
Orleans.1
MARD is considered the simplest measurement of sensor
accuracy2 and represents the difference between a CGM
system's glucose readings and a reference blood glucose
measurement. The lower the MARD, the more accurate the CGM
system.
"Abbott revolutionized glucose monitoring with our
world-leading FreeStyle Libre technology -- the
first sensor to eliminate painful fingersticks by
offering factory-calibrated continuous glucose monitoring that is
affordable, accessible and accurate," said Mahmood Kazemi, M.D., divisional vice president,
global medical affairs and chief medical officer of Abbott's
diabetes care business. "A sub-8% overall MARD for the
FreeStyle Libre 3 system is a significant milestone, not just in
terms of CGM innovation, but because it empowers people with
diabetes to be more confident when making important diabetes
management decisions."
The multi-center study evaluated the accuracy of the
FreeStyle Libre 3 system in people with type 1 or type 2 diabetes,
aged 4 or older, who were on insulin therapy. By age group, MARD
values were 7.6% for adults (people ages 18 and up) and 8.7% for
children ages 6-17.3 For children aged 4-5 years
old, MARD value was 10.1%.3
Other notable findings presented at ADA:
- FreeStyle Libre system helps prevent therapeutic
inertia4: Getting glycemic levels under control
earlier can lead to better outcomes, including a reduction in
long-term vascular complications. An analysis of retrospective
data collected over 24 months from more than 370,000 patients
with type 2 diabetes in Canada
shows that insights from FreeStyle Libre data helped clinicians
make earlier decisions or adjustments to type 2 diabetes treatments
versus making decisions based on conventional blood glucose
monitoring (BGM).
- A comparative study suggests that new
Glucose Pattern Insights report in LibreView helps primary care
providers identify and treat hypoglycemia events that are missed
when using standardized reports5: Powered by
LibreView,6 the Glucose Pattern Insights report is a new
CGM-based tool that was developed to identify patterns of poor
glycemic control and offer considerations for the clinician.
More than 133 million Americans currently live with diabetes or
prediabetes, equivalent to nearly half of the U.S. population,
according to the American Diabetes Association.7
Diabetes is also the most common underlying chronic condition in
the U.S., with 1.4 million Americans aged 18 years or older newly
diagnosed each year.8,9 Abbott is committed to
innovating new tools and technologies to help people with diabetes
achieve the best health outcomes possible.
Indications and Important Safety Information
FreeStyle Libre 14 day system: Failure to use FreeStyle
Libre 14 day 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 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 for safety
info.
FreeStyle Libre 3 system:
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 for 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.
1Alva S, Brazg R, Castorino K, Liljenquist D, Liu H,
and Kipnes M. Performance of the FreeStyle Libre 3 System.
Poster presented at ADA
82nd Scientific Sessions; June 5,
2022; New Orleans, LA.
2Reiterer F, Polterauer P, Schoemaker M, et al.
Significance and Reliability of MARD for the Accuracy of CGM
Systems. J Diabetes Sci Technol. 2017;11(1):59-67.
3 MARD Values for Age 4-5 is vs fingerstick
reference. Age 6-17 and adults is vs YSI reference.
4 Harris S and Levrat-Guillen F. Effect of the
FreeStyle Libre system on Diabetes Treatment for People with T2D:
Results from a Retrospective Cohort Study Using Canadian Private
Payer Claims Database. Poster presented at ADA 82nd Scientific Sessions;
June 4, 2022; New Orleans, LA.
5 Wright Jr EE, Novak MT, Hayter GA, et al. The
effects of glucose reporting tools on therapeutic decision making:
a comparative reading study with primary care providers. Poster
presented at ADA 82nd Scientific
Sessions; June 5, 2022; New Orleans, LA.
6The 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.
7American Diabetes Association's "Statistics About
Diabetes." https://diabetes.org/about-us/statistics/about-diabetes.
Accessed May 10, 2022.
8American Diabetes Association, Fast Facts: Data and
Statistics about Diabetes, from the National Diabetes Statistics
Report, 2022.
https://professional.diabetes.org/sites/professional.diabetes.org/files/media/diabetes_fast_facts22322.pdf.
Accessed May 10, 2022.
9 CDC Diabetes Statistics Report.
https://www.cdc.gov/diabetes/data/statistics-report/. Accessed
May 10, 2022.
View original
content:https://www.prnewswire.com/news-releases/late-breaking-data-demonstrate-abbotts-freestyle-libre-3-system-is-most-accurate-14-day-continuous-glucose-monitor-301561401.html
SOURCE Abbott