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:
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.
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.
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.