Late-Breaking Data Demonstrate Abbott's FreeStyle® Libre System Supports Health Equity for Millions of Americans Living with Diabetes

Abbott (NYSE: ABT) today announced late-breaking data that showed FreeStyle Libre, the world's leading 7 continuous glucose monitoring (CGM) system, can support health equity through access to more affordable, life-changing technology for Americans living with diabetes, including those in underserved communities.

Presented at the American Diabetes Association ® (ADA) 81st Scientific Sessions, the data demonstrate meaningful outcomes for people with diabetes using FreeStyle Libre   system, including reductions in HbA1C levels, acute diabetes events and all-cause hospitalizations 1,2 . Globally priced at a third of the cost of other CGMs 3 , the FreeStyle Libre technology is widely available to people with diabetes, reaching more diverse and at-risk populations than other systems. Notable findings include:

  • FreeStyle Libre users reflect the diverse population of people with type 1 and type 2 diabetes (Abstract 67-LB, Abstract 68-LB): In comparative real-world data for U.S.-only matched patient groups, the FreeStyle Libre system was shown to achieve the same health benefits, including reductions in HbA1C levels and acute complications (hypoglycemia and hyperglycemia), while being accessible to a greater population of people with diabetes compared to other competitor CGM systems. Demographic data from these studies show that FreeStyle Libre users more closely represent America's diverse type 1 and type 2 diabetes population, including older people, those living in rural areas, people of color and those with higher rates of comorbidities.
  • Increased use of CGM could save Medicaid millions annually while reducing complications (Abstract 136-LB): Using a CGM compared to traditional blood glucose monitoring with fingersticks can reduce potentially harmful and expensive complications, leading to an overall cost savings for individuals living with type 1 and type 2 diabetes. Cost analysis data showed that increasing the population of FreeStyle Libre users by 10% could save the Medicaid budget $23 million in one year due to the reduction in complications.

"Abbott is helping to close the health disparity gap for the millions of people living with diabetes. We designed FreeStyle Libre system to be broadly accessible to all those who need it, no matter a person's income level, race or background," said Mahmood Kazemi , M.D., divisional vice president, global medical and scientific affairs and chief medical officer, Diabetes Care, Abbott. "This new data adds to the unparalleled clinical evidence and real-world data from more than 1 million users demonstrating the positive impacts — in both health and equity — that come from the significant cost-savings of Abbott's life-changing continuous glucose monitoring technology."

Supporting Health Equity

Despite technological advancements in diabetes care, health inequity is increasing across many underserved populations, including low-income families, individuals with disabilities, older adults and people of color. Individuals with diabetes span a diverse population and it is critical that everyone living with diabetes has access to affordable and easy-to-use CGM systems that work.

More than 75 million Americans rely on Medicaid 8 . This often-overlooked population is twice as likely to be living with diabetes and CGM access is limited by many state Medicaid programs. The median percentage of Medicaid beneficiaries with HbA1c of more than 9% (indicating poor control of diabetes) is about 39% 9 , more than double the corresponding national average of 16% 10 .

"For millions of people living with diabetes, systemic disparities are limiting access to healthcare resources, diabetes education, care and technology," said James R. Gavin III , MD, PhD, clinical professor of medicine at Emory University and chief medical officer of Healing Our Village, Inc. in Atlanta . "By opening the vital gateway to access, including to technology to monitor glucose continuously, we can drive improved health outcomes, stabilize glucose levels and keep people out of the hospital."

To further address the health and economic disparities, Abbott committed $5 million over three   years   to support the ADA's Health Equity Now   initiative that champions the right for all people with diabetes to access better care and the latest medical advances. This includes community initiatives and efforts to support low-income Americans – of which more than 75% are made up of people of color – with access to the latest technologies.

"The COVID-19 pandemic has brought increased attention to the significant health disparities faced by millions of people from low-income and underserved communities across America, and has put a spotlight on the additional challenges faced by the particularly underserved population with diabetes," said Tracey D. Brown , chief executive officer, American Diabetes Association.

"Access is at the center point of how we can bridge the inequity gap for people with diabetes. Everyone living with diabetes should be able to lead healthy, full lives and that begins with ensuring widespread access to the latest technologies, including continuous glucose monitoring technology."

About the FreeStyle Libre Portfolio:  
Abbott's FreeStyle Libre portfolio, the world's leading 7 continuous glucose monitoring system, has changed the lives of more than 3 million people across more than 50 countries 11 by delivering breakthrough technology that is accessible and affordable. FreeStyle Libre provides glucose readings and trends every minute through a sensor that is worn on the back of the upper arm and scanned with a reader or phone, eliminating the need for fingerstick 12 . Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including France , Ireland , Japan , the United Kingdom , and the U.S.

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 https://www.FreeStyle.abbott/us-en/safety   information.html for safety info.

FreeStyle Libre 2 system : Failure to use FreeStyle Libre 2 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 https://www.FreeStyle.abbott/us-en/safety   information.html for safety info.

About Abbott:
Abbott has a clear focus on innovating for access and affordability, with the goal of improving the lives of more than a third of all the people on Earth each year through its 2030 Sustainability Plan. An important part of this work is advancing health equity, working side-by-side with the communities we serve to address health disparities and tackle barriers to health. This includes efforts across our business and in partnership with others to expand access to technology, quality care and nutrition, and to advance STEM and health education to inspire a diverse and innovative next generation. To learn more, please visit abbott.com/sustainability.

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 109,000 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   .

1 Miller et al. A Comparison of Continues Glucose Monitors in Reducing A1c in Type 1 and Type 2 Diabetes: FreeStyle Libre ® and Dexcom
2 Hirsch et al. Acute Diabetes Events and All-Cause Hospitalizations among Continuous Glucose Monitoring Device Recipients with Type 1 and Type 2 Diabetes: A Comparison of FreeStyle Libre ® and Dexcom
3 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
4 Frank et al. Budget Impact of Adding Flash Continuous Glucose Monitoring (CGM) to Medicaid 5 Data on file, Abbott Diabetes Care.
6 Fokkert M, van Dijk P,Edens M, et al. Improved wellbeing and decreased disease burden after 1-year use of flash glucose monitoring (FLARENL4). BMJ Open Diab Res Care. https://drc.bmj.com/content/7/1/e000809
7 Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.
8 Medicaid.gov. November 2020 Medicaid & CHIP Enrollment Data Highlights https://www.medicaid.gov/medicaid/program-information/medicaid-andchip-enrollment-data/report-highlights/index.html
9 Medicaid.gov. Comprehensive Diabetes Care: Hemoglobin A1c (HbA1c) Poor Control (>9.0%): Ages 18 to 75. https://www.medicaid.gov/stateoverviews/scorecard/comprehensive-diabetes-care/index.html . Accessed April 20, 2021 .
10 Carls G. Huynh J. Tuttle E, et al. Achievement of glycated hemoglobin goals in the US remains unchanged through 2014. Diabetes Ther 2017;8:863–873.
11 Data on file, Abbott Diabetes Care.
12 Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours

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SOURCE Abbott

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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