U.S. FDA Clears Abbott's FreeStyle Libre® 2 and FreeStyle Libre® 3 Sensors for Integration with Automated Insulin Delivery Systems

  • Abbott's world's leading 1 and affordable 2 integrated continuous glucose monitoring (iCGM) sensors are cleared for connectivity with automated insulin delivery (AID) systems in the U.S.
  • 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

- 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.

Abbott's FreeStyle Libre 2 iCGM system

"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 affordable 2 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 this year.

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 pregnant.

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 world 1 , having changed the lives of 4.5 million people across more than 60 countries 4 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.

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 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 .

  1. 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.
  2. 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.
  3. 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.
  4. Data on file, Abbott Diabetes Care.

Abbott's FreeStyle Libre 3 iCGM system

Abbott Logo (PRNewsFoto/Abbott)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/us-fda-clears-abbotts-freestyle-libre-2-and-freestyle-libre-3-sensors-for-integration-with-automated-insulin-delivery-systems-301763020.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

ABT
The Conversation (0)
Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

  • New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
  • Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
  • The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
richard murray md

Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

As quoted in the press release:

Keep reading...Show less

Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

Keep reading...Show less

Enanta Pharmaceuticals Announces AbbVie’s Investigational Regimen of Glecaprevir/Pibrentasvir Shows High SVR Rates

Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.1 In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD2.
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.3
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR4
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR
12) are considered cured of
hepatitis C

About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR12.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
1 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
2 IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
3 American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

Cleo Diagnostics

Cleo Commences U.S. Clinical Trials

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to confirm the commencement of U.S. clinical trials for its ovarian cancer diagnostic blood test.

Keep reading...Show less
Truscreen

TruScreen Cervical Cancer Screening Test Outperforms Traditional Pap Smear in Saudi Arabia Study

TruScreen Group Limited (NZX/ASX:TRU) is pleased to announce the preliminary publication, on 25 July 2024, of a study titled “Beyond Tradition: Investigating TruScreen’s Performance Versus Pap Smear in Cervical Cancer Detection” on Research Square1Link. The preliminary publication is subject to peer review.

Keep reading...Show less

Thermo Fisher Scientific to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, chairman, president and chief executive officer, will present at the Morgan Stanley 22 nd Annual Global Healthcare Conference on Thursday, September 5, 2024 at 8:30 a.m. (EDT).

You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic chairman and CEO Geoff Martha to speak at the Wells Fargo Healthcare Conference

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 2024 Wells Fargo Healthcare Conference on Wednesday, September 4, 2024 .

Geoff Martha , Medtronic chairman and chief executive officer, will answer questions on the medtech industry and on the company beginning at approximately 11:55 a.m. EDT ( 12:55 p.m. CDT ).

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

Appendix 4E and 2024 Annual Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to present its Annual Report.
Keep reading...Show less
  Artrya Limited

Artrya on Track for FDA Application Submission Following Second Q-Submission Meeting

Artrya Limited (ASX:AYA), (‘Artrya’ or the ‘Company’), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has received feedback its application for regulatory approval for the Salix product with the US Food and Drug Administration (FDA) is on track following a Q-Submission meeting.

Keep reading...Show less

Latest Press Releases

Related News

×