New Study Published in The New England Journal of Medicine Demonstrates Abbott's FreeStyle Libre® 2 System Has Positive Impacts on Glucose Levels and Quality of Life

  • Randomized clinical trial of Abbott's FreeStyle Libre 2 system compared to self-monitoring of blood glucose (SMBG) shows FreeStyle Libre 2 leads to significant reductions in glycated hemoglobin (HbA1c) levels at 24 weeks in people with Type 1 diabetes and sub-optimal glycemic control 1
  • People using the FreeStyle Libre technology had average HbA1c levels a significant 0.5% lower than those using SMBG at the end of the study period 1
  • The FreeStyle Libre 2 system use was also linked to improvements in overall satisfaction and reduced burden associated with glucose monitoring 1

A new study published in The New England Journal of Medicine finds that for adults with Type 1 diabetes and sub-optimal glycemic control, Abbott's FreeStyle Libre ® 2 glucose monitoring system provided significant reductions in glycated hemoglobin (HbA1c) compared to self-monitoring of blood glucose (SMBG), which were sustained for the study duration of 24 weeks.1 Use of the FreeStyle Libre 2 system was also linked to improvements in participant-reported quality of life outcomes, including overall satisfaction and reduction in burden associated with glucose monitoring.

FreeStyle Libre 2

After six months, people who used the FreeStyle Libre 2 system reduced their HbA1c levels by an average of 0.8% (8.7% to 7.9%). 1 Lowering HbA1c by this amount can decrease the risk of developing diabetes complication in the future. In comparison, people using SMBG reduced their HbA1c levels by an average of only 0.2% (8.5% to 8.3%). 1

HbA1c provides an estimate of average glucose levels over the preceding three months and is the standard measurement of glycemic control for people with diabetes. 2 Increased HbA1c is associated with a greater risk of developing complications related to diabetes, such as cardiovascular disease, kidney disease and eye problems. 3

"Continuous glucose monitoring has been a critical tool for people living with diabetes, both to avoid painful fingersticks and to help manage glucose levels," said study author Dr. Lalantha Leelarathna from the University of Manchester NHS Foundation Trust. "This data adds to the growing body of evidence that demonstrates the technology helps bring HbA1c levels closer to the target range, which ultimately decreases risks of further complications."

The trial included 156 people aged 16 years or older with Type 1 diabetes and HbA1c levels of 7.5% to 11%, none of whom had previously used continuous glucose sensing technology. For 24 weeks, half the participants were randomized to monitor their glucose with the FreeStyle Libre 2 system and the other half with SMBG.

The average HbA1c level of participants using the FreeStyle Libre 2 system was 0.3% lower at 12 weeks and 0.5% lower at 24 weeks, statistically significant compared to those using SMBG. FreeStyle Libre users also had a greater likelihood of reducing their HbA1c by a full percentage point by the end of the study period. They spent an additional 130 minutes per day with glucose levels in the target range (70-180 mg/dL) and 43 minutes per day less time with dangerously low glucose levels (

FreeStyle Libre 2 users also reported a positive impact on quality of life, captured by participant-reported answers to the Diabetes Treatment Satisfaction Questionnaire and the Glucose Monitoring Satisfaction Survey. At 24 weeks, these participants reported greater overall treatment satisfaction and reduced burden associated with glucose monitoring.

"This randomized study clearly illustrates the importance of continuous glucose monitoring for adults with Type 1 diabetes," said Dr. Mahmood Kazemi , chief medical officer for Abbott's diabetes care business. "This clinically-significant change in HbA1c levels shows FreeStyle Libre technology empowers people to make lifestyle decisions that improve their glucose control and, ultimately, may result in a reduction in diabetes-related health problems down the line."

The study is part of FLASH-UK, the first randomized clinical trial of the FreeStyle Libre 2 system compared to SMBG. It was led by a team at The University of Manchester together with investigators from eight centers in the United Kingdom ( Birmingham , Cambridge , Derby , Dorset , Ipswich , Manchester , Norwich and Portsmouth ) and funded by Diabetes UK. Abbott was not involved in the execution or funding of the study.

Abbott's FreeStyle Libre systems include a sensor, which is applied to the back of the upper arm for up to 14 days and continuously measures glucose, paired with a compatible smartphone app 4 or reader that display glucose readings. The FreeStyle Libre portfolio is the number one sensor-based glucose monitoring system in the world 5 , having changed the lives of more than 4 million people across more than 60 countries 6 by providing breakthrough technology that is accessible and affordable. 7

About Abbott:

Abbott (NYSE: ABT) 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 .

Indications and Important Safety Information

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 FreeStyleLibre.us for safety info.

References

1 Leelarathna L, Evans M, Neupane S, et al. (2022) Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. New England Journal of Medicine, Oct. 5 , DOI: 10.1056/NEJMoa2205650
2 World Health Organization. Use of Glycated Hemoglobin (HbA1C) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation Published. 2011. p. 2, Glycated hemoglobin (HbA1c) for the diagnosis of diabetes. Available online at: https://www.who.int/diabetes/publications/report-hba1c_2011.pdf . Last accessed April 2022 .
3 Sherwani SI, Khan HA, Ekhzaimy, et al. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights 2016:11 95–104 doi: 10.4137/BMI.S38440
4 The app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app.
5 Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.
6 Data on file. Abbott Diabetes Care.
7 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems available worldwide. The actual cost to patients may or may not be lower than other CGM systems, depending on local reimbursement, if any.

Abbott Logo (PRNewsFoto/Abbott)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/new-study-published-in-the-new-england-journal-of-medicine-demonstrates-abbotts-freestyle-libre-2-system-has-positive-impacts-on-glucose-levels-and-quality-of-life-301642360.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
Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

Keep reading...Show less
abt stock

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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

Notice of Knight Therapeutics' First Quarter 2024 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its first quarter 2024 financial results on Thursday, May 9, 2024 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, May 9, 2024

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health Announces First Quarter 2024 Results

  • First quarter revenues of $2.15 billion, up 11% on a Reported and 8% on an Organic1 basis
  • Year-over-year revenue growth in all segments on both a Reported and Organic1 Basis
  • GAAP Net Loss Attributable to Bausch Health Companies Inc. of $64 Million
  • Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $665 Million, up 13%
  • Xifaxan® Appeal Decision Represents a Significant Milestone related to Full Separation of Bausch + Lomb
  • Reaffirmed full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its first quarter 2024 financial results and other key updates from the quarter

"We are pleased with our strong start to the year, delivering solid first-quarter performance, and our fourth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA. Furthermore, all our business segments posted year-over-year revenue growth on both a reported and organic basis. I'm very proud of what our team has accomplished and we remain focused on continuing our momentum by advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Scientists working in a modern medical research laboratory.

Pathways to Commercializing Biotech Innovations

In the medical technology industry, innovation is only the first step. While key to long-term success, innovation is only as good as a company’s commercialization strategy. Once a technology has been developed and proven, the organization must then embark on a process to commercialize it for revenue generation.

The strategy a company leverages to pursue commercialization is a crucial ingredient in building a successful and profitable venture.

Investors would do well to understand the distinctive process and strategies required to bring medtech solutions to market to help them make more informed investment decisions.

Keep reading...Show less

Medtronic: 'Pivotal Moment' in Women's Heart Health

Female-specific results from first-of-its-kind clinical trial

Teaching first graders takes a lot of energy. So when Julia Garcia started feeling worn out, teaching became extremely difficult

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

March 2024 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the March 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Keep reading...Show less

Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×