Abbott Receives Health Canada Authorization Under Interim Order to Expand Use of FreeStyle® Libre System for Pregnant Women in the Hospital and Professional Health Care Settings

- March 3rd, 2021

Expanded use of FreeStyle Libre system allows health care workers in hospital and professional health care settings to remotely monitor expectant mothers’ glucose status to minimize exposure to COVID-19 FreeStyle Libre is the only glucose sensing technology in Canada to replace the need for traditional finger pricks for people with and without diabetes, including pregnant women, in the healthcare setting – Abbott …

  • Expanded use of FreeStyle Libre system allows health care workers in hospital and professional health care settings to remotely monitor expectant mothers’ glucose status to minimize exposure to COVID-19
  • FreeStyle Libre is the only glucose sensing technology in Canada to replace the need for traditional finger pricks for people with and without diabetes, including pregnant women, in the healthcare setting

– Abbott (NYSE: ABT) announced today that Health Canada, under interim order, authorized the expanded use of the FreeStyle Libre flash glucose monitoring system in hospital and professional health care settings to include Canadian women who are pregnant.

In April 2020 , Abbott received authorization from Health Canada to allow the FreeStyle Libre system to be used by frontline health care workers to remotely monitor the glucose status and glucose history of their patients without the need for painful finger pricks. 1 This minimized exposure to COVID-19 and preserved the use of personal protective equipment (PPE) while enabling healthcare providers to make important treatment decisions, as needed. The expanded indication gives people with or without diabetes – now including expectant mothers – and patients receiving medical intervention/therapy for COVID-19 access to the FreeStyle Libre system in the hospital or professional health care setting.

“The COVID-19 pandemic has presented a new set of challenges for pregnant women who are at higher risk of contracting the virus,” said Nazli Topors , Pharm.D., medical director of Abbott’s diabetes care business in Canada . “The expanded indication for FreeStyle Libre demonstrates the technology’s positive impact on managing diabetes and the ability for health care workers to support patients during such an important time in their lives and, at the same time, limit their COVID-19 exposure while they are in the hospital.”

With a one-second scan using a reader or smartphone 2 over the FreeStyle Libre sensor worn on the back of the upper arm, users can see current glucose readings, which are measured every minute, historical trends and patterns, and arrows showing where glucose levels are going without having to fingerstick. 3

At the same time, physicians will receive glucose data and actionable information remotely to help make important treatment decisions through LibreView, 4 a secure, cloud-based diabetes management system available at no cost to healthcare providers and users. Recent studies showed that users of the FreeStyle Libre system have improved glucose control, 5 decreased time in hyperglycemia 6 and hypoglycemia 7 as well as reduced hospitalizations 8 and HbA1c 9 levels.

About FreeStyle Libre Portfolio
As the #1 sensor-based glucose monitoring system used in Canada and worldwide, 10 Abbott’s FreeStyle Libre portfolio has changed the lives of nearly 3 million people across more than 50 countries 11 by providing breakthrough technology that is accessible. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada , France , Germany , Japan , the United Kingdom and the U.S.

For more information on the FreeStyle Libre system, please visit myfreestyle.ca .

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 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 http://www.facebook.com/Abbott and on Twitter @AbbottNews .

INDICATIONS AND IMPORTANT SAFETY INFORMATION

The FreeStyle Libre Flash Glucose Monitoring System Reader (“Reader”)/FreeStyle LibreLink app (“App”) when used with a FreeStyle Libre Flash Glucose Monitoring System Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older (with or without diabetes, including pregnant women) in all hospital and all professional healthcare settings including patients receiving medical intervention/therapy for COVID-19. The Reader/App and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. Treatment decisions should not be based on real time Sensor glucose readings alone and instead should consider all the information on the results screen.

1 A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycemia or impending hypoglycemia is reported, or the symptoms do not match the system readings.
2 The FreeStyle LibreLink app and the FreeStyle Libre reader have similar but not identical features. A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycemia or impending hypoglycemia is reported by the FreeStyle LibreLink app or when symptoms do not match the app readings. The FreeStyle Libre sensor communicates with the FreeStyle Libre reader that started it or the FreeStyle LibreLink app that started it. A sensor started by the FreeStyle Libre reader will also communicate with the FreeStyle LibreLink app. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink requires registration with LibreView.
3 A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycemia or impending hypoglycemia is reported, or the symptoms do not match the system readings.
4 LibreView is developed, distributed, and supported by Newyu, Inc. The 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.
5 Haak, Thomas, et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Therapy 8.1 (2017): 55-73r
6 Acute diabetes complications defined by hypoglycemia, hypoglycemic coma, hyperglycemia, ketoacidosis, or hyperosmolarity ICD-10 codes as primary diagnosis for inpatient or as any position in the outpatient emergency claim; Matthew Kerr , Gregory Roberts , Diana Souto , Yelena Nabutovsky
7 Bolinder, Jan, et al. Novel glucose-sensing technology and hypoglycemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet 388.10057 (2016): 2254-2263.
8 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
2019;7:e000809. doi:10.1136/bmjdrc-2019-000809.
9 Improving HbA1c control in people with Type 1 or Type 2 diabetes using flash glucose monitoring: a retrospective observational analysis in two German centers; Gerhard Klausmann , Ludger Rose , Alexander Seibold .
10 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.
11 Data on file, Abbott Diabetes Care.

SOURCE Abbott

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