Abbott Receives Health Canada Authorization under Interim Order to Use FreeStyle® Libre System for Hospitalized Patients During COVID-19 Pandemic
- New authorization from Health Canada allows FreeStyle Libre system to be used by frontline healthcare workers in hospitals to remotely monitor patients' glucose status to minimize exposure during COVID-19 and preserve use of personal protective equipment (PPE)
- Abbott will donate 3,000 FreeStyle Libre sensors to Canadian hospitals in need to help accelerate access to technology
MISSISSAUGA, Ontario, April 27, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that Health Canada authorized use of FreeStyle Libre system, the world's leading1 sensor-based glucose monitoring technology, in hospital setting during the COVID-19 pandemic. This will permit frontline healthcare workers to remotely monitor patients' glucose status2 and glucose history. In addition, Abbott will donate 3,000 FreeStyle Libre sensors to ensure hospitals in need have immediate access to the technology.
"The in-hospital challenges presented by the COVID-19 pandemic have forced frontline workers to think creatively about how to safeguard against unnecessary exposure between themselves and patients, especially people with diabetes," said Bruce Perkins, M.D., Director, Leadership Sinai Centre for Diabetes and Clinician-Scientist, University of Toronto. "Having access to sensor-based glucose monitoring technology in hospitals is one such creative solution to significantly help healthcare workers closely monitor glucose status while limiting direct contact and preserving valuable personal protective equipment."
With a one-second scan using a reader or smartphone3 over the FreeStyle Libre sensor worn on the back of the upper arm, glucose readings are measured every minute and the user can get current glucose measurements, historical trends and patterns, and arrows showing where glucose levels are going without having to fingerstick4. At the same time, physicians will receive glucose data and actionable information remotely to help make important treatment decisions through LibreView5, 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 control6, decreased time in hyperglycemia7 and hypoglycemia8 as well as reduced hospitalizations9 and HbA1C10 levels.
"Providing frontline healthcare workers with technology and equipment is critical in the fight against COVID-19," said Marie-Flore Nabor, general manager of Abbott's diabetes care business in Canada. "Health Canada's quick action to make FreeStyle Libre sensors available in hospitals will help frontline healthcare workers better monitor and manage the glucose levels of patients and, at the same time, help limit COVID-19 exposure."
More than 15% of Canadians diagnosed with COVID-19 are hospitalized, according to Health Canada11. The use of the FreeStyle Libre system in Canadian hospitals received support from the country's leading diabetes organizations, including Diabetes Canada and Diabète Quebec.
For more information about using the FreeStyle Libre system in the hospital, please contact 1-855-421-6177.
About FreeStyle Libre Portfolio
As the #1 sensor-based glucose monitoring system used worldwide1, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across 46 countries12 by providing breakthrough technology that is accessible13. Abbott has also secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada, Japan, the United Kingdom, and the U.S. For more information, please visit www.freestylelibre.ca.
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 107,000 colleagues serve people in more than 160 countries.
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) in all hospital and all professional healthcare settings including patients receiving medical intervention/therapy for COVID-19. In home setting, FreeStyle Libre system is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older with diabetes. 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 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
2 The user must be connected to data services for glucose data to automatically upload to LibreView.
3 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.
4 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.
5 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.
6 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
7 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
8 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.
9 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
10 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
11 Coronavirus Disease Update: Daily Epidemiology Update. Government of Canada. Accessed on April 24, 2020. https://www.canada.ca/content/dam/phac-aspc/documents/services/diseases/2019-novel-coronavirus-infection/surv-covid19-epi-update-eng.pdf
12 Data on file, Abbott Diabetes Care