FDA OKs Abbott’s FreeStyle Libre CGM Use in Hospitals

Abbott’s FreeStyle Libre 14 day system, the world’s leading³ continuous glucose monitoring (CGM) technology, can now be used in the hospital setting² during the COVID-19 pandemic, according to the U.S. Food and Drug Administration (FDA). This will permit frontline healthcare workers to remotely monitor patients with diabetes receiving inpatient care by assessing real-time glucose levels⁴ and glucose history. To help hospitals and medical centers in COVID-19 outbreak hotspots ramp up access to the technology, Abbott will donate 25,000 FreeStyle Libre 14 day sensors in partnership with the American Diabetes Association (ADA), Insulin for Life USA and Diabetes Disaster Response Coalition.
 
According to a recent report¹ by the Centers for Disease Control and Prevention (CDC), more than 50 percent of people with diabetes who have been diagnosed with COVID-19 are hospitalized.
 
“There’s been a spike in demand for health technology as hospitals are looking for ways to minimize COVID-19 exposure, especially to high-risk patients such as people with chronic conditions like diabetes,” said Eugene E. Wright, Jr., M.D., medical director for performance improvement, Charlotte Area Health Education Center in North Carolina. “Having access to technology like FreeStyle Libre 14 day system allows physicians to keep a close eye on hospitalized patients while minimizing transmission risks, PPE use and contact with hospital staff.”
 
With a one-second scan using a reader or smartphone⁵ over the FreeStyle Libre 14 day sensor worn on the back of the upper arm, users get real-time glucose readings every minute, historical trends and patterns, and arrows showing where glucose levels are going without having to fingerstick⁶. At the same time, physicians will receive real-time glucose data and actionable information to help make important treatment decisions through LibreView⁷, a secure, cloud-based diabetes management system. Recent studies showed that users of the FreeStyle Libre 14 day system have improved glucose control⁸, decreased time in hyperglycemia⁹ and hypoglycemia¹⁰ as well as reduced hospitalizations¹¹, and HbA1C¹² levels.
 
“We appreciate the FDA’s quick action to make medical products available during this public health crisis,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “By working with our partners at the American Diabetes Association to arm frontline healthcare workers with FreeStyle Libre technology, Abbott will enable them to protect and monitor their patients with diabetes, limit COVID-19 exposure and also manage the influx of critical care needs.”
 
References
¹ Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 — United States, February 12–March 28, 2020. MMWR Morb Mortal Wkly Rep 2020;69:382–386. DOI: http://dx.doi.org/10.15585/mmwr.mm6913e2 external icon.
² Patients must be able to scan their FreeStyle Libre 14 day sensor by themselves.
³ 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
⁴ The user must be connected to data services for glucose data to automatically upload to LibreView.
⁵ The FreeStyle LibreLink app is compatible with NFC-enabled smartphones running Android OS 5.0 or higher and iPhone 7 or later running iOS 11 or later. Use of the FreeStyle LibreLink app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.
⁶ Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
⁷ 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.
⁸ 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
⁹ 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
¹⁰ 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.
¹¹ 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
¹² 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