FDA OKs FreeStyle Libre 2 System for Adults and Children With Diabetes

Officials with the FDA have approved Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes, according to a press release.¹

The FreeStyle Libre 2 system is the only iCGM system with customizable, optional real-time alarms that measures glucose levels every minute, using Bluetooth technology to alert users when their glucose is too high or low without scanning. The system has a combined mean absolute relative difference, a measurement of performance for CGMs, of 9.3%, making it the only iCGM sensor sustaining a high level of accuracy over 14 days, according to Abbott.¹

This approval comes after real-world data presented at the American Diabetes Association’s (ADA) 80th Scientific Sessions showed that use of the FreeStyle Libre system significantly reduces hemoglobin A1c (HbA1c) levels for patients with type 2 diabetes on either long-acting insulin or no insulin therapy. Additionally, a separate late-breaking presentation revealed that use of the CGM system is associated with significant reductions in acute diabetes events and hospitalizations for a similar population.²

Related: ADA 2020: FreeStyle Libre System Use Decreases Diabetic Ketoacidosis Rates

In the observational, retrospective study of HbA1c levels presented during the meeting, the investigators analyzed HbA1c levels from baseline to 6 months and baseline to 12 months after initiating use of the FreeStyle Libre system. The results showed that overall lower HbA1c levels associated with the use of the technology, specifically a 0.8% drop after 6 months and 0.6% drop after 1 year of FreeStyle Libre system use.²

“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” Larry Kurt Midyett, MD, pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group, said in a statement.1 “Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child’s glucose levels are doing without having to disrupt their play or sleep with painful fingersticks. The alarms are a bonus because they provide parents a level of reassurance.”

Worn on the back of the upper arm for 14 days, the FreeStyle Libre 2 next-generation sensor is a third less bulky than other CGM sensors. Users are able to view their glucose reading, trend arrow, and 8-hour history with a 1-second scan through a handheld reader. The device is also designed for use with a mobile app, which Abbott is currently working to bring to the US market, according to the release.¹

Abbott will offer the new system at the same price as currently available FreeStyle Libre 14-day system. The FreeStyle Libre 2 system will be available in coming weeks at participating pharmacies and durable medical equipment suppliers across the United States.¹

References

1. Abbott’s FreeStyle® Libre 2 iCGM Cleared in US for Adults and Children With Diabetes, Achieving Highest Level of Accuracy and Performance Standards. News Release. Abbott; June 15, 2020. Accessed June 15, 2020. https://abbott.mediaroom.com/2020-06-15-Abbotts-FreeStyle-R-Libre-2-iCGM-Cleared-in-U-S-for-Adults-and-Children-with-Diabetes-Achieving-Highest-Level-of-Accuracy-and-Performance-Standards

2. New Late-Breaking Data Show Use of Abbott’s FreeStyle® Libre System Significantly Reduces HbA1C Levels in People With Type 2 Diabetes Using Insulin or Not. News Release. Abbott; June 13, 2020. https://abbott.mediaroom.com/2020-06-13-New-Late-Breaking-Data-Show-Use-of-Abbotts-FreeStyle-R-Libre-System-Significantly-Reduces-HbA1C-Levels-in-People-with-Type-2-Diabetes-Using-Insulin-or-Not.