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

June 15, 2020
Jennifer Barrett
Jennifer Barrett

Abbott’s FreeStyle Libre 2 is an integrated continuous glucose monitoring system for adults and children ages 4 and older 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.