FDA Approves FreeStyle Libre 2 iCGM System for Patients With Diabetes

The FDA today granted approval to 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

New data demonstrating use of Abbott’s FreeStyle Libre continuous glucose monitoring (CGM) technology linked the system with significant reduction in hemoglobin A1c (HbA1c) levels for people living with type 2 diabetes on either long-acting insulin or non-insulin therapy. Presented during the American Diabetes Association (ADA) 80^th Virtual Scientific Sessions, these study results are similar to outcomes typically seen when adding insulin therapy to treatment regimens, which indicates that people may be able to manage their glucose levels with CGM technology instead of adding insulin.²

Abbott’s FreeStyle Libre device is indicated for replacing blood glucose testing, and for detecting trends and tracking patterns that aid in the discovery of hyperglycemia and hypoglycemia episodes, facilitating therapy adjustments in persons aged 18 years and older with diabetes. The system is intended for single patient use and require a prescription.

In the observational, retrospective study (Abstract 84-LB)1 researchers assessed changes in HbA1c levels in people with type 2 diabetes who were either on long-acting insulin or non-insulin therapy. They analyzed HbA1c levels from baseline to 6 months, and baseline to 12 months after initiating use of the FreeStyle Libre system.

The results demonstrated overall lower HbA1c levels associated with the use of Abbott's technology, specifically a 0.8% drop after 6 months (from 8.5% to 7.7%) and 0.6% drop after 1 year of using this CGM system (from 8.5% to 7.9%). The data show clinically significant reductions of average glucose levels over time toward the ADA's recommended A1c goal of 7% for adults with diabetes.

Additional findings showed:

• The greatest HbA1c decreases occurred among the non-insulin users with type 2 diabetes, including a 0.9% reduction at 6 months and 0.7% drop after 12 months.
• Among those people with type 2 diabetes on long-acting insulin, HbA1c reductions were 0.6% and 0.5% at 6 and 12 months, respectively.

Additionally, 2 other late-breaking abstracts assessed the impacts of using Abbott’s CGM system in people living with type 2 diabetes not on intensive insulin therapy.

Results of those studies demonstrated the following:

• HbA1c Reduction Associated with a FreeStyle Libre System in People with Type 2 Diabetes Not on Bolus Insulin Therapy⁶ (Abstract 78-LB): A retrospective study found that a prescription for the FreeStyle Libre system in people with type 2 diabetes not on intensive insulin who had poor glucose control was associated with a substantial decrease in HbA1c, with the greatest reduction in those with higher baseline HbA1c levels. Specifically, A1c levels decreased 0.99% after 6 months in those on long-acting insulin and 1.56% after 6 months in those not on insulin. For those not using insulin, these results imply that using FreeStyle Libre technology can have a similar impact to using insulin therapy,⁴ meaning people could use the FreeStyle Libre system to manage their glucose levels instead of adding insulin.
• FreeStyle Libre System Use Associated with Reduction in Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes Without Bolus Insulin² (Abstract 85-LB): In a retrospective, observational analysis, researchers found that using the FreeStyle Libre system was associated with a sizeable reduction of 30% in acute diabetes events, or complications that can arise from diabetes, and 13% in all-cause hospitalizations among people with type 2 diabetes not on intensive insulin therapy. These data suggest cost-savings associated with use of the FreeStyle Libre technology, which is priced at a third of the cost of other CGMs, by lowering diabetes-related complications and hospitalizations.

“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” said Larry Kurt Midyett, MD, pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group, said in a press release.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.”

The FreeStyle Libre 2 next-generation sensor is orn on the back of the upper arm for 14 days is a third less bulky than other CGM sensors. It allows patients with diabetes to view their glucose reading, trend arrow, and 8-hour history with a 1-second scan through a handheld reader.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

• 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
• 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 Park, Il; June 13, 2020: Abbott website. 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 Accessed June 15, 2020.