FDA Approves FreeStyle Libre 2 Integrated Continuous Glucose Monitor

June 15, 2020
Samara Rosenfeld

The monitor is approved for children and adults 4 years and older with diabetes.

Larry Kurt Midyett, MD

The US Food and Drug Administration (FDA) has cleared Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring system for children and adults at least 4 years old with diabetes.

The next-generation system includes optional real-time alarms to measure glucose levels every minute. The technology sustains performance for up to 14 days and provides trends, insights, and actionable data.

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

The alarms, Midyett added, are a bonus because they provide parents with a level of reassurance.

The FreeStyle Libre 2 sensor is not as bulky as other systems of its kind. The technology is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help patients and their providers make more informed healthcare decisions. A handheld reader completes a one-second scan and allows users to see their glucose reading, trend arrow, and eight-hour history. Developers designed a mobile app to go with the monitor, though it is not yet approved for the market in the US.

The FDA approval comes on the heels of data presented at the American Diabetes Association’s (ADA’s) 80th Virtual Scientific Sessions.

The findings of the study, “Dramatic Drop in Ketoacidosis Rate after FreeStyle Libre System Initiation in Type 1 and Type 2 Diabetes in France, Especially in People with Low Self-Monitoring of Blood Glucose (SMBG): A Nationwide Study,” suggested hospitalizations decreased 52% for patients with type 1 diabetes and 47% among patients with type 2 diabetes who used the FreeStyle Libre 2 glucose monitoring device.

What’s more, additional late-breaking data from ADA demonstrated the use of the technology was associated with a significant reduction in HbA1c levels for patients living with type 2 diabetes on long-acting insulin or non-insulin therapy. There was a .8% drop after 6 months from 8.5% to 7.7% and a .6% drop after 1 year using the system from 8.5% to 7.9%.

FreeStyle Libre 2 is priced the same as the FreeStyle Libre 14-day system, which is reportedly one-third of the cost of other available continuous glucose monitors. The 14-day system was approved by the FDA in July 2018. The newly approved technology will be available in upcoming weeks at participating pharmacies and durable medical equipment suppliers across the US.

“We’re thrilled to bring out next-generation technology on our world-leading sensing platform to both children and adults with diabetes in the US,” Jared Watkin, senior vice president of Diabetes Care at Abbott, said. “With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other (continuous glucose monitors), Abbott’s FreeStyle Libre 2 system will change the future of diabetes care in the US the same way it has around the globe.”


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