New FreeStyle Libre Glucose Monitoring System Gets EU Approval

Miriam E. Tucker

October 02, 2020

The FreeStyle Libre 3 glucose monitoring system (Abbott) has been granted a CE mark for use by people with diabetes in the countries of the European Union (EU).

The next-generation FreeStyle Libre 3 sensor, worn on the back of the upper arm for 14 days, is 70% thinner than the Libre 2. Glucose readings are delivered every minute to a smartphone app, which also displays trend arrows and glucose history. This latest version eliminates the need for scanning the sensor with a separate device.

The Libre 3 is also more environmentally friendly ― it contains 41% less plastic and uses 43% less carton paper. As with the prior version, the Libre 3 includes optional alarms for high and low glucose values.

The price will be the same as that of previous versions, Abbott said in a statement. Following the approval, Abbott says it will launch the FreeStyle Libre 3 system across Europe in the coming months.

Version one of the FreeStyle Libre, sometimes referred to as "flash" glucose monitoring, was first cleared for use in the EU in 2014. The Libre 2 was approved 2 years ago, in October 2018, and is available for use in children and adults.

In the United States, the Libre 2 was approved by the US Food and Drug Administration in June 2020 for adults and for children aged 4 years and older.

Asked for an update as to when the Libre 3 may be available in the United States and elsewhere, Abbott spokeswoman Jessica Sachariason told Medscape Medical News, "Abbott aims to make the technology broadly available and will roll it out based on in-country approvals.

"We will share further details on launch timing for additional countries when available. Abbott has an approach in place that will allow for integration with [automated insulin delivery] systems in the US in time."

Abbott says it has secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

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