New FreeStyle Libre Glucose Monitoring System Will get EU Approval

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The FreeStyle Libre 3 glucose monitoring system (Abbott) has been granted a CE mark to be used by folks with diabetes within the international locations of the European Union (EU).

The following-generation FreeStyle Libre 3 sensor, worn on the again of the higher arm for 14 days, is 70% thinner than the Libre 2. Glucose readings are delivered each minute to a smartphone app, which additionally shows development arrows and glucose historical past. This newest model eliminates the necessity for scanning the sensor with a separate system.

The Libre 3 can be extra environmentally pleasant ― it comprises 41% much less plastic and makes use of 43% much less carton paper. As with the prior model, the Libre 3 consists of non-obligatory alarms for prime and low glucose values.

The value would be the similar as that of earlier variations, Abbott mentioned in a press release. Following the approval, Abbott says it should launch the FreeStyle Libre 3 system throughout Europe within the coming months.

Model one of many FreeStyle Libre, generally known as “flash” glucose monitoring, was first cleared to be used within the EU in 2014. The Libre 2 was approved 2 years in the past, in October 2018, and is offered to be used in youngsters and adults.

In the USA, the Libre 2 was approved by the US Meals and Drug Administration in June 2020 for adults and for kids aged 4 years and older.

Requested for an replace as to when the Libre 3 could also be obtainable in the USA and elsewhere, Abbott spokeswoman Jessica Sachariason informed Medscape Medical Information, “Abbott goals to make the expertise broadly obtainable and can roll it out primarily based on in-country approvals.

“We are going to share additional particulars on launch timing for extra international locations when obtainable. Abbott has an method in place that may permit for integration with [automated insulin delivery] techniques within the US in time.”

Abbott says it has secured partial or full reimbursement for the FreeStyle Libre system in 37 international locations, together with Canada, France, Germany, Japan, the UK, and the USA.

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