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FreeStyle Libre flash glucose monitoring device receives CE mark for use in children aged 4–17 years

Abbott have announced that its FreeStyle Libre flash glucose monitoring system has received the CE (Conformité Européenne) Mark for use in children and teens aged 4–17 years with diabetes. The device can now be marketed for this age group in the UK.

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The FreeStyle Libre system is designed to change how people with diabetes measure their blood glucose levels. It reads glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days, eliminating the need for routine finger pricks. In addition, the device is unique in that it does not require finger prick calibration for accuracy. In a recent accuracy study (Abbott data on file), the device was shown to be accurate, stable and consistent over 14 days without the need for calibration, for children and teens in this age group. In addition, more than 97% of the participants said that it was is easier to use than finger prick testing.

The system also allows parents who are worried about nocturnal hypoglycaemia to test their children’s blood glucose levels without waking them up, as the device can read glucose levels simply by passing it over the sensor.

Commenting on the approval, Emanuele Bosi (Associate Professor, Department of Endocrinology and Diabetology, Università Vita-Salute in San Raffaele, Milan) said: “The availability of FreeStyle Libre system for children is a critical milestone for children living with diabetes. The technology in Abbott’s FreeStyle Libre system is transformative because it changes how self-monitoring has been done for decades—and is proven to be accurate and stable.  I look forward to seeing my young patients achieve better diabetes management, while giving their parents and caretakers more peace of mind.”

The FreeStyle Libre system is currently available in the UK via www.freestylelibre.co.uk

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