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NICE briefing on glucose monitoring device

By Editor
5th July 2017
Clinical guidance, Medical devices NICE

The National Institute For Health and Clinical Excellence (NICE) has developed a medtech innovation briefing (MIB) on the FreeStyle Libre for glucose monitoring.

The device works by taking measurements via a sensor which is applied to the skin as an alternative to routine finger-prick blood glucose testing.

It produces almost a continuous record of measurements which can be accessed on demand by measuring interstitial fluid glucose levels in people with diabetes.  It can also indicate glucose level trends over time.

Five studies, involving 700 people were summarised in the briefing, which included two randomised controlled trials.

NICE said: “All of the included studies report a high level of user preference for FreeStyle Libre over finger-prick blood glucose monitoring, although some people had problems with inserting or wearing the sensor (despite allergies to medical adhesive being included in the exclusion criteria for several of these studies).

It is convenient because it can provide predicted HbA1c measurements between clinic appointments, and can be used with home computers and smartphones

“There are currently no high quality, peer-reviewed studies on the use of FreeStyle Libre by people with very unstable glucose levels. Studies in this patient group would be beneficial to understanding which people with diabetes would benefit most from using FreeStyle Libre.”

The organisation also laid out the commercial retail costs of the technology which currently stands at £57.95 for the reader, which has a three-year lifespan. The sensor costs £57.95, which must be replaced every 14 days (this equates to £1,526.02 per year). The company has an application pending for inclusion in the NHS Drug Tariff.

The current retail cost for FreeStyle Optium blood glucose test strips is £15.97 for 50 strips. FreeStyle Optium blood ketone test strips cost £21.36 for 10 strips. The FreeStyle lancets for taking finger-prick blood cost 3.5p each and the LibreLink app can be downloaded for free.

‘Huge leap forward’

As part of the document, NICE asked four clinical experts working in the field and relevant patient organisations to comment on the technology. All those asked said they regularly use FreeStyle Libre with the people they treat, and once is also a self-user.

They all agreed the device is an “innovative technology” with one of them describing it as a “huge leap forward”.  However, although it is easy to use, all the experts agreed that basic training or information would need to be provided for people and healthcare professionals.

At the of time of publication, no NHS price for FreeStyle Libre was available. NICE plans to update the MIB when there is further relevant information.

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