NICE guidance FreeStyle Libre for glucose monitoring

NICE has developed a medtech innovation briefing (MIB) on FreeStyle Libre for glucose monitoring. Published date: 4 July 2017. These guidelines have come prior to news of FreeStyle Libre becoming available on UK formulary (i.e. available on prescription). Something that Abbott, the manufacturer behind the device, is trying to achieve. Currently, most users self-fund.

The guidance states: The intended place in therapy is as an alternative to routine blood glucose monitoring in people with Type 1 and 2 diabetes who use insulin injections. Finger-prick blood glucose measurements are sometimes still needed, such as when a person is ill or when they are driving.

The evidence suggests that using FreeStyle Libre for up to 12 months reduces time spent in hypoglycaemia compared with self-monitoring of blood glucose using finger-prick tests, and reduces the average number of finger-prick blood glucose tests needed.

The current commercial list price of FreeStyle Libre is £57.95 for the reader, plus £57.95 for a disposable sensor (including VAT) that must be replaced every 2 weeks. At the of time publication, no NHS price for FreeStyle Libre was available. The reader is reusable and has a rechargeable battery that must be charged every 7 days. It also has built-in blood glucose and blood ketone meters, which can be used with FreeStyle Optium blood glucose strips or Optium Beta ketone test strips to test finger-prick blood samples.

As an alternative to using the reader, the sensor can be scanned with a mobile device capable of near-field communication (NFC) and on which the LibreLink companion app has been installed. The LibreLink app can be used on Android mobile devices and has similar features to the reader. It can be used with the LibreLinkUp app to share glucose readings through the LibreView software. LibreView can be used to upload and store data to cloud storage and to view data on mobile devices and web browsers. FreeStyle Libre does not provide real-time continuous glucose monitoring or a hypoglycaemia alarm.

Resource impact
The resource impact is uncertain, and depends upon the extent to which improved glucose control through the adoption of FreeStyle Libre translates into fewer complications, reduced emergency admissions and less use of glucose test strips.

FreeStyle Libre uses ‘flash’ monitoring to measure interstitial fluid glucose levels at regular intervals. Once applied, the sensor allows readings to be taken non-invasively, potentially reducing the number of finger-prick blood glucose tests needed. This avoids the pain caused by finger-prick sampling, which can deter people with diabetes from taking regular measurements.

FreeStyle Libre allows people to see their glucose levels at times when readings are not usually taken, such as overnight. The ambulatory glucose profile allows day-to-day patterns in glucose levels to be seen, which can be used to plan treatment.

FreeStyle Libre is intended to be used as an alternative to routine blood glucose monitoring for people aged 4 or over with Type 1 or type 2 diabetes, who have multiple daily injections of insulin or who use insulin pumps and are self-managing their diabetes.

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. (The comments received are individual opinions and do not represent NICE’s view.) All four clinical experts stated that they regularly use FreeStyle Libre with patients and one is also a self-user. All four of the clinical experts agreed that FreeStyle Libre is an innovative technology, one of them describing it as a ‘huge leap forward’, another as a minor variation of continuous glucose monitoring. Although easy to use, the experts all felt that some basic training or information would need to be provided for patients and healthcare professionals using FreeStyle Libre. All four experts felt that this technology could offer benefits to patients.

Diabetes UK noted: FreeStyle Libre might be particularly useful for certain groups of people. Continuous glucose monitors are sometimes recommended for pregnant women, but because these are fixed to the abdomen FreeStyle Libre may be a suitable alternative. Other people who may benefit include people with highly variable blood glucose, people with poor peripheral circulation, older people, and hospital inpatients who need regular monitoring. FreeStyle Libre should not be used for people with no awareness of the symptoms of hypoglycaemia. Using FreeStyle Libre may benefit people in certain jobs where finger-prick testing is not always practical. It could also provide education by allowing people to link certain foods or behaviours to changes in their glucose levels. FreeStyle Libre could have a positive impact on NHS services because of improved management of HbA1c levels leading to potentially fewer emergency admissions, less inpatient care and better outcomes for patients. It would help people to meet the frequency of glucose testing recommended in NICE guidance. It could also save costs associated with glucose test strips.

NICE plans to update this MIB when there is further relevant information.

Download the PDF of the full guidance here:

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