Recommendation for NHSScotland

It is recommended that flash glucose monitoring with Freestyle Libre® is available for individuals with diabetes who are actively engaged in the management of their diabetes and who intensively manage their condition with multiple daily insulin injections or insulin pump therapy.

In keeping with the Scottish Diabetes Group criteria, use should be restricted to those who:

• Agree to attend a locally provided flash glucose monitoring education session;
• Agree to scan glucose levels no fewer than six times per day;
• Satisfy their clinical team that they (or carer) have the required knowledge/skills to self-manage diabetes; for example, having attended a recognised diabetes structured education programme.

Clinical review timescales should be agreed to ensure that use of the device continues to support individuals’ diabetes care management. NHS Boards should consider the continuation and discontinuation criteria contained within the Managed Clinical Network (MCN) leads interim position statement (see Annex 1).

Recipients should be encouraged to share data with their care team to facilitate clinical review and to contribute to local and national audit.

Please note a Safety Action Notice issued in September 2021, which relates to the risks of mis-identification of wearable medical devices used in the monitoring and treatment of diabetes.

NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.

What we were asked to look at?

We were asked to provide advice on the use of Freestyle Libre® flash glucose monitoring for patients with diabetes mellitus treated with intensive insulin therapy.

Our advice was based on a EUnetHTA rapid review of published clinical effectiveness and safety literature, but also incorporated a range of additional evidence sources including: a Healthcare Improvement Scotland economic evaluation; a patient group submission from Diabetes Scotland; and NHSScotland clinical expert input.

Why is this important?

Diabetes mellitus is a major cause of morbidity and mortality in Scotland with around 300,000 people diagnosed with the condition. Self-monitoring of blood glucose is essential for people with type 1 (T1) diabetes mellitus (DM) and is used by roughly one in 10 people with type 2 (T2) DM to manage glycaemic control and adjust insulin or other medications. Currently, finger prick self-monitoring of blood glucose (SMBG) using test strips and blood glucose meters is the most frequently used monitoring method. Freestyle Libre® is a flash glucose monitoring system comprising a handheld reader and sensor that patients wear on their upper arm, and offers an alternative to finger prick testing.  

Referred by

Scottish Diabetes Group.