FreeStyle Libre flash glucose monitoring
Topic Status Complete
FreeStyle Libre flash glucose monitoring for the management of diabetes.
Outcome of the appraisal
The evidence supports the routine adoption of Freestyle Libre flash glucose monitoring to guide blood glucose regulation in people with diabetes who require treatment with insulin.
The use of Freestyle Libre flash glucose monitoring in these people improves the proportion of time that the blood glucose is in target range and reduces time in hypo and hyperglycaemia.
Health economic modelling indicates that the use of Freestyle Libre flash glucose monitoring is a cost effective intervention compared to finger-prick self monitoring of blood glucose with incremental cost effectiveness ratios (ICERs) of £4,706 and £13,137 per QALY for type 1 and type 2 diabetes, respectively.
Why was this topic appraised?
Maintaining the blood glucose concentration as close as possible to the normal range is an important objective for successful diabetes care since this helps to minimize short and long term complications. Regular blood glucose measurements are essential throughout the day for many people with diabetes, particularly those receiving insulin treatment, to guide treatment and nutrition decisions and to avoid the potentially serious consequences of blood glucose being too low (hypoglycaemia) or too high (hyperglycaemia). The standard means of monitoring blood glucose involves finger-prick testing (self-monitoring of blood glucose, SMBG). The Freestyle Libre flash glucose monitoring (FLFGM) technology provides an alternative to this by measuring the glucose level in subcutaneous tissue using a disposable sensor applied to the upper arm. Glucose levels recorded by the sensor are accessed by scanning over the sensor using either a dedicated reader or a mobile phone app. This means that a ‘snapshot’ as well as a trend in blood glucose can be obtained to guide decision-making.
HTW originally issued Guidance on FLFGM in November 2018. HTW Guidance is periodically updated when necessary. Following consultation with stakeholders, HTW agreed it was appropriate to issue updated Guidance, since there has been a substantial change in the available evidence since the original Guidance was published.
Plain language summary
Diabetes is a long term health condition that affects how your body turns food into energy. It is a complicated condition and there are many forms. When food is eaten, it is broken down into sugar (glucose) and released into your bloodstream. This triggers the pancreas to start producing insulin. The insulin then helps the glucose enter the body’s cells, where it can be used for energy or stored for future use. People with type 1 diabetes don’t produce enough insulin to manage all the glucose in their bloodstream. People with type 2 diabetes can produce insulin, but the insulin either can’t work properly or the pancreas can’t make enough insulin.
Having too much glucose in the blood (hyperglycaemia) or too little (hypoglycaemia) can lead to health complications, such as damage to the heart, eyes, feet and kidneys. It is therefore important that people with diabetes can test their blood to check the amount of glucose in their bloodstream at any time, to help manage the condition and reduce complications. This has commonly been achieved by pricking the tips of fingers with a needle to produce a droplet of blood, which is analysed by a device. This is known as self-monitoring of blood glucose (SMBG). This method may need to be performed up to 11 times a day and can result in pain, embarrassment and incorrect glucose readings.
Flash Glucose Monitoring (FGM) is an alternative to SMBG proposed to reduce some of the difficulties reported with SMBG. In FGM, a sensor is inserted underneath the skin where it reads and records glucose levels continuously. These can be accessed by passing a scanner over the sensor, which will show users their blood glucose level.
HTW looked for evidence on the use of FGM in people with type 1 and type 2 diabetes. The evidence supports the routine adoption of flash glucose monitoring to monitor blood glucose for people with diabetes who require treatment with insulin.
This is an updated version of an appraisal. HTW originally issued Guidance on this topic in November 2018. The Guidance and supporting documents from previous appraisals are available from HTW upon request.