NHS DORSET CLINICAL COMMISSIONING GROUP COMMISSIONING STATEMENT ON THE USE OF FREESTYLE LIBRE FOR BLOOD MONITORING IN DIABETES. The CCG will not routinely commission use of the Freestyle Libre glucose monitoring system for use in diabetic patients hence it’s use is not recommended. This statement will be reviewed after 18 months or sooner if new evidence is published BACKGROUND INFORMATION 1. PRODUCT DESCRIPTION 1.1 The Freestyle Libre is a flash glucose monitoring system which allows people to check blood glucose levels and trends without performing capillary (fingerprick) testing. A sensor, with a microfilament sited in the skin is placed on the back of the arm and the reader when passed over the sensor displays interstitial glucose levels. Results can be obtained through clothing. The sensor can tolerate immersion in water up to 1 metre for up to 30minutes. 1.2 Finger prick testing is still recommended during periods of rapidly changing levels. 1.3 Scanning of the sensor at least every 8hours provides the user with a 24 hour continuous blood glucose profile. The reader can store 90 days of data. 1.4 A sensor lasts for 14 days. 2. NICE APPRAISALS 2.1 There is no indication at present of NICE appraising this product. 3. EVIDENCE 3.1 Trial data for the equipment comes from company sponsored trials which indicate accuracy being marginally superior to existing continuous glucose monitoring systems. 3.2 Two RCTs looking at change in HbA1c compared to standard capillary glucose testing in type 2 diabetes and time in hypolgycaemia for type 1 patients are underway in the USA and Europe. Reports from these are due towards the end of 2015. 3.3 The product received European CE mark certification in August 2014. 4. COST 4.1 The meter and sensor discs are not currently prescribable on FP10 although the company expects the inclusion to the drug tariff within 12 months. 4.2 The products are available to buy online (excl. VAT): Reader + 2xSensors: £133.29 Single sensor: £48.29 5.0 POLICY 5.1 Dorset CCG will not commission use of the Freestyle libre system. The position will be reviewed within 18months or sooner if new data becomes available. Approved by (committee) Date Approved: Produced by (Title); Dorset Medicines Advisory Group January 2015 Version 1 Nick Bolton,Senior Pharmacist, Dorset CCG