Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.Subject has a history of hypoglycemia unawareness.Additional criteria for hypoglycemia induction.Subject must be willing and able to provide written signed and dated informed consent.At the time of enrollment, subject must be available to participate in all study visits.In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.Willing to have their blood sugar manipulated during in-clinic sessions.Subject must be able to read and understand English.Willing to perform a minimum of 8 finger sticks per day while wearing the sensor in the study.Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
Subject must be at least 18 years of age.Why Should I Register and Submit Results?.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. Currently, finger prick self-monitoring of blood glucose (SMBG) using test strips and blood glucose meters is the most frequently used monitoring method. 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. 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.ĭiabetes mellitus is a major cause of morbidity and mortality in Scotland with around 300,000 people diagnosed with the condition. 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. NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice. 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. Recipients should be encouraged to share data with their care team to facilitate clinical review and to contribute to local and national audit. NHS Boards should consider the continuation and discontinuation criteria contained within the Managed Clinical Network (MCN) leads interim position statement (see Annex 1). 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.Ĭlinical review timescales should be agreed to ensure that use of the device continues to support individuals’ diabetes care management.
Agree to scan glucose levels no fewer than six times per day.Agree to attend a locally provided flash glucose monitoring education session.In keeping with the Scottish Diabetes Group criteria, use should be restricted to those who: 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.
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