ABSTRACT
Objectives To evaluate whether intermittently scanned continuous glucose monitoring (isCGM) with optional alarms (FreeStyle Libre 2) improves glycaemia as measured by HbA1c and sensor-based gluco-metrics, patient reported outcome measures (PROMS) and cost-effectiveness compared with selfmonitoring of blood glucose (SMBG). Design Flash UK is a multicenter, open-label, two arm, parallel, randomised controlled trial delivered in 7 specialist hospital diabetes clinics and 1 primary care centre. Participants 156 people with Type 1 diabetes, age 16 years and over treated with either multiple daily insulin injections or insulin pump therapy with HbA1c 7.5%-11% were randomised. Interventions Participants were randomised (1:1) to the FreeStyle Libre 2 (n = 72) or standard care with SMBG (n = 69). Participants were reviewed at 4, 12 and 24 weeks post-randomisation. Education and treatment optimisation was provided to both groups at randomisation, 4 and 12 weeks. Participants in the SMBG arm wore blinded glucose sensor (Freestyle Libre Pro) during the last 2 weeks of the study;all participants wore a 2-week blinded sensor prior to randomisation. All study visits were conducted either inperson or virtually owing to the COVID-19 pandemic. Main outcome measures The primary outcome was HbA1c at 24 weeks, analysed by intention to treat. Secondary outcomes included glucose time in range (3.9 to 10mmol/l), time below and above range and glucose variability. PROMS included EQ-5DL-5L, Type 1 Diabetes Distress Scale, Diabetes fear of injecting and self-testing, Diabetes Eating Problem Survey, Diabetes Treatment Satisfaction, Patient Health Questionnaire and The Glucose Monitoring Satisfaction Survey. Economic evaluation included healthcare resource use, insulin usage and Freestyle Libre 2 utilisation. Results & Conclusion Results and conclusions will be presented during the 15th International Conference on Advanced Technologies & Treatments for Diabetes, April 27 to 30th Barcelona, Spain and Online.