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Flash glucose monitoring with the FreeStyle Libre 2: Results from the FLASH-UK randomised controlled trial (on behalf of the Study group)
Abstract
Abstract Body
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 self-monitoring 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 in-person 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.