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.
ABSTRACT
INTRODUCTION: Optimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG. METHODS: This open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%-11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected. ANALYSIS: Efficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed. ETHICS: The study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants. TRIAL REGISTRATION NUMBER: NCT03815006. PROTOCOL VERSION: 4.0 dated 29 June 2020.