Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol

Emma G Wilmot, Mark Evans, Katharine Barnard-Kelly, M Burns, Iain Cranston, Rachel Ann Elliott, G Gkountouras, N Kanumilli, A Krishan, C Kotonya, S Lumley, P Narendran, Sankalpa Neupane, Gerry Rayman, Christopher Sutton, V P Taxiarchi, H Thabit, L Leelarathna, Emma G Wilmot, Mark Evans, Katharine Barnard-Kelly, M Burns, Iain Cranston, Rachel Ann Elliott, G Gkountouras, N Kanumilli, A Krishan, C Kotonya, S Lumley, P Narendran, Sankalpa Neupane, Gerry Rayman, Christopher Sutton, V P Taxiarchi, H Thabit, L Leelarathna

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.

Keywords: clinical trials; diabetes & endocrinology; general diabetes; health economics.

Conflict of interest statement

Competing interests: EGW has received personal fees from Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, Sanofi Diabetes Care. LL has received personal fees from Abbott Diabetes Care, Dexcom, Insulet, Medtronic, Novo Nordisk, Sanofi Diabetes Care. ME has received personal fees from Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk, Astra Zeneca, Zucara. SN has received personalised fees from QUIN,Roche. NK has received personal fees from Abbott,Eli Lilly,Novo Nordisk, Astra Zeneca, Napp, Sanofi. PN has acted as a clinical expert for NICE Medtech innovation briefing MIB110 relating to FreeStyle Libre system. GR has received lecture and consultancy fees from Abbott Diabetes UK.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Flash UK study flow chart. HbA1c, glycated haemoglobin; SMBG, self-monitoring of blood glucose.

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Source: PubMed

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