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
Gerry Rayman,
Christopher Sutton,
M Burns,
Rachel Ann Elliott,
Sankalpa Neupane,
Mark Evans,
S Lumley,
A Krishan,
Emma G Wilmot,
P Narendran,
Katharine Barnard-Kelly,
Iain Cranston,
G Gkountouras,
N Kanumilli,
C Kotonya,
V P Taxiarchi,
H Thabit,
L Leelarathna
Affiliations
Gerry Rayman
6University of East Anglia, Norwich, UK
Christopher Sutton
Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK
M Burns
Manchester Clinical Trials Unit, Division of Population Health, Health Service Research and Primary Care, University of Manchester, Manchester, UK
Rachel Ann Elliott
Manchester Centre for Health Economics, The University of Manchester, Manchester, UK
Sankalpa Neupane
Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Trust, Colney Lane Norwich, Norfolk, UK
Mark Evans
National Institute for Health Research Clinical Research Network West Midlands, Birmingham, UK
S Lumley
The Adam Practice, Upton, Poole, UK
A Krishan
Centre for Biostatistics, Division of Population Health, Health Service Research and Primary Care, University of Manchester, Manchester, UK
Emma G Wilmot
1 Department of Diabetes & Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
P Narendran
Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK
Katharine Barnard-Kelly
Barnard Health, BHR Limited, Hampshire, UK
Iain Cranston
Academic Department of Diabetes and Endocrinology, Queen Alexandra Hospital, Cosham, Portsmouth, UK
G Gkountouras
Manchester Centre for Health Economics, Divison of Population Health, Health Service Research and Primary Care, University of Manchester, Manchester, UK
N Kanumilli
Northenden Group Practice, Northenden, Manchester, UK
C Kotonya
Diabetes Department, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
V P Taxiarchi
Centre for Biostatistics, Division of Population Health, Health Service Research and Primary Care, University of Manchester, Manchester, UK
H Thabit
Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Greater Manchester, UK
L Leelarathna
Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Greater Manchester, UK
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.
