TY - JOUR
T1 - Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes
T2 - The FLASH-UK randomised controlled trial protocol
AU - Wilmot, Emma G.
AU - Evans, Mark
AU - Barnard-Kelly, Katharine
AU - Burns, M.
AU - Cranston, Iain
AU - Elliott, Rachel Ann
AU - Gkountouras, G.
AU - Kanumilli, N.
AU - Krishan, A.
AU - Kotonya, C.
AU - Lumley, S.
AU - Narendran, P.
AU - Neupane, Sankalpa
AU - Rayman, Gerry
AU - Sutton, Christopher
AU - Taxiarchi, V. P.
AU - Thabit, H.
AU - Leelarathna, L.
N1 - Funding Information:
This work was supported by Diabetes UK grant number 18/0005836. The device manufacturer played no part in design, conduct or any other aspects of the study. The study devices were paid by the National Health Service (NHS) UK. Work was supported by the NIHR Cambridge Biomedical Research Centre. The University of Cambridge has received salary support for MLE from the National Health Service in the East of England through the Clinical Academic Reserve.
Funding Information:
Kanumilli @drnkan Contributors LL, EGW and ME conceptualised the study. LL, EGW, ME, IC, PN, SN, RAE, CS and HT contributed to the grant application. MB is the lead clinical trial manager. CS, AK and VPT are responsible for statistical analysis. All authors contributed to protocol development at various stages. LL, EGW, ME, IC, PN, SN, HT, GR, SL, NK, CK provides site oversight and are responsible for study conduct at each site. RAE and GG are responsible for the health economic analysis. KB-K is responsible for the process evaluation. EGW and LL wrote the first draft of the manuscript and all authors reviewed and had the opportunity to comment on the content prior to submission. The corresponding author confirms that all co-authors are ICMJE recommendation compliant for the submission of this manuscript. No professional writers have been engaged for the preparation of this manuscript. Funding This work was supported by Diabetes UK grant number 18/0005836. The device manufacturer played no part in design, conduct or any other aspects of the study. The study devices were paid by the National Health Service (NHS) UK. Work was supported by the NIHR Cambridge Biomedical Research Centre. The University of Cambridge has received salary support for MLE from the National Health Service in the East of England through the Clinical Academic Reserve. 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.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
PY - 2021/7/14
Y1 - 2021/7/14
N2 - 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.
AB - 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.
KW - Adolescent
KW - Blood Glucose
KW - Blood Glucose Self-Monitoring
KW - COVID-19
KW - Diabetes Mellitus, Type 1/drug therapy
KW - Humans
KW - Hypoglycemic Agents
KW - Multicenter Studies as Topic
KW - Pandemics
KW - Randomized Controlled Trials as Topic
KW - SARS-CoV-2
KW - State Medicine
KW - United Kingdom
U2 - 10.1136/bmjopen-2021-050713
DO - 10.1136/bmjopen-2021-050713
M3 - Article
C2 - 34261691
AN - SCOPUS:85110452431
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e050713
ER -
