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

Abstract

IntroductionOptimising 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.MethodsThis 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.AnalysisEfficacy 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.EthicsThe study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants.Trial registration numberNCT03815006.Protocol version4.0 dated 29 June 2020.

Estimating the cost‐effectiveness of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in England

“…The protocol was approved by Greater Manchester West Research Ethics Committee on 21/03/2019 (Reference 19/ NW/0081). 7 People 16 years or above with type 1 diabetes and HbA1c 58-97 mmol/mol (7.5%-11.0%), either on continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) were eligible. Trial information (List of study investigators at participating clinical sites, trial inclusion and exclusion criteria, schedule of study visits, and CONSORT diagram) is provided in Appendices S1-S4.…”

Flash glucose monitoring: the story so far and the journey ahead

“…FSL2 recently arrived with the addition of alarms, allowing further improved recognition of glucose levels above target or in the hypoglycaemic range. Many of us have already seen people with diabetes in our clinics benefit from these alarms, and we look forward to seeing randomised control trial data from the FLASH-UK study, which is currently underway and will hopefully further support the use of the updated system 16…”

Delivering value‐based healthcare for people with diabetes in a national publicly funded health service: Lessons from Ireland and Wales

“…Over recent years technology has rapidly developed in glucose monitoring technology, with the use of intermittently scanned and continuous glucose monitoring (CGM) sensors, as a non-invasive alternative to finger-prick or capillary blood glucose testing. There is good evidence that this type of technology improves glycemic control thereby reducing the likelihood of developing diabetes related complications, reduces events such as hypoglycemia which require paramedic attendances or hospital admissions, and promotes increased self-management for people living with diabetes, improving quality of life 14 . Most of the use of this technology has been focused on people living with type 1 diabetes in secondary care settings, but new guidance from both the National Institute for Health and Care Excellence (NICE) and Health Technology Wales now advises the use of CGM technology for select people living with type 2 diabetes.…”