Flash Blood Glucose Monitoring with the FreeStyle Libre 2 Versus Self-Monitoring of Blood Glucose in Suboptimally Controlled Type 1 Diabetes: The FLASH-UK Randomized Controlled Trial Protocol
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BMJ Open. Jul 14, 2021; 11 (7): e050713. doi: 10.1136 / bmjopen-2021-050713.
INTRODUCTION: Optimizing glycemic control in type 1 diabetes (T1D) remains a challenge. Flash Glucose Monitoring with FreeStyle Libre 2 (FSL2) is a new alternative to the current standard of self-monitoring blood glucose (SMBG) care. No randomized 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 T1D blood sugar control compared to SMBG.
METHODS: This open-label, multicenter, randomized (via stochastic minimization) design study conducted in parallel at eight UK secondary and primary care centers will aim to recruit 180 people aged ≥16 years with T1D for> 1 year and glycated hemoglobin (HbA1c) 7.5% -11%. Eligible participants will be randomized over 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2 weeks of blind sensor wear. Participants will be assessed virtually or in person due to the COVID-19 pandemic. HbA1c will be measured at baseline, at 12 and 24 weeks (main result). Participants will be contacted at 4 and 12 weeks for blood sugar optimization. Control participants will wear a blind sensor for the past 2 weeks. Psychosocial outcomes will be measured at baseline and at 24 weeks. Secondary outcomes include sensor-based measures, insulin doses, adverse events, and psychosocial self-report measures. The usefulness, acceptability, expectations and experience of using FSL2 will be explored. Data on the use of health services resources will be collected.
ANALYSIS: Efficacy analyzes will follow the principle of intention to treat. The results will be analyzed using an analysis of covariance, adjusted for the baseline value of the corresponding result, minimization factors and other known prognostic factors. Economic evaluations over the course of the trial and over the life course, informed by modeling from the perspective of the National Health Service framework, will be carried out.
ETHICS: The study was approved by the Greater Manchester West Research Ethics Board (reference 19 / NW / 0081). Informed consent will be requested from all participants.
TEST REGISTRATION NUMBER: NCT03815006.
PROTOCOL VERSION: 4.0 of June 29, 2020.