使用 FreeStyle Libre 2 的动态血糖监测与自我监测不佳的 1 型糖尿病患者的血糖监测相比：FLASH-UK 随机对照试验方案。

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.

机构信息

Diabetes Department, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.

University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK.

出版信息

BMJ Open. 2021 Jul 14;11(7):e050713. doi: 10.1136/bmjopen-2021-050713.

DOI:10.1136/bmjopen-2021-050713

PMID:34261691

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8280849/

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.

摘要

简介

优化 1 型糖尿病（T1D）的血糖控制仍然具有挑战性。与当前的血糖自我监测（SMBG）标准相比，FreeStyle Libre 2（FSL2）的闪光血糖监测是一种新颖的替代方案。迄今为止，尚无随机对照试验探讨 FSL2 在 T1D 中的潜在益处。我们旨在评估 FSL2 在血糖控制不佳的 T1D 患者中的影响与 SMBG 相比。

方法

这是一项在英国 8 个二级和初级保健中心进行的开放标签、多中心、随机（通过随机最小化）、平行设计研究，旨在招募 180 名年龄≥16 岁、T1D 患病时间超过 1 年且糖化血红蛋白（HbA1c）为 7.5%-11%的患者。符合条件的参与者将被随机分配到 24 周的 FSL2（干预）或 SMBG（对照）期，在 2 周的盲法传感器佩戴后。由于 COVID-19 大流行，参与者将通过虚拟或面对面的方式进行评估。HbA1c 将在基线、12 周和 24 周进行测量（主要结局）。参与者将在第 4 周和第 12 周接受葡萄糖优化。对照参与者将在最后 2 周佩戴盲法传感器。在基线和 24 周时将测量心理社会结局。次要结局包括基于传感器的指标、胰岛素剂量、不良事件和自我报告的心理社会测量。将探索使用 FSL2 的效用、可接受性、期望和经验。还将收集卫生服务资源利用的数据。