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首页> 外文期刊>BMC Endocrine Disorders >Effect of 6?months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol
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Effect of 6?months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol

机译：对1型糖尿病和未达到最佳血糖控制水平的青少年和年轻人进行6个月快速血糖监测的效果：通过“快速”随机对照试验方案管理糖尿病

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Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D. This is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13–20?years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6?months ≥75?mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6?months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6?months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability. If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group. This trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 ( ACTRN12618000320257p ) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).
机译：患有1型糖尿病（T1D）的青少年和成年人在应付这种严重的慢性疾病时承受着沉重的负担，在这一生阶段，血糖控制处于最不健康的状态。闪速血糖监测（FGM）是一项新技术，与传统的手指毛细血管葡萄糖采样相反，当手持式阅读器扫描戴在上臂的组织间葡萄糖传感器时，可以轻松，谨慎地显示葡萄糖信息，从而减轻了血糖监测的负担刺痛（也称为自我监测血糖，SMBG）。尚不清楚该技术的有效性及其长期使用对已存在欠佳血糖控制的年轻人的影响。因此，本研究旨在研究除标准治疗外，FGM在T1D年轻人中的有效性。这是一个分为两个阶段的研究计划，包括多中心随机平行研究，包括SMBG和FGM之间6个月的比较，以及另外6个月的延续阶段。我们将招募T1D年龄在13至20岁（含）之间，血糖控制不佳的青少年（过去6个月中平均糖化血红蛋白（HbA1c）≥75？mmol / mol [≥9％]）。参与者将被随机分配（1：1）参加FGM（FreeStyle Libre;干预组）或继续进行SMBG并进行毛细血管血糖测试（常规护理组）。所有参与者将继续进行标准护理的其他方面，而这项研究仅提供FreeStyle Libre。在6个月时，对照组将进行干预。主要结局是6个月时HbA1c变化的组间差异。其他结果包括一系列社会心理和健康经济措施以及女性外阴残割的可接受性。 >如果发现改善的话，这将进一步鼓励采取步骤，将FGM纳入血糖控制不佳的青年人的常规糖尿病治疗中，并期望它将减轻日常的糖尿病管理负担，并改善这种高风险人群的短期和长期健康状况组。该试验已于2018年3月5日在澳大利亚新西兰临床试验注册中心（ACTRN12618000320257p）和世界卫生组织国际临床试验注册平台（通用试验号U1111-1205-5784）注册。

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