Elbalshy Mona, Boucher Sara, Galland Barbara, Haszard Jillian J, Crocket Hamish, Wiltshire Esko, Jefferies Craig, de Bock Martin I, Tomlinson Paul, Jones Shirley, Wheeler Benjamin J
Department of Women's and Children's Health, Otago Medical School, Dunedin Campus, University of Otago, 201 Great King St, Dunedin, Otago 9016 New Zealand.
Department of Human Nutrition, Division of Sciences, University of Otago, PO Box56, Dunedin, 9054 New Zealand.
J Diabetes Metab Disord. 2020 Oct 30;19(2):1647-1658. doi: 10.1007/s40200-020-00671-5. eCollection 2020 Dec.
Type 1 diabetes (T1D) is one of the most common chronic diseases of childhood and comes with considerable management and psychological burden for children and their families. Fear of hypoglycaemia (FOH), particularly nocturnal hypoglycaemia, is a common worry. Continuous glucose monitoring (CGM) is a tool that may help reduce FOH, as well as reduce overall diabetes burden. However, CGM systems are expensive and often not publicly funded or subsidised. MiaoMiao (MM) is a novel relatively affordable third-party add-on technology to intermittently scanned CGM (isCGM). MM allows users to convert their isCGM to a form of "Do-it-yourself" (DIY)-CGM. Our hypothesis is that MM-CGM will result in significant reduction in parental fear from hypoglycaemia. The primary objective is to determine the impact of real-time DIY-CGM on parental fear of hypoglycaemia using Hypoglycaemia Fear Survey (HFS).
This is a multisite randomised cross-over study of 55 New Zealand children (ages 2-13 years) with established T1D and current users of isCGM (Abbott FreeStyle Libre). DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 6 weeks followed by a 4-week wash-out period before crossing over to the other study arm for a further 6 weeks.
The results of this study will provide much needed clinical trial data regarding DIY-CGM effectiveness in reducing parental FOH, as measured by HFS, as well as various other secondary outcomes including traditional glycaemic metrics, and child and caregiver sleep. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12619001551189) on 18 November 2019, and the World Health Organisation International Clinical Trial Registry Platform (Universal Trial Number U1111-1236-9189).
1型糖尿病（T1D）是儿童期最常见的慢性病之一，给儿童及其家庭带来了相当大的管理和心理负担。对低血糖的恐惧（FOH），尤其是夜间低血糖，是一个常见的担忧。持续葡萄糖监测（CGM）是一种可能有助于减轻对低血糖的恐惧以及减轻总体糖尿病负担的工具。然而，CGM系统价格昂贵，且通常没有公共资金资助或补贴。苗苗（MM）是一种新型的、相对经济实惠的第三方附加技术，可用于间歇性扫描CGM（isCGM）。MM允许用户将其isCGM转换为一种“自己动手做”（DIY）-CGM的形式。我们的假设是，MM-CGM将显著降低家长对低血糖的恐惧。主要目标是使用低血糖恐惧调查（HFS）来确定实时DIY-CGM对家长低血糖恐惧的影响。
这是一项多中心随机交叉研究，研究对象为55名患有T1D且目前正在使用isCGM（雅培自由风格Libre）的新西兰儿童（2至13岁）。将DIY-CGM与isCGM的常规护理进行比较。参与者将被随机分配到研究的任一臂，为期6周，然后有4周的洗脱期，之后再交叉到另一研究臂，再进行6周。
本研究的结果将提供急需的临床试验数据，以证明DIY-CGM在降低家长对低血糖的恐惧方面的有效性（通过HFS测量），以及其他各种次要结果，包括传统血糖指标、儿童和照顾者的睡眠情况。该试验于2019年11月18日在澳大利亚新西兰临床试验注册中心（ACTRN 12619001551189）以及世界卫生组织国际临床试验注册平台（通用试验编号U1111-1236-9189）注册。
