Abstract
PURPOSE: 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). METHODS: 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. DISCUSSION: 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).