Thuraisingam Sharmala, Halliday Jennifer A, Søholm Uffe, Holmes-Truscott Elizabeth, Hendrieckx Christel, Skinner Timothy C, Versace Vincent L, Speight Jane
Deakin Rural Health, School of Medicine, Faculty of Health, Deakin University, Warrnambool, Victoria, 3280, Australia.
School of Psychology, Deakin University, 1 Gheringhap St, Geelong, Victoria, 3220, Australia.
Contemp Clin Trials Commun. 2025 Jul 2;46:101513. doi: 10.1016/j.conctc.2025.101513. eCollection 2025 Aug.
The HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment) randomised controlled trial aims to examine the effectiveness of an online psycho-educational intervention for reducing fear of hypoglycaemia among adults with type 1 diabetes. This statistical analysis plan provides the framework to assess the primary, secondary, and safety outcomes of the trial. The plan was written prior to database lock and in accordance with the SPIRIT guidelines.
HypoPAST is a 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial. The primary outcome is the difference in mean Hypoglycaemia Fear Survey II Worry subscale scores at 24 weeks between intervention and control arms. Secondary outcomes include between-arm differences in psychological, clinical and behavioural measures at mid- and end-trial. Primary and secondary outcomes will be analysed using mixed-effects models under the intention-to-treat principle. A sensitivity analysis will examine assumptions regarding missing data, and a per-protocol analysis will estimate the intervention effect among participants who engage with HypoPAST. Table shells for all prespecified analyses are provided to support transparent reporting.
Consistent with best practice, all analyses described were prespecified prior to completion of trial data collection. The analysis methods were developed by statisticians, with input from trial investigators. This analysis plan provides a rigorous framework for the analysis of the HypoPAST trial data, ensuring the results will be robust and reproducible.
The trial is registered on the Australian and New Zealand Clinical Trials Registry: ACTRN12623000894695 (August 21, 2023).
HypoPAST（低血糖预防、症状认知与治疗）随机对照试验旨在检验一项在线心理教育干预措施对降低1型糖尿病成年患者低血糖恐惧的有效性。本统计分析计划提供了评估该试验主要、次要和安全性结局的框架。该计划在数据库锁定之前编写，并符合SPIRIT指南。
HypoPAST是一项为期24周的双臂平行组1型混合随机对照试验。主要结局是干预组和对照组在24周时低血糖恐惧调查II担忧分量表平均得分的差异。次要结局包括试验中期和末期心理、临床和行为测量指标的组间差异。主要和次要结局将根据意向性分析原则，使用混合效应模型进行分析。敏感性分析将检验关于缺失数据的假设，符合方案分析将估计参与HypoPAST的参与者的干预效果。提供了所有预先指定分析的表格框架，以支持透明报告。
与最佳实践一致，所有描述的分析均在试验数据收集完成之前预先指定。分析方法由统计学家制定，并得到试验研究者的投入。本分析计划为HypoPAST试验数据的分析提供了一个严谨的框架，确保结果将是稳健且可重复的。
该试验已在澳大利亚和新西兰临床试验注册中心注册：ACTRN12623000894695（2023年8月21日）。
