Statistical analysis plan for the 24-week randomised trial of hypoglycaemia prevention, awareness of symptoms, and treatment: HypoPAST.

ABSTRACT:

Background

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.

Methods

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 psycho

SUBMITTER: Thuraisingam S 

PROVIDER: S-EPMC12271082 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature