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© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms (‘awareness’), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme.

Methods

A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews.

Discussion

This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D.

Trial registration

Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

Details

Title
Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST): protocol for a 24-week hybrid type 1 randomised controlled trial of a fully online psycho-educational programme for adults with type 1 diabetes
Author
Halliday, Jennifer A. 1   VIAFID ORCID Logo  ; Holmes-Truscott, Elizabeth 2   VIAFID ORCID Logo  ; Thuraisingam, Sharmala 3   VIAFID ORCID Logo  ; Søholm, Uffe 1   VIAFID ORCID Logo  ; Chatterton, Mary Lou 4   VIAFID ORCID Logo  ; Russell-Green, Sienna 5 ; O, Eric 6 ; Andrikopoulos, Sof 7 ; Black, Taryn 8 ; Davidson, Susan 9 ; Noonan, Glen 10 ; Scibilia, Renza 11 ; Hagger, Virginia 12   VIAFID ORCID Logo  ; Hendrieckx, Christel 5   VIAFID ORCID Logo  ; Mihalopoulos, Cathrine 4   VIAFID ORCID Logo  ; Shaw, James A. M. 13   VIAFID ORCID Logo  ; Versace, Vincent L. 14   VIAFID ORCID Logo  ; Zoungas, Sophia 4   VIAFID ORCID Logo  ; Skinner, Timothy C. 15   VIAFID ORCID Logo  ; Speight, Jane 1   VIAFID ORCID Logo  ; Baptista, Shaira; Prasertsung, Chatpakorn; Robinson, Alison

 Deakin University, School of Psychology, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia (GRID:grid.1021.2); Institute for Health Transformation, Deakin University, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
 Deakin University, School of Psychology, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia (GRID:grid.1021.2); Institute for Health Transformation, Deakin University, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); The University of Melbourne, Australian Centre for Accelerating Diabetes Innovations, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X) 
 The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia (GRID:grid.1008.9); Deakin Rural Health, Deakin University, Warrnambool, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
 Monash University, School of Public Health and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857) 
 Deakin University, School of Psychology, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia (GRID:grid.1021.2) 
 Deakin University, Digital Engagement, Digital Service, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
 Australian Diabetes Society, Sydney, Australia (GRID:grid.470804.f) (ISNI:0000 0004 5898 9456) 
 Diabetes Australia, Turner, Australia (GRID:grid.453637.0) (ISNI:0000 0004 0635 2322) 
 Australian Diabetes Educators Association, Turner, Australia (GRID:grid.453637.0) (ISNI:0000 0000 9917 4633) 
10  Diabetes Victoria, Carlton, Australia (GRID:grid.453637.0) 
11  Breakthrough T1D, New York, USA (GRID:grid.429307.b) (ISNI:0000 0004 0575 6413) 
12  Institute for Health Transformation, Deakin University, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); Deakin University, School of Nursing and Midwifery, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
13  Newcastle University, Translational and Clinical Research Institute, Newcastle Upon Tyne, UK (GRID:grid.1006.7) (ISNI:0000 0001 0462 7212) 
14  The University of Melbourne, Australian Centre for Accelerating Diabetes Innovations, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); Deakin Rural Health, Deakin University, Warrnambool, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
15  Deakin University, School of Psychology, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079); The Australian Centre for Behavioural Research in Diabetes, Melbourne, Australia (GRID:grid.1021.2); Copenhagen University, Institute of Psychology, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
Pages
725
Publication year
2024
Publication date
Dec 2024
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3121489721
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.