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 |
Trial registration |
Australian and New Zealand Clinical Trials Registry: ACTRN12623000894695 (Registered: 21 August 2023). All with all items from the WHO Trial Registration Data Set can be found in the Australian and New Zealand Clinical Trials Registry: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385968&isReview=true |
Protocol version | Protocol version 1.1 [24 January 2024]. |
Funding | This project is funded by the Medical Research Future Fund (MRFF) Targeted Translation Research Accelerator (TTRA). In-kind support is provided by our partners: Australian Diabetes Educators Association, Australian Diabetes Society, Diabetes Australia, Diabetes Victoria, and uMotif, and academic partners: Deakin University, La Trobe University, Monash University, and Newcastle University. EH-T, CH and JSp are supported by the core funding to the Australian Centre for Behavioural Research in Diabetes (ACBRD) provided by the collaboration between Diabetes Victoria and Deakin University. VLV is supported by the Rural Health Multidisciplinary Training (RHMT) training programme (funded by the Australian Government Department of Health and Aged Care). SZ receives funding from NHMRC, MRFF, and the Victorian Department of Health and Human Services. We acknowledge peer-reviewed funding from Diabetes UK which enabled creation of the ‘my hypo compass’ educational programme which was provided by Newcastle University to facilitate generation of the novel HypoPAST programme. |
Author details |
Jennifer A Halliday1,2,3, Elizabeth Holmes-Truscott1,2,3,4, Sharmala Thuraisingam2,5, Uffe Søholm1,2,3, Mary Lou Chatterton6, Sienna Russell-Green1,2, Eric O7, Sof Andrikopoulos8, Taryn Black9, Susan Davidson10, Glen Noonan11, Renza Scibilia12, Virginia Hagger3,13, Christel Hendrieckx1,2, Cathrine Mihalopoulos6, James AM Shaw14, Vincent L Versace4,5, Sophia Zoungas6, Timothy C Skinner1,2,15, and Jane Speight1,2,3, on behalf of the HypoPAST Research Group 1School of Psychology, Deakin University, Geelong, Victoria, Australia 2The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria, Australia 3Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia 4 Australian Centre for Accelerating Diabetes Innovations, The University of Melbourne, Melbourne, VIC, Australia 5Deakin Rural Health, Deakin University, Warrnambool, Australia 6 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia 7 Digital Engagement, Digital Service, Deakin University, Geelong, Victoria, Australia 8Australian Diabetes Society, Sydney, NSW, Australia 9Diabetes Australia, Turner, ACT, Australia 10 Australian Diabetes Educators Association, Turner, ACT, Australia 11 Diabetes Victoria, Carlton, Victoria, Australia 12Breakthrough T1D, New York, USA 13School of Nursing and Midwifery, Deakin University, Geelong, Victoria, Australia 14Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK 15Institute of Psychology, Copenhagen University, Copenhagen, Denmark |
Name and contact information for the trial sponsor | Not applicable, as the study does not involve an unapproved therapeutic good requiring a Clinical Trial Notification. |
Role of sponsor and funding body | The funder, The Medical Research Future Fund (MRFF) Targeted Translation Research Accelerator, did not contribute to the development of this trial protocol, and will not be involved in the conduct of the trial data collection, analysis, interpretation or write-up of findings. |