Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct 29;25(1):725.
doi: 10.1186/s13063-024-08556-1.

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

Jennifer A Halliday  1   2   3 , Elizabeth Holmes-Truscott  1   2   3   4 , Sharmala Thuraisingam  2   5 , Uffe Søholm  1   2   3 , Mary Lou Chatterton  6 , Sienna Russell-Green  1   2 , Eric O  7 , Sof Andrikopoulos  8 , Taryn Black  9 , Susan Davidson  10 , Glen Noonan  11 , Renza Scibilia  12 , Virginia Hagger  3   13 , Christel Hendrieckx  1   2 , Cathrine Mihalopoulos  6 , James A M Shaw  14 , Vincent L Versace  4   5 , Sophia Zoungas  6 , Timothy C Skinner  1   2   15 , Jane Speight  16   17   18 ; HypoPAST Research Group
Collaborators, Affiliations

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

Jennifer A Halliday et al. Trials. .

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).

Keywords: Fear of hypoglycaemia; Hypoglycaemia; Psycho-educational training; Type 1 diabetes.

PubMed Disclaimer

Conflict of interest statement

JAH reports speaker honoraria from Roche Diabetes Care, paid to her institution, for a one-off presentation unrelated to the HypoPAST protocol. EH-T has undertaken research funded by an unrestricted educational grant from Abbott Diabetes Care, AstraZeneca and Sanofi, Australia; received speaker fees from Novo Nordisk and Roche; and has served on an advisory board for AstraZeneca. All honoraria paid to her institution. GN reports that he is on the Board of Directors at the Royal Women’s Hospital, Melbourne. VLV reports that he is on the Board of Directors of the Australian Rural Health Education Network (ARHEN). SZ reports payment to institution (Monash University) from Amgen Australia Pty Ltd, Eli Lilly Australia, MSD Australia Pty Ltd, AstraZeneca Pty Ltd, Novo Nordisk, and Sanofi for work unrelated to the HypoPAST protocol. JAMS has received consultancy fees as a member of a Mogrify Limited and RegMedXB International Scientific Advisory Boards. JSp has served on advisory boards for Janssen, Medtronic, Omnipod, Roche Diabetes Care and Sanofi Diabetes; received unrestricted educational grants and in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care and Sanofi Diabetes, and consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Insulet, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi Diabetes. All honoraria paid to her institution. JSp is also the copyright holder of the HypoA-Q used in this study. TCS reports that he has received funding from Roche Diagnostics for research projects, and been CI on grants with Roche as a co-funder. TCS has sat on Advisory Boards for Novo Nordisk (last in 2020), AstraZeneca, Eli Lilly and Sanofi (all of these pre-2007). CH, MLC, EO, ST, SR-G and CM declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
HypoPAST overview
Fig. 2
Fig. 2
Flow diagram for HypoPAST randomised controlled trial
See this image and copyright information in PMC

References

    1. Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, et al. A real-world prospective study of the safety and effectiveness of the loop open source automated insulin delivery system. Diabetes Technol Ther. 2021;23(5):367–75. - PMC - PubMed
    1. Little SA, Leelarathna L, Barendse SM, Walkinshaw E, Tan HK, Lubina Solomon A, et al. Severe hypoglycaemia in type 1 diabetes mellitus: underlying drivers and potential strategies for successful prevention. Diabetes Metab Res Rev. 2014;30(3):175–90. - PubMed
    1. Hendrieckx C, Gonder-Frederick L, Heller SR, Snoek FJ, Speight J. How has psycho-behavioural research advanced our understanding of hypoglycaemia in type 1 diabetes? Diabet Med. 2020;37(3):409–17. - PubMed
    1. Zoungas S, Patel A, Chalmers J, de Galan BE, Li Q, Billot L, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med. 2010;363(15):1410–8. - PubMed
    1. Irvine AA, Cox D, Gonder-Frederick L. Fear of hypoglycemia: relationship to physical and psychological symptoms in patients with insulin-dependent diabetes mellitus. Health Psychol. 1992;11(2):135. - PubMed

Publication types

MeSH terms

LinkOut - more resources