Evidence map›Paper›PMID 39468682›Full record

ArticleTrials2024

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, Elizabeth Holmes-Truscott, Sharmala Thuraisingam, Uffe Søholm, Mary Lou Chatterton, Sienna Russell-Green, Eric O, Sof Andrikopoulos, Taryn Black, Susan Davidson and 11 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Jennifer A HallidaySchool of Psychology, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0003-1156-279X
Elizabeth Holmes-TruscottSchool of Psychology, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0001-9139-4663
Sharmala ThuraisingamThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-9450-1302
Uffe SøholmSchool of Psychology, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0003-0848-9421
Mary Lou ChattertonSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0003-4902-9448
Sienna Russell-GreenSchool of Psychology, Deakin University, Geelong, VIC, Australia.
Eric ODigital Engagement, Digital Service, Deakin University, Geelong, VIC, Australia.
Sof AndrikopoulosAustralian Diabetes Society, Sydney, NSW, Australia.
Taryn BlackDiabetes Australia, Turner, ACT, Australia.
Susan DavidsonAustralian Diabetes Educators Association, Turner, ACT, Australia.
Glen NoonanDiabetes Victoria, Carlton, VIC, Australia.
Renza ScibiliaBreakthrough T1D, New York, USA.
Virginia HaggerInstitute for Health Transformation, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0003-3845-2814
Christel HendrieckxSchool of Psychology, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0002-0075-828X
Cathrine MihalopoulosSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-7127-9462
James A M ShawTranslational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.ORCID http://orcid.org/0000-0002-2893-3211
Vincent L VersaceAustralian Centre for Accelerating Diabetes Innovations, The University of Melbourne, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-8514-1763
Sophia ZoungasSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0003-2672-0949
Timothy C SkinnerSchool of Psychology, Deakin University, Geelong, VIC, Australia.ORCID http://orcid.org/0000-0002-0018-6963
Jane SpeightSchool of Psychology, Deakin University, Geelong, VIC, Australia. jspeight@acbrd.org.au.ORCID http://orcid.org/0000-0002-1204-6896
HypoPAST Research Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManagement 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.

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

Indexed as

Diabetes Mellitus, Type 1Health Knowledge, Attitudes, PracticeHypoglycemiaPatient Education as TopicRandomized Controlled Trials as TopicAdultAwarenessBlood GlucoseFearGlycemic ControlHumansHypoglycemic AgentsInsulinInternet-Based InterventionQuality of LifeTime FactorsBlood GlucoseHypoglycemic AgentsInsulinFear of hypoglycaemiaHypoglycaemiaPsycho-educational trainingType 1 diabetes

Identifiers

PMID39468682
PMCPMC11520494

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.