Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000894695
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
21/08/2023
Date last updated
10/11/2024
Date data sharing statement initially provided
21/08/2023
Date results provided
10/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The HypoPAST study: evaluation of an online program for Hypoglycaemia Prevention, Awareness of Symptoms and Treatment among adults with type 1 diabetes
Scientific title
The Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) online psycho-educational program for adults with type 1 diabetes experiencing fear of hypoglycaemia: A 24-week randomised controlled trial
Secondary ID [1] 309749 0
TTRARP2100
Universal Trial Number (UTN)
Trial acronym
HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 330150 0
fear of hypoglycaemia 330151 0
Condition category
Condition code
Mental Health 327029 327029 0 0
Anxiety
Metabolic and Endocrine 327030 327030 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HypoPAST is an online psycho-educational training program. It includes 8 modules (30 minutes to 1 hour each), covering topics such as timely and appropriate treatment of hypoglycaemia; personal risks for hypoglycaemia; recognising warning signs of hypoglycaemia; drivers of frequent hypoglycaemia; talking about hypoglycaemia with family, friends, health professionals and colleagues; hypoglycaemia while asleep; and managing worries. HypoPAST includes short videos, slides with voiceovers, reflection and problem-solving activities, and information leaflets. HypoPAST is designed to enable participants to discover for themselves how to strengthen their skills and develop preventative habits enabling them to reduce both their fear and their risk of hypoglycaemia.
Upon entry to the program, a brief ‘Getting Started’ self-assessment will help participants to recognise which modules are most relevant to their needs. Participants will be advised that completing all modules is recommended, but they will be able to begin with the modules that are most relevant to them, based on their responses to some brief questions. After completing the 'Getting Started' module, participants will be able to view and complete the HypoPAST modules and resources (activity sheets, information leaflets, videos). HypoPAST is self-guided, thus participants can choose whether they complete some or all the modules, all in one sitting or spread out over several days or a few weeks. There is no limit on how often they access the intervention. It is anticipated that 4-8 weeks will be sufficient time for participants to access HypoPAST online, do the activities, and begin to benefit from the program, however they will be able to access the intervention for 24 weeks. Program utilisation will be monitored using website analytics.
Intervention code [1] 326196 0
Behaviour
Intervention code [2] 326197 0
Treatment: Other
Comparator / control treatment
The wait-list control group will be advised to continue with their usual diabetes self-management, clinical care and support during the trial. Usual diabetes self-management and care varies from person to person, as it is tailored to the person's needs and preferences. However, self-management includes monitoring glucose and taking insulin several times a day according to need, and as advised by their health professional. Usual clinical care typically involves attending consultations every 6-12 months (or more frequently if needed) with an endocrinologist (e.g. for review of HbA1c, medications, screening for complications) and may also involve consultations with a diabetes educator and/or other allied health professionals as needed, in accordance with the annual cycle of care: www.ndss.com.au/managing-diabetes/diabetes-related-complications/diabetes-health-checks.
Control group
Active

Outcomes
Primary outcome [1] 334896 0
Fear of hypoglycaemia worry score, measured with the Hypoglycaemia Fear Survey (HFS-II) worry subscale.
Timepoint [1] 334896 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation). The primary timepoint is end-trial (24-weeks post-randomisation).
Secondary outcome [1] 424017 0
Frequency of severe hypoglycaemia, measured with the Hypoglycaemia Awareness Questionnaire (HypoA-Q; item 2).
Timepoint [1] 424017 0
Will be measured at baseline (pre-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [2] 424018 0
Hypoglycaemia confidence score, measured with the Hypoglycaemia Confidence Scale (HCS).
Timepoint [2] 424018 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [3] 424019 0
Fear of hypoglycaemia behaviour (avoidance) score, measured with the Hypoglycaemia Fear Survey II Short Form Avoidance subscale (HFS-SF).
Timepoint [3] 424019 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [4] 424020 0
Hypoglycaemia-specific quality of life score, measured with the Hypoglycaemia Impact Profile (HIP-12).
Timepoint [4] 424020 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [5] 424021 0
Attitudes to hypoglycaemia awareness score, measured with the Attitudes to Awareness of Hypoglycaemia (A2A; items 4-19).
Timepoint [5] 424021 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [6] 424022 0
Diabetes distress score, measured with the Problem Areas in Diabetes Eleven (PAID-11).
Timepoint [6] 424022 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [7] 424023 0
Depressive symptoms, measured with the Patient Health Questionnaire 2-item screener
Timepoint [7] 424023 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [8] 424024 0
Hypoglycaemia-related post-traumatic stress score, measured with the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) adapted for hypoglycaemia.
Timepoint [8] 424024 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [9] 424390 0
Insulin use, measured with two study specific questions about the number of daily insulin doses/boluses and number of daily insulin units taken.
Timepoint [9] 424390 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [10] 424391 0
Hypoglycaemia symptom burden, measured using a study specific question.
Timepoint [10] 424391 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [11] 424536 0
Impaired awareness of hypoglycaemia symptoms using the Hypoglycaemia Awareness Questionnaire Impaired Awareness subscale (HypoA-Q IA; items 7, 8, 10-12).
Timepoint [11] 424536 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [12] 424538 0
Impaired awareness of hypoglycaemia symptoms using the Gold score.
Timepoint [12] 424538 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [13] 424542 0
Technology awareness of hypoglycaemia, measured with 1 study-specific item.
Timepoint [13] 424542 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [14] 424546 0
Most recent HbA1c (self-reported) using two study-specific questions.
Timepoint [14] 424546 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [15] 424547 0
Target glucose range (upper and lower limits, self-reported) measured with two study-specific questions.
Timepoint [15] 424547 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [16] 424549 0
Comfortable glucose level (upper and lower limits, self-reported), measured with two study-specific questions.
Timepoint [16] 424549 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [17] 424550 0
Time below range (self reported, participants wearing a CGM or iCGM device only), measured with a study-specific question.
Timepoint [17] 424550 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [18] 424551 0
Frequency of glucose checks, measured using three study-specific questions.
Timepoint [18] 424551 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [19] 424561 0
Glucose monitoring behaviours (method of recording and use of information), measured using two study-specific questions.
Timepoint [19] 424561 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [20] 424567 0
Hypoglycaemia episodes, measured using uMotif app ‘flower motif’ Ecological Momentary Assessments (10 questions).
Timepoint [20] 424567 0
Measured daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [21] 424568 0
Hypoglycaemia while awake during the day, measured via uMotif app 'check-ins' Ecological Momentary Assessments (6 questions).
Timepoint [21] 424568 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [22] 424569 0
Hypoglycaemia while asleep at night, measured via uMotif app 'check-ins' Ecological Momentary Assessments (7 questions).
Timepoint [22] 424569 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [23] 424570 0
Sleep quality measured via uMotif app 'check-ins' Ecological Momentary Assessments (1 question)
Timepoint [23] 424570 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [24] 424571 0
General well-being measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [24] 424571 0
Measured for twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [25] 424572 0
Fear of hypoglycaemia measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [25] 424572 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [26] 424573 0
Fear of hyperglycaemia measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [26] 424573 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [27] 424574 0
Work productivity measured via uMotif app 'check-ins' Ecological Momentary Assessments (4 questions)
Timepoint [27] 424574 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [28] 424575 0
Health status, measured with the Assessment of Quality of Life (AQOL-4D) (for economic evaluation).
Timepoint [28] 424575 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [29] 424576 0
Healthcare utilisation, measured with study-specific items (for economic evaluation). .
Timepoint [29] 424576 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [30] 424577 0
Hypo Cues, measured with the Hypo Cues Questionnaire (Hypo C-Q; Items 2 to 40). The Hypo Cues Questionnaires focuses on potential attributions (e.g. attitudes, beliefs, behaviours) for hypoglycaemia . Cues are attributions or clues as to why a person may experience low glucose.
Timepoint [30] 424577 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [31] 424578 0
Will be measured at mid-trial (12-weeks post randomisation) and end-trial (24-weeks post-randomisation). Ethics approval for this protocol change was granted by DUHREC on Friday, 9 August 2024. The protocol change was implemented on 16 August 2024, after enrolment of 158 participants (2 of whom withdrew prior to randomisation).
Timepoint [31] 424578 0
Will be measured at mid-trial (12-weeks post-randomisation).
Secondary outcome [32] 424579 0
Intervention acceptability, measured with study-specific questions (intervention group only).
Timepoint [32] 424579 0
Will be measured at mid-trial (12-weeks post randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [33] 424585 0
User engagement (intervention group only), including login patterns (e.g. whether the intervention was accessed via the webpage or the email reminders), devices used to access the intervention, time spent (minutes) on the intervention and its components, frequency of accessing the intervention and its components. Measured by website analytics (Google Analytics and ADUCI).
Timepoint [33] 424585 0
Will be measured throughout 24-week intervention access period (i.e. post-randomisation to end-trial).
Secondary outcome [34] 425165 0
Anxiety symptoms, measured with the Generalised Anxiety Disorder 2-item screener
Timepoint [34] 425165 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [35] 425166 0
Fear of hypoglycaemia behaviour (maintain high) scores, measured with the Hypoglycaemia Fear Survey II Short Form Maintain High subscale (HFS-SF).
Timepoint [35] 425166 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [36] 425167 0
Response to hypoglycaemia, measured with a study-specific item.
Timepoint [36] 425167 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [37] 425191 0
Work productivity, measured with study-specific items (for economic evaluation).
Timepoint [37] 425191 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [38] 425768 0
Time above range (self reported, participants wearing a CGM or iCGM device only), measured with a study-specific question.
Timepoint [38] 425768 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).

Eligibility
Key inclusion criteria
Eligible participants will meet all of the following criteria:
1) Adults (18 years or older)
2) Living in Australia
3) Self-reported type 1 diabetes (measured by a study-specific item asking 'What type of diabetes do you have')
4) Self-reported fear of hypoglycaemia (response to a single item from the PAID scale: 'Worrying about low blood glucose reactions' is currently a 'moderate', 'somewhat serious', or 'serious' problem)
5) Access to the internet via a smartphone, laptop or desktop computer, or tablet computer.

Ethics approval for this protocol change (change to inclusion criteria 5) was granted by DUHREC on Thursday 13 June 2024. The protocol change was implemented on 14 June 2024, after enrolment of 151 participants (2 of whom withdrew prior to randomisation).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HypoPAST Steering Group member

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant registration, eligibility screening, randomisation, and email notification of group allocations to participants will all be automated and performed centrally by a computer using an eResearch platform (Platform O).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated at random to the intervention or waitlist control arm (1:1). Randomisation sequence will be computer-generated (via Qualtrics/Platform O) arm using randomly permuted block sizes of four and six.

Randomisation will be stratified by: 1) gender: men versus women. If participants have a ‘non-binary’ or ‘another term’ gender identity, they will be allocated at random to either the male or female gender strata. 2) Glucose monitoring method: finger-prick versus CGM or intermittent-scanned CGM (isCGM, also known as ‘flash’ monitoring).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Clinical, psychological and behavioural outcomes
To examine the effect of the intervention on primary and secondary outcomes (collected via survey), we will use an intention to treat (ITT) approach where all randomised participants will be analysed according to their study group assignment. Statistical analyses will be performed using STATA. Linear mixed models using restricted maximum likelihood estimation will be used to estimate group differences in the primary (HFS-II Worry scale score) and secondary clinical, psychological and behavioural outcomes. As the primary and secondary outcomes will be measured longitudinally, the outcome at 12 and 24 weeks will be included in the model as the dependent variable. The outcome at baseline, time and an interaction between time and trial arm . Repeated outcome measures will be treated as random effects in the model and an unstructured variance-covariance structure assumed. Models will be adjusted by stratification factors gender and glucose monitoring method. Transformations for skewed outcome measures will be considered. The estimated mean HFS-II Worry scale score at baseline, 12 and 24 weeks will be plotted for each trial arm with 95% confidence intervals. The estimated difference in mean HFS-II Worry score between arms at 12 and 24 weeks and associated 95% confidence intervals will be presented.
A similar modelling approach will be used to estimate group differences in hypoglycaemic events, however, a negative binomial mixed model will be used to account for repeated count data. In secondary analyses, the primary outcome will be adjusted by age, diabetes duration, HbA1c, severe hypoglycaemia episodes in the past 6 months, Gold score, and insulin administration modality. Secondary outcomes will also be adjusted by these potential confounders where relevant. A per protocol analysis for the primary outcome will be conducted to estimate the treatment effect in those who engage with the intervention (defined as using 2 or more modules). A sensitivity analysis using multiple imputation may be conducted should there be between 10%-40% missing data in the primary outcome and auxiliary variables available in the data set to explain the missingness. A second sensitivity analysis will be performed on the primary analysis to test the robustness of the missing data assumption of mixed-linear models using pattern-mixture modelling.
2. Health economic outcomes
Detailed costing of HypoPAST intervention will be performed using micro-costing methods. The AQoL-4D utility values for each participant at each timepoint will be used to calculate QALYs [35] using the area under the curve method. The within-trial economic evaluation will measure and value any change in healthcare resource use and lost productivity and then compare any additional costs to additional QALYs through an incremental cost-effectiveness ratio (ICER). Bootstrapping will be used to determine confidence intervals for the ICER and construct an acceptability curve to determine the cost-effectiveness of the intervention against the commonly used willingness to pay threshold of AU$50,000/QALY [46]. Missing data will be explored and managed for the resource use and AQoL-4D questionnaires based on recommendations for analysis of trial-based economic evaluations with missing data. Sensitivity analyses will be undertaken to evaluate the robustness of results with changes to costing or analytical assumptions. Scale-up and implementation costs as well as longer-term cost-effectiveness will be estimated based on population-wide modelling techniques using published epidemiological data. STATA will be used for these analyses.
3. Ecological momentary assessment outcomes
To examine the effect of the intervention on EMA outcomes (daily functioning, number of hypoglycaemic episodes, awareness of symptoms and hypoglycaemia burden collected via an app), we will use linear mixed models (for continuous outcomes) and mixed negative binomial models (for count outcomes). Trial arm, time of day (morning/night) and timepoint (baseline or 24 weeks) will be included as a fixed effects in the models. Participants will be included as random effects in the models and an unstructured variance-covariance structure used to account for repeated measures and the correlation in outcome within individuals. A separate mixed linear model will be used to explore whether the effect of person-reported hypoglycaemia on daily functioning domains (fear of hypoglycaemia, x, y) differs between trial arms. The independent variable will be person-reported hypoglycaemia, and an interaction between this variable and trial arm (intervention or control) will be included in the model. If sufficient data, we will also assess additional models exploring effects of person-reported hypoglycaemia subtypes (i.e. how the episodes where detected and managed) and whether number of reported hypoglycaemia episodes, awareness (in terms of symptoms) and hypoglycaemia burden differ between trial arms. Models will be adjusted as for the primary outcome. Similarly, missing data will be managed as for the primary objective. Due to the question phrasing and timing of the check-ins, people who expect to primarily sleep during the day during the 2-week EMA data collection will have their EMA data excluded from analysis as it may confound the results. R-studio will be used for these analyses.
4. Reach, acceptability, usability, fidelity, and sustainability
Quantitative data: Will be analysed using descriptive statistics. This includes both survey and website analytics data, including: study registration rates; proportion of registrants meeting the eligibility criteria; method of referral into the study; demographic and clinical characteristics; study attrition; number of, and which modules, were accessed; study-specific survey items about intervention acceptability and sustainability. To determine socioeconomic status and geographical location, code will be generated to match postcodes against Australian Bureau of Statistics (ABS) Australian Statistical Geography Standards (ASGS) and Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) Socio-Economic Indexes for Areas (SEIFA) quintiles.
Qualitative data: Open-text survey responses will be collated and summarised descriptively in Microsoft Excel. Interview transcripts will be coded using NVivo and/or Microsoft Excel and analysed using thematic analysis using inductive and deductive approaches. Prior to coding the data, the researcher(s) will become familiar with the dataset by reading the transcripts and/or listening to the audio recordings.

Regarding 'Clinical, psychological and behavioural survey outcomes' and 'Ecological Momentary Assessment outcomes' - the update to the statistical analysis plan was made on 1 May 2024, after enrolment of 147 participants (2 of whom withdrew prior to randomisation).
Regarding 'Health economic survey outcomes' - this was planned prior to commencement of participant recruitment; however, it was unintentionally omitted from the ANZCTR entry when we first registered the trial.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
29/01/2024
Date of last participant enrolment
Anticipated
Actual
4/09/2024
Date of last data collection
Anticipated
26/03/2025
Actual
Sample size
Target
218
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313939 0
Government body
Name [1] 313939 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF) Targeted Translation Research Accelerator (TTRA)
Country [1] 313939 0
Australia
Funding source category [2] 314323 0
Charities/Societies/Foundations
Name [2] 314323 0
Diabetes Australia
Country [2] 314323 0
Australia
Funding source category [3] 314324 0
Charities/Societies/Foundations
Name [3] 314324 0
Diabetes Victoria
Country [3] 314324 0
Australia
Funding source category [4] 314325 0
Charities/Societies/Foundations
Name [4] 314325 0
Australian Diabetes Society
Country [4] 314325 0
Australia
Funding source category [5] 314326 0
Charities/Societies/Foundations
Name [5] 314326 0
Australian Diabetes Educators Association
Country [5] 314326 0
Australia
Funding source category [6] 314327 0
University
Name [6] 314327 0
Deakin University
Country [6] 314327 0
Australia
Funding source category [7] 314328 0
University
Name [7] 314328 0
La Trobe University
Country [7] 314328 0
Australia
Funding source category [8] 314329 0
University
Name [8] 314329 0
Monash University
Country [8] 314329 0
Australia
Funding source category [9] 314331 0
University
Name [9] 314331 0
Newcastle University
Country [9] 314331 0
United Kingdom
Funding source category [10] 317791 0
Commercial sector/Industry
Name [10] 317791 0
uMotif
Country [10] 317791 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd, Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 316243 0
None
Name [1] 316243 0
Address [1] 316243 0
Country [1] 316243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313081 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313081 0
Ethics committee country [1] 313081 0
Australia
Date submitted for ethics approval [1] 313081 0
21/04/2023
Approval date [1] 313081 0
27/06/2023
Ethics approval number [1] 313081 0
2023-132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126930 0
Prof Jane Speight
Address 126930 0
The Australian Centre for Behavioural Research in Diabetes Diabetes Victoria Woi-wurrung Country Suite G01 15-31 Pelham Street Carlton VIC 3053
Country 126930 0
Australia
Phone 126930 0
+61 3 5227 8415
Fax 126930 0
Email 126930 0
[email protected]
Contact person for public queries
Name 126931 0
Jennifer Halliday
Address 126931 0
The Australian Centre for Behavioural Research in Diabetes Diabetes Victoria Woi-wurrung Country Suite G01 15-31 Pelham Street Carlton VIC 3053
Country 126931 0
Australia
Phone 126931 0
+61 3 9244 5278
Fax 126931 0
Email 126931 0
[email protected]
Contact person for scientific queries
Name 126932 0
Jane Speight
Address 126932 0
The Australian Centre for Behavioural Research in Diabetes Diabetes Victoria Woi-wurrung Country Suite G01 15-31 Pelham Street Carlton VIC 3053
Country 126932 0
Australia
Phone 126932 0
+61 3 522 78415
Fax 126932 0
Email 126932 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically and ethically sound proposal and who sign a Data Sharing Agreement that documents their rationale, how they intend to use the data, and how it will be transferred, stored, and disposed of.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Metadata of quantitative data will be placed in an open-access repository (Deakin Research Data Store (RDS) with a link to Deakin Research Online (DRO record) and with conditional access to the de-identified data variables available to other researchers upon reasonable request. Data of participants who don't agree for their data to be shared will be removed before data are made open-access/shared.

What types of analyses could be done with individual participant data?
• The data will be made available only to achieve the aims in the approved proposal and as per the Data Sharing Agreement.

When can requests for individual participant data be made (start and end dates)?
From:
Metadata will be made available after publication of the research findings. Data will be retained for at least fifteen (15) years after the study findings are published.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Metadata of quantitative data will be open-access via Deakin Research Data Store. Conditional access to the de-identified dataset is available upon reasonable request (to be made to the HypoPAST Project Manager via email: [email protected]). Data will only be shared with researchers willing to sign a Data Sharing Agreement.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.