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Trial registered on ANZCTR
Registration number
ACTRN12623000771651
Ethics application status
Approved
Date submitted
5/06/2023
Date registered
14/07/2023
Date last updated
14/07/2023
Date data sharing statement initially provided
14/07/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Glycemic variability in Indigenous and Non-indigenous Australians with type 2 diabetes.
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Scientific title
Glycemic variability in Indigenous and Non-indigenous Australians with type 2 diabetes.
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Secondary ID [1]
309821
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None
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Universal Trial Number (UTN)
U1111-1293-4076
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Trial acronym
GVPayCycle
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Indigenous Health
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Food Insecurity
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Condition category
Condition code
Metabolic and Endocrine
327138
327138
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
All participants will wear a blinded version of a continuous glucose monitoring (CGM) sensor - Freestyle libre Pro IQ for a period of 4 weeks. The glycaemic variability will be compared between those with and without food security (as determined by a validated questionnaire USDA-18).
The CGM sensor will be placed on the participant's arm by the research personnel. Each sensor lasts up to 14 days. We will be using a blinded version of this device which is approved for research purposes only and automatically measures glucose levels every few minutes. The participant does not need to take any action other than ensuring that the sensor is worn at all times. At the end of 14 days the participant simply has to return the sensor to the research team. This process will be repeated once more so that data for two consecutive fortnights or 28 days will be captured.
The CGM sensor will be provided free of cost to the participants during the period of the study.
The research staff will educate the participants prior to the sensor being worn. The participant will be provided support and help in case of any difficulty with wearing the sensor.
Clinical assessment:
1. Anthropocentric measurements: 1. Weight, 2. Height, 3. Waist and Hip Circumference (This will take ~ 5 minutes).
2. A standardized battery of tests to test cardiovascular autonomic neuropathy consisting of measuring blood pressure and heart rate at rest and in response to light exercise such as sitting/standing, deep breathing and sustained hand grip will be performed and expected to take 20-30 minutes.
3. Blood will be sampled to measure baseline full blood count, urea and electrolytes, liver function, lipid profile and glycated hemoglobin level (this will take ~20 minutes).
4. List of questionnaires: 1. Baseline demographic information,
2. Food Frequency questionnaire (DQES v3.2),
3. Diabetes Distress Score (DDS-17)
4. Gastrointestinal Symptoms Score (PAGI-SYM)
5. Diabetes Bowel Survey (DBSQ)
6. Depression Score (PHQ-9)
7. Depression and Anxiety Score (DASS-21)
8. Michigan Neuropathy Screening Instrument
This set of questionnaires will take ~40 minutes in total.
Education regarding CGM sensors will take about 25 minutes.
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Intervention code [1]
326272
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Diagnosis / Prognosis
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Comparator / control treatment
People with food security will be considered as the comparator.
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Control group
Active
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Outcomes
Primary outcome [1]
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Glycemic variability (GV) expressed as a percentage (%) from the CGM sensor output data.
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Assessment method [1]
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Timepoint [1]
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14 days and 28 days post-enrolment.
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Secondary outcome [1]
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Depression - assessed using the Patient Health Questionnaire-9 (PHQ-9). A nine-item validated depression scale.
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Assessment method [1]
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Timepoint [1]
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28 days post-enrolment.
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Secondary outcome [2]
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Dietary intake - assessed using the Dietary Questionnaire for Epidemiological Study (DQES v 3.2). A 80 item validated dietary intake scale.
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Assessment method [2]
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Timepoint [2]
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28 days post-enrolment.
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Secondary outcome [3]
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Diabetes distress - assessed using the Diabetes Distress-17 (DDS-17). A 17-item validated diabetes distress scale.
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Assessment method [3]
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Timepoint [3]
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At the time of enrollment.
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Secondary outcome [4]
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Gastrointestinal Symptoms - assessed using the Patient Assessment of Upper-Gastrointestinal Symptom Severity Index-20 (PAGI-SYM-20). A 20-item validated gastrointestinal symptom scale.
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Assessment method [4]
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Timepoint [4]
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28 days-post enrolment.
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Eligibility
Key inclusion criteria
Aboriginal and/or Torres Strait Islander and and Non-Indigenous peoples aged 18 to 80 years with T2DM diagnosed as per WHO criteria with or without food insecurity as per USDA (HFSSM) questionnaire, residing in South Australia who are registered with an Aboriginal health clinic and who receive payment (for salaried work or as unemployment benefits) on a fortnightly basis.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Individuals not residing in South Australia, unable to provide informed consent, refusal, or inability to have a CGM sensor applied to the back of the upper arm, or unwillingness to provide informed consent, pregnancy, or receipt of dialysis.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/07/2023
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Actual
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Date of last participant enrolment
Anticipated
7/04/2025
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Actual
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Date of last data collection
Anticipated
7/10/2025
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Diabetes Australia Research Programme
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Address [1]
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GPO Box 9824, Brisbane, QLD, 4001
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Chinmay Marathe
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Address
Adelaide Medical School
The University of Adelaide
Level 5, AHMS Building,
North Terrace
Adelaide, SA 5000
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Adelaide
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Address [1]
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Faculty of Health and Medical Science,
Adelaide Medical School,
Level 5, AHMS Building,
North Terrace
Adelaide, SA 5000
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Aboriginal Health Research Committee (AHRC)
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Ethics committee address [1]
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220 Franklin Street, Adelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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03/06/2022
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Ethics approval number [1]
313144
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Summary
Brief summary
Type 2 diabetes (T2DM) is a very important chronic health condition that impacts Indigenous Australians disproportionately with devastating effects. T2DM is a major contributor to the reduced life span in Indigenous Australians. It is characterized by a younger age at onset and early and aggressive development of micro- (blindness, renal disease and lower extremity amputations) and macro-vascular (cardiovascular disease) complications. The risk of the complications of T2DM – both their development and the propensity for progression is markedly reduced if good glycaemic control can be achieved. Glycated haemoglobin (HbA1c) is traditionally used for assessment of glycaemic control in T2DM but fails to capture intra- and inter-day acute fluctuations in glycaemic excursions (glycaemic variability), which are associated with postprandial hyperglycaemia. Glycaemic variability is an independent predictor of cardiovascular mortality. Recently developed diabetes-related technology, continuous glucose monitors (CGM), can now easily estimate glycaemic variability by providing 24-hour data.
Diet is a major aspect of an optimal glycaemic control strategy, but often subject to economic considerations, particularly in Indigenous Australians. The prevalence of food insecurity (a situation when availability of nutritionally adequate and safe foods or the ability to acquire acceptable food in socially acceptable ways is limited or uncertain) in Indigenous Australians is extremely high at 26%, 5-times the national prevalence.
In response to food insecurity, individuals and households often develop ‘coping strategies’ including altered dietary patterns (choosing inexpensive high glycaemic simple carbohydrates over complex carbohydrates, fruits and vegetables or excessive food consumption when money is available and starvation when not). While these coping strategies are intuitively likely to impact glycaemic control adversely, the impact of food insecurity on glycaemic control, including glycaemic excursions in Indigenous Australians with T2DM is not known.
We propose to investigate the glycaemic variability around pay cycles in Indigenous Australians with T2DM and with and without food insecurity using CGM.
Both food insecurity and pay cycles are likely to affect glycaemic control adversely in Indigenous Australians with T2DM by increasing glycaemic variability. The impact of food insecurity and coping strategies on glycaemic control has apparently never been evaluated with 24-hour CGM data anywhere in the world. While this would be a preliminary study, the findings have the potential to make a major impact on both clinical practice (e.g. actively screening for food insecurity, further interventional studies designed to reduce glycaemic variability) and health policy (e.g. implementing food assistance programs and assessing impact on glycaemic variability).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Chinmay Marathe
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Address
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Adelaide Medical School
The University of Adelaide
Level 5, AHMS Building
North Terrace
Adelaide, SA 5000
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Country
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Australia
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Phone
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+61431266075
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Chinmay Marathe
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Address
127143
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Adelaide Medical School
The University of Adelaide
Level 5, AHMS Building
North Terrace
Adelaide, SA 5000
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Country
127143
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Australia
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Phone
127143
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+61431266075
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Fax
127143
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Email
127143
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[email protected]
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Contact person for scientific queries
Name
127144
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Dr Chinmay Marathe
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Address
127144
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Adelaide Medical School
The University of Adelaide
Level 5, AHMS Building
North Terrace
Adelaide, SA 5000
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Country
127144
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Australia
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Phone
127144
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+61431266075
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Fax
127144
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Email
127144
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD will not be shared to protect the identity of the individual. However, de-identified data will be freely available in the public domain in the form of scientific abstracts, peer-reviewed manuscripts, and power-point presentations made by the research team upon completion of the study.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19371
Study protocol
[email protected]
This document contains study protocol, participant...
[
More Details
]
386021-(Uploaded-21-06-2023-16-14-39)-Study-related document.pdf
19374
Ethical approval
[email protected]
Ethics approval is attached here.
386021-(Uploaded-05-06-2023-18-29-01)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF