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Trial registered on ANZCTR
Registration number
ACTRN12621000912886
Ethics application status
Approved
Date submitted
4/06/2021
Date registered
14/07/2021
Date last updated
4/04/2024
Date data sharing statement initially provided
14/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Automated Patch-Pump Insulin Delivery System in Adults with Type 1 Diabetes
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Scientific title
Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Patch-Pump Closed Loop Insulin Delivery System in Adults with Type 1 Diabetes (Phase 1)
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Secondary ID [1]
304369
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes
322159
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Condition category
Condition code
Metabolic and Endocrine
319851
319851
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Phase 1 of the study will be completed before commencing on Phase 2. Participants in Phase 1 of the study will be offered the option of participating in Phase 2 of the study - this will be registered in a separate record.
Phase 1: 50% insulin bolus for a carbohydrate load
- the EOPatch pump will be used during two in-clinic visits (up to 8 hours each including baseline measurements, EOPatch pump insertion/programming and meal challenge) conducted by a doctor and nurse experienced in managing hypo/hyperglycaemia during daylight hours in a major university hospital with a full resuscitation team available if necessary
- the EOPatch pump will be inserted by study staff at the start of the in-clinic visit for the meal challenge and removed at the end of each meal challenge
- participants will receive (in randomized order) a full insulin bolus (100%) and an underestimated insulin bolus (50%) during the meal challenge with a carbohydrate load (80g high carbohydrate meal) and have monitoring of glycaemia over 6 hours
- the first and second meal challenge will be 5-7 days apart (to avoid weekends so as to allow for access to a full resuscitation team, which will be difficult on weekends)
EOPatch pump use will be monitored on a regular basis (during the 30-minutely blood glucose checks) to ensure participants are in Auto mode during the meal challenges in the in-clinic visits and pump analytics can be accessed to verify that. Check-in and discharge times for these in-clinic visit will be documented in the case report forms.
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Intervention code [1]
320733
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Treatment: Devices
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Comparator / control treatment
Phase 1: 100% insulin bolus for carbohydrate load
- during the meal challenge with a carbohydrate load, participants in this arm are given the full 100% insulin bolus via the EOPatch pump for the carbohydrate load
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Control group
Active
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Outcomes
Primary outcome [1]
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Percentage of time in target glucose range (TIR) 3.9-10 mmol/L measured by Dexcom G6 continuous glucose monitor
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Assessment method [1]
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Timepoint [1]
327720
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For 6 hours post commencement of meal challenge
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Secondary outcome [1]
396335
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Percentage of time >10 mmol/L measured by Dexcom G6 continuous glucose monitor
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Assessment method [1]
396335
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Timepoint [1]
396335
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For 6 hours post commencement of meal challenge
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Secondary outcome [2]
396336
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Glycaemic excursion (peak glucose minus baseline) measured by Dexcom G6 continuous glucose monitor
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Assessment method [2]
396336
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Timepoint [2]
396336
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For 6 hours post commencement of meal challenge
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Secondary outcome [3]
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Percentage of time >13.9 mmol/L measured by Dexcom G6 continuous glucose monitor
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Assessment method [3]
396337
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Timepoint [3]
396337
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For 6 hours post commencement of meal challenge
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Secondary outcome [4]
396338
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Percentage of time <3.9 mmol/L measured by Dexcom G6 continuous glucose monitor
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Assessment method [4]
396338
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Timepoint [4]
396338
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For 6 hours post commencement of meal challenge
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Secondary outcome [5]
396339
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Percentage of time <3.0 mmol/L measured by Dexcom G6 continuous glucose monitor
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Assessment method [5]
396339
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Timepoint [5]
396339
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For 6 hours post commencement of meal challenge
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Secondary outcome [6]
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Occurrence of adverse events and serious adverse events, including:
- altered glucose levels (hyper/hypoglycaemia) will be assessed by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels during meal challenges
- any other participant reported adverse events during follow-up phone calls or patient-initiated contact
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Assessment method [6]
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Timepoint [6]
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During meal challenge (6 hours) and for the next 7 days prior to the next meal challenge
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Secondary outcome [7]
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Mean glucose measured by Dexcom G6 continuous glucose monitor
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Assessment method [7]
396341
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Timepoint [7]
396341
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For 6 hours post commencement of meal challenge
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Secondary outcome [8]
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Incidence rate of hypoglycaemia with glucose levels <3.9 mmol/L measured by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels
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Assessment method [8]
397425
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Timepoint [8]
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For 6 hours post commencement of meal challenge
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Secondary outcome [9]
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Incidence rate of hypoglycaemia with glucose levels <3.0 mmol/L measured by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels
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Assessment method [9]
397426
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Timepoint [9]
397426
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For 6 hours post commencement of meal challenge
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Eligibility
Key inclusion criteria
- Type 1 diabetes, of at least 6 months duration.
- Age 21-75 Years
- Insulin pump usage at the time of screening and for at least 3 months prior to screening.
- HbA1c between 5.8% and 9.0%
- Willingness and ability to follow all study procedures and to attend all clinic visits.
- Living with a person knowledgeable regarding the management of hypoglycaemia.
- No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months
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Minimum age
21
Years
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Maximum age
75
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
- Chronic kidney disease as defined by estimated-GFR < 45 ml/min
- Inability to read pump or CGM display due to reduced visual acuity
- Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- Cognitive limitations precluding the participant’s ability to operate the insulin pump.
- Any major active medical condition which in the investigator’s opinion precludes involvement in the study. Known active infection such as HIV or hepatitis
- Schizophrenia or other untreated mental illness
- Chronic substance abuse
- Major surgical procedure within 30 days prior to screening
- Bleeding disorder, or treatment with anticoagulants
- Allergy to Lispro insulin
- Allergy to acrylate-based skin adhesives
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
- Diabetic ketoacidosis or major hypoglycemia within the last 6 months
- Insulin resistance as defined by insulin requirement of more than 200 units per day
- Use of glucose-lowering medications other than insulin
- Need for uninterrupted treatment with acetaminophen
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed
This is done through central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
This feasibility study is exploratory for data generation to determine sample size for larger studies. The sample size for this study is based on experience with prototype closed loop studies.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Safety concerns
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Date of first participant enrolment
Anticipated
19/07/2021
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Actual
29/07/2021
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Date of last participant enrolment
Anticipated
20/03/2022
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Actual
6/08/2021
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Date of last data collection
Anticipated
31/03/2022
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Actual
2/09/2021
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Sample size
Target
12
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
19606
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
34241
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
308741
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Commercial sector/Industry
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Name [1]
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EOFlow Inc
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Address [1]
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15 Rye Street, Suite #307, Portsmouth, New Hampshire USA 03801
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Country [1]
308741
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United States of America
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
41 Victoria Parade, Fitzroy, Victoria 3065
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Country
Australia
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Secondary sponsor category [1]
309637
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None
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Name [1]
309637
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Address [1]
309637
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Country [1]
309637
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308661
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St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
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Ethics committee address [1]
308661
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41 Victoria Parade Fitzroy VIC 3065
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Ethics committee country [1]
308661
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Australia
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Date submitted for ethics approval [1]
308661
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07/04/2021
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Approval date [1]
308661
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26/05/2021
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Ethics approval number [1]
308661
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HREC 079/21
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Summary
Brief summary
Phase 1 of the study will obtain safety data for the investigational automated insulin delivery EOPatch pump.
We hypothesize that the EOPatch pump is as safe and is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes who under-bolus mealtime insulin.
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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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Prof David O'Neal
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Address
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St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
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Country
111462
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Australia
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Phone
111462
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+61 425731665
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Fax
111462
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Query!
Email
111462
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[email protected]
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Contact person for public queries
Name
111463
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Dr Yee Wen Kong
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Address
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St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
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Country
111463
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Australia
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Phone
111463
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+61 433593020
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Fax
111463
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Email
111463
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[email protected]
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Contact person for scientific queries
Name
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Prof David O'Neal
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Address
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St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
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Country
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Australia
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Phone
111464
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+61 425731665
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Fax
111464
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Email
111464
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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
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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