Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000210875
Ethics application status
Approved
Date submitted
16/12/2020
Date registered
26/02/2021
Date last updated
26/02/2021
Date data sharing statement initially provided
26/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity in Very Young Children With Type 1 Diabetes
Scientific title
Physical Activity in Very Young Children With Type 1 Diabetes
Secondary ID [1] 303025 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 320099 0
Condition category
Condition code
Metabolic and Endocrine 318033 318033 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children aged between 2 and 7 years with type 1 diabetes will be recruited for this study.
Dexcom G5 Continous glucose monitors will be used to collect interstitial glucose levels for the 7 days of the study, with a new sensor inserted on day 1 of the study.
GTX3+ accelerometers will be utilised to measure physical activity. These will be attached to the hip of the child and be worn continuously for 7 days. The accelerometres will be collected from the parent at the end of the 7 days.
Intervention code [1] 319316 0
Not applicable
Comparator / control treatment
The mean daily MVPA (moderate to vigorous physical activity) of children less than 7yrs with type 1 diabetes will be compared with an age matched general population control group.

This data was collected from toddlers attending long day care centres in the Hunter Area NSW from February 2019 to December 2019.
Control group
Historical

Outcomes
Primary outcome [1] 326018 0
The average daily amount of moderate to vigorous physical activity (MVPA) in minutes. GTX3+ accelerometers will be utilised to measure physical activity. These will be attached to the hip of the child
Timepoint [1] 326018 0
Over 7 days
Secondary outcome [1] 389895 0
Time in glucose target range (4-10mmol/L)
This will be collected using a Dexcom G5 continuous glucose monitor.
Timepoint [1] 389895 0
Assessed continuously for 7 days
Secondary outcome [2] 389896 0
Number of hypoglycaemic events as determined through glucose readings provided by the Dexcom G5.
Timepoint [2] 389896 0
7 days
Secondary outcome [3] 389897 0
Hypoglycemia Fear Survey -Parent modified for young children as per Patton SR, Dolan LM, Henry R, Powers SW. Fear of hypoglycemia in parents of young children with type 1 diabetes mellitus. J Clin Psychol Med Settings. 2008;15(3):252-259.10.1007/s10880-008-9123-x
Timepoint [3] 389897 0
At baseline
Secondary outcome [4] 389898 0
Barriers to physical activity questionnaire.
Timepoint [4] 389898 0
Baseline

Eligibility
Key inclusion criteria
• Age between the ages of 2.0 and 6.9 years
• Duration of type 1 diabetes greater than 6 months
• Willingness to wear an accelerometer and continuous glucose monitor for 7 days

Data from this study will be compared to age matched controls data already collected from a previous study which looked at physical activity in standard population.
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Comorbid congenital heart disease, severe asthma or other lung disease, physical disability that would affect the ability of the participant to be physically active
Data from this study will be compared to age matched controls data already collected from a previous study which looked at physical activity in standard population.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
9/08/2021
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 18222 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 18223 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 32282 0
2305 - New Lambton
Recruitment postcode(s) [2] 32283 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307435 0
Charities/Societies/Foundations
Name [1] 307435 0
International Society for Pediatric and Adolescent Diabetes
Country [1] 307435 0
Germany
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308109 0
Other Collaborative groups
Name [1] 308109 0
Hunter Medical Research Institute
Address [1] 308109 0
Lot 1, Kookaburra Cct,
New Lambton Heights NSW 2305
Country [1] 308109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307516 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 307516 0
Ethics committee country [1] 307516 0
Australia
Date submitted for ethics approval [1] 307516 0
Approval date [1] 307516 0
16/09/2020
Ethics approval number [1] 307516 0

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

Contacts
Principal investigator
Name 107518 0
Prof Bruce King
Address 107518 0
Department of Endocrinology and Diabetes
John Hunter Children's Hospital
Lookout Road,
Newcastle, NSW 2310
Country 107518 0
Australia
Phone 107518 0
+61 2 49 855634
Fax 107518 0
Email 107518 0
Bruce.King@health.nsw.gov.au
Contact person for public queries
Name 107519 0
Jordan Rafferty
Address 107519 0
Hunter Medical Research Institute
Lot 1, Kookaburra Circuit,
New Lambton Heights NSW 2305
Country 107519 0
Australia
Phone 107519 0
+61 0403106451
Fax 107519 0
Email 107519 0
jordan.rafferty@newcastle.edu.au
Contact person for scientific queries
Name 107520 0
Jordan Rafferty
Address 107520 0
Hunter Medical Research Institute
Lot 1, Kookaburra Circuit,
New Lambton Heights NSW 2305
Country 107520 0
Australia
Phone 107520 0
+61 0403106451
Fax 107520 0
Email 107520 0
jordan.rafferty@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.