Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001414101
Ethics application status
Approved
Date submitted
12/09/2019
Date registered
15/10/2019
Date last updated
8/06/2021
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of new exercise guidelines for young people with Type 1 Diabetes
Scientific title
Evaluation of new exercise guidelines for young people with Type 1 Diabetes
Secondary ID [1] 299279 0
None
Universal Trial Number (UTN)
U1111-1240-1520
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 314412 0
Condition category
Condition code
Metabolic and Endocrine 312753 312753 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will use an app for six weeks during physical activity, developed to provide guidance on carbohydrate and insulin dosing for young people with type 1 diabetes.

The app is broken down into two main sections. The first is the activity log where participants will enter the type of physical activity they will be completing. They will be guided through a series of questions related to the activity, the timing of their last insulin bolus, and their blood glucose level before the app provides them with advice on the amount of carbohydrates to consume, and any adjustments to their basal insulin. The second section contains additional educational information on treating hypoglycaemia, pre and post exercise advice and food advice. The advice and educational content is sourced from the International Society for Paediatric and Adolescent Diabetes (ISPAD 2018) guidelines, the American Diabetes Association (ADA) 2016 guidelines, and Lancet guidelines (Riddell et al 2017).

Participants will be instructed to use the app for all physical activity they take part in during the six weeks. The type of physical activity is not set. The additional educational information section is available for participants to use at their own discretion.

Participants will download the app at visit 1. This visit will be attended by an endocrinologist, and a research assistant or nurse.

The App has been co-designed with the target population for this study and being trialled for the first time in this study.

Google data analytics will provide information about how frequently the app is being used, how long users are interacting with the app, and time spent on specific features of the app. This study it to test the acceptability and usability of the app and obtain feedback from young people with T1D. It is not to test the adherence to the advice.
Intervention code [1] 315558 0
Treatment: Devices
Intervention code [2] 315559 0
Lifestyle
Intervention code [3] 315560 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321380 0
This trials has a composite primary outcome. To evaluate the acceptability and usability of a smartphone exercise app designed to encourage individuals with type 1 diabetes to exercise more frequently.

At the end of the six week period, participants will visit the research laboratory to complete the Mobile Application Rating Scale: user version (uMARS) survey and an interview.
All items in the uMARS are rated on a 5-point scale. The interviews will take approximately 30 minutes and the questions are a combination of 5-point rated scale and open-ended questions. The interviews will be recorded and transcribed verbatim in preparation for thematic analysis.
Timepoint [1] 321380 0
At the end of the six week period.
Secondary outcome [1] 375051 0
Change in confidence of young people with T1D to be physically active as assessed by interview. The interviews will take approximately 30 minutes and the questions are a combination of 5-point rated scale and open-ended questions. The interviews will be recorded and transcribed verbatim in preparation for thematic analysis.
Timepoint [1] 375051 0
At the end of the six week period.

Eligibility
Key inclusion criteria
Healthy individuals with T1D aged from 12 to 25 years
T1D > 6 months
Exercising regularly at least 2 times per week
Insulin pump or MDI
Own and use a smartphone (i.e., separate to their parents’/guardians’ personal smartphone).
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not willing or unable to exercise
Non-english speaking participants
Individuals with reduced cognitive capacity who do not have capacity to consent/assent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A - All participants will use the app.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A- no randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2019
Actual
25/11/2019
Date of last participant enrolment
Anticipated
29/11/2019
Actual
27/11/2019
Date of last data collection
Anticipated
17/01/2020
Actual
7/01/2020
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303810 0
Charities/Societies/Foundations
Name [1] 303810 0
JDRF Australia
Country [1] 303810 0
Australia
Funding source category [2] 303811 0
Charities/Societies/Foundations
Name [2] 303811 0
Channel 7 Telethon Trust
Country [2] 303811 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service
Address
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 303932 0
None
Name [1] 303932 0
Address [1] 303932 0
Country [1] 303932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304326 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 304326 0
15 Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 304326 0
Australia
Date submitted for ethics approval [1] 304326 0
Approval date [1] 304326 0
18/04/2019
Ethics approval number [1] 304326 0

Summary
Brief summary
Exercise has numerous physical and psychological health benefits for people with type 1 diabetes (T1D) however, the varying effects exercise has on blood glucose levels makes it challenging for young people with T1D.

The current T1D guidelines available for exercise vary, are challenging to follow and not very accessible. Our research team have developed an app collating the guidelines with data from our previous studies to assist people with T1D to safely participate in a more physically active lifestyle.
This project aims to evaluate the acceptability and usability of the app in individuals with T1D aged between 12 to 25 years during physical activity. At the end of the pilot test, these participants will complete an interview and survey. Analysis of pilot results will contribute to amending the features of the App to improve its usability and acceptability before conducting a trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96550 0
Dr Vinutha Shetty
Address 96550 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 96550 0
Australia
Phone 96550 0
+61 08 64565020
Fax 96550 0
Email 96550 0
[email protected]
Contact person for public queries
Name 96551 0
Dr Vinutha Shetty
Address 96551 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 96551 0
Australia
Phone 96551 0
+61 08 64565020
Fax 96551 0
Email 96551 0
[email protected]
Contact person for scientific queries
Name 96552 0
Dr Vinutha Shetty
Address 96552 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 96552 0
Australia
Phone 96552 0
+61 08 64565020
Fax 96552 0
Email 96552 0
[email protected]

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.