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Trial registered on ANZCTR


Registration number
ACTRN12620001066976
Ethics application status
Approved
Date submitted
17/08/2020
Date registered
16/10/2020
Date last updated
5/05/2022
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel digital solution to educate and empower young people with
Type 1 Diabetes on how to exercise safely.
Scientific title
Evaluation of a novel digital solution to educate and empower young people with type 1 diabetes on how to exercise safely, and the impact of this on exercise-associated hypoglycaemia.
Secondary ID [1] 301187 0
RGS0000003886
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up to study ACTRN12619001414101

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 317335 0
Condition category
Condition code
Metabolic and Endocrine 315443 315443 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be trialling a newly-refined mobile App for physical activity, (first developed for project ACTRN12619001414101), to provide guidance on carbohydrate and insulin dosing for young people with type 1 diabetes.

Participants will be involved in the study for 12 weeks. In the first four weeks (run-in period), participants will be given time to become familiar with the activity-monitoring watch and continuous glucose monitoring system that they will be required to wear for the remainder of the study period. During the next four weeks (pre-intervention period), participants will continue to wear the continuous glucose monitor and activity-monitoring watch during periods of physical activity, while following their usual diabetes management. At the end of this 4-week period, participants will have the App installed on their smartphone at an in-clinic visit, under the guidance of an endocrinologist and/or research assistant/officer. For the last 4-week period (intervention period), participants will continue their regular exercise/physical activity, using advice provided by the App to assist with their diabetes management. During the 4-week pre-intervention and 4-week intervention periods, CGM readings uploaded to Dexcom Clarity will allow us to assess rates of hypoglycaemia during these periods, including during times of exercise which will be captured by the activity-monitoring watch. Participants will be advised to change their sensor every 10 days, and participants will be supplied with enough sensors for the duration of the study.

The App has been co-designed with the target population for this study, with further refinements made based on initial feedback received from participants during project ACTRN12619001414101. The content of the App is split into two main sections/features, with participants required to enter basic demographics the first time they use the App. The main feature of the App begins with the “Exercise Now” button. This prompts users to either “Add an activity”, or “Use one of your favourites”. If “Add an activity” is selected, the user is prompted to select Walk, Run, Swim, Cycle, Team Sports, Strength Training, or Other. The user is then asked to select from one of three ‘emojis’ to indicate the intensity of their activity, select their duration of exercise (up to 30 minutes, 31 to 45 minutes or 45 to 60 minutes), the time of their last insulin bolus, and their current blood glucose (BGL) reading. Based on the user selections, the App will then provide carbohydrate and insulin advice for that activity. This advice provided is split into three brief sections, displayed on the one screen as follows:
‘Pre-exercise advice’ suggests an amount of carbohydrates to take before starting the activity, e.g., “Have 15g Carbs before you start exercise.”
‘Insulin advice’ suggests adjustments to insulin, e.g., “If you are using an insulin pump, reduce your basal rate by 50% until the end of exercise.”
‘During exercise advice’ suggests an amount of carbohydrates to take during the activity and reminds participants to check their blood glucose level, e.g., “Have 12g Carbs at the 30 minute point of exercise if your glucose level is less than 7 mmol/l.” If the exercise duration entered by the participant is longer than 30 minutes, the App will also notify them to check their blood glucose level at the 30 minute mark of exercise. Users can also ‘save’ the activity as a favourite to quickly use again in the future, while the activity log/calendar function also allows users to view past activities and advice.

The other main feature of the App is the “More Info” tab, which allows users to access more generalised exercise advice without having to log a specific activity. This section is split into four sections:
- Hypo (hypoglycaemia) treatment: Suggestions for hypo treatment.
- Food Guide: Definitions of low and high GI foods and their effect on glucose levels.
- Pre-exercise advice: Generalised meal and insulin advice for 1 to 3 hours prior to exercise.
- Post-exercise advice: Advice on managing glucose levels immediately after exercise and in the following hours (e.g., overnight).

The advice used in the App is based on guidelines from the International Society for Pediatric and Adolescent Diabetes, American Diabetes Association, and the Lancet: Diabetes and Endocrinology.

Participants will be asked to exercise at least twice a week using the App. Google Analytics in conjunction with RedCap will provide information about participant adherence to this (i.e. how frequently the App is being used), how long users are interacting with the App, and time spent on specific features/pages of the App. Questionnaires relating to participants' physical activity, diabetes management, anxiety, hypoglycaemia fear and hypoglycaemia awareness will be administered at four-week intervals via RedCap. Participant diaries (to record events such as sick days and new medications) will be provided as paper copies, with data manually uploaded to RedCap by the study team. At the end of the study, participants will also complete a user mobile application rating scale (uMARS) and may complete a semi-structured interview with a trained member of our research staff. Participants will be invited to participate in the interviews until investigators are satisfied that theme saturation is reached. Parents of participants under 18 years of age will also complete a single-item questionnaire about their confidence in their child's ability to exercise safely.
Intervention code [1] 318294 0
Treatment: Devices
Intervention code [2] 318295 0
Lifestyle
Intervention code [3] 318296 0
Behaviour
Comparator / control treatment
The study is a pre-post longitudinal design. Participants will spend four weeks exercising and participating in physical activity while following their usual diabetes management, followed by four weeks exercise and participating in physical activity with the App to assist with their diabetes management.
Control group
Active

Outcomes
Primary outcome [1] 324713 0
Incidence of level 1 hypoglycaemia, defined as sensor glucose levels < 3.9 mmol/L for a period of 15 minutes or longer.
Timepoint [1] 324713 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [1] 385498 0
Time spent with sensor glucose levels between 3.9 and 10 mmol/L, and >10 mmol/L.
Timepoint [1] 385498 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [2] 385499 0
Incidence of level 1 hypoglycaemia or treated hypoglycaemia during the subsequent 24 hours after exercise. The timing of exercise will be assessed from the App itself, i.e. the time that the participant selects the ‘exercise now’ function of the App, and confirmed by the activity-monitoring watch.
Timepoint [2] 385499 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [3] 385500 0
Incidence of level 2 hypoglycaemia (sensor glucose level of <3.0 mmol/L for a period of 15 minutes or longer) during and in the subsequent 24 hours after exercise. The timing of exercise will be assessed from the App itself, i.e. the time that the participant selects the ‘exercise now’ function of the App, and confirmed by the activity-monitoring watch.
Timepoint [3] 385500 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [4] 385501 0
Frequency of exercise, as assessed by the child/adolescent/adult Physical Activity Questionnaire (PAQ)
Timepoint [4] 385501 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [5] 385502 0
Anxiety level (assessed by the GAD-7 scale).
Timepoint [5] 385502 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [6] 385503 0
Quality of life (assessed by the Problem areas in diabetes (PAID) scale.
Timepoint [6] 385503 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [7] 385504 0
Fear of hypoglycaemia (assessed by Hypoglycaemia Fear Scales (HFS)). The specific scales to be used are the “University of Virginia Low Blood Sugar Survey – Adolescents” and the “University of Virginia Low Blood Sugar Survey – Participants greater than or equal to 18 years.”
Timepoint [7] 385504 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [8] 385505 0
Hypoglycaemia awareness (assessed by the Gold Score).
Timepoint [8] 385505 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [9] 385506 0
Perceived barriers to physical activity (BAPAD1 Scale).
Timepoint [9] 385506 0
This will be assessed once at the start of the 4-week pre-intervention period, once at the end of the pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [10] 385507 0
Ease of App/guidelines use will be assessed by semi-structured interview at the end of the study in a subset of participants. The interview will be conducted one on one, face-to-face with a team member trained in facilitating semi-structured interviews.
Timepoint [10] 385507 0
Once at the end of the 4-week intervention period.
Secondary outcome [11] 385752 0
Parents’ confidence in their child’s ability to exercise safely, assessed by a single-item question using a Likert scale designed specifically for this study.
Timepoint [11] 385752 0
Once at the end of the 4-week intervention period.
Secondary outcome [12] 387069 0
Duration of exercise, as recorded by the activity monitoring watch.
Timepoint [12] 387069 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [13] 387070 0
Intensity of exercise, as assessed by heart rate data recorded the activity monitoring watch.
Timepoint [13] 387070 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [14] 387071 0
Frequency of exercise, as recorded by the activity-monitoring watch.
Timepoint [14] 387071 0
This will be assessed once at the end of the 4-week pre-intervention period and once at the end of the 4-week intervention period.
Secondary outcome [15] 387072 0
Overall user rating of the App (including scales for App engagement, functionality, aesthetics, information, subjective quality, and perceived impact), as assessed by the user Mobile Application Rating Scale (uMARS).
Timepoint [15] 387072 0
Once at the end of the 4-week intervention period.

Eligibility
Key inclusion criteria
Healthy individuals with type 1 diabetes aged 12 to 25 years;
Diagnosed with T1D for more than 6 months;
Exercising regularly or willing to exercise;
Using insulin pump therapy or multiple daily injections (MDI);
Willing to use a Dexcom CGM system and Garmin Forerunner activity-monitoring watch;
Own and use a device with iOS (Apple) or Android operating system separate to their parent/guardian's 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Actual
1/10/2020
Date of last participant enrolment
Anticipated
2/08/2021
Actual
29/09/2021
Date of last data collection
Anticipated
26/11/2021
Actual
12/01/2022
Sample size
Target
40
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305637 0
Charities/Societies/Foundations
Name [1] 305637 0
JDRF Australia (formerly known as the Juvenile Diabetes Research Foundation)
Country [1] 305637 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 306043 0
None
Name [1] 306043 0
Address [1] 306043 0
Country [1] 306043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305924 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 305924 0
Ethics committee country [1] 305924 0
Australia
Date submitted for ethics approval [1] 305924 0
17/03/2020
Approval date [1] 305924 0
11/06/2020
Ethics approval number [1] 305924 0
RGS0000003886

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

Contacts
Principal investigator
Name 102082 0
Dr Vinutha B Shetty
Address 102082 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 102082 0
Australia
Phone 102082 0
+61 8 6456 5020
Fax 102082 0
Email 102082 0
vinutha.shetty@health.wa.gov.au
Contact person for public queries
Name 102083 0
Vinutha B Shetty
Address 102083 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 102083 0
Australia
Phone 102083 0
+61 8 6456 5020
Fax 102083 0
Email 102083 0
vinutha.shetty@health.wa.gov.au
Contact person for scientific queries
Name 102084 0
Vinutha B Shetty
Address 102084 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 102084 0
Australia
Phone 102084 0
+61 8 6456 5020
Fax 102084 0
Email 102084 0
vinutha.shetty@health.wa.gov.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.