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Trial registered on ANZCTR


Registration number
ACTRN12620000228987
Ethics application status
Approved
Date submitted
13/02/2020
Date registered
24/02/2020
Date last updated
19/03/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the mySugr app for adults with type 1 diabetes
Scientific title
Evaluating the efficacy of the mySugr app to improve glycaemic control in adults with type 1 diabetes: a randomized controlled trial
Secondary ID [1] 300507 0
None
Universal Trial Number (UTN)
U1111-1244-8101
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 316215 0
Condition category
Condition code
Metabolic and Endocrine 314506 314506 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will be asked to use the pro version of the 'mySugr' app for 12 weeks. MySugr is a diabetes management app that allows users to log and keep track of changes in their blood glucose levels, HbA1c levels, body weight, medication, meals, carbohydrate intake, insulin, and physical activity. Users can also set reminders and goals related to the management of their diabetes. In addition, the mysugr app analyses the information logged and creates daily, weekly and monthly reports allowing users to evaluate how well they meet the goals set.

Participants can use any of the features of the app over the 12-week period. They will be encouraged to use the app daily and will be sent text message reminders to use the app once every 2 weeks.
Intervention code [1] 316827 0
Behaviour
Intervention code [2] 316913 0
Lifestyle
Comparator / control treatment
The participants randomised to the control group will be asked to continue with standard care. Standard care includes 3-4 monthly clinic appointments to see their endocrinologist, appointments with diabetes nurse educators and other allied health staff as necessary, and continuing with their diabetes self-care regimen (e.g. monitoring blood glucose levels, taking insulin etc.)
Control group
Active

Outcomes
Primary outcome [1] 322832 0
Glycaemic control will be assessed by glycated haemoglobin (HbA1c) levels. This information is collected as part of standard care and will be obtained from patient medical records.
Timepoint [1] 322832 0
The most recent HbA1c collected prior to intervention, at completion of the 12-week intervention (primary timepoint), and 6-months after randomisation
Secondary outcome [1] 379955 0
Self-care behaviours will be assessed using the Self-Care Inventory-Revised Version (SCI-R). The scale measures patients adherence to diabetes treatment regimen and recommended lifestyle changes.
Timepoint [1] 379955 0
Baseline and at completion of the 12-week intervention
Secondary outcome [2] 379956 0
Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire.
Timepoint [2] 379956 0
Baseline and at completion of the 12-week intervention
Secondary outcome [3] 379957 0
Quality of life will be assessed using the World Health Organisation-Five Well-Being Index (WHO-5).
Timepoint [3] 379957 0
Baseline and at completion of the 12-week intervention
Secondary outcome [4] 379958 0
Diabetes self-efficacy will be assessed using the Diabetes Self Efficacy Scale (DSES). The scale measures patient’s perceived self-efficacy in managing diabetes.
Timepoint [4] 379958 0
Baseline and at completion of the 12-week intervention
Secondary outcome [5] 379959 0
Optimism will be assessed using the revised version of the Life Orientation Test (LOT-R).
Timepoint [5] 379959 0
Baseline and at completion of the 12-week intervention
Secondary outcome [6] 379960 0
For participants in the intervention group only, engagement with the MySugr will be assessed using the end user version of the Mobile Application Rating Scale (MARS). It is a 20-item scale that assesses the quality of mobile health apps based on engagement, functionality, aesthetics, quality of information, and subjective quality.
Timepoint [6] 379960 0
At completion of the 12-week intervention
Secondary outcome [7] 381351 0
The Perceived Stress Scale (PSS-10) will be used to assess stress. It is a 10-item scale that assesses the extent to which individuals perceive events as stressful in the previous month
Timepoint [7] 381351 0
Baseline and at completion of the 12-week intervention

Eligibility
Key inclusion criteria
Inclusion criteria are: (1) a diagnosis of type 1 diabetes >1 year; (2) 18 years of age or older; (3) ability to speak, read and understand English and provide informed consent; (4) own an iOS or android smartphone that can download apps
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: (1) already using a diabetes app to manage their type 1 diabetes, (2) being pregnant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based random number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation

A sample size calculation using G power was conducted based on the mean effect size for a between-group difference in glycaemic control (Cohen’s d=0.42) reported in a mHealth intervention for adults with Type 1 diabetes (Kirwan, Vandelanotte, Fenning, & Duncan, 2013). An a priori analysis using 80% power and 5% significance with an independent samples t-test suggested a minimum sample size of 80 (40 per group) would be required.

Statistical method

Linear mixed models will be conducted to assess differences in primary and secondary outcome measures between the groups and across time. Persons correlations will also be conducted to explore the relationship between demographic variables, self-care behaviours, psychological outcomes and glycaemic control.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22346 0
New Zealand
State/province [1] 22346 0
Auckland

Funding & Sponsors
Funding source category [1] 304924 0
University
Name [1] 304924 0
The University of Auckland
Address [1] 304924 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West,
Auckland, 1142
Country [1] 304924 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 305289 0
None
Name [1] 305289 0
Address [1] 305289 0
Country [1] 305289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305332 0
Health and Disability Ethics Committees
Ethics committee address [1] 305332 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 305332 0
New Zealand
Date submitted for ethics approval [1] 305332 0
03/12/2019
Approval date [1] 305332 0
16/03/2020
Ethics approval number [1] 305332 0

Summary
Brief summary
This study will evaluate the effectiveness of the mySugr app in adults with type 1 diabetes. The study will examine whether using mySugr for 12 weeks can improve glycaemic control, diabetes self-care behaviours, and psychological outcomes in patients with type 1 diabetes relative to standard care.

Eighty adults with type 1 diabetes will be recruited from diabetes outpatient clinics of the Waitemata District Health Board. Participants will be randomly assigned to use the mySugr app for 12 weeks (intervention) or to continue with standard care (control). Regardless of which group they are assigned to, participants' glycaemic control will be collected when they are recruited, at the completion of the 12-week intervention and 6-months after randomisation. Participants will also be asked to complete questionnaires at baseline and at completion of the 12-week intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100030 0
Dr Anna Serlachius
Address 100030 0
Dept, of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country 100030 0
New Zealand
Phone 100030 0
+64 09 9233073
Fax 100030 0
Email 100030 0
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 100031 0
Dr Anna Serlachius
Address 100031 0
Dept, of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country 100031 0
New Zealand
Phone 100031 0
+64 09 9233073
Fax 100031 0
Email 100031 0
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 100032 0
Dr Anna Serlachius
Address 100032 0
Dept, of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country 100032 0
New Zealand
Phone 100032 0
+64 09 9233073
Fax 100032 0
Email 100032 0
a.serlachius@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have informed consent from patients to share their data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results