Preventing complications in people with type 2 diabetes by using new technologies to optimise self-management.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001229662
• Date of registration: 24/11/2014
• Prospective Registration: Yes
• Primary sponsor: University of Melbourne
• Public title: Preventing complications in people with type 2 diabetes by using new technologies to optimise self-management.
• Scientific title: Improving self-management of type 2 diabetes using new technologies: The My Diabetes Coach Project.
• Date of first enrolment: 02/05/2016
• Target sample size: 1200
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001229662.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Professor Brian Oldenburg

• Name: Prof Brian Oldenburg

Key inclusion & exclusion criteria

Inclusion criteria: Project suitability requires NDSS registration of 10 years or less; age of at least 18 years;
basic English language skills, and access to a smart device (phone or tablet with iOS 8.0 or later, or Android 4.2XX or later).
Exclusion criteria: Persons with Type 1 diabetes, persons diagnosed more than 10 years prior to registering in the NDSS, women who are currently or planning to become pregnant, and those with severe mental or physical illnesses will be excluded.
We will not exclude those who've recently started insulin treatment, but will delay their start until their insulin initiation phase concluded, i.e. a routine insulin dose has been established.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Type 2 Diabetes;
Type 2 Diabetes

Metabolic and Endocrine - Diabetes

Intervention(s)

Participants randomised to the intervention group will receive access to the My Diabetes Coach program which consists of four complementary components:
1. A smart phone and/or web based application
The app uses the latest digital technology to deliver support and resources to people with type 2 diabetes. Over a series of sessions, a virtual 'coach' interacts with and provides feedback on blood glucose monitoring, healthy eating, physical activity, foot-care and medication taking. The behaviour change strategies used within the application will complement strategies used within the other components of the program, providing a seamless experience for the participant. For example, the goal setting strategies within the application will be complemented by a section within the user guide providing an explanation of the benefits of setting goals. Finally the application will have built in reminders at the end of each chat to remind users to also use the user guide and participant website to get the most of the program. Participants will be encouraged to use the app weekly, after uploading their previous week’s BG readings.
They will also receive a blood glucose (BG) uploading kit: a new Roche Diagnostics Bluetooth-equipped BG meter with capability to upload self-monitored BG readings to the program database via smartphone "app". We estimate that 25% of participants will either not own a smartphone and/or will prefer to continue to use their own meter. Those who choose this option will be able to manually update their BG via the app. Roche Diagnostics will provide BG meters and uploading devices (SmartPix) at no cost for this study, which participants may or may not use i.e. they can use their own existing monitor.
2.A User Guide
The user guide complements the

Primary Outcome(s)

Program effectiveness (E) is measured via three methods: i) self-completed questionnaires; ii) pathology as part of diabetes annual cycle of care; and iii) other clinical measurements by GP as part of annual cycle of care. The following clinical outcomes will be measured by a GP: Blood Glucose, measured by HbA1c; Fasting Lipid profile, measured by total cholesterol, LDL, HDL, triglycerides, blood sample (HCP); blood pressure, measured by BP systolic/diastolic; and body mass index (BMI), measured by weight (kg)/height (m2). The following outcomes will be measured by a self-report baseline questionnaire: health-rated quality of life, measured by the assessment of quality of life (AQoL)-8D; medication adherence (number of days per week medication is taken as prescribed, measured by the Summary of Diabetes Self Care Activities (SDSCA) instrument); nutrition (number of serves of fruit & vegetables/day, measured by the National Nutrition Survey); Confidence in self-management of type 2 diabetes and how PWDs could overcome barriers (measured by the Confidence in Diabetes Scale (CIDS-II); Physical activity (number of physical activity minutes/week, number of physical activity sessions/week); foot care, frequency of foot checks, measured by the expanded SDSCA; emotional wellbeing, anxiety and depression symptoms (measured by the Hospital Anxiety and Depression Scale – HADS) and diabetes related distress (measured by the Problem Areas in Diabetes instrument – PAID); smoking status (current, ex-smoker, never smoked) measured by self-reported frequency and status.[Baseline (upon registration - prior to receiving access to the program) and 6- and 12-months Post-Baseline]

Program Reach, Adoption, Implementation and Maintenance will be collected at the end of the program delivery phase in Victoria, Queensland, and Western Australia for each of the relevant RE-AIM dimensions, with a particular focus on vulnerable and disadvantaged populations. We shall also assess both Waitlist and Intervention group participants' use of other ICT resources related to self-management during the study and follow-up.

Specifically, it will be measured by the following questions: How do we ensure: Implementation in various contexts and groups? Adherence to program delivery? There are no barriers and enablers to delivery? The cost of delivery and staffing requirements are kept low? The answers will be provided by logs of study invitation letters sent and queries received by DA staff, Diabetes Australia staff, coordinator and users’ interviews, GP questionnaires and interviews, program/system logs, coordinator notes, user acceptability questionnaires, and implementation cost questionnaires. [6 and 12 months post baseline]

Secondary Outcome(s)

Economic evaluation - Costing data will include staff costs and equipment costs for operating the program. Data on healthcare utilisation and implementation of the program will also be collected. Primary care and other community service use as well as hospitalisations will be collected using standard costing questionnaires. Quality adjusted life year (QALY) data will be calculated using the AQoL-8D administered at baseline and 12-month, for which Australian-specific conversion algorithms are available. For the implementation analysis, data on the staffing needs, staff and participant training, and infrastructure costs will also be collected during the trial. In addition, throughput and “staff load” will be recorded. A standardised questionnaire will be developed and administered online with key informants for this purpose.[6- & 12-months post-baseline]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Diabetes Australia

Roche Diagnostics

National Health and Medical Research Council (NHMRC)

Secondary Sponsor(s)

Diabetes Australia

Roche Diagnostics

Ethics review

Status: Approved
Approval date:
Contact:

THE UNIVERSITY OF MELBOURNE HUMAN RESEARCH ETHICS COMMITTEE

Results

• Results available: Yes
• Date Posted: 02/12/2019
• Date Completed: 28/09/2018