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

Improving self-management of type 2 diabetes using new technologies: The My Diabetes Coach Project.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001229662
Acronym
My Diabetes Coach (MDC) Partnership Project
Enrollment
187
Registered
2014-11-24
Start date
2016-05-02
Completion date
2017-04-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to evaluate the 'real-world' implementation of a digital health program that is aimed to improve type 2 diabetes self-management. The trial will determine: i) the program’s reach, adoption, implementation and maintenance amongst persons with diabetes (PWDs) type 2; ii) clinical, psychosocial, and behavioural outcomes for PWDs provided with the program; and iii) the costs and value for money of the program.

Interventions

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 c

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 use of the app and contains information to help users to get the most out of My Diabetes Coach program. Included within the guide is an introductory module on how to use the program for the first time, a frequently asked questions section, an explanation of the usefulness of using goal setting and problem solving strategies, tracking sheets for participants to record your progress throughout the program, and sources of more information on managing diabetes. 3. A Private Participant Website The program website will be restricted to the users of the program and will contain specific content that will complement the smart device application and user guide. The planned components of the website include: -Electronic version of the GP information sheet that participants can download and show to their health care professionals -Electronic versions of all sections of the user guide -Electronic versions of Diabetes Australia Factsheets (blood glucose monitoring, hypoglycaemia and diabetes, physical activity and type 2 diabetes, food choices for people with diabetes, medications for type 2 diabetes, sick days and type 2 diabetes, diabetes and your feet, smoking, prediabetes and diabetes, depression and diabetes) and links to state specific information Diabetes Queensland, Diabetes WA and Diabetes Victoria. -An online community that participants can read and comment upon -Links to helpful information about eye health and diabetes (Vision Australia and Macular Disease Foundation Australia) -Links to general health information (National Heart Foundation, Healthinsite, Health Direct Information Line, Queensland Health, Department of Health Victoria, WA Health, Kidney Health Australia). 4.A Public Project Website This project website will have general information about the project and the people involved with its execution, as well as an expression of interest form and general information for GP’s and health professionals. 5.A Program Coordinator The Coordinator trains participants in how to use the app, resolves any technical issues relating to use of the app, and responds to and relays clinical alerts produced by the system to GP’s when necessary. After receiving the participants registration, and consent form, and prior to receiving access to the app, the research team will send a letter to their GP which will explain how the GP can help participants to tailor the program to the person with diabetes’ (PWD) needs i.e. asking them to provide individualised self-care clinical targets (e.g. targets for BG, and frequency of testing, and physical activity goals). The latter will be entered into the program database to tailor conversations with each person. These steps have been implemented successfully with more than 95% of previous trial participants. Participants will be contacted at weeks 4, 8, 12 and 24 weeks to elicit and address any difficulties. Additionally, alerts will be generated by the system, prompting the Research Team to call the participant if s/he does not call the program for two consecutive weeks and/or after any clinical alerts (e.g. high/low BG levels) or technical alerts (e.g. BG uploading failed). A summary of the participant’s self-management data and alerts will be sent to his/her GP at regular intervals. At 6 – and 12-months, GPs will be contacted again and encouraged to review the participant’s progress according to his/her set targets and/or their preference for continuing use of the program and/or access to other DA self-management resources to facilitate program maintenance. Participants will be encouraged to discuss this with their GPs. The weekly chats will last approximately 20-30 minutes. The intervention period is 12-months during which time the GPs will receive summaries from their patient whenever the patient chooses to generate one (a feature of the program) and quarterly from the research team. The current program is easily accessible by most Australians, requiring them to have an internet-enabled smart device but not requiring high English literacy or advanced technical skills. However, based on our evaluation to date and feedback provided by program consumers, program partners and our health advisory team, we have refined the program to include new modules (i.e., foot-care). Further, the mobile and Web “apps” to enhance user engagement and to improve links with GPs. Large scale implementation of technology-delivered programs to support T2DM self-management is very promising in Australia, as Australians are known to be high adopters of technology. For example, by mid-2013, >80% of mobile phone owners will own smartphones. Mobile networks now cover 99% of populated areas in Australia and >85% of Australian adults have at least reasonable access to a mobile phone service. Currently, 79% of all Australian households have internet access.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026