The Effectiveness of MyDiaMate, a Self-guided Web-based App for Mental Health in Type 1 Diabetes: a Multinational Randomized Controlled Trial

Mental health is a priority in the care for people with Type 1 diabetes (T1D). However, access to psychological services is generally limited, and if available, often not tailored to the needs of people with T1D. To expand the reach of psychological support, online interventions can be helpful, are safe and carry relatively low costs. More so, if the application is fully self-guided, i.e. not in need of healthcare professionals involvement. In this study the effectiveness of a diabetes type 1 tailored web-based self-help app, called MyDiaMate, will be tested. The app is designed for adults living with T1D and the first of its kind. It was developed and tested in the Netherlands with input from people with T1D and health care professionals, building on Cognitive Behavioral Therapy (CBT) and offering insights and strategies to help improve coping with the burden of T1D and strengthen mental health. The app is focused on improving diabetes distress, with additional modules on emotional well-being and fatigue. MyDiaMate can be used (anonymously) on a smartphone, personal computer or laptop. Personalised feedback and reminders are offered to promote participants’ motivation and engagement with the app. The trial will be carried out in 4 countries: Germany, Spain, United Kingdom and the Netherlands. Participants are adults with T1D who experience diabetes distress, which may be accompanied with low well-being and/or fatigue. They are randomized over two conditions: the control group who receives care as usual, and the intervention group, who receive access to MyDiaMate. Participants will fill out questionnaires at baseline, 3 and 6 months follow-up. The effectiveness of MyDiaMate is determined at 3 months, after which the participants in the control group are also given the option to access to MyDiaMate for the remaining 3 months of the trial. The trial will show how effective MyDiaMate is and for whom the use of the app is most beneficial. The primary outcome is change in diabetes distress. Sercondary outcomes are emotional well-being, fatigue, diabetes self-management and indicators of glycemic control. If shown to be effective, MyDiaMate can be made available in English, German and Spanish, allowing for a broad dissemination, reaching a large group of people with T1D across the globe.”