Mobile application intervention to promote self-management in insulin-requiring type 1 and type 2 diabetes individuals: protocol for a mixed methods study and non-blinded randomized controlled trial.

Mobile applications (apps) have proven to be useful in supporting diabetes self-care, but non-consideration of users' needs and non-inclusion of educational features are reasons for low continual use. Well-designed mobile apps that meet the needs of diabetes patients and provide ongoing self-management education and support are required. It was hypothesized that apps designed with such features can improve a range of measures including clinical outcomes, knowledge of diabetes, medication adherence, perceived ability for self-management, and quality-of-life. This may eventually facilitate a more robust and cost-effective approach for improving skills and motivation for the management of diabetes. This project will be conducted in two phases. It will initially employ a mixed methods study design to investigate the self-management needs and perceptions of diabetes patients on the use of mobile apps to support diabetes self-management. Results of the mixed methods study will inform the content and design of an app which will be employed as an intervention tool in a 12-month parallel randomized controlled trial (RCT). The RCT will compare outcomes in relation to standard-of-care alone with standard-of-care plus a mobile phone diabetes app among 150 insulin-requiring types 1 and 2 diabetes patients. The primary outcome measures are clinical parameters such as hemoglobin A1c (HbA1c), lipids, urine albumin-to-creatinine ratio, blood pressure, frequency in events of emergency hyperglycemia and hypoglycemia. Secondary outcomes include knowledge of diabetes, medication intake and adherence, perception of self-care, and quality-of-life. Results from this study will provide empirical evidence on the usefulness of a mobile app developed based on self-management needs analysis of diabetic patients. The long-term goal is to harness knowledge gained from this study to provide evidenced-based data, which promote the scale-up or adoption of mobile applications that provide regular, ongoing education and self-management support to people living with diabetes. Australian New Zealand Clinical Trials Registry, ACTRN12618000065291, Registered on 17 January, 2018 (prospectively registered).