Controlling type 2 diabetes (T2DM) requires a comprehensive approach including patient education, self-monitoring of blood glucose, individualized behavioral strategies, and frequent contact with healthcare professionals (HCPs). We aimed to compare the efficacy of a personalized lifestyle intervention based on a mobile phone application with regular care in participants with T2DM. This is an ongoing randomized controlled open-label parallel-group trial with a target accrual of 282 participants, of which 181 have been enrolled to date. Participants are randomly assigned to one of three groups: (1) regular care; (2) mobile diabetes management; or (3) mobile diabetes management with HCP feedback. The mobile application is enabled to integrate with both electronic medical records (EMR) and a web-based diabetes management system for HCPs. It can send customized messages based on participants' responses to lifestyle questionnaires administered at the baseline. The intervention period is 26 weeks followed by observation for 26 weeks. We evaluate the intervention's features in order to assess its clinical utility and efficacy and compare outcomes with regular care considering relevant clinical factors, such as age, baseline HbA1c, etc. We expect our study to provide new evidence in support of customized mobile application tools for the management of T2DM.
Keywords: digital health; mHealth; self-monitoring; type 2 diabetes mellitus.