Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J): Study design and rationale for a multicenter, open-label, randomized parallel-group trial.

The use of the Internet-of-Things has improved glycemic control in individuals with diabetes in several small-scale studies with a short follow-up period. This large-scale randomized controlled trial investigates whether a smartphone-based self-management support system prevents the worsening of glycemic control in individuals with type 2 diabetes. Individuals with type 2 diabetes (age range 20-74 years; = 2,000) will be recruited, enrolled, and randomly assigned to two groups: the intensive therapy group and the conventional therapy group. Participants in the intensive therapy group will be supervised to use an automated Internet-of-Things system that demonstrates a summary of lifelogging data (, weight, blood pressure, and daily activities) obtained from each measurement device and will receive feedback messages smartphone applications to encourage them to increase their physical activity and to monitor weight and blood pressure. Participants in the conventional therapy group are allowed to use the same measurement devices as part of the routine diabetes care but without the Internet-of-Things system. The primary endpoint is the between-group difference in HbA1c levels from baseline to 52 weeks. This randomized controlled study will test the hypothesis that an Internet-of-Things-based self-monitoring system could effectively prevent the worsening of diabetes in individuals with type 2 diabetes. The expected results of the study should facilitate the development of novel strategies for both diabetes treatment and social health.