JMIR Publications

ABSTRACT

Background:

Lifestyle modifications are a key part of type 2 diabetes mellitus (T2DM) treatment. Many patients find long-term self-management difficult, and mobile applications could be a solution. In 2010 in the U.S., a mobile application was approved as an official medical device. Similar applications have entered the Japanese market but are yet to be classified as medical devices. In this trial, we assessed the efficacy of such an application, SMC-01, among Japanese T2DM patients.

Objective:

This trial was designed to evaluate the efficacy and safety of the SMC-01 application among Japanese type 2 diabetes mellitus patients.

Methods:

This was a 24-week multi-institutional, prospective randomized controlled trial. Patients were evaluated in person at institutions in Tokyo, Japan. The intervention group received SMC-01, an application with fully-automated functions allowing patients to record data and receive personalized feedback to encourage a healthier lifestyle. The control group used paper journals for diabetes self-management. The primary outcome was the between-group difference in change in HbA1c from baseline to week 12.

Results:

The change in HbA1c from baseline to week 12 was -0.05% (95% CI [-0.14%, 0.04%]) in the intervention group and 0.06% (95% CI [-0.04%, 0.15%]) in the control group. The between-group difference in change was -0.11% (95% CI [-0.24%, 0.03%], P = 0.114).

Conclusions:

There was no statistically significant change in glycemic control. The lack of change could be due to SMC-01 insufficiently inducing behavior change, absence of screening for patients who have high intention to change their lifestyle, low effective usage of SMC-01 due to design issues, or problems with the SMC-01 intervention. Future efforts should focus on these issues in the early phase of developing interventions. Clinical Trial: Trial Registration: This study was registered in the Japan Registry of Clinical Trials (jRCT2032200033) on May 17, 2020.