%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 26
%N 
%P e53740
%T Efficacy of Save Medical Corporation (SMC)–01, a Smartphone App Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Randomized Controlled Trial
%A Leung,Nicholas
%A Waki,Kayo
%A Nozoe,Satoshi
%A Enomoto,Shunpei
%A Saito,Ryo
%A Hamagami,Sakurako
%A Yamauchi,Toshimasa
%A Nangaku,Masaomi
%A Ohe,Kazuhiko
%A Onishi,Yukiko
%+ Department of Planning, Information and Management, University of Tokyo Hospital, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 0358009129, kwaki-tky@m.u-tokyo.ac.jp
%K behavioral change
%K HbA1c
%K hemoglobin A1c
%K mHealth
%K randomized controlled trial
%K smartphone application
%K T2DM
%K diabetes mellitus
%K mobile apps
%K mobile app
%K type 2 diabetes
%K diabetes
%K self-management
%K Japan
%K multi-institutional
%K RCT
%K RCTs
%K efficacy
%K app development
%K safety
%K mobile phone
%D 2024
%7 10.9.2024
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: Lifestyle modifications are a key part of type 2 diabetes mellitus treatment. Many patients find long-term self-management difficult, and mobile apps could be a solution. In 2010, in the United States, a mobile app was approved as an official medical device. Similar apps have entered the Japanese market but are yet to be classified as medical devices. Objective: The objective of this study was to determine the efficacy of Save Medical Corporation (SMC)–01, a mobile app for the support of lifestyle modifications among Japanese patients with type 2 diabetes mellitus. Methods: This was a 24-week multi-institutional, prospective randomized controlled trial. The intervention group received SMC-01, an app with 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 hemoglobin A1c from baseline to week 12. Results: The change in hemoglobin A1c from baseline to week 12 was –0.05% (95% CI –0.14% to 0.04%) in the intervention group and 0.06% (95% CI –0.04% to 0.15%) in the control group. The between-group difference in change was –0.11% (95% CI –0.24% to 0.03%; P=.11). 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. Trial Registration: Japan Registry of Clinical Trials jRCT2032200033; https://jrct.niph.go.jp/latest-detail/jRCT2032200033 
%R 10.2196/53740
%U https://www.jmir.org/2024/1/e53740
%U https://doi.org/10.2196/53740