@Article{info:doi/10.2196/53740,
author="Leung, Nicholas
and Waki, Kayo
and Nozoe, Satoshi
and Enomoto, Shunpei
and Saito, Ryo
and Hamagami, Sakurako
and Yamauchi, Toshimasa
and Nangaku, Masaomi
and Ohe, Kazuhiko
and Onishi, Yukiko",
title="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",
journal="J Med Internet Res",
year="2024",
month="Sep",
day="10",
volume="26",
pages="e53740",
keywords="behavioral change; HbA1c; hemoglobin A1c; mHealth; randomized controlled trial; smartphone application; T2DM; diabetes mellitus; mobile apps; mobile app; type 2 diabetes; diabetes; self-management; Japan; multi-institutional; RCT; RCTs; efficacy; app development; safety; mobile phone",
abstract="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 ",
issn="1438-8871",
doi="10.2196/53740",
url="https://www.jmir.org/2024/1/e53740",
url="https://doi.org/10.2196/53740"
}