TY  - JOUR
AU  - Leung, Nicholas
AU  - Waki, Kayo
AU  - Nozoe, Satoshi
AU  - Enomoto, Shunpei
AU  - Saito, Ryo
AU  - Hamagami, Sakurako
AU  - Yamauchi, Toshimasa
AU  - Nangaku, Masaomi
AU  - Ohe, Kazuhiko
AU  - Onishi, Yukiko
PY  - 2024
DA  - 2024/9/10
TI  - 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
JO  - J Med Internet Res
SP  - e53740
VL  - 26
KW  - behavioral change
KW  - HbA1c
KW  - hemoglobin A1c
KW  - mHealth
KW  - randomized controlled trial
KW  - smartphone application
KW  - T2DM
KW  - diabetes mellitus
KW  - mobile apps
KW  - mobile app
KW  - type 2 diabetes
KW  - diabetes
KW  - self-management
KW  - Japan
KW  - multi-institutional
KW  - RCT
KW  - RCTs
KW  - efficacy
KW  - app development
KW  - safety
KW  - mobile phone
AB  - 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 
SN  - 1438-8871
UR  - https://www.jmir.org/2024/1/e53740
UR  - https://doi.org/10.2196/53740
DO  - 10.2196/53740
ID  - info:doi/10.2196/53740
ER  -