Efficacy of SMC-01, a Smartphone Application Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Protocol for a Randomized Controlled Trial (Preprint)
Authors: Leung Nicholas , Nozoe Satoshi , Nozoe Satoshi , Waki Kayo , Enomoto Shunpei , Yamauchi Toshimasa , Nangaku Masaomi , Ohe Kazuhiko , Onishi Yukiko 
Published: September 2023

BACKGROUND

Diabetes is an illness that requires not only accurate medical treatment, but also self-management to promote a healthier lifestyle. A system that supports self-management could be effective and efficient. In Japan, self-management smartphone applications marketed towards diabetes patients have recently been released, but they are not yet officially-approved medical devices. They have not been implemented as official treatment covered by health insurance and have therefore not yet seen wide use. In the United States, a smartphone application that provides feedback to patients based on American diabetes treatment guidelines has been shown to be effective in diabetes treatment and has been approved as an official medical device. To determine if a similar application could be used in the Japanese population, the study commissioner Save Medical developed a mobile application, SMC-01, that provides feedback in accordance with Japanese diabetes treatment guidelines for the self-management of diabetes in type 2 diabetes mellitus patients.

OBJECTIVE

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

METHODS

This study was a multi-institutional prospective, randomized, unblinded clinical trial, with a 26 week duration consisting of a two week observation period, a 12 week intervention period, and a 12 week intervention sustainment period. Patients assigned to the SMC-01 group were loaned SMC-01 and incorporated its use into their own diabetes self-management. SMC-01 provides feedback on diet and exercise habits, as well as measurements including weight and blood pressure, with the expectation that lifestyle habits and therefore diabetes self-management will improve. On the other hand, patients assigned to the control group were asked to carry out normal diabetes self-management using a paper journal.

The primary outcome was the between-group difference in change in HbA1c from baseline to the end of the intervention period. Secondary outcomes included adherence to self-maintenance, between-group difference in change in HbA1c from baseline to the end of the intervention sustainment period, and, for each of fasting blood glucose, fasting insulin, and fasting intact-proinsulin/insulin ratio, between-group difference in change from baseline to the end of the intervention period and to the end of the intervention sustainment period.

RESULTS

This study ran from May 11th, 2020 to April 5th, 2021. Data analysis and a final report were completed on August 6th, 2021. Statistical analysis showed no statistically significant difference in glycemic control between the intervention and control groups. Further analysis will be provided in a future publication.

CONCLUSIONS

This study evaluated the efficacy and safety of the SMC-01 application and provided evidence for the effectiveness of mHealth applications based on established guidelines. It was a step towards the approval in Japan of an mHealth application as an official medical device.

CLINICALTRIAL

This study was registered in the Japan Registry of Clinical Trials (jRCT2032200033) on May 17, 2020.