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.
J Med Internet Res
; 26: e53740, 2024 Sep 10.
Article
en En
| MEDLINE
| ID: mdl-39255478
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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Diabetes Mellitus Tipo 2
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Aplicaciones Móviles
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Automanejo
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
J Med Internet Res
Asunto de la revista:
INFORMATICA MEDICA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos