Nomura Akihiro
College of Transdisciplinary Sciences for Innovation, Kanazawa University, Kanazawa, Japan; Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan; Frontier Institute of Tourism Sciences, Kanazawa University, Kanazawa, Japan; CureApp Institute, Karuizawa, Japan.
J Cardiol. 2025 May;85(5):360-365. doi: 10.1016/j.jjcc.2024.11.005. Epub 2024 Nov 28.
Digital therapeutics (DTx) represent an innovative approach to healthcare, leveraging software applications (apps) delivered through digital devices to treat medical conditions. This review focuses on three DTx apps approved in Japan, targeting nicotine dependence, hypertension, and insomnia. CureApp SC, the DTx system for nicotine dependence, comprises a patient smartphone app, an Internet of Things device for exhaled carbon monoxide measurement, and a Web-based physician app. A clinical trial demonstrated significantly higher rates of continuous abstinence in the intervention group than in the controls (63.9 % vs. 50.5 %, p = 0.001) at 24 weeks, with effects persisting through 52 weeks. For hypertension management, CureApp HT focuses on lifestyle modifications with daily home blood pressure monitoring. The HERB-DH1 trial showed a significant reduction in 24-h systolic blood pressure (between-group difference, -2.4 mmHg; p = 0.024) and morning home blood pressure (between-group difference, -4.3 mmHg; p < 0.001) in the intervention group compared with those in the controls. This hypertension DTx app also exhibits potential lifetime cost-effectiveness. Regarding insomnia management, SUSMED MedCBT-i supports physician-delivered cognitive behavioral therapy for insomnia. In a randomized controlled trial, Athens Insomnia Scale scores significantly improved in the intervention group compared with those in the controls (between-group difference, -3.4 point; p < 0.001) at 8 weeks. These DTx apps represent a significant advancement in managing chronic conditions, offering scalable and accessible methods for delivering evidence-based interventions. They also address the challenges in implementing lifestyle modifications and behavioral therapies in traditional healthcare settings. As DTx become more integrated into routine clinical practice, ongoing research is crucial to evaluate their long-term efficacy, safety, and cost-effectiveness. The success of these initial DTx apps in Japan paves the way for more comprehensive digital health solutions, potentially improving individual patient outcomes and contributing to larger-scale public health improvements in managing chronic conditions.
数字疗法（DTx）代表了一种创新的医疗保健方法，它利用通过数字设备交付的软件应用程序（应用）来治疗医疗状况。本综述重点关注在日本获批的三款数字疗法应用，分别针对尼古丁依赖、高血压和失眠。CureApp SC是用于治疗尼古丁依赖的数字疗法系统，由患者智能手机应用、用于测量呼出一氧化碳的物联网设备以及基于网络的医生应用组成。一项临床试验表明，干预组在24周时的持续戒烟率显著高于对照组（63.9%对50.5%，p = 0.001），且效果持续至52周。对于高血压管理，CureApp HT专注于通过每日家庭血压监测来改善生活方式。HERB - DH1试验表明，与对照组相比，干预组的24小时收缩压显著降低（组间差异为 -2.4 mmHg；p = 0.024），早晨家庭血压也显著降低（组间差异为 -4.3 mmHg；p < 0.001）。这款高血压数字疗法应用还显示出潜在的终身成本效益。关于失眠管理，SUSMED MedCBT - i支持医生提供的失眠认知行为疗法。在一项随机对照试验中，干预组在8周时的雅典失眠量表得分与对照组相比显著改善（组间差异为 -3.4分；p < 0.001）。这些数字疗法应用代表了慢性病管理方面的重大进展，提供了可扩展且易于获取的方法来实施循证干预。它们还解决了在传统医疗环境中实施生活方式改善和行为疗法所面临的挑战。随着数字疗法越来越融入常规临床实践，持续的研究对于评估其长期疗效、安全性和成本效益至关重要。这些最初的数字疗法应用在日本的成功为更全面的数字健康解决方案铺平了道路，有可能改善个体患者的治疗效果，并有助于在慢性病管理方面实现更大规模的公共卫生改善。
