OBJECTIVES: Digitalization is transforming our daily lives, in particular the healthcare sector, where patient-managed Digital Medical Devices (pDMDs), including Digital Therapeutics (DTx), bring the promise to revolutionize our approach to treatments. The clinical development of pDMDs is based on the demonstration of efficacy and safety of software with a medical purpose to be used directly by patients. The aim of this work is to provide an overview of this new segment of the healthcare industry.

METHODS: We set up a Microsoft Excel database populated with data from a continuous desk research on the most relevant clinical trials online repositories (e.g., clinicaltrials.gov, DRK), identifying 992 studies. After analyzing each single technical data sheet, we separated ordinary wellness app from pDMDs and collected 295 relevant studies referring to 236 technologies, analyzing features such as underlying technology, country of the study, and therapeutic area/disease.

RESULTS: Our analysis revealed that 69.9% of the considered trials concern mobile applications, 13.2% on web-based platforms, and 7.5% on videogames. Over 50% of the digital therapies encompass cognitive behavioral therapy (CBT), mental disorders (primarily anxiety and depression) being the most investigated diseases and covering 30% of the studies. The USA, accounting for over 50% of the trials, are the most prolific country, while Germany emerged as the European leader with over 40 studies, followed by the UK with 19 studies.

CONCLUSIONS:

Compared to a similar analysis relying on early 2021 data [1], our research highlights a 70% growth in clinical trials, suggesting that pDMDs development has a positive trend, and their adoption will impact our future. To our knowledge this is the infrastructure focused on DTx monitoring, able to help Pharma Corps, startups, Institutions, and all stakeholders working and collaborating more efficiently, by collecting and sharing info on pDMDs, including DTx, for human health.