Digital therapeutics: a systematic review of clinical trials characteristics

Abstract

Introduction: Digital therapeutics (DTx) are a subset of digital health tools delivering evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are studied using randomized clinical trial methodology and reviewed, cleared or certified by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use. Purpose: To perform a systematic review of clinical research/studies conducted in the field of DTx with the aim to describe studies where DTx were used, classifying them by digital intervention and condition, and analysing and reporting the characteristics of clinical trials. Methods: The U.S. National Library of Medicine ClinicalTrials.gov was searched using the terms "digital therapeutics", "digital therapeutic", "digi-tal therapy", and "digital therapies" within the fields "Intervention/treatment" and "Title/Acronym", and the resulting trial characteristics were extracted and analysed. Results: In total, 560 clinical trials were retrieved on January 10, 2021. Most of them (n=424, 75.7%) were excluded because they were observational studies (n=82), non-randomized/single arm assignment studies (n=123), not involving any digital health tool (n=181), or involving digital health tools not classified as DTx (n=38). Of the remaining 136 trials, the DTx intervention was delivered through apps (n=57, 41.9%), web-based systems (n=35, 25.7%), videogames (n=12, 8.8%), virtual reality (n=6,