OBJECTIVES: Digital therapeutics (DTx), a subcategory of digital-health, provides evidence-based software-driven therapeutic interventions to prevent/manage/treat various diseases/disorders. Current analysis of trials aimed to assess trends in DTx indications and its end-usage scenarios.

METHODS: All trials reported on ClinicalTrials.gov for last 10 years were analyzed. Screening for finding relevant trials was performed for 1,556 trials.

RESULTS: Total of 352 trials were included. Of these, most were from North America and Europe (72.4%) and were randomized controlled (79.5%). Majority of the trials considered treatment (94.6%) as end-usage scenario. The other end-usage scenarios were rehabilitation, monitoring, prevention, etc. It was also observed that 69.3% of trials were conducted by academic/government institutions. Overall, disease area of interest across trials was observed to be neuropsychological, followed by sleep disorders, smoking/drug abuse, pain, etc.

Of the included trials, 184 were ongoing while 118 were completed. Status of remaining trials was either unknown or terminated. Comparing ongoing and completed trials, it was observed that there has been an increase in trials being conducted in Europe and in general, these trials have increased over the period of last decade. Also, it was observed that there has been substantial rise in academic/government institutions research in this field, while the treatment has remained the key primary endpoint. In terms of disease areas, eating disorders, eye, gastrointestinal and kidney dysfunctions have come up as new fields of interest and there has been increased research in the field of cancer, pain, endocrinal and metabolic disorders.

CONCLUSIONS: Significant involvement of government agencies in trials evaluating DTx is an indication of favorable policy shaping in the domain in near future. The increasing trend of trials being conducted in Europe could also be associated with recent advancements. Behavioral, neuropsychological, and metabolic disorders are key disease areas for DTx with increasing interest in other indications like oncology and gastrointestinal/renal disorders.