Evidence map›Paper›PMID 42873745›Full record

ArticlePLOS digital health2026

Pathologies and technologies for digital therapeutics: An analysis of global clinical trials.

Paolo Rocco, Valentina Pagella, Umberto M Musazzi, Sara Manellari, Elena Paola Lanati, Paola Minghetti

Abstract read
In one paragraph

Article in PLOS digital health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Paolo RoccoDepartment of Pharmaceutical Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0003-0753-5414
Valentina PagellaDepartment of Pharmaceutical Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0009-0002-3333-2848
Umberto M MusazziDepartment of Pharmaceutical Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0002-7049-4152
Sara ManellariDepartment of Pharmaceutical Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0009-0002-0465-8478
Elena Paola LanatiINDICON S.r.l. Società Benefit, Milan, Italy.ORCID https://orcid.org/0000-0003-3760-1865
Paola MinghettiDepartment of Pharmaceutical Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0001-7723-441X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CDigital therapeutics (DTx) are software-based medical devices that deliver evidence-based therapeutic interventions directly to patients. While the clinical use of DTx is expanding rapidly, regulatory fragmentation and the absence of harmonized legal definitions hinder their assessment and reimbursement policies, as well as their integration into healthcare systems. There is currently a lack of comprehensive overviews of DTx clinical development, which are essential for informing policy, research and regulatory priorities. This paper provides an updated overview of randomised clinical trials involving DTx. 254 eligible trials on DTx, (defined according to ISO/TR 11147:2023) registered through January 2025 were identified through a search on ClinicalTrials.gov. Mobile applications represent the most prevalent technology (65%), followed by web-based tools and virtual reality (20%). Psychiatric disorders are the primary therapeutic target (52% of the studies) with insomnia, depression, and anxiety being the most addressed conditions. Trials were primarily conducted in North America (41%) and Europe (32%), where Germany, Spain, and Italy represent the most active countries. The analysis of clinical trials registrations on ClinicalTrials.gov reveals a heterogenous geographical distribution of DTx development but also a clear direction in the type of conditions for which they are mostly indicated, namely psychiatric and nervous system disorders. The fragmented policies on DTx reimbursement, even among EU countries, and the different capacity of governments to fund DTx research and development emerge as key factors, along with cultural and ethical issues, in determining the willingness of the industry to invest in these devices.

Identifiers

PMID42873745
PMCPMC13667809

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.