Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

The review highlights that decentralized clinical trials can improve inclusivity and efficiency by overcoming geographical and logistical barriers through remote digital technologies, though challenges remain regarding data security, privacy, and regulatory standardisation.

The value of decentralized clinical trials: Inclusion, accessibility, and innovation — Jean-Louis & Seixas, Science (paywalled) · source ↗

• dct
• rpm
• standards

The narrative review identified gaps in sustainability assessment within current DCT frameworks, noting that environmental impacts such as carbon footprint and disposal of sensors and investigational medicinal products are not comprehensively addressed, highlighting a need for more complete guidance.

Design and Execution of Sustainable Decentralized Clinical Trials — Singh et al., Clinical pharmacology and therapeutics (paywalled) · source ↗

• dct
• wearable
• rpm
• standards

A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.

Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment Regimens — Nørgaard et al., Diabetes technology & therapeutics (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• interstitial-fluid

Viloxazine extended release improved ADHD, depression and anxiety symptoms in adults with comorbid conditions during a 14-week decentralised trial. The study demonstrates that remote monitoring via televisit, mobile app and home devices can deliver real-world efficacy and safety data for psychiatric medications.

Viloxazine Extended Release in Adults With Attention-Deficit/Hyperactivity Disorder and Depression and/or Anxiety Symptoms: Results From a Decentralized, Open-Label, Phase 4 Trial — Adler et al., The Journal of clinical psychiatry (paywalled) · source ↗

• dct
• rpm

A proof-of-concept decentralised trial generated 169 support tickets over 17 months from 90% of sites, with device-related problems accounting for 46% of requests. Most issues were resolved within three days and required two to six exchanges, demonstrating that robust technical support infrastructure is essential for successful remote monitoring and wearable-based trial conduct.

Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL — Weitlaner et al., Journal of medical systems · source ↗

• dct
• wearable
• rpm