2025 · Clinical pharmacology and therapeutics · open access
Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial
Lipinska et al.
The finding, in our words
In the RADIAL proof-of-concept trial in type 2 diabetes, run conventionally, hybrid and fully decentralised across five European countries, sites struggled at first with technology and participant onboarding despite proactive training; the authors conclude that decentralised conduct needs firm oversight and clear contracts with third-party providers.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Ali et al., Journal of diabetes science and technology (paywalled) · source ↗
In a crossover trial of 23 adults with newly diagnosed type 2 diabetes, a personalised diet based on predicted postprandial glucose responses improved continuous glucose monitoring measures significantly more than a Mediterranean diet, including lower average postprandial glucose response and less time in hyperglycaemia. A six-month follow-up of the personalised diet further improved glycaemic control and metabolic health, supporting its clinical utility for decentralised diabetes management.
A six-month randomised trial in 225 adults with prediabetes showed that a personalised postprandial-targeting diet, guided by a machine-learning algorithm integrating microbiome data, reduced daily time with glucose above 140 mg/dL and HbA1c significantly more than a Mediterranean diet, with benefits persisting at 12 months. The study illustrates how continuous glucose monitoring and smartphone-based dietary logging can enable patient-centric, decentralised nutritional interventions for glycaemic control.
Ben-Yacov et al., Diabetes care (paywalled) · source ↗
The study observed favourable trends in the accrual of participants residing far from the site and those from underrepresented groups following the implementation of a decentralised clinical trial program.