2023 · Clinical and translational science · open access
Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study
Huh et al.
The finding, in our words
The study found that smartwatch-based adherence monitoring showed consistent concordance over time and may be more reliable than app or pill count methods in measuring treatment adherence in a decentralised setting. This supports the use of wearable devices as objective tools in patient-centric monitoring for decentralised clinical trials.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
In progressive multiple sclerosis, higher serum neurofilament light chain levels were associated with reduced daily step counts from wearables, while higher step counts were linked to lower sNfL. A ten percent increase in steps corresponded to a 0.015 decrease in sNfL z-score, suggesting rising sNfL may predict subsequent mobility decline.
Wearable-derived digital biomarkers have been accepted by regulatory agencies as endpoints in clinical trials for Duchenne muscular dystrophy, showing their potential to support decentralised diagnostics through patient-centric monitoring. This matters because it enables more sensitive and continuous assessment of disease progression outside clinical settings.
In this decentralised n-of-1 crossover trial of dapagliflozin in 20 adults with type 2 diabetes, remote collection of urine and capillary blood samples achieved 99.4% and 98.4% delivery success respectively, demonstrating that remote monitoring can reliably track individual albuminuria responses to therapy.
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.