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.
Malhotra et al., Clinical pharmacology and therapeutics · source ↗
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.
Joseph et al., Annals of clinical and translational neurology (paywalled) · source ↗
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.
Ma et al., Neurology and therapy (paywalled) · source ↗
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.
Ali et al., Journal of diabetes science and technology (paywalled) · source ↗