Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial
Beernink et al.
The finding, in our words
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.
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.
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
This proof-of-concept study demonstrated that patients with inflammatory bowel disease could successfully perform capillary blood microsampling at home with high analytical success rates, and a majority preferred this decentralised approach over hospital venous draws.
In a 20-person proof-of-concept pilot among veterans with HIV, remote self-collection of dried blood spots for phosphatidylethanol monitoring was feasible and acceptable, with high return and analysis rates and positive feedback; a small first step toward decentralised alcohol biomarker monitoring rather than proof of it.
In a feasibility randomised controlled trial with 28 adults aged 65 years, 62% successfully self-collected finger-prick capillary blood samples for influenza antibody and vitamin D measurement. While overall study procedures were acceptable, the capillary sampling method requires refinement before wider deployment in decentralised diagnostics for older adults.