Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial

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.

Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial — Beernink et al., JAMA network open · source ↗

• dct
• multimodal
• blood
• rpm
• self-collection
• capillary
• urine
• biomarkers

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.

Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study — Huh et al., Clinical and translational science · source ↗

• dct
• wearable
• multimodal
• blood
• rpm
• digital-biomarker
• biomarkers

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.

Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial — Ali et al., Journal of diabetes science and technology (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• self-collection
• digital-biomarker
• interstitial-fluid

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.

Implementation of a Capillary Blood Self-Sampling Technique at Home for Monitoring of Patients With IBD — Schuurman et al., Inflammatory bowel diseases · source ↗

• acceptability
• multimodal
• blood
• rpm
• self-collection
• capillary
• liquid

This study found strong concordance between capillary samples collected via the Tasso device and standard venous draws for VirScan serology, indicating that self-collected samples are a practical alternative for decentralised research. The authors advise against interchanging these collection methods within a single longitudinal study to avoid introducing technical variability.

Assessing VirScan serosurvey epitope profiling variability between in-clinic venous blood draw and capillary blood self-sampling device — Sircy et al., Microbiology spectrum · source ↗

• dct
• venous-agreement
• blood
• self-collection
• serology
• capillary
• liquid