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OpenSampling

2025 · Digital biomarkers · open access

Analysis Method of Real-World Digital Biomarkers for Clinical Impact in Cancer Patients

Oakley-Girvan et al.

The finding, in our words

In 50 cancer patients monitored at home with an Apple Watch for 28 days, a method that classified missing step data by gap duration and context produced the most reliable daily step estimates. Daily step counts on days with at least ten hours of wear time predicted time to first clinical event (p=0.068) and identified participants at lower hazard of mortality, with 83.3% accuracy for clinical event prediction, demonstrating that processed consumer wearable data can support remote monitoring in decentralised oncology trials.

A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.

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  1. 2025

    This study found that a decentralised approach using home-based sleep apnoea screening, heart rhythm monitoring and activity tracking in patients with atrial fibrillation is feasible, with high data completeness and low drop-out rates. The results support the use of patient-centric digital tools in decentralised trials for chronic cardiac conditions.

    Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillationHashiba et al., Danish medical journal (paywalled) · source ↗

    • dct
    • wearable
    • rpm
    • digital-biomarker
    • actigraphy
  2. 2023

    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 TrialAli et al., Journal of diabetes science and technology (paywalled) · source ↗

    • dct
    • actigraphy
    • wearable
    • multimodal
    • cgm
    • rpm
    • self-collection
    • digital-biomarker
    • interstitial-fluid
  3. 2026

    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.

    Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment RegimensNørgaard et al., Diabetes technology & therapeutics (paywalled) · source ↗

    • dct
    • actigraphy
    • wearable
    • multimodal
    • cgm
    • rpm
    • interstitial-fluid
  4. 2026

    A direct-to-participant, multichannel recruitment strategy enrolled 34,244 older adults into a virtual trial testing an Apple Watch based heart health programme with electrocardiogram and irregular rhythm notification features, achieving broad geographic and gender diversity but under-representing non-White ethnic groups.

    Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline StudyHills et al., JACC. Advances · source ↗

    • dct
    • wearable
    • rpm
    • digital-biomarker
  5. 2026

    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.

    Association Between Neurofilament Light Chain and Real-World Ambulatory Function in Progressive MSJoseph et al., Annals of clinical and translational neurology (paywalled) · source ↗

    • blood
    • biomarkers
    • wearable
    • digital-biomarker
    • actigraphy
    • multimodal