The Library
1530 papers on microsampling and monitoring, each with a finding paraphrased to our standard and labelled in one vocabulary. Every entry links to a legitimate copy; nothing is copied from an abstract.
34 papers labelled “digital-biomarker”, newest first.
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 Study — Hills et al., JACC. Advances
- dct
- wearable
- rpm
- digital-biomarker
2026
Home spirometry gave slightly lower percent-predicted FEV1 values than office measurements cross-sectionally, but the three-month change in lung function did not differ significantly between settings. This suggests home spirometry can reliably detect treatment effects, supporting its use as an endpoint for decentralised cystic fibrosis trials.
Home Spirometry as a Clinical Trial Endpoint in People with Cystic Fibrosis: Results of the OUTREACH Study — Rosenfeld et al., Annals of the American Thoracic Society (paywalled)
- dct
- rpm
- digital-biomarker
2025
A critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.
Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences — Wang et al., Clinical and Translational Science
- dct
- standards
- digital-biomarker
2025
The study found that acoustic speech features differed significantly between Android and iOS devices, with iOS recordings showing more periodic content but less high-frequency energy, while Android devices exhibited greater measurement variability. These platform-specific differences, coupled with participant experience challenges such as iOS users struggling with background noise checks, demonstrate that device choice and app instruction design materially affect data quality and trial outcomes in decentralised digital biomarker studies.
Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study — Chappie et al., Journal of voice : official journal of the Voice Foundation (paywalled)
- dct
- rpm
- digital-biomarker
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 fibrillation — Hashiba et al., Danish medical journal (paywalled)
- dct
- wearable
- rpm
- digital-biomarker
- actigraphy
2025
Remote motor assessment achieved a 95 percent completion rate and high caregiver acceptability in children with Canavan disease. Good to excellent inter- and intra-rater reliability demonstrates that rigorous remote assessment protocols can be implemented in decentralised trials for rare pediatric conditions, reducing burden on families.
Feasibility, Acceptability, and Reliability of Remote Motor Assessment in Children With Canavan Disease — Kiefer et al., Pediatric neurology (paywalled)
- pediatric
- dct
- rpm
- digital-biomarker
2025
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.
Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial — Malhotra et al., Clinical pharmacology and therapeutics
- blood
- capillary
- self-collection
- venous-agreement
- dct
- wearable
- rpm
- digital-biomarker
- multimodal
2025
A fully decentralised trial of 9151 participants using a mobile app for daily voice capture found two machine learning algorithms met pre-specified success criteria for screening viral respiratory illness, with sensitivity increasing as symptoms increased while specificity remained consistent. This demonstrates voice-based digital biomarkers can identify infections remotely and validates bring-your-own-device trial designs.
Longitudinal voice monitoring in a decentralized Bring Your Own Device trial for respiratory illness detection — Santamaria et al., NPJ digital medicine
- dct
- rpm
- digital-biomarker
2025
WELT-I significantly improved sleep efficiency and reduced dysfunctional beliefs about sleep compared with a sham app in a decentralised clinical trial, supporting the feasibility of remote digital therapeutics for insomnia.
Validating the Efficacy of a Mobile Digital Therapeutic for Insomnia (WELT-I): Randomized Controlled Decentralized Clinical Trial — Park et al., Journal of medical Internet research
- dct
- digital-biomarker
2025
Home-based ECG and blood pressure monitoring in 3,820 elderly hypertensive patients detected undiagnosed atrial fibrillation in 5.8 per cent over three months. The detection rate was not significantly associated with baseline blood pressure category, measurement frequency, or antihypertensive medication use, indicating that broad screening may be warranted regardless of blood pressure control.
Relationship Between Screening-Detected Atrial Fibrillation and Blood Pressure Levels in Elderly Hypertensive Patients: The OMRON Heart Study — Senoo et al., Thrombosis and haemostasis
- dct
- rpm
- digital-biomarker
2025
Healthy older adults performed similarly on functional capacity tests whether delivered by computer or cloud-based tablet, with only a five per cent speed improvement on the iPad version of one test. This supports the feasibility of migrating digital clinical assessments to remote cloud-based delivery for decentralised trials without compromising validity.
Migration of digital functional capacity assessments from device resident to cloud-based delivery: Development and convergent validity — Harvey et al., Schizophrenia research. Cognition
- dct
- digital-biomarker
2025
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.
Analysis Method of Real-World Digital Biomarkers for Clinical Impact in Cancer Patients — Oakley-Girvan et al., Digital biomarkers
- oncology
- dct
- wearable
- digital-biomarker
- actigraphy
2025
In this decentralised trial of 899 adults with asthma, participants using a digital self-management programme with wearable device integration showed a 4.6-point gain on the Asthma Control Test at 12 months relative to usual care. This provides evidence that remote digital interventions can achieve clinically significant improvements in asthma control without in-person visits.
A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial — Silberman et al., JAMA network open
- dct
- wearable
- rpm
- digital-biomarker
2025
The analysis highlights that leveraging digital health technologies and decentralised clinical trials can improve evidence generation and access in rare disease drug development, offering more efficient and inclusive processes where traditional approaches are limited.
Addressing global regulatory challenges in rare disease drug development — Costa et al., Drug discovery today (paywalled)
- dct
- digital-biomarker
2025
In a decentralised trial of 108 pulmonary fibrosis patients, a nine-week digital cognitive behavioural therapy programme reduced GAD-7 anxiety scores by 2.7 points more than treatment as usual (p=0.0006). This shows decentralised digital interventions can deliver clinically significant psychological benefit in chronic respiratory disease, supporting remote patient management.
A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial — Solomon et al., Respirology
- dct
- digital-biomarker
2024
BATURA is a fully decentralised, phase 3b, randomised, double blind study comparing as needed albuterol budesonide with albuterol alone in mild asthma, with all visits conducted virtually and study medication shipped to participants; medication use is captured by a digital sensor and the primary endpoint is time to first severe asthma exacerbation, enabling assessment of efficacy while reducing participant burden and improving access.
A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design — LaForce et al., Journal of asthma and allergy
- dct
- digital-biomarker
2024
The survey of 80 clinical research stakeholders in India highlights the growing adoption of remote data capture, wearables, and digital biomarkers in decentralized clinical trials, driven by the COVID-19 pandemic, while also identifying key challenges that need to be addressed for wider implementation.
The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials — Chodankar et al., Perspectives in clinical research
- dct
- wearable
- rpm
- digital-biomarker
2024
Brief spontaneous speech analysis using machine learning can accurately identify individuals with Alzheimer's dementia and mild cognitive impairment and predict performance across attention, memory, executive function, language and visuospatial domains, supporting its use for remote screening and disease monitoring.
Unveiling the sound of the cognitive status: Machine Learning-based speech analysis in the Alzheimer's disease spectrum — García-Gutiérrez et al., Alzheimer's research & therapy
- dct
- digital-biomarker
2023
In this observational study of 14 female students, greater total daily energy expenditure and a later midpoint of sleep were associated with lower severity of several menstruation-related symptoms during the menstrual and luteal phases. These findings suggest that lifestyle factors such as physical activity and sleep timing may inform non-pharmacological management of menstrual symptoms, though larger studies are needed to confirm clinical utility.
Menstruation-related symptoms are associated with physical activity and midpoint of sleep: a pilot study — Masuda & Okada, Frontiers in global women's health
- fertility
- wearable
- digital-biomarker
- actigraphy
2023
An intensive protocol combining daily at-home saliva collection for ovarian hormones with smartphone-based ecological momentary assessment achieved 85% compliance in 50 female smokers, revealing substantial within- and between-subject heterogeneity in hormone levels, anxiety and nicotine craving. This demonstrates feasibility of decentralised, patient-centric data collection for studying complex comorbidities.
Methodological approach for an integrated female-specific study of anxiety and smoking comorbidity — Farris et al., Frontiers in psychiatry
- saliva
- self-collection
- fertility
- hormones
- digital-biomarker
- multimodal
2023
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
- blood
- dct
- wearable
- digital-biomarker
- multimodal
2023
The CHIEF-HF trial showed a fully decentralised, placebo-controlled heart failure trial can run without in-person visits, yet recruitment remained challenging: just 2.0% of 130,832 contacted people expressed interest, and 18.5% of those were enrolled. At the highest-enrolling site, electronic medical record portal messaging yielded higher opt-in rates than email alone (7.8% versus 4.4%), suggesting targeted digital channels can improve participation in decentralised diagnostic studies.
Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial — Nassif et al., Journal of cardiac failure (paywalled)
- dct
- digital-biomarker
2023
A fully remote, randomised pilot trial of 30 people with functional constipation demonstrated geographic reach with 27% residing outside metropolitan areas. Lactobacillus supplementation increased weekly bowel movements by 0.80 and reduced defecation time by 3.94 hours versus vitamin C alone, but 33% of mobile diary entries were not completed as scheduled, highlighting the need for real-time data quality monitoring in decentralised trials.
Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms — Huh et al., Clinical and translational science
- dct
- digital-biomarker
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 Trial — Ali et al., Journal of diabetes science and technology (paywalled)
- dct
- wearable
- rpm
- cgm
- digital-biomarker
- actigraphy
2023
Remote smartphone cognitive testing using the ALLFTD Mobile App was feasible and acceptable for people with frontotemporal dementia and at-risk kindreds, supporting decentralised trials and improved access to research.
Feasibility and acceptability of remote smartphone cognitive testing in frontotemporal dementia research — Taylor et al., Alzheimer's & dementia
- dct
- rpm
- digital-biomarker
2023
A wireless, battery-free pathogenic infection diagnosis system achieved 100% accuracy for diagnosing SARS-CoV-2 infection and 92% accuracy for evaluating symptom severity in 42 participants using blow and breath samples within 110 s and 350 s respectively, offering rapid decentralised diagnostics for respiratory infections.
Wireless, battery-free, multifunctional integrated bioelectronics for respiratory pathogens monitoring and severity evaluation — Li et al., Nature communications
- wearable
- digital-biomarker
2022
Thirty-eight patients with rheumatic diseases showed high engagement with twice-daily smartphone symptom reporting (95% completion) and remote dried blood spot collection (84% returned samples, all viable for C-reactive protein analysis). Although symptoms varied considerably, clinically meaningful CRP changes were rare, confirming the feasibility of integrating microsampling with patient-generated health data in decentralised rheumatology research.
Remote sampling of biomarkers of inflammation with linked patient generated health data in patients with rheumatic and musculoskeletal diseases: an Ecological Momentary Assessment feasibility study — Druce et al., BMC musculoskeletal disorders
- blood
- dried
- dbs
- self-collection
- acceptability
- biomarkers
- rpm
- digital-biomarker
- multimodal
2022
An end-to-end remote digital protocol using the Current Health wearable and platform achieved rapid deployment and moderate adherence, capturing continuous pulse rate, respiratory rate, SpO2, skin temperature and step count alongside tablet-administered symptom surveys; vital signs remained within normal ranges and symptoms decreased over the 30-day period, demonstrating feasibility and clinical-grade signal quality for decentralised monitoring.
Deployment of an End-to-End Remote, Digitalized Clinical Study Protocol in COVID-19: Process Evaluation — Zahradka et al., JMIR formative research
- dct
- wearable
- rpm
- digital-biomarker
2022
In an Italian sample of 359 healthy adults the telephone ALS-CBS-PhV showed good reliability and diagnostic accuracy against established telephone cognitive tests (AUC 0.82-0.89) and was statistically equivalent to the in-person version, supporting its use for remote cognitive screening in motor neuron disease and in decentralised clinical trials.
ALS Cognitive Behavioral Screen-Phone Version (ALS-CBS™-PhV): norms, psychometrics, and diagnostics in an Italian population sample — Aiello et al., Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
- dct
- digital-biomarker
2022
A six-month, fully decentralised trial in 100 atrial fibrillation patients using remote blood pressure and six-lead ECG sensors achieved 99% completion for device measurements and 91% for televisits, with oral anticoagulation adherence remaining stable at 96–97%. Rapid recruitment via social media (94 participants in 12 days) demonstrates that remote monitoring can sustain high engagement without clinic visits, supporting pandemic-proof trial designs.
Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP) — Sarraju et al., NPJ digital medicine
- dct
- wearable
- rpm
- digital-biomarker
2022
Decentralised trial designs using digital tools such as wearables and electronic assessments can reduce patient burden and improve inclusion and data quality in rare disease studies by enabling measurements in real-world settings. This matters for decentralised diagnostics as it supports more accessible, patient-centric research with environmentally valid endpoints.
What role can decentralized trial designs play to improve rare disease studies? — Moore et al., Orphanet journal of rare diseases
- dct
- wearable
- digital-biomarker
2021
The authors built a home-use ovulation detector that measures basal body temperature and cervical mucus pH, validated it in twenty women, and reported satisfactory performance for identifying fertility windows to aid both contraception and conception. This supports decentralised, patient-managed fertility monitoring integrated with smartphone e-health platforms.
Development of a Permanent Device for Fertility Period Detection by Basal Body Temperature and Analysis of the Cervical Mucus Potential of Hydrogen — Mansouri, Journal of medical signals and sensors
- fertility
- wearable
- rpm
- digital-biomarker
2021
A non-invasive opto-mechanical system using photoplethysmography in finger and toe cuffs can measure capillary blood pressure and distinguish between healthy subjects and those with peripheral arterial disease, varicose veins or heart failure. This could enable early detection of venous congestion before overt oedema develops, supporting point-of-care management of cardiovascular conditions.
Non-Invasive Capillary Blood Pressure Measurement Enabling Early Detection and Classification of Venous Congestion — Liu et al., IEEE journal of biomedical and health informatics (paywalled)
- wearable
- digital-biomarker
2021
Smartphone photographs of atopic dermatitis lesions produced severity scores that correlated strongly with in-person clinical assessment (r=0.78) and were comparable to digital SLR camera images. The high inter-rater reliability among dermatologists supports remote photo-based scoring for decentralised trials and telehealth, reducing patient burden.
Remote Rating of Atopic Dermatitis Severity Using Photo-Based Assessments: Proof-of-Concept and Reliability Evaluation — Ali et al., JMIR formative research
- dct
- rpm
- digital-biomarker
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