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Abstract
Introduction Determination of blood lactate levels supports decision-making in a range of medical conditions. Invasive blood-sampling and laboratory access are often required, and measurements provide a static profile at each instance. We conducted a phase I clinical study validating performance of a microneedle patch for minimally invasive, continuous lactate measurement in healthy volunteers.
Methods Five healthy adult participants wore a solid microneedle biosensor patch on their forearms and undertook aerobic exercise for 30 min. The microneedle biosensor quantifies lactate concentrations in interstitial fluid within the dermis continuously and in real-time. Outputs were captured as sensor current and compared with lactate concentrations from venous blood and microdialysis.
Results The biosensor was well-tolerated. Participants generated a median peak venous lactate of 9.25 mmol/L (IQR 6.73–10.71). Microdialysate concentrations of lactate closely correlated with blood. Microneedle biosensor current followed venous lactate concentrations and dynamics, with good agreement seen in all participants. There was an estimated lag-time of 5 min (IQR −4 to 11 min) between microneedle and blood lactate measurements.
Conclusion This study provides first-in-human data on use of a minimally invasive microneedle patch for continuous lactate measurement, providing dynamic monitoring. This low-cost platform offers distinct advantages to frequent blood sampling in a wide range of clinical settings, especially where access to laboratory services is limited or blood sampling is infeasible. Implementation of this technology in healthcare settings could support personalised decision-making in a variety of hospital and community settings.
Trial registration number NCT04238611.
- diagnosis
- clinical decision-making
- biomedical engineering
- patient care
- infectious disease medicine
Data availability statement
Data are available upon reasonable request. Data is available upon request to the corresponding author.
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Data availability statement
Data are available upon reasonable request. Data is available upon request to the corresponding author.
Supplementary materials
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This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Correction notice This article has been corrected since it was published Online First. Orcid Id of Saylee Jangam has been added.
Contributors DKM, DO'H and AHH conceived and designed the study. SJ, DO'H, SANG, DMEF, AEGC were responsible for the design, fabrication and all technical aspects of the microneedle biosensor. SANG and MGB were responsible for microdialysis. DKM, RW and AHH performed the clinical study. DKM performed the analyses and wrote the first draft of the manuscript. All authors contributed to the revision of the manuscript and have approved the final version to be published. DKM accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
Funding The research was funded by the Department of Health and Social Care, Centre for Antimicrobial Optimisation, at Imperial College, London. This report is independent research funded by the Department of Health and Social Care. Infrastructure support was provided by the NIHR Imperial Biomedical Research Centre and the NIHR Imperial Clinical Research Facility. AHH is a National Institute for Health Research (NIHR) Senior Investigator. DKM is supported by the Wellcome Trust (215010/Z/18/Z). DMEF is supported by the funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 825549 (ELSAH project).
Disclaimer The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the article. The corresponding author had full access to all the data in the study and final responsibility for the decision to submit for publication. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research or the UK Department of Health.
Competing interests AEGC is the founder of a company ‘Continuous Diagnostics Ltd’ exploring applications of microneedle sensing technologies. All other authors have no competing interests to declare.
Provenance and peer review Not commissioned; externally peer reviewed.
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