Real-time continuous measurement of lactate through a minimally invasive microneedle patch: a phase I clinical study

Ming, Damien K ORCID: 0000-0003-3125-6378, Jangam, Saylee, Gowers, Sally AN, Wilson, Richard ORCID: 0000-0002-3275-6932, Freeman, David ME, Boutelle, Martyn G, Cass, Anthony EG, O'Hare, Danny and Holmes, Alison H ORCID: 0000-0001-5554-5743 (2022) Real-time continuous measurement of lactate through a minimally invasive microneedle patch: a phase I clinical study BMJ INNOVATIONS, 8 (2). pp. 87-94. ISSN 2055-8074, 2055-642X

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Abstract

<h4>Introduction</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration number</h4>NCT04238611.

Item Type:	Article
Uncontrolled Keywords:	32 Biomedical and Clinical Sciences, 3202 Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Bioengineering, Cardiovascular, 4.1 Discovery and preclinical testing of markers and technologies
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Systems, Molec & Integrative Biology > Inst. Systems, Molec & Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	28 Mar 2023 14:32
Last Modified:	16 Jan 2026 10:36
DOI:	10.1136/bmjinnov-2021-000864
Open Access URL:	http://dx.doi.org/10.1136/bmjinnov-2021-000864
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3169321
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