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.

Access the full-text of this item by clicking on the Open Access link.

Official URL: http://dx.doi.org/10.1136/bmjinnov-2021-000864

Abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04238611">NCT04238611</jats:ext-link>.</jats:p></jats:sec>

Item Type:	Article
Uncontrolled Keywords:	Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, Bioengineering, Generic health relevance
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	28 Mar 2023 14:32
Last Modified:	15 Mar 2024 14:11
DOI:	10.1136/bmjinnov-2021-000864
Open Access URL:	http://dx.doi.org/10.1136/bmjinnov-2021-000864
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3169321