Ming Damien K, Jangam Saylee, Gowers Sally An, Wilson Richard, Freeman David Me, Boutelle Martyn G, Cass Anthony Eg, O'Hare Danny, Holmes Alison H
Centre for Antimicrobial Optimisation, Imperial College London, London, United Kingdom.
Department of Bioengineering, Imperial College London, London, United Kingdom.
BMJ Innov. 2022 Apr;8(2):87-94. doi: 10.1136/bmjinnov-2021-000864. Epub 2022 Feb 28.
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.
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.
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.
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.
NCT04238611.
测定血乳酸水平有助于一系列医疗状况的决策制定。通常需要进行侵入性采血并具备实验室条件，且每次测量提供的是静态数据。我们开展了一项I期临床研究，以验证用于健康志愿者微创连续乳酸测量的微针贴片的性能。
五名健康成年参与者在其前臂佩戴了固体微针生物传感器贴片，并进行了30分钟的有氧运动。微针生物传感器可连续实时量化真皮内间质液中的乳酸浓度。输出结果以传感器电流形式记录，并与静脉血和微透析得到的乳酸浓度进行比较。
该生物传感器耐受性良好。参与者静脉血乳酸峰值中位数为9.25 mmol/L（四分位距6.73 - 10.71）。微透析液中乳酸浓度与血液密切相关。微针生物传感器电流跟随静脉血乳酸浓度及动态变化，所有参与者均显示出良好的一致性。微针测量与血乳酸测量之间估计存在5分钟的滞后时间（四分位距 -4至11分钟）。
本研究提供了关于使用微创微针贴片进行连续乳酸测量的人体首次数据，实现了动态监测。这个低成本平台在广泛的临床环境中对频繁采血具有明显优势，特别是在实验室服务受限或采血不可行的情况下。在医疗环境中实施这项技术可支持在各种医院和社区环境中的个性化决策制定。
NCT04238611。
