Minimally-Invasive Lactate in Exercise
Research type
Research Study
Full title
Minimally Invasive Realtime Assessment of Continuous Lactate in Exercise (MIRACLE)
IRAS ID
274161
Contact name
Alison Holmes
Contact email
Sponsor organisation
Imperial College London JRCO
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Research Summary
Lactate is a naturally-occurring compound produced by the body, and measuring its level is useful for clinicians. A normal increase in lactate can come from exercise and the levels can help with designing training regimens for athletes. However, an abnormal increase in lactate can also result from serious conditions like sepsis. Measuring lactate in this situation is useful to assess the severity of the condition, and help with treatment. At the moment, lactate can only be measured by a blood test. This can be uncomfortable, and if you needed to know how the lactate levels change over time, repeated blood tests are required.We would like to test a new device called a microneedle biosensor to measure lactate. This is a small postage-stamped device placed on the top of your skin, and can measure lactate continuously. The device has been tested in people with diabetes and for measuring antibiotic levels – it is safe, painless and has shown to work well. We have laboratory data showing that the microneedle can also measure lactate accurately, but this needs to be tested in real life.
We plan to recruit 15 healthy participants to cycle on an exercise bike for 30 minutes. During this time the microneedle will be used to measure lactate in the arm. We will also measure lactate normally using blood tests and a technique called microdialysis which measures lactate from the skin. We will compare how well the microneedle performs compared with the other ways of measurement, and get feedback from the participants. The study will last around 3 hours overall.
This research will be important in improving the microneedle design. The results will also allow us to explore if we can use the microneedle for patients who are ill in hospitals, and improve their care in the future.
Summary of Results
In this study, we looked at whether a new microneedle patch placed on your skin can measure a substance called lactate. Lactate is produced by your body and is an important marker of illness (such as in sepsis or blood loss). This device sits on your skin surface at a depth of less than 1 mm and continuously measures what is happening in the fluid in the skin.We wanted to know how accurate this device was when compared with blood tests when tested in people. This type research has never been done before.
Our findings are that the microneedle patch performed well. During the study we placed this patch on the surface of the skin of the participant to record lactate levels. We found that levels of lactate during, and after exercise matched with the levels measured by blood tests. Importantly, most participants felt that the device was not uncomfortable and prefer it over having repeated blood testing.
To take the research forward, we will use these results improve the device so it performs reliably and can be used by doctors and nurses in healthcare. It is possible that in the future we will be able to avoid taking blood from patients and use this device to improve health.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0364
Date of REC Opinion
3 Apr 2020
REC opinion
Favourable Opinion