LabClasp Wearable Device for Monitoring in Healthy Individuals

Overseen By Madeline S Reid

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals

Disqualifiers: Malignancy, HIV, Smokers, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device called the LabClasp, which measures blood lactate levels. Blood lactate serves as a marker to check for metabolic issues, especially during exercise or in critical care situations. The trial consists of two parts: one for healthy adults who can perform high-intensity exercise and another for ICU patients at risk for sepsis. Participants should be nonsmokers and either capable of vigorous exercise or currently in the ICU undergoing regular blood tests. The goal is to determine if LabClasp provides accurate readings compared to standard methods. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance metabolic monitoring.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the LabClasp device is safe for monitoring blood lactate?

Research shows that wearable devices like the LabClasp are generally safe for users. Studies with similar technology have reported no serious safety issues. These devices are non-invasive, meaning they don't break the skin or enter the body.

Wearable devices often monitor health data continuously in healthcare settings, and most people tolerate them well. For example, studies have shown that these devices can safely monitor patients in intensive care units (ICUs).

While specific safety data for the LabClasp is not available, similar wearable devices typically don't cause major problems. If there are any concerns, discussing them with the research team or a doctor before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LabClasp wearable device because it offers a novel way to monitor blood lactate levels continuously and non-invasively. Unlike traditional methods that require blood draws and laboratory analysis, LabClasp provides real-time data through a wearable gadget, which is less invasive and more convenient for both ICU patients at risk of sepsis and healthy individuals during exercise. This real-time monitoring could lead to quicker interventions and a better understanding of how the body responds to stress, potentially improving outcomes for patients.

What evidence suggests that the LabClasp device is effective for estimating blood lactate?

Research has shown that wearable devices like the LabClasp can effectively monitor blood lactate levels. These devices use sensors to track lactate in sweat, providing a good estimate of blood lactate without needing blood tests. One study found that these wearables reliably measure lactate during activities like cycling and kayaking. The trial will test the LabClasp in two separate groups: healthy adults performing whole-body exercise and ICU patients susceptible to developing sepsis. This is promising because tracking lactate helps understand muscle performance and can alert to potential issues early. Although more research is needed, early findings suggest that the LabClasp could benefit both athletes and patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who can do high-intensity exercise, are not smokers, haven't been hospitalized recently, aren't in the ICU but have sepsis risk factors. They must be able to consent and agree to regular blood tests for lactate levels.

Inclusion Criteria

Aim 2: Nonsmokers

Aim 2: Current ICU patient

Aim 1: Nonsmokers

Exclusion Criteria

Smokers

I am HIV positive and on antiretroviral treatment.

I have or had another type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo blood lactate measurement using the LabClasp device during clinical assessments or exercise stress tests

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LabClasp

Trial Overview The study is testing LabClasp's technology to estimate blood lactate levels non-invasively during high-intensity exercise compared with traditional blood sampling methods.

How Is the Trial Designed?

Group I: Whole-body exercise in healthy adults (Aim 1) Experimental Treatment 1 Intervention

Subjects will have blood \[lactate\] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle.

Group II: ICU patients susceptible to developing sepsis (Aim 2) Experimental Treatment 1 Intervention

Subjects will have blood \[lactate\] measurement obtained with the LabClasp device as frequently as required for clinical purposes

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. withpower.com withpower.com/trial/phase-9-2021-10b8b

LabClasp Wearable Device for Monitoring in Healthy ... Trial Overview The study is testing LabClasp's technology to estimate blood lactate levels non-invasively during high-intensity exercise compared with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11025537/

Wearable device for continuous sweat lactate monitoring in ... This narrative review rigorously explores the evolution and contemporary state of wearable devices specifically engineered for continuously monitoring lactate ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11886925/

Mind the Gap: Wearable Lactate and Glucose Monitors for ... In this article, we describe how the advent of wearable metabolic monitors, specifically for lactate and glucose, provides new opportunities to improve care ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0141813023044756

Advancements in wearable technology for monitoring ... In this review, we evaluate different types of wearable biosensors for lactate monitoring using lactate oxidase enzyme as biological recognition element and ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acssensors.3c00708

Fully Integrated Wearable Device for Continuous Sweat ... The device can be conveniently worn in the skin to monitor real-time sweat lactate during sports, such as cycling and kayaking.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11431615/

Update on Patient Self-Testing with Portable and Wearable ... A wearable medical device is usually defined as a tool that can be used by the patient to record data, usable for the care of the wearer [7].

7. sciencedirect.com sciencedirect.com/science/article/pii/S0889159123002313

Wearable technologies for health research We provide key considerations researchers should be aware of when choosing wearable-derived metrics and devices for research use.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666953/

Wearable chemical sensors for biomarker discovery in the ... This Review introduces criteria, strategies and technologies involved in biomarker discovery using wearable chemical sensors coupled with data analysis towards ...

9. nature.com nature.com/articles/s43856-025-01072-6

A retrospective cross-sectional study showing wearable ... Wearable smartwatches present a novel approach to continuous patient monitoring in ICU settings, with the potential to enhance patient ...