Estimating Blood [Lactate] Non-Invasively

NCT ID: NCT05036122

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Whole-body exercise in healthy adults (Aim 1)

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

Group Type EXPERIMENTAL

LabClasp

Intervention Type DEVICE

Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.

ICU patients susceptible to developing sepsis (Aim 2)

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

Group Type EXPERIMENTAL

LabClasp

Intervention Type DEVICE

Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.

Interventions

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LabClasp

Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be able to provide written consent.
* Adults 18 years of age and older.
* Nonsmokers.
* No recent hospitalization (\< 60 days).
* Ability to perform high-intensity exercise.


* Subjects must be able to provide written consent to be included in the research study.
* Adults 18 years of age and older.
* Nonsmokers.
* Current ICU patient.
* Have regular blood samples taken for \[lactate\] measurements.
* Have one or more risk factors for sepsis.

Exclusion Criteria

* History of, or active malignancy.
* History of HIV with antiretroviral treatment.
* Smokers.
* Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Virend Somers, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virend Somers

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Madeline S Reid

Role: CONTACT

507-255-0007

Other Identifiers

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21-000318

Identifier Type: -

Identifier Source: org_study_id

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