NCT03242161

Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations

Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.

Detailed description

Nanotechnology has the potential to become a powerful tool in addiction medicine. The potential utility for passive, non-invasive wearable alcohol monitors is great and could play a major role in public safety as well as in both research, clinical, and treatment settings. Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and imperceptibly samples interstitial fluid from the skin surface and measures relevant biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial fluid from just underneath the skin and then uses an electrochemical reaction to measure either glucose or alcohol concentration. The participants' interstitial alcohol concentration (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood alcohol concentrations. The LabPatch operational circuit lies on the underside of the bandage. The circuit surface is placed in contact with the skin by the application of the elastic adhesive bandage with a contact tension that provides modest pressure, as in the case of a conventional wound bandage. The temperature of the skin is measured electrically and the consistency of temperature is used to verify good contact and to monitor continued contact. The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3 additional seconds to conduct the analysis.

Conditions

• Alcohol Intoxication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LabPatch-alcohol	a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol

Timeline

• Start date: 2018-01-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2017-08-08
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study