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The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System

NCT05754281 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The primary endpoint of this study is the mean absolute relative difference (MARD) for 2nd Gen LabPatch system compared to each of the above mentioned glucose references over a 6 hour outpatient visit.

Conditions

Interventions

DEVICE

2nd Gen LabPatch Glucose Sensing System

I. The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements

Sponsors & Collaborators

  • Cambridge Medical Technologies, LLC

    collaborator INDUSTRY

  • Joslin Diabetes Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754281 on ClinicalTrials.gov