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PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor

NCT03262415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-02-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite.

The LabPatch system includes:

1. The LabPatch circuit chip which lies in the center of a circular push-button. The circuit is in the form of a small chip (approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]) placed in contact with the skin. 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.
2. A Lab Patch holding device (blue box).
3. A wire that connects the chip to a laptop that continuously captures glucose data.

Conditions

Interventions

DEVICE

LabPatch Continuous Glucose Monitoring (CGM)

1. The patch device that will be applied to subjects' arms in this study is about 3 inches in length and one inch in width, with adhesive tape on the sides. 2. The LabPatch circuit chip lies on the underside of the bandage. The circuit is in the form of a small chip (approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]) placed in contact with the skin. 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. 3. A wire that connects the chip to a laptop that continuously captures glucose data.

Sponsors & Collaborators

  • Cambridge Medical Technologies, LLC

    collaborator INDUSTRY

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Osama Hamdy, M.D.,Ph.D · Joslin Diabetes Center

Eligibility

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

Timeline & Regulatory

Start
2017-02-17
Primary Completion
2019-05-22
Completion
2019-05-22

Countries

  • United States

Study Locations

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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 NCT03262415 on ClinicalTrials.gov