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A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study

NCT05348928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2022-06-30

No results posted yet for this study

Summary

The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.

Conditions

  • Continuous Glucose Monitoring

Interventions

DEVICE

Continuous glucose monitoring device

Continuous glucose monitoring device

OTHER

Laboratory plasma glucose concentration determination

Laboratory plasma glucose concentration determination

Sponsors & Collaborators

  • Integrated Medical Development

    collaborator INDUSTRY

  • Sinocare Meditech Inc.

    lead INDUSTRY

Principal Investigators

  • Poul Strange, MD, PhD · Integrated Medical Development

Eligibility

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

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2022-06-16
Completion
2022-06-16
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05348928 on ClinicalTrials.gov