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User Performance of the TV4 BGMS

NCT05647824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 402

Last updated 2023-02-02

No results posted yet for this study

Summary

Thunder V4 (TV4) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and new Contour FIT test strips. This clinical trial will assess the performance (accuracy) of the TV4 meter by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).

Conditions

Interventions

DEVICE

Capillary Testing

Testing Contour Fit BGMS with capillary blood

DEVICE

Alternative Site Testing (AST)

Testing Contour Fit BGMS using blood from alternative site

DEVICE

Venous Testing

Testing Contour Fit BGMS with venous blood

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Mark P Christiansen, MD · Diablo Clinical Research (DCR)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2020-03-20
Completion
2020-07-23
FDA Device
Yes

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 NCT05647824 on ClinicalTrials.gov