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User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

NCT03730480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2022-01-18

Study results available
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Summary

This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.

Conditions

Interventions

DEVICE

Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes

Using the first blood glucose monitoring system (BGMS), which is either Contour Next or Contour TV3, subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Using the second BGMS, the palm, self test and staff tests are performed. Subjects with diabetes get a venipuncture and staff tests using both BGMS using the venous blood.

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD · AMCR Institute

  • Leslie J Klaff, MD · Ranier Clinical Research Center, Inc.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2018-10-31
Completion
2018-10-31
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 NCT03730480 on ClinicalTrials.gov