NCT03730480

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial will assess the performance (accuracy) of the CONTOUR NEXT and the CONTOUR TV3 monitoring systems ("BGMS") by lay users enrolled as subjects in the study, and by health care professionals. According to a randomization schedule, subjects will be assigned to use either the CONTOUR NEXT or CONTOUR TV3 meters first and then switch and use the second meter, performing the same testing with both meters. They will learn to use the assigned meter by reading the corresponding User Guide (UG) and Quick Reference Guide (QRG). Each subject will perform one fingerstick self-test a palm (AST) test and the study staff will perform a fingerstick test on the subject. All subject self-test results and study staff results will be compared to results from the reference analyzer from a deeper fingerstick. Hematocrit will be measured for all subjects. After testing, all subjects will then complete a questionnaire (Questionnaire 1) to provide feedback on the meter system and instructions for use (UG and QRG). Subjects with diabetes will also have their glucose tested via venipuncture. After all testing is completed on these subjects, the study staff will demonstrate several features of the meter system that would not necessarily be experienced during the brief accuracy testing. These subjects with diabetes will be given a second questionnaire (Questionnaire 2) to provide feedback about the new features of the system. After completing the study procedures for one BGMS, all subjects will then repeat all of these procedures using the second BGMS, except the hematocrit and venipuncture procedures.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-06
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2018-11-05
• Last updated: 2022-01-18
• Results posted: 2022-01-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study