User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2019 |
| Start Date: | September 6, 2018 |
| End Date: | October 31, 2018 |
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System
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 further testing and meter result verification. 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.
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 further testing and meter result verification. 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.
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 using a lancing device and the assigned
meter. Immediately following the subject self-test, the study staff will collect a capillary
sample for testing on the reference analyzer from the subject's finger (same hand) using a
different lance. Immediately following this lancing, subjects will lance their palm using
another lancing device and will perform a self-test using the meter. Immediately following
the test, 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. 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.
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 using a lancing device and the assigned
meter. Immediately following the subject self-test, the study staff will collect a capillary
sample for testing on the reference analyzer from the subject's finger (same hand) using a
different lance. Immediately following this lancing, subjects will lance their palm using
another lancing device and will perform a self-test using the meter. Immediately following
the test, 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. 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.
Inclusion Criteria:
- Males and females, 18 years of age and older
- Ability to speak, read and understand English. Subjects must demonstrate ability to
read a paragraph from the first page of the User Guide to qualify for the study.
- Willing to complete all study procedures.
Exclusion Criteria:
- Hemophilia or any other bleeding disorder.
- Pregnancy (self-reported).
- Physical, visual or neurological impairments that would make the person unable to
perform testing with the BGMS.
- Previous participation in a blood glucose monitoring study using the Ascensia CONTOUR
NEXT or CONTOUR TV3 BGMS.
- Working for a medical laboratory, hospital or other clinical setting that involves
training on or clinical use of blood glucose monitors.
- Working for a competitive medical device company, or having an immediate family member
or someone who is not a family member but is living within the household of someone
who works for such a company.
- A condition, which in the opinion of the investigator or designee, would put the
person or study conduct at risk.
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