Trial Outcomes & Findings for User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) (NCT NCT03730480)
NCT ID: NCT03730480
Last Updated: 2022-01-18
Results Overview
Number of Participants with self fingerstick results from the Contour Next BGMS and Contour TV3 BGMS that are within 15% of results from the Reference Analyzer. Results from the two meter systems will not be compared to each other.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
372 participants
Primary outcome timeframe
1 day
Results posted on
2022-01-18
Participant Flow
Persons with and without diabetes were enrolled in the study from September 06, 2018 to October 31, 2018. These subjects had one visit to the clinical trial center for the study.
No pre assignment
Participant milestones
| Measure |
Contour Next and Contour TV3 -Subjects With and Without Diabetes
All subjects test CONTOUR NEXT BGMS and Contour TV3.
Contour Next BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.
Contour TV3 BGMS: same testing as Contour Next.
Subjects with diabetes get a venipuncture and staff tests the venous blood on both BGMS.
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|---|---|
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Overall Study
STARTED
|
372
|
|
Overall Study
COMPLETED
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371
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Contour Next and Contour TV3 -Subjects With and Without Diabetes
All subjects test CONTOUR NEXT BGMS and Contour TV3.
Contour Next BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.
Contour TV3 BGMS: same testing as Contour Next.
Subjects with diabetes get a venipuncture and staff tests the venous blood on both BGMS.
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|---|---|
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Overall Study
Meter displayed a HI result which is non evaluable.
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1
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Baseline Characteristics
Some results were non evaluable due to protocol deviations, non serious AE, or no results obtained.
Baseline characteristics by cohort
| Measure |
Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
n=372 Participants
All subjects test CONTOUR NEXT and Contour TV3 BGMS.
Contour Next BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.
Contour TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.
Subjects with diabetes get a venipuncture and staff tests the venous blood with both BGMS.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=371 Participants • Some results were non evaluable due to protocol deviations, non serious AE, or no results obtained.
|
|
Age, Categorical
Between 18 and 65 years
|
295 Participants
n=371 Participants • Some results were non evaluable due to protocol deviations, non serious AE, or no results obtained.
|
|
Age, Categorical
>=65 years
|
76 Participants
n=371 Participants • Some results were non evaluable due to protocol deviations, non serious AE, or no results obtained.
|
|
Age, Continuous
mean age
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53.1 years
STANDARD_DEVIATION 14.86 • n=372 Participants
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|
Sex: Female, Male
Female
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206 Participants
n=372 Participants
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Sex: Female, Male
Male
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166 Participants
n=372 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=372 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
323 Participants
n=372 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=372 Participants
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PRIMARY outcome
Timeframe: 1 dayPopulation: Number of fingerstick self test results from Contour Next BGMS and Contour TV3 BGMS that are within 15% of reference analyzer results.
Number of Participants with self fingerstick results from the Contour Next BGMS and Contour TV3 BGMS that are within 15% of results from the Reference Analyzer. Results from the two meter systems will not be compared to each other.
Outcome measures
| Measure |
Contour Next and Contour TV3 -Subjects With and Without Diabetes
n=371 Participants
All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS.
Contour Next BGMS and Contour TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Subjects with diabetes get a venipuncture and staff tests the venous blood.
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|---|---|
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Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
Contour Next Contour Next BGMS
|
366 Participants
|
|
Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
Contour TV3 BGMS
|
360 Participants
|
SECONDARY outcome
Timeframe: 1 dayA questionnaire was given to participants with 8 statements about the BGMS instructions for use and ease of use of the meter system. These statements were rated by subjects on a Likert Scale with ratings of 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree. Participants reporting ratings greater than or equal to 3 are reported. The statements are: 1. I find it easy to do a fingerstick blood test with this meter. 2. The meter display is easy to see and read. 3. It was easy to understand my test results. 4. I like the overall meter design. 5. I find the meter easy to use. 6. The instructions (User Guide and Quick Reference Guide) were easy to understand. 7. The instructions clearly explain how to run a test. 8. The instructions clearly explain what to do if an error message is displayed by the meter. Note that results from the two meter systems will not be compared to each other.
Outcome measures
| Measure |
Contour Next and Contour TV3 -Subjects With and Without Diabetes
n=372 Participants
All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS.
Contour Next BGMS and Contour TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Subjects with diabetes get a venipuncture and staff tests the venous blood.
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|---|---|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 1
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371 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 2
|
371 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 3
|
370 Participants
|
|
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 4
|
359 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 5
|
371 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 6
|
367 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 7
|
368 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour Next: Responses greater than or equal to 3 for Statement 8
|
368 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 1
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369 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 2
|
370 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 3
|
369 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 4
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353 Participants
|
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Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 5
|
370 Participants
|
|
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 6
|
369 Participants
|
|
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 7
|
370 Participants
|
|
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Contour TV3: Responses greater than or equal to 3 for Statement 8
|
368 Participants
|
Adverse Events
Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
n=372 participants at risk
All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS.
Contour Next BGMS and CONTOUR TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Subjects with diabetes get a venipuncture and staff tests the venous blood.
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|---|---|
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General disorders
Vasovagal Reaction
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0.27%
1/372 • Number of events 1 • 1 day.
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General disorders
Fainting
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0.27%
1/372 • Number of events 1 • 1 day.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place