- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Escondido, California, United States, 92025
- AMCR Institute
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Washington
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Renton, Washington, United States, 98057
- Ranier Clinical Research Center, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with and without Diabetes test Contour Next and Contour TV3
All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
Time Frame: 1 day
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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.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Time Frame: 1 day
|
A 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:
Note that results from the two meter systems will not be compared to each other. |
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leslie J Klaff, MD, Ranier Clinical Research Center, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GCA-PRO-2018-006-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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