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

• Sponsor: Ascensia Diabetes Care (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03730480
• Collaborator: Regulatory and Clinical Research Institute Inc (Other)
• Enrollment: 372
• Locations: 2
• Arm: 1
• Actual Duration (Months): 1.8
• Patients Per Site: 186
• Patients Per Site Per Month: 102.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 372 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System
• Actual Study Start Date: Sep 6, 2018
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 31, 2018

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

1. Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer [1 day]

   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.

Secondary Outcome Measures

1. Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS [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: I find it easy to do a fingerstick blood test with this meter. The meter display is easy to see and read. It was easy to understand my test results. I like the overall meter design. I find the meter easy to use. The instructions (User Guide and Quick Reference Guide) were easy to understand. The instructions clearly explain how to run a test. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMCR Institute	Escondido	California	United States	92025
2	Ranier Clinical Research Center, Inc.	Renton	Washington	United States	98057

Sponsors and Collaborators

• Ascensia Diabetes Care
• Regulatory and Clinical Research Institute Inc

Investigators

• Principal Investigator: Timothy Bailey, MD, AMCR Institute
• Principal Investigator: Leslie J Klaff, MD, Ranier Clinical Research Center, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 6, 2018

More Information

Publications

None provided.

• Responsible Party: Ascensia Diabetes Care
• ClinicalTrials.gov Identifier: NCT03730480
• Other Study ID Numbers: GCA-PRO-2018-006-01
• First Posted: Nov 5, 2018
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	No pre assignment

Arm/Group Title	Contour Next and Contour TV3 -Subjects With and Without Diabetes
Arm/Group Description	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.
Period Title: Overall Study
STARTED	372
COMPLETED	371
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
Arm/Group Description	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.
Overall Participants	372
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	295 79.3%
>=65 years	76 20.4%
Age (years) [Mean (Standard Deviation) ]
mean age	53.1 (14.86)
Sex: Female, Male (Count of Participants)
Female	206 55.4%
Male	166 44.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	49 13.2%
Not Hispanic or Latino	323 86.8%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Number of fingerstick self test results from Contour Next BGMS and Contour TV3 BGMS that are within 15% of reference analyzer results.

Arm/Group Title	Contour Next and Contour TV3 -Subjects With and Without Diabetes
Arm/Group Description	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.
Measure Participants	371
Contour Next Contour Next BGMS	366 98.4%
Contour TV3 BGMS	360 96.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contour Next and Contour TV3 -Subjects With and Without Diabetes
	Comments	count of number of responses
	Type of Statistical Test	Other
	Comments	count of number of results within 15% of reference analyzer
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		The number of results that are within 15% of reference analyzer is reported.

2. Secondary Outcome

Title	Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Description	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: I find it easy to do a fingerstick blood test with this meter. The meter display is easy to see and read. It was easy to understand my test results. I like the overall meter design. I find the meter easy to use. The instructions (User Guide and Quick Reference Guide) were easy to understand. The instructions clearly explain how to run a test. 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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes
Arm/Group Description	All subjects respond to statements about CONTOUR NEXT BGMS CONTOUR TV3 BGMS.
Measure Participants	372
Contour Next: Responses greater than or equal to 3 for Statement 1	371 99.7%
Contour Next: Responses greater than or equal to 3 for Statement 2	371 99.7%
Contour Next: Responses greater than or equal to 3 for Statement 3	370 99.5%
Contour Next: Responses greater than or equal to 3 for Statement 4	359 96.5%
Contour Next: Responses greater than or equal to 3 for Statement 5	371 99.7%
Contour Next: Responses greater than or equal to 3 for Statement 6	367 98.7%
Contour Next: Responses greater than or equal to 3 for Statement 7	368 98.9%
Contour Next: Responses greater than or equal to 3 for Statement 8	368 98.9%
Contour TV3: Responses greater than or equal to 3 for Statement 1	369 99.2%
Contour TV3: Responses greater than or equal to 3 for Statement 2	370 99.5%
Contour TV3: Responses greater than or equal to 3 for Statement 3	369 99.2%
Contour TV3: Responses greater than or equal to 3 for Statement 4	353 94.9%
Contour TV3: Responses greater than or equal to 3 for Statement 5	370 99.5%
Contour TV3: Responses greater than or equal to 3 for Statement 6	369 99.2%
Contour TV3: Responses greater than or equal to 3 for Statement 7	370 99.5%
Contour TV3: Responses greater than or equal to 3 for Statement 8	368 98.9%

Adverse Events

Time Frame	1 day.
Arm/Group Title	Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
Arm/Group Description	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.
All Cause Mortality
	Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
	Affected / at Risk (%)	# Events
Total	0/372 (0%)
Serious Adverse Events
	Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
	Affected / at Risk (%)	# Events
Total	0/372 (0%)
Other (Not Including Serious) Adverse Events
	Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes
	Affected / at Risk (%)	# Events
Total	2/372 (0.5%)
General disorders
Vasovagal Reaction	1/372 (0.3%)	1
Fainting	1/372 (0.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.