Diabetes MellitusNCT03730480
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
A study testing Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMCR Institute
Escondido, California, 92025
Ranier Clinical Research Center, Inc.
Renton, Washington, 98057
About this study
Official title: 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 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.
Read the 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
- Being tested
- Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour Next and Contour TV3 BGMS testing by subjects with and without DiabetesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with and without Diabetes test Contour Next and Contour TV3 | Experimental | All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS Receives: Device: Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
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.
Measured: 1 day
Secondary outcomes (1)
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start6 Sep 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Responsible party
- Sponsor
- Investigators
- Timothy Bailey, MD, Principal investigator, AMCR InstituteLeslie J Klaff, MD, Principal investigator, Ranier Clinical Research Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730480
- Sponsor's protocol ID
- GCA-PRO-2018-006-01
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2018
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT03730480
- Acronym / sponsor ID
- GCA-PRO-2018-006-01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 5 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with and without Diabetes test Contour Next and Contour TV3 | Experimental | Device: Contour Next and Contour TV3 BGMS testing by subjects with and without DiabetesAll subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contour Next and Contour TV3 BGMS testing by subjects with and without DiabetesUsing 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. | Device | Subjects with and without Diabetes test Contour Next and Contour TV3 |
Primary outcome
Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer
Time frame: 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.
1 secondary outcome
Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Bailey, MD principal investigator
AMCR Institute
Leslie J Klaff, MD principal investigator
Ranier Clinical Research Center, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.