Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regulatory and Clinical Research Institute Inc | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with and without Diabetes test Contour Next and Contour TV3 | Experimental | All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Note that results from the two meter systems will not be compared to each other. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Leslie J Klaff, MD | Ranier Clinical Research Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| Ranier Clinical Research Center, Inc. |
No pre assignment
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | age recorded per subject response |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of fingerstick self test results from Contour Next BGMS and Contour TV3 BGMS that are within 15% of reference analyzer results. | Posted | Count of Participants | Participants | 1 day |
|
1 day.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Reaction | General disorders | Non-systematic Assessment | The subject had a vasovagal reaction not related to the device. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pragathi Shelat | Ascensia Diabetes Care | 1 (862) 229-6679 | pragathi.shelat@ascensia.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2018 | Sep 29, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 day |
| Renton |
| Washington |
| 98057 |
| United States |
Some results were non evaluable due to protocol deviations, non serious AE, or no results obtained.
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | 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:
Note that results from the two meter systems will not be compared to each other. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 372 |
| 0 |
| 372 |
| 2 |
| 372 |
|
| Fainting | General disorders | Non-systematic Assessment | The subject showed symptoms of fainting not related to the study device. |
|
Not provided
Not provided
|
| Contour Next: Responses greater than or equal to 3 for Statement 4 |
|
| Contour Next: Responses greater than or equal to 3 for Statement 5 |
|
| Contour Next: Responses greater than or equal to 3 for Statement 6 |
|
| Contour Next: Responses greater than or equal to 3 for Statement 7 |
|
| Contour Next: Responses greater than or equal to 3 for Statement 8 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 1 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 2 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 3 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 4 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 5 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 6 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 7 |
|
| Contour TV3: Responses greater than or equal to 3 for Statement 8 |
|