Diabetes Mellitus
Conditions
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.
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.
Interventions
DEVICEContour 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.
Sponsors
Regulatory and Clinical Research Institute Inc
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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. |
Countries
United States
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 details
No pre assignment
Participants by arm
| Arm | Count |
|---|---|
| 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. | 372 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Meter displayed a HI result which is non evaluable. | 1 |
Baseline characteristics
| Characteristic | Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 76 Participants |
| Age, Categorical Between 18 and 65 years | 295 Participants |
| Age, Continuous mean age | 53.1 years STANDARD_DEVIATION 14.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 323 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 372 |
| other Total, other adverse events | 2 / 372 |
| serious Total, serious adverse events | 0 / 372 |
Outcome results
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.
Time frame: 1 day
Population: Number of fingerstick self test results from Contour Next BGMS and Contour TV3 BGMS that are within 15% of reference analyzer results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer | Contour Next Contour Next BGMS | 366 Participants |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer | Contour TV3 BGMS | 360 Participants |
Comparison: count of number of responses
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: 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.
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 | 371 Participants |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 | 369 Participants |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 | 353 Participants |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |
| Contour Next and Contour TV3 -Subjects With and Without Diabetes | 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 |