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The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes | Other | Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Blood Glucose Monitoring System | Device | Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:
| 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cuddihy, MD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
5 subjects signed informed consents but did not meet inclusion/exclusion criteria so were not considered enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Diabetes | Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Diabetes | Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:
| per protocol | Posted | Dec 2009 | Number | percentage of participants | 1-2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Diabetes | Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold or flu-like symptoms during the home-use portion of the study | General disorders | Non-systematic Assessment | Subjects reported cold or flu-like symptoms during the home-use portion of the study. (Unrelated) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Scientist | Ascensia Diabetes Care | 574-257-3040 | carmine.greene@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
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| 1-2 hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects. | Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results. | Posted | Dec 2009 | Number | Number of Duplicate Results (n=74x2) | 1-2 hours |
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| 0 |
| 74 |
| 4 |
| 74 |
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