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The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.
The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes | Other | Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Blood Glucose Monitoring System | Device | Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Capillary and Venous 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. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips. | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Rated as <=3 (Labeling Comprehension) | Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy Frank, RN | Consumer Product Testing Co., Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consumer Product Testing Co., Inc. | Fairfield | New Jersey | 07004 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Diabetes | Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Diabetes | Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Capillary and Venous 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. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips. | One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study. The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method. | Posted | Nov 2009 | Number | number of blood glucose (BG) results | One hour |
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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 use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmine Greene, 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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| One hour |
| Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent). | One hour |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. |
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| Secondary | Percentage of Participants Rated as <=3 (Labeling Comprehension) | Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:
| per protocol | Posted | Nov 2009 | Number | percent of participants | One hour |
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| Secondary | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent). | Posted | Nov 2009 | Number | number of participants | One hour |
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| 0 |
| 102 |
| 0 |
| 102 |
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| Title | Measurements |
|---|---|
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| 1 Poor |
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| 0 Unacceptable |
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