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The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the Monitoring System | Experimental | Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTOUR® PLUS Investigational BG Monitoring System | Device | Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip D Toth, MD, FACP | Midwest Institute For Clinical Research | Principal Investigator |
| Michael Caswell, PhD | Consumer Product Testing Co. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Institute For Clinical Research | Indianapolis | Indiana | 46260 | United States | ||
| Consumer Product Testing Co. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. |
| 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, Continuous | Mean |
| 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 | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. | 216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects. | Posted | Number | percentage of BG Test Results | 1 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 | Intended Users of the Monitoring System | Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmine Greene | 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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| 1 hour |
| Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results. | 1 hour |
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results. | 1 hour |
| Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff | Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. | 1 hour |
| Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'. | 1 hour |
| Fairfield |
| New Jersey |
| 07004 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. |
|
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| Secondary | Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. | 213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects. | Posted | Number | percentage of BG Test Results | 1 hour |
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| Secondary | Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results. | 213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. | Posted | Number | percentage of BG Test Results | 1 hour |
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| Secondary | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results. | 108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject. | Posted | Number | percentage of BG Test Results | 1 hour |
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| Secondary | Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff | Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results. | 217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject. | Posted | Number | percentage of BG Test Results | 1 hour |
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| Secondary | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'. | Per protocol | Posted | Number | participants | 1 hour |
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| 0 |
| 220 |
| 2 |
| 220 |
| hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| w/in +/-5mg/dL(<100mg/dL) or +/- 5% (>=100mg/dL) |
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| I like the overall meter design. |
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| I find the meter easy to handle. |
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| Easy to handle the individual test strips. |
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| Instructions (User Guide) easy to understand. |
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| Instructions clearly explain how to run a test. |
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| Instructions clearly explain meter error messages. |
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