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The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-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 the Apollo Evolution Investigational BG Monitoring System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Evolution Investigational BG Monitoring System | Device | Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. |
| 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 the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. 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). Site staff tested in parallel after subjects. | 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. YSI capillary plasma 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Simmons, MD | Ascensia Diabetes Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer HealthCare LLC, Diabetes Care | Mishawaka | Indiana | 46544 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. |
| 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 the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. |
| 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 the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. 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). Site staff tested in parallel after subjects. | Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available. | Posted | Number | percentage of Blood Glucose Test Results | 1 hour | Blood Glucose Test Results | Participants |
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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 the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. |
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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 | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@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. YSI venous plasma 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). | 1 hour |
| Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system. | 1 hour |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Intended Users of the Monitoring System |
Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. |
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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. YSI capillary plasma 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). | Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available. | Posted | Number | percentage of Blood Glucose Test Results | 1 hour | Blood Glucose Test Results | Participants |
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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. YSI venous plasma 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). | 609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots. | Posted | Number | percentage of Blood Glucose Test Results | 1 hour | Venous BG Test Results | Participants |
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| Secondary | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system. | Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available. | Posted | Number | participants | 1 hour |
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| 0 |
| 207 |
| 1 |
| 207 |
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