Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the Monitoring System | Experimental | Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour TS Blood Glucose Monitoring System | Device | Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using the 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 (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm 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 palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using the 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 (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). | 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System. | Posted | Number | Number of BG Test Results | 1 hour | BG test results | Participants |
|
Not provided
Not provided
Not provided
| 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 TS Blood Glucose Monitoring System. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmine Greene | Ascensia Diabetes Care | 574-257-3040 | carmine.greene@ascensia.com |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 hour |
| Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm 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 forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). | 1 hour |
| Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'. | 1 hour |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm 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 palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). | 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System | Posted | Number | Number of BG Test Results | 1 hour | BG test results | Participants |
|
|
|
| Secondary | Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm 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 forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma). | 102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed | Posted | Number | Number of BG Test Results | 1 hour | BG test results | Participants |
|
|
|
| Secondary | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'. | Posted | Number | participants | 1 hour |
|
|
|
| 0 |
| 102 |
| 2 |
| 102 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|
|
| I like the overall meter design |
|
| Meter is easy to handle |
|
| Easy to handle the individual test strips |
|
| Instructions (User Guide) easy to understand |
|
| Instructions clearly explain how to run a test |
|
| Instructions clearly explain meter error message |
|
| I found this meter easy to use |
|
| I found this meter intuitive |
|
| I found this meter practical |
|