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This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to use the enhanced meter feature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced meter feature usability | Other | Home diabetes monitoring by patient using provided blood glucose monitoring system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AgaMatrix Blood Glucose Monitor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced Meter Feature Usability | The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1). | 4 weeks |
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Inclusion criteria:
IC 1. Age of subject is 18 years or older
IC 2. Type I or type II diabetes inclusive of the following populations:
Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
EC 9. Previous experience using the MyStar Extra BGMS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Procedure | 5.5 Evaluation Procedure The evaluation shall be performed in the following sequence and be supervised by one or more healthcare providers trained in the use of the device under evaluation (ISO 15197:2013 8.1).
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Demographics | Age group ranged from ages 18-86, Male and female with both Type 1 and Type 2 diabetics. Race was both white, black/African American and Hispanic who are able to read and understand English per the subject consent form. |
| 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 | Enhanced Meter Feature Usability | The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1). | All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system, and applicable regulatory requirements, shall be eligible to participate in the study | Posted | Count of Participants | Participants | 4 weeks |
|
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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 | Adverse and Serious Events | No adverse or serious events occurred during this study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Technician | AgaMatrix, Inc | 603-328-6035 | krocha@agamatrix.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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 113 |
| 0 |
| 113 |
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