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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usability testing | Experimental | Patients will participate in summative human factors testing of the Vigilant Diabetes Management Application in a controlled environment and during home use testing. Clinicians will participate in summative human factors testing in a controlled environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigilant Diabetes Management Application | Device | Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale) | An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined. | 1 month home use |
| Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed) | Percent successful initial or reattempt task completion across the range of usability tasks. Example: One task is to access the "Trends" screen to review and interpret weekly and monthly trend data for blood glucose variability and average glucose values. | Controlled in-office testing for up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey Anderson, MD | University of Virginia | Principal Investigator |
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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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