Human Factors and Home Use Study of the Vigilant Diabetes Management Application
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|ClinicalTrials.gov Identifier: NCT02276131|
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: Vigilant Diabetes Management Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Human Factors and Home Use Study of the Vigilant Diabetes Management Application|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Usability testing
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.
Device: Vigilant Diabetes Management Application
Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers
- Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale) [ Time Frame: 1 month home use ]An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined.
- Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed) [ Time Frame: Controlled in-office testing for up to 2 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276131
|Principal Investigator:||Stacey Anderson, MD||University of Virginia|