Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers
Sponsors
University of Virginia
InSpark Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons with diabetes mellitus testing blood glucose 3 or more times per day * Clinicians who see diabetes patients
Exclusion criteria
* Admission for diabetic ketoacidosis in the 6 months prior to enrollment * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol * Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale) | 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) | 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. |
Outcome results
None listed