Human Factors and Home Use Study of the Vigilant Diabetes Management Application

Diabetes Mellitus Clinical Trial

Official title:

Human Factors and Home Use Study of the Vigilant Diabetes Management Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276131
• Other study ID #: VG1HFHUS1
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: February 23, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: InSpark Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Vigilant Diabetes Management Application
Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
InSpark Technologies, Inc.	University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No