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

NCT02276131 | Completed

• 1 other identifier: VG1HFHUS1
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: Vigilant Diabetes Management Application

Interventions

Vigilant Diabetes Management Application DEVICE

Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers

Usability testing

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with diabetes mellitus testing blood glucose 3 or more times per day
• Clinicians who see diabetes patients

You may not qualify if:

• 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

Sponsors & Collaborators

• InSpark Technologies, Inc.: lead
• University of Virginia: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stacey Anderson, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 28, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02