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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
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
InSpark Technologies, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Vigilant Diabetes Management Application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
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
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
InSpark Technologies, Inc.
University of Virginia
Investigators
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Principal Investigator: Stacey Anderson, MD University of Virginia
More Information
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Responsible Party: InSpark Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02276131    
Other Study ID Numbers: VG1HFHUS1
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases