Skip to main content
OpenTrials
Completed

NCT Number: NCT02276131

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigilant Diabetes Management Application

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

InSpark Technologies, Inc.

Industry

Collaborators

  • University of Virginia

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.