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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Vigilant Diabetes Management Application

• Registration Number: NCT02276131
• Lead Sponsor: InSpark Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usability testing	Vigilant Diabetes Management Application	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.

Primary Outcome Measures

Name	Time	Method
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.