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

InSpark Technologies, Inc.61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Vigilant Diabetes Management ApplicationDEVICE

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

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Controlled in-office testing for up to 2 hours

Data from ClinicalTrials.gov

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