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

InSpark Technologies

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Vigilant Diabetes Management Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02276131

VG1HFHUS1

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

61 participants in 1 patient group

Usability testing

Experimental group

Description:

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.

Treatment:

Device: Vigilant Diabetes Management Application