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

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.

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