Lay-user Trial of the iGlucose Blood Glucose Monitoring System

Nina Peled

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Blood glucose monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT02709707

CP00001

Details and patient eligibility

About

Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

Full description

A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

Enrollment: 153 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be 12 years of age and older
• Have pre-existing diagnosis of diabetes
• Be able to read and understand English
• Agree to participate in the study
• Be able and willing to provide informed consent

Exclusion criteria

• Do not meet Inclusion Criteria
• With Hemophilia or any other bleeding disorder
• With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
• With physical condition/limitation preventing the use of SMBG on their own

Trial design

153 participants in 1 patient group

Patients with diabetes

Treatment:

Device: Blood glucose monitor