Lay-user Trial of the iGlucose Blood Glucose Monitoring System

A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation

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

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.

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