POGO® Automatic Blood Glucose Monitoring System Clinical Study

The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.

Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.

Inclusion Criteria:

• Be diagnosed with diabetes
• Be 18 years of age or older
• Be able to read, write, and understand English fluently
• Be able and willing to give written informed consent and have provided signed, written consent

Exclusion Criteria:

• Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
• A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
• Previous experience with the POGO® BGMS
• Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field