POGO® Automatic Blood Glucose Monitoring System Clinical Study

Intuity Medical

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: POGO® BGMS

Study type: Observational

Funder types: Industry

Identifiers

NCT02333864

TP-000321

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

287 participants in 1 patient group

PWD testing POGO® BGMS

Description:

All enrolled persons with diabetes

Treatment:

Device: POGO® BGMS