POGO® Automatic Blood Glucose Monitoring System Clinical Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | December 2014 |
| End Date: | March 2015 |
| Contact: | Charlette Vargas |
| Email: | CVargas@diabloclinical.com |
| Phone: | 925.930.7267 |
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.
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.
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
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