Diabetes Mellitus
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEPOGO® BGMS
SMBG
Sponsors
Intuity Medical, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement. | Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.) | Lay-user accuracy |
| Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement. | Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.) | HCP accuracy |
Countries
United States
Outcome results
None listed