POGO® Automatic Blood Glucose Monitoring System Clinical Study

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333864
• Other study ID #: TP-000321
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: May 26, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Intuity Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• POGO® BGMS
SMBG

Locations

Country	Name	City	State
United States	Park Nicollett Institute - International Diabetes Center	Minneapolis	Minnesota
United States	Diablo Clinical Reasearch	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Intuity Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.	Lay-user accuracy	Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)	No
Primary	Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.	HCP accuracy	Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)	No