POGO® Automatic Blood Glucose Monitoring System Clinical Study

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: POGO® BGMS

• Registration Number: NCT02333864
• Lead Sponsor: Intuity Medical, Inc

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PWD testing POGO® BGMS	POGO® BGMS	All enrolled persons with diabetes

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Park Nicollett Institute - International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States

Diablo Clinical Reasearch; 🇺🇸 Walnut Creek, California, United States