POGO® Automatic Blood Glucose Monitoring System Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: POGO® BGMS

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 Type: Observational
• Enrollment (Actual): 287

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Reasearch
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Park Nicollett Institute - International Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who are 18 years of age or older and have been diagnosed with diabetes

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PWD testing POGO® BGMS; All enrolled persons with diabetes	Device: POGO® BGMS; SMBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)
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.)

Collaborators and Investigators

• Sponsor: Intuity Medical, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: TP-000321