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Completed

NCT Number: NCT02333864

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diablo Clinical Reasearch, Walnut Creek, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POGO® BGMS

Device

SMBG

Primary outcomes

  1. Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.

    Time frame: 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

  2. Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.

    Time frame: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)

    HCP accuracy

Sponsors and collaborators

Lead sponsor

Intuity Medical, Inc

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2015
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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