Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System

Last updated: October 16, 2019
Sponsor: Ascensia Diabetes Care
Overall Status: Completed

Phase

N/A

Condition

Diabetic Neuropathy

Diabetic Retinopathy

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT02371876
GCA-2014-005-01
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and Females, 18 years of age and older

  • Able to speak, read, and understand English

  • Willing to complete all study procedures

Exclusion

Exclusion Criteria:

  • Hemophilia or other bleeding disorder

  • Pregnancy

  • Physical, visual, or neurological impairments that would make the person unable toperform testing with the BGM

  • Previously participated in a BG monitor study using the ONYX PLUS BGMS

  • Working for a medical laboratory, hospital, or other clinical setting that involvestraining on or clinical use of blood glucose monitors

  • Working for a competitive medical device company, or having an immediate family memberwho works for such a company

  • A condition which, in the opinion of the investigator or designee, would put theperson or study conduct at risk The enrollment goal for the intended use population:

  1. At least 70% of subjects will be younger than age 65

  2. At least 20% of subjects will have type 1 diabetes

Study Design

Total Participants: 134
Study Start date:
February 01, 2015
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • AMCR Institute

    Escondido, California 92025
    United States

    Site Not Available

  • Diablo Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

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