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Completed

NCT Number: NCT02371876

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

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.

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Key information

Conditions

Diabetes 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

Interventional

Phase

Not applicable

Primary location

AMCR Institute, Escondido, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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 criteria

  • Hemophilia or other bleeding disorder
  • Pregnancy
  • Physical, visual, or neurological impairments that would make the person unable to perform 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 involves training on or clinical use of blood glucose monitors
  • Working for a competitive medical device company, or having an immediate family member who works for such a company
  • A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

The enrollment goal for the intended use population:

  • At least 70% of subjects will be younger than age 65
  • At least 20% of subjects will have type 1 diabetes

Treatment and study plan

ONYX PLUS Investigational Blood Glucose Monitoring System

Device

Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Primary outcomes

  1. Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).

Secondary outcomes

  1. Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).

  2. Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff

    Time frame: 1 hour

    Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).

  3. Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    Time frame: 1 hour

    Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma).

  4. Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma).

  5. Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS

    Time frame: 1 hour

    Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated.

  6. Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose

    Time frame: 1 hour

    Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

User Performance of the ONYX PLUS Blood Glucose Monitoring System

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Oct 30, 2019

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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