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

Study Overview
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Brief Summary
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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.

Official Title
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User Performance of the ONYX PLUS Blood Glucose Monitoring System

Conditions
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Diabetes

Intervention / Treatment
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* Device: ONYX PLUS Investigational Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Users of the Monitoring System<br>Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System. | Device: ONYX PLUS Investigational Blood Glucose Monitoring System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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). | 1 hour | 
| 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 | 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). | 1 hour | 
| Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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). | 1 hour | 
| 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 | 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). | 1 hour | 
| Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | 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. | 1 hour | 
| 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 | 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. | 1 hour |