Diabetes
Conditions
Brief 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.
Interventions
DEVICEONYX PLUS Investigational Blood Glucose Monitoring System
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.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. At least 70% of subjects will be younger than age 65 2. At least 20% of subjects will have type 1 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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). |
| Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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). |
| Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | 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. |
| 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 | 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. |
| 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Users of the Monitoring System Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: 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. | 134 |
| Total | 134 |
Baseline characteristics
| Characteristic | Users of the Monitoring System |
|---|---|
| Age, Continuous | 54.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants |
| Race/Ethnicity, Customized Asian | 4 participants |
| Race/Ethnicity, Customized Black or African American | 14 participants |
| Race/Ethnicity, Customized More than one race | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 2 participants |
| Race/Ethnicity, Customized White | 112 participants |
| Region of Enrollment United States | 134 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 134 |
| serious Total, serious adverse events | 0 / 134 |
Outcome results
Primary
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).
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 99.2 Percentage of BG Results |
Secondary
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).
Time frame: 1 hour
Population: 126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Monitoring System | Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 99.2 Percentage of BG Results |
Secondary
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.
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | I find it easy to do a blood test with this meter. | 99.2 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | The meter display was easy to see and read. | 98.5 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | It was easy to understand my test results. | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | I like the overall meter design. | 97.8 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | I find the meter easy to use. | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | The instructions were easy to understand. | 96.3 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | Instructions clearly explain meter error messages. | 99.2 Percentage of Participants Who Responded |
| Users of the Monitoring System | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | Instructions clearly explain how to run a test. | 97.8 Percentage of Participants Who Responded |
Secondary
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.
Time frame: 1 hour
Population: Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Users of the Monitoring System | 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 | Acc:important to help me talk w my HCP. | 99.25 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:important to help w self-monitor satisfaction. | 99.25 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:important to help w managing my diabetes. | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:important to help prevent low blood sugar | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:important to understand food/exercise effects. | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:help w using results to better control diabete | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | Acc:important to achieve greater peace of mind. | 100 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | I prefer the meter I just used to my regular meter | 86.5 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | I use my current meter -my insurance covers strips | 80 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | I use my current meter-I think it is most accurate | 86.9 Percentage of Participants Who Responded |
| Users of the Monitoring System | 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 | I use my meter - my care provider gave it to me. | 84.1 Percentage of Participants Who Responded |
Secondary
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).
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Monitoring System | 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 | 98.5 Percentage of BG Results |
Secondary
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).
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Monitoring System | 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 | 99.2 Percentage of BG Results |
Secondary
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).
Time frame: 1 hour
Population: 132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Monitoring System | Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 100 Percentage of BG Results |