Trial Outcomes & Findings for Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System (NCT NCT02371876)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

1 hour

Results posted on

2019-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	134
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Users of the Monitoring System n=134 Participants 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.
Age, Continuous	54.0 years n=99 Participants
Sex: Female, Male Female	70 Participants n=99 Participants
Sex: Female, Male Male	64 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 participants n=99 Participants
Race/Ethnicity, Customized Asian	4 participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=99 Participants
Race/Ethnicity, Customized Black or African American	14 participants n=99 Participants
Race/Ethnicity, Customized White	112 participants n=99 Participants
Race/Ethnicity, Customized More than one race	3 participants n=99 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 participants n=99 Participants
Region of Enrollment United States	134 participants n=99 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=134 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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 outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=126 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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 outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=134 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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 outcome

Timeframe: 1 hour

Population: 132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.

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).

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=132 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=134 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=134 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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
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
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
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
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
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
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
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

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=134 Participants 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 blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood.
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
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
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
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
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
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
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
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
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
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
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

Adverse Events

Users of the Monitoring System

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Users of the Monitoring System n=134 participants at risk 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.
Endocrine disorders Hypoglycemia	3.0% 4/134 • Number of events 4 • Subject visits were approximately 1 hour.

Additional Information

Jane Wallace, Deputy Director for Global Clinical Affairs

Ascensia Diabetes Care

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60