Trial Outcomes & Findings for Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System (NCT NCT02390167)

NCT ID: NCT02390167

Last Updated: 2019-07-17

Results Overview

Untrained subjects WITH Diabetes (332) 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 +/- 15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 15% (\>=100 mg/dL YSI capillary plasma).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 376 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2019-07-17

Participant Flow

Participant milestones

Measure	Persons With and Without Diabetes Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Overall Study STARTED	376
Overall Study With Diabetes	333
Overall Study Without Diabetes	43
Overall Study COMPLETED	375
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Persons With and Without Diabetes Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Study Lost to Follow-up

1

Baseline Characteristics

Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Measure	Persons With and Without Diabetes n=376 Participants Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Age, Continuous	52.1 years n=5 Participants
Sex: Female, Male Female	202 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	50 Number of responses n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	321 Number of responses n=5 Participants
Race/Ethnicity, Customized Ethnicity Unknown or Not Reported	5 Number of responses n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 Number of responses n=5 Participants
Race/Ethnicity, Customized Asian	23 Number of responses n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Number of responses n=5 Participants
Race/Ethnicity, Customized Black or African American	52 Number of responses n=5 Participants
Race/Ethnicity, Customized White	292 Number of responses n=5 Participants
Race/Ethnicity, Customized Race Unknown or Not Reported	9 Number of responses n=5 Participants
Region of Enrollment United States	376 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.

Untrained subjects WITH Diabetes (332) 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 +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=329 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

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

99.4 Percent of Results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.

Untrained subjects WITH Diabetes (332) 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 +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=318 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

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

97.2 Percent of Results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 332 Blood glucose results from subjects with diabetes were analyzed.

Study staff tested subject (332 WITH diabetes) 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 +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=332 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

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

99.7 Percent of Results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.

Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).

Outcome measures

Measure

Persons With Diabetes n=330 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff

100 Percent of Results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.

Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) 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 +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=372 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

99.5 Percent of Results within 15%

SECONDARY outcome

Timeframe: 1 hour

Population: 372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) 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 +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=372 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

99.7 Percent of Results within 20%

SECONDARY outcome

Timeframe: 1 hour

Population: 361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested 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 +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=361 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

96.7 Percent of Results within 15%

SECONDARY outcome

Timeframe: 1 hour

Population: 361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested 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 +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=361 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

98.6 Percent of Results within 20%

SECONDARY outcome

Timeframe: 1 hour

Population: 375 Blood glucose results were analyzed.

Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 +/- 15% of the laboratory method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=375 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff

99.7 Percent of Results within 15%

SECONDARY outcome

Timeframe: 1 hour

Population: 375 Blood glucose results were analyzed.

Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 +/- 20% of the laboratory method across the entire tested YSI glucose range.

Outcome measures

Measure

Persons With Diabetes n=375 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff

100 Percent of Results within 20%

SECONDARY outcome

Timeframe: 1 hour

Population: 329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.

Untrained subjects WITH Diabetes (332) 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 +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=329 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

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

98.5 Percent of Results within12.5mg/dL/12.5%

SECONDARY outcome

Timeframe: 1 hour

Staff obtained responses from persons WITH Diabetes (332) 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 are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

Outcome measures

Measure	Persons With Diabetes n=332 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
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.	97.9 Percent of Subjects who responded
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.	98.2 Percent of Subjects 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.	99.7 Percent of Subjects 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.	97.3 Percent of Subjects 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.	97.9 Percent of Subjects who responded
Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS Instructions (User Guide) were easy to understand.	97.6 Percent of Subjects 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.	98.5 Percent of Subjects 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.	99.4 Percent of Subjects who responded

SECONDARY outcome

Timeframe: 1 hour

Staff obtained responses from persons WITH and WITHOUT 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 are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

Outcome measures

Measure	Persons With Diabetes n=375 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Percent of Responses From Persons WITH and WITHOUT 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.	98.1 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS The meter display was easy to see and read.	98.4 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS It was easy to understand my test results.	99.7 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS I like the overall meter design.	97.6 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS I find the meter easy to use.	98.1 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS Instructions (User Guide) were easy to understand.	97.6 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS Instructions clearly explain how to run a test.	98.7 Percent of Subjects who responded
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS Instructions clearly explain meter error messages.	99.2 Percent of Subjects who responded

SECONDARY outcome

Timeframe: 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 are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.

Outcome measures

Measure	Persons With Diabetes n=332 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
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.	100 Percent of Subjects 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.	99.70 Percent of Subjects 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.	99.40 Percent of Subjects 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 prevent low blood sugar	99.69 Percent of Subjects 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.	99.70 Percent of Subjects 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	99.40 Percent of Subjects 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.	99.09 Percent of Subjects 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	92.09 Percent of Subjects 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.	85.27 Percent of Subjects 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	85.62 Percent of Subjects 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	84.09 Percent of Subjects who responded

SECONDARY outcome

Timeframe: 1 hour

Population: 372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.

Untrained subject WITH and WITHOUT 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 +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=372 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method

99.7 Percent of Results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.

Untrained subject WITH and WITHOUT 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 +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).

Outcome measures

Measure

Persons With Diabetes n=366 Participants Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method

97.0 Percent of Results within 15mg/dL/15%

Adverse Events

Persons With and Without Diabetes

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Persons With and Without Diabetes n=375 participants at risk Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Endocrine disorders Hypoglycemia

2.1% 8/375 • Number of events 8

Additional Information

Jane Wallace, Deputy Director for Global Clinical Affairs

Ascensia Diabetes Care

Phone: 574-257-3063

Email: jane.wallace@ascensia.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60