Trial Outcomes & Findings for Evaluation of an Investigational Blood Glucose Monitoring System (NCT NCT01859494)

Last Updated: 2017-02-10

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 number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma).

Recruitment status

COMPLETED

Study phase

Target enrollment

219 participants

Primary outcome timeframe

1 hour

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Users of the Monitoring System Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Overall Study STARTED	219
Overall Study COMPLETED	218
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Users of the Monitoring System Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of an Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Users of the Monitoring System n=221 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Age, Continuous	51.8 years n=5 Participants
Gender Female	108 Participants n=5 Participants
Gender Male	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	197 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	9 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 participants n=5 Participants
Race/Ethnicity, Customized White	194 participants n=5 Participants
Race/Ethnicity, Customized More than one race	3 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	5 participants n=5 Participants
Region of Enrollment United States	221 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=218 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method	218 Blood Glucose results within 15mg/dL/20%

SECONDARY outcome

Timeframe: 1 hour

Population: 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.

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 BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma)

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=218 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method	215 Blood Glucose results within 15mg/dL/15%

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 BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (\<100mg/dL YSI capillary plasma) or +/- 12.5% (\>=100mg/dL YSI capillary plasma)

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=218 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method	214 Bld Glucose results w/in 12.5mg/dL/12.5%

SECONDARY outcome

Timeframe: 1 hour

Population: 211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.

Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma)

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=211 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method	209 Blood Glucose results within 15mg/dL/20%

SECONDARY outcome

Timeframe: 1 hour

Population: 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.

Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma)

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=218 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff	218 Blood Glucose results within 15mg/dL/20%

SECONDARY outcome

Timeframe: 1 hour

Population: 218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).

Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.

Outcome measures

Outcome measures
Measure	Users of the Monitoring System n=218 Participants Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find it easy to do a blood test with this meter.	218 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The meter display was easy to see and read.	216 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements It was easy to understand my test results.	218 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I like the overall meter design.	215 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find the meter easy to use.	217 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The instructions were easy to understand.	213 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain how to run a test.	216 Participant Responses
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain meter error messages.	217 Participant Responses

Adverse Events

Users of the Monitoring System

Serious events: 0 serious events

Other events: 8 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=219 participants at risk Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Endocrine disorders Hypoglycemia	3.7% 8/219 • Number of events 8 • 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