Trial Outcomes & Findings for Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study) (NCT NCT02150109)

Results Overview

Untrained subjects WITH diabetes (329) 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 +/-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

372 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Persons With and Without Diabetes Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
Overall Study STARTED	372
Overall Study COMPLETED	372
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Persons With and Without Diabetes n=372 Participants Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
Age, Continuous	51.1 years n=5 Participants
Sex: Female, Male Female	201 Participants n=5 Participants
Sex: Female, Male Male	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	320 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 responses n=5 Participants
Race (NIH/OMB) Asian	23 responses n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 responses n=5 Participants
Race (NIH/OMB) Black or African American	32 responses n=5 Participants
Race (NIH/OMB) White	305 responses n=5 Participants
Race (NIH/OMB) More than one race	6 responses n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 responses n=5 Participants
Region of Enrollment United States	372 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts.

Untrained subjects WITH diabetes (329) 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 +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=324 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method	317 Blood glucose results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.

Study staff tested venous blood of subjects WITH diabetes (329) 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 number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI venous plasma) and +/-15% (\>=100 mg/dL YSI venous plasma).

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=318 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method	318 Blood glucose results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Population: 326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation.

Study staff obtained and tested subject (329 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 capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=326 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff	325 Blood glucose results within 15mg/dL/15%

SECONDARY outcome

Timeframe: 1 hour

Staff obtained responses from persons WITH diabetes (329) 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.'

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=329 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find it easy to do a blood test with this meter	326 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The meter display is easy to see and read.	329 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements It was easy to understand my test results.	329 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I like the overall meter design.	326 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find the meter easy to use.	328 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions (User Guide) were easy to understand.	326 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain how to run a test.	327 number who strongly agree,agree,neutral
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain meter error messages.	329 number who strongly agree,agree,neutral

SECONDARY outcome

Timeframe: 1 hour

Population: 365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.

Untrained subjects WITH diabetes (329) 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 number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=365 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range	353 Blood glucose results within +/- 15%

SECONDARY outcome

Timeframe: 1 hour

Population: 365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.

Untrained subjects WITH diabetes (329) 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 number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=365 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range	359 Blood glucose results within +/- 20%

SECONDARY outcome

Timeframe: 1 hour

Population: 369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.

Study staff obtained and tested subject (WITH and 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 capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=369 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff	365 Blood glucose results within +/- 20%

SECONDARY outcome

Timeframe: 1 hour

Population: 369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.

Study staff obtained and tested subject (WITH and 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 capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=369 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff	367 Blood glucose results within +/- 20%

SECONDARY outcome

Timeframe: 1 hour

Staff obtained responses from subjects 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 'Neutral' or 'Disagree' or 'Strongly Disagree.'

Outcome measures

Outcome measures
Measure	Persons With Diabetes n=372 Participants Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find it easy to do a blood test with this meter.	368 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The meter display is easy to see and read.	371 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements It is easy to understand my test results.	371 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I like the overall meter design.	368 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find the meter easy to use.	369 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The instruction (User Guide) is easy to understand	368 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain how to run a test.	368 Number who strongly agree,agree,neutral
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain meter error messages.	371 Number who strongly agree,agree,neutral

Adverse Events

Persons With and Without Diabetes

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Persons With and Without Diabetes n=372 participants at risk Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
Endocrine disorders Hypoglycemia	4.0% 15/372 • Number of events 15
Endocrine disorders Presyncope	0.27% 1/372 • Number of events 1

Additional Information

Jane Wallace, Deputy Director Clinical Trials

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