Trial Outcomes & Findings for Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System (NCT NCT02041377)

NCT ID: NCT02041377

Last Updated: 2016-02-29

Results Overview

Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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

Target enrollment

134 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the Monitoring System Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from 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	134
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=134 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from 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, Customized Age of enrolled subjects	53.8 years n=93 Participants
Sex: Female, Male Female	71 Participants n=93 Participants
Sex: Female, Male Male	63 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 responses n=93 Participants
Race (NIH/OMB) Asian	8 responses n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 responses n=93 Participants
Race (NIH/OMB) Black or African American	11 responses n=93 Participants
Race (NIH/OMB) White	108 responses n=93 Participants
Race (NIH/OMB) More than one race	5 responses n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 responses n=93 Participants
Region of Enrollment United States	134 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=132 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous 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	127 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

Population: 131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.

Study staff tested subject venous blood 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	Intended Users of the Monitoring System n=131 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous 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	131 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

Population: 129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.

Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm 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	Intended Users of the Monitoring System n=129 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method	121 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

Population: 133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.

Study staff obtained and 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 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	Intended Users of the Monitoring System n=133 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
Number of Subject 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	131 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

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	Intended Users of the Monitoring System n=134 Participants Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous 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.	132 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements The meter display is easy to see and read.	133 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements It is easy to understand my test results.	133 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements I like the overall meter design.	134 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements I find the meter easy to use.	132 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements The instruction (User Guide) is easy to understand	132 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements Instructions clearly explain how to run a test.	134 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements Instructions clearly explain meter error messages.	134 participants

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the Monitoring System n=134 participants at risk Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
Endocrine disorders Hypoglycemia	1.5% 2/134 • Number of events 2 • 1 hour subject visit

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