Trial Outcomes & Findings for Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (NCT NCT02041286)

NCT ID: NCT02041286

Last Updated: 2016-02-29

Results Overview

Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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

136 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 use the Karajishi Contour Investigational BG 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 Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG 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.
Overall Study STARTED	136
Overall Study COMPLETED	135
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the Monitoring System Subjects with diabetes use the Karajishi Contour Investigational BG 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 Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG 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.
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=136 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
Age, Customized Age of enrolled subjects	52.5 years n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 participants n=5 Participants
Race (NIH/OMB) Asian	7 participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants
Race (NIH/OMB) Black or African American	10 participants n=5 Participants
Race (NIH/OMB) White	118 participants n=5 Participants
Race (NIH/OMB) More than one race	3 participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 participants n=5 Participants
Region of Enrollment United States	136 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=135 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
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: 132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.

Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are 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=132 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
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: 130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.

Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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=130 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
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	112 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

Population: 135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.

Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are 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=135 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
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	133 Blood glucose results

SECONDARY outcome

Timeframe: 1 hour

Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=136 Participants Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
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.	136 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.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements It is easy to understand my test results.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements I like the overall meter design.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements I find the meter easy to use.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements Instructions clearly explain how to run a test.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements Instructions clearly explain meter error messages.	136 participants
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements The instruction (User Guide) is easy to understand	136 participants

Adverse Events

Intended 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	Intended Users of the Monitoring System n=136 participants at risk Subjects with diabetes use the Karajishi Contour Investigational BG 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 Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG 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	2.9% 4/136 • Number of events 4 • 1 hour subject visit

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60