Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

• Sponsor: Ascensia Diabetes Care (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02041286
• Collaborator: (none)
• Enrollment: 136
• Locations: 2
• Arm: 1
• Patients Per Site: 68

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: Karajishi Contour Investigational BG Monitoring System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: User Performance of the Karajishi Contour Blood Glucose Monitoring System
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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: At least 60% of subjects will be younger than age 65 At least 10% of subjects will have type 1 diabetes

Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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 [1 hour]

   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).

Secondary Outcome Measures

1. Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method [1 hour]

   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).

2. 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 [1 hour]

   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).

3. 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 [1 hour]

   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).

4. Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females, 18 years of age and older

• People with type 1 or type 2 diabetes

• Able to speak, read, and understand English

• Willing to complete all study procedures

Exclusion Criteria:

• Hemophilia or any other bleeding disorder

• Pregnancy

• Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM

• Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)

• Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors

• Working for a competitive medical device company, or having an immediate family member who works for such a company

• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMCR Institute	Escondido	California	United States	92026
2	Rainier Clinical Research Center	Renton	Washington	United States	98057

Sponsors and Collaborators

• Ascensia Diabetes Care

Investigators

• Principal Investigator: Leslie J Klaff, MD, Rainier Clinical Research Center
• Principal Investigator: Timothy Bailey, MD, AMCR Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ascensia Diabetes Care
• ClinicalTrials.gov Identifier: NCT02041286
• Other Study ID Numbers: GCA-2013-001-01
• First Posted: Jan 22, 2014
• Last Update Posted: Feb 29, 2016
• Last Verified: Jan 1, 2016

Study Results

Participant Flow

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population: At least 60% of subjects will be younger than age 65 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.
Period Title: Overall Study
STARTED	136
COMPLETED	135
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
Overall Participants	136
Age, Customized (years) [Mean (Full Range) ]
Age of enrolled subjects	52.5
Sex: Female, Male (Count of Participants)
Female	63 46.3%
Male	73 53.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 3.7%
Not Hispanic or Latino	130 95.6%
Unknown or Not Reported	1 0.7%
Race (NIH/OMB) (participants) [Number]
American Indian or Alaska Native	2 1.5%
Asian	7 5.1%
Native Hawaiian or Other Pacific Islander	1 0.7%
Black or African American	10 7.4%
White	118 86.8%
More than one race	3 2.2%
Unknown or Not Reported	1 0.7%
Region of Enrollment (participants) [Number]
United States	136 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
Measure Participants	135
Number [Blood glucose results]	127

2. Secondary Outcome

Title	Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
Measure Participants	132
Number [Blood glucose results]	131

3. Secondary Outcome

Title	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
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
Measure Participants	130
Number [Blood glucose results]	112

4. Secondary Outcome

Title	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
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
Measure Participants	135
Number [Blood glucose results]	133

5. Secondary Outcome

Title	Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
Measure Participants	136
I find it easy to do a blood test with this meter.	136 100%
The meter display is easy to see and read.	136 100%
It is easy to understand my test results.	136 100%
I like the overall meter design.	136 100%
I find the meter easy to use.	136 100%
The instruction (User Guide) is easy to understand	136 100%
Instructions clearly explain how to run a test.	136 100%
Instructions clearly explain meter error messages.	136 100%

Adverse Events

Time Frame	1 hour subject visit
Arm/Group Title	Intended Users of the Monitoring System
Arm/Group Description	Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population: At least 60% of subjects will be younger than age 65 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.
All Cause Mortality
	Intended Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intended Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	0/136 (0%)
Other (Not Including Serious) Adverse Events
	Intended Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	4/136 (2.9%)
Endocrine disorders
Hypoglycemia	4/136 (2.9%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.