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

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ClinicalTrials.gov Identifier: NCT02150109
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 21, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Diabetes
Interventions Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS
Device: Subjects WITH Diabetes Use Karajishi Contour BGMS
Enrollment 372
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 372
Completed 372
Not Completed 0
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 372
Hide Baseline Analysis Population Description
The 'Persons With Diabetes' Arm (329) is a subset of the 'Persons With and Without Diabetes' Arm (372).
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 372 participants
51.1
(18 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 372 participants
Female
201
  54.0%
Male
171
  46.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 372 participants
Hispanic or Latino
47
  12.6%
Not Hispanic or Latino
320
  86.0%
Unknown or Not Reported
5
   1.3%
Race (NIH/OMB)   [1] 
Measure Type: Number
Unit of measure:  Responses
Number Analyzed 372 participants
American Indian or Alaska Native 7
Asian 23
Native Hawaiian or Other Pacific Islander 4
Black or African American 32
White 305
More than one race 6
Unknown or Not Reported 7
[1]
Measure Description: Subjects provided more than one choice for Race, therefore the apparent frequency total for Race was different from number of subjects.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 372 participants
372
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
Hide Description 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).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 324
Measure Type: Number
Unit of Measure: Blood glucose results within 15mg/dL/15%
317
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
Hide Description 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).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma.

Overall Number of Participants Analyzed 318
Measure Type: Number
Unit of Measure: Blood glucose results within 15mg/dL/15%
318
3.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 326
Measure Type: Number
Unit of Measure: Blood glucose results within 15mg/dL/15%
325
4.Secondary Outcome
Title Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Hide Description 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.'
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the 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 Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: number who strongly agree,agree,neutral
I find it easy to do a blood test with this meter 326
The meter display is easy to see and read. 329
It was easy to understand my test results. 329
I like the overall meter design. 326
I find the meter easy to use. 328
Instructions (User Guide) were easy to understand. 326
Instructions clearly explain how to run a test. 327
Instructions clearly explain meter error messages. 329
5.Secondary Outcome
Title Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

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 using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 365
Measure Type: Number
Unit of Measure: Blood glucose results within +/- 15%
353
6.Secondary Outcome
Title Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

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 using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 365
Measure Type: Number
Unit of Measure: Blood glucose results within +/- 20%
359
7.Secondary Outcome
Title Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: 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.

Overall Number of Participants Analyzed 369
Measure Type: Number
Unit of Measure: Blood glucose results within +/- 20%
365
8.Secondary Outcome
Title Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: 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.

Overall Number of Participants Analyzed 369
Measure Type: Number
Unit of Measure: Blood glucose results within +/- 20%
367
9.Secondary Outcome
Title Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Hide Description 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.'
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

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 Number of Participants Analyzed 372
Measure Type: Number
Unit of Measure: Number who strongly agree,agree,neutral
I find it easy to do a blood test with this meter. 368
The meter display is easy to see and read. 371
It is easy to understand my test results. 371
I like the overall meter design. 368
I find the meter easy to use. 369
The instruction (User Guide) is easy to understand 368
Instructions clearly explain how to run a test. 368
Instructions clearly explain meter error messages. 371
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

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.

All-Cause Mortality
Persons With and Without Diabetes
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Persons With and Without Diabetes
Affected / at Risk (%) # Events
Total   0/372 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Persons With and Without Diabetes
Affected / at Risk (%) # Events
Total   16/372 (4.30%)    
Endocrine disorders   
Hypoglycemia *  15/372 (4.03%)  15
Presyncope *  1/372 (0.27%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane Wallace, Deputy Director Clinical Trials
Organization: Ascensia Diabetes Care
Phone: 574-257-3063
EMail: jane.wallace@ascensia.com
Layout table for additonal information
Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT02150109     History of Changes
Other Study ID Numbers: GCA-2014-002-01
First Submitted: May 27, 2014
First Posted: May 29, 2014
Results First Submitted: June 3, 2015
Results First Posted: July 21, 2015
Last Update Posted: February 29, 2016