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

User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Subjects WITH Diabetes Use Karajishi Contour BGMS; Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92026
      • AMCR Institute
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females, 18 years of age and older
• 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 Contour BGMS (or used a Bayer Contour meter)
• Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Work 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

General enrollment guidelines:

• Most subjects will be persons with type 1 or type 2 diabetes
• At least 10% of subjects with diabetes will have type 1 diabetes
• Approximately 10% of subjects will be persons without diabetes
• At least 60% of subjects will be younger than age 65

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Persons With Diabetes; Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).	Device: Subjects WITH Diabetes Use Karajishi Contour BGMS; Untrained subjects WITH diabetes use 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.
Experimental: Persons With and Without Diabetes; Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).	Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS; Untrained subjects WITH and WITHOUT diabetes use 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method	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).	1 hour
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	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).	1 hour
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements	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.'	1 hour
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range	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.	1 hour
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range	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.	1 hour
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff	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.	1 hour
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff	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.	1 hour
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements	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.'	1 hour

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Leslie J Klaff, MD, Rainier Clinical Research Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: GCA-2014-002-01