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

Not Applicable

Completed

Conditions: Diabetes

Interventions: Device: Subjects WITH Diabetes Use Karajishi Contour BGMS
Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS

Registration Number: NCT02150109

Lead Sponsor: Ascensia Diabetes Care

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 372

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persons With Diabetes	Subjects WITH Diabetes Use Karajishi Contour BGMS	Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Persons With and Without Diabetes	Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS	Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

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