Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

Not Applicable

Completed

Conditions: Diabetes

Interventions: Device: Karajishi Contour Investigational BG Monitoring System

Registration Number: NCT02041286

Lead Sponsor: Ascensia Diabetes Care

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the Monitoring System	Karajishi Contour Investigational BG 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

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	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

Name	Time	Method
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).
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).
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).
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.