User Performance of the Karajishi Contour TS Blood Glucose Monitoring System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 TS BGMS (or used a Bayer Contour TS 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
Arms & Interventions
Intended Users of the Monitoring System
Subjects with diabetes used the Karajishi TS Investigational Blood Glucose 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
Intervention: Karajishi TS Investigational Blood Glucose Monitoring System (Device)
Outcomes
Primary Outcomes
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
Time Frame: 1 hour
Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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 Outcomes
- 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)
- 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)
- Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements(1 hour)
- 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)