Clinical trial NCT02150109: Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
Official title: User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
timeFrame: 1 hour
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
timeFrame: 1 hour
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
timeFrame: 1 hour
measure: Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff
timeFrame: 1 hour
measure: Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff
timeFrame: 1 hour
measure: Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Leslie J Klaff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: