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

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Subjects WITH Diabetes Use Karajishi Contour BGMS; Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02150109

GCA-2014-002-01

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

Persons With Diabetes

Experimental group

Description:

Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Treatment:

Device: Subjects WITH Diabetes Use Karajishi Contour BGMS

Persons With and Without Diabetes

Experimental group

Description:

Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).

Treatment:

Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS