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Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

NCT ID: NCT02041286

Last Updated: 2016-02-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intended Users of the 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

Group Type EXPERIMENTAL

Karajishi Contour Investigational BG Monitoring System

Intervention Type DEVICE

Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.

Interventions

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Karajishi Contour Investigational BG Monitoring System

Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascensia Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie J Klaff, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Locations

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AMCR Institute

Escondido, California, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GCA-2013-001-01

Identifier Type: -

Identifier Source: org_study_id