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Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

NCT02041286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-02-29

Study results available
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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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Leslie J Klaff, MD · Rainier Clinical Research Center

  • Timothy Bailey, MD · AMCR Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041286 on ClinicalTrials.gov