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

NCT02150109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2016-02-29

Study results available
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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.

Conditions

Interventions

DEVICE

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS

Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

DEVICE

Subjects WITH Diabetes Use Karajishi Contour BGMS

Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were 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
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02150109 on ClinicalTrials.gov