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Study of an Investigational Glucose Meter System

NCT01474317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2016-02-29

Study results available
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Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Interventions

DEVICE

G3 Investigational Blood Glucose Monitoring System

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Robert Bernstein, MD, FACE · Southwest Clinical Research Center

  • Michael Caswell, PhD · Consumer Product Testing Co.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT01474317 on ClinicalTrials.gov