Performance Evaluation of an Investigational Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01598610

Run by

Ascensia Diabetes Care

People needed

220

Starts

2012-05-01

Expected to finish

2012-05-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 18 years of age and older
• Type 1 or type 2 diabetes
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if…

• Pregnancy
• Hemophilia or any other bleeding disorder
• Previously participated in a study using the CONTOUR PLUS system
• 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 or someone who is not a family member but is living within the household of someone who works for such a company.
• A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).

Where it is running

• Midwest Institute For Clinical Research — Indianapolis, Indiana, United States
• Consumer Product Testing Co. — Fairfield, New Jersey, United States

Full record on ClinicalTrials.gov

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