Study of an Investigational Glucose Meter 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

NCT01474317

Run by

Ascensia Diabetes Care

People needed

226

Starts

2011-11-01

Expected to finish

2011-11-01

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 G3 system
• Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
• 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).
• 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.

Where it is running

• Consumer Product Testing Co. — Fairfield, New Jersey, United States
• Southwest Clinical Research Center — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

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