User Study of an Investigational Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

Key facts

Study ID

NCT01447121

Run by

Ascensia Diabetes Care

People needed

118

Starts

2011-09-01

Expected to finish

2011-09-01

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…

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

You may not qualify if…

• Previously participated in a study using this investigational system
• Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
• Pregnancy
• Hemophilia or any other bleeding disorder
• 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

• AMCR Institute — Escondido, California, United States

Full record on ClinicalTrials.gov

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