Evaluation of an Investigational Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

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

Key facts

Study ID

NCT01859494

Run by

Ascensia Diabetes Care

People needed

219

Starts

2013-04-01

Expected to finish

2013-05-01

Last updated by the study team

2017-02-10

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
• People with type 1 or type 2 diabetes
• Able to speak, read, and understand English
• Willing to complete all study procedures

You may not qualify if…

• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
• Previously participated in a BG monitor study using the Ninja 3 BGMS
• 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 who works for such a company
• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk.
• The enrollment criteria for the study population:
• At least 60% of subjects will be younger than age 65
• At least 20% of subjects will have type 1 diabetes
• At least 50% of subjects with type 2 diabetes wil be insulin users.

Where it is running

• AMCR Institute — Escondido, California, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.