Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Key facts

Study ID

NCT02390167

Run by

Ascensia Diabetes Care

People needed

376

Starts

2015-03-01

Expected to finish

2015-04-01

Last updated by the study team

2019-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females, 18 years of age and older
• 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 blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS
• Working for a medical laboratory, hospital, or other clinical setting that involves training on or 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
• General enrollment guidelines:
• At least 70% of subjects will be younger than age 65
• At least 10% (approximately 10-15%) of subjects will be naive users
• At least 20% of subjects with diabetes will have type 1 diabetes

Where it is running

• AMCR Institute — Escondido, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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