Evaluation of the YOFiMeter Glucometer

Completed

Conditions studied: Diabetes

In brief

This evaluation will evaluate a new system from YOFiMeter, known as YOFiLife Blood Glucose Monitoring System with YOFiMeter glucometer. YOFiLife includes a web- based data system known as the Web Portal and smart phone apps for the iPhone and Android. The new YOFiMeter is similar to other glucometers with the exception of built in test cassettes, lancet cassettes with enhanced communications and data reviewing options. This evaluation will also collect data from a YSI 2300 Stat Plus Glucose Analyzer reference glucometer. The YSI 2300 Stat Plus Glucose Analyzer will be used as the "gold" standard with all results compared to the YSI results.

Key facts

Study ID

NCT02147314

Run by

YofiMeter, LLC

People needed

150

Starts

2014-06-01

Expected to finish

2014-12-01

Last updated by the study team

2014-12-18

Who can join

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

You may qualify if…

• Is the subject currently self-testing for blood glucose levels?
• Is the subject able to provide legal, written informed consent?
• Is the subject willing to have fingersticks for blood glucose determination?
• Does the subject show an ability and willingness to follow directions of the Investigator and staff?
• Is the subject 18 years of age or older?
• Does the subject have a hematocrit value in the range of 20-60?

You may not qualify if…

• Does the subject demonstrate a lack of compliance as determined by the Principal or Lead Site Investigator and/or staff?
• Is the subject currently participating in another clinical study of an investigational device or drug?
• Is the subject unwilling or unable to provide concurrent blood glucose level determinations with the YOFiMeter whenever blood glucose levels are determined at the Investigator's site?
• Is the subject, or a family member, employed by a company that develops or markets blood glucose level determining devices?
• Does the subject have any other condition or finding, which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol?
• Is the subject unwilling or unable to provide Informed Consent (IC)?

Where it is running

• Profil Institute for Clinical Research — Chula Vista, California, United States
• AMCR Institute — Escondido, California, United States
• Tri City Endocrinology — Oceanside, California, United States

Full record on ClinicalTrials.gov

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