Evaluation of the YOFiMeter Glucometer

Diabetes Clinical Trial

Official title: Evaluation of the YOFiLife Blood Glucose Monitoring System With YOFiMeter Glucometer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This is a single evaluation to assess both the Yofimeter system accuracy in the hands of the intended users, as well as other aspects to support lay use, such as labeling assessment and usability. The company is presenting diabetics who monitor their blood glucose with new technological innovations aimed at improving their daily lives (e.g., a unique blood glucose monitor, Web Portal applications and "smart phone" applications).

Each subject selected for the comparison evaluation will perform their own fingerstick and test on their subject device following device instructions. A trained technician will perform a fingerstick on the subject immediately after and perform the test on the same device. Separate results will be recorded by subject and technician. A trained technician will take another blood sample, within as short of a time as practicable, for a glucose assay on the YSI 2300 Stat Plus Glucose Analyzer. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

• NCT number: NCT02147314
• Study type: Observational
• Source: YofiMeter, LLC
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Completion date: December 2014