PositiveID has initiated its Easy Check non-invasive breath glucose detection device's clinical trial at Schneider Children's Medical Center in Israel.
The objective of the trial is to evaluate the feasibility of Easy Check compared to a standard invasive blood glucose meter and also to assess the reliability of Easy Check in measuring blood glucose levels in type 1 diabetes, under conditions of altered blood glucose levels.
PositiveID said the trial which will run for a period of six months, is expected to start enrolling patients this February 2012.
Easy Check, which is beig developed in Israel, is a non-invasive breath glucose detection device which measures the level of acetone in a patient’s exhaled breath and then correlates that acetone level to a measure of blood glucose.
Easy Check utilizes the company’s FDA-cleared iglucose technology which is based on a patent-pending reagent cell that mixes patient’s exhaled air with a proprietary chemical compound, thus triggering a chemical reaction.
The reaction is measured and then the Easy Check device’ software interprets the measurement and correlates the patient’s acetone level to the level of glucose in the body.
Study principal investigator and Jesse Z professor and director Moshe Phillip said they are eager to begin testing PositiveID’s Easy Check breath device with the hope that one day, Easy Check will offer a non-invasive way to follow the metabolic control of diabetes patients.
PositiveID chairman and CEO William Caragol said after previously announcing positive preliminary laboratory results from testing Easy Check in 2011, this independent clinical study is an important milestone in the advancement of Easy Check.