PositiveID has begun a clinical trial of its Easy Check™ non-invasive breath glucose detection device, intended for use in people with diabetes.
Easy Check determines the level of acetone in a patient’s exhaled breath and correlates that acetone level to a measure of blood glucose.
The clinical trial is being conducted at Schneider Children’s Medical Center in Israel, and the company expects to initiate the recruitment of subjects this month.
The Easy Check technology relies on a patent-pending reagent cell that combines patient’s exhaled air with a proprietary chemical compound, triggering a chemical reaction.
The glucose monitoring device eliminates a patient’s need to prick his or her finger multiple times per day to get a blood sugar reading.
The clinical study will evaluate the feasibility and reliability of Easy Check in measuring blood glucose levels under conditions of altered blood glucose levels compared to a standard invasive blood glucose metre.
Principal investigator of the trial Moshe Phillip said: "We 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 develops medical devices and molecular diagnostic systems for diabetes management, rapid medical testing and airborne bio-threat detection.
Last month PositiveID partnered with Diabetes Research Institute (DRI) at the University of Miami and Schneider Children’s Medical Center of Israel to support the continued development and study of its diabetes management products.
In April 2011, the company conducted initial side-by-side studies of its Easy Check device, and evaluated the accuracy of breath glucose detection device versus standard finger stick method.
According to the 2011 National Diabetes Fact Sheet, more than 25 million children and adults in the US have diabetes.