PositiveID Corp., a developer of medical technologies for diabetes management, announced today that it has commenced a clinical trial of its Easy Check™ non-invasive breath glucose detection device for people with diabetes. The clinical trial, being held at Schneider Children’s Medical Center in Israel, a preeminent research hospital, will initially focus on people with type 1 diabetes and the Company expects to begin recruiting subjects this month.
Currently under development in Israel, Easy Check is a non-invasive breath glucose detection device that measures the level of acetone in a patient’s exhaled breath and correlates that acetone level to a measure of blood glucose. The Easy Check technology is based on a patent-pending reagent cell that mixes a patient’s exhaled air with a proprietary chemical compound, triggering a chemical reaction. The reaction is measured and software in the Easy Check device then interprets the measurement and correlates the patient’s acetone level to the level of glucose in the body. The goal of Easy Check is to eliminate a patient’s need to prick his or her finger multiple times per day to get a blood sugar reading.
The purpose of the clinical study is to assess the feasibility of Easy Check compared to a standard invasive blood glucose meter and to assess the reliability of Easy Check in measuring blood glucose levels under conditions of altered blood glucose levels. The study will be led by principal investigator Moshe Phillip, Professor and Director of the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes at Schneider Children’s Medical Center of Israel.
Prof. 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 Chairman and CEO William J. 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. We are very pleased that Prof. Phillip, a world renowned endocrinologist heavily involved in groundbreaking diabetes research, is spearheading this study and we look forward to communicating our progress.”
The clinical study has been approved as compliant with the Declaration of Helsinki, which is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
Schneider Children’s is the only comprehensive, highly specialized care hospital of its kind in the country of Israel and in the Middle East, dedicated exclusively to the well-being of all children and adolescents. Schneider Children’s provides the full range of pediatric subspecialties and comprehensive paramedical services to all children. The medical center serves as the national referral center for Hematology-Oncology, Endocrinology and Childhood Diabetes, and Cardiology and is the country’s leading institution in the field of bone marrow and organ transplants, such as heart and lung, liver and kidney.
Let us hear your thoughts below:
