A.Menarini Diagnostics announced that it will be completing the study of Glucoday by May 2011.
GlucoDay is semi-invasive continuous glucose monitor. Glucoday is in size of a portable audio device like a walkman tape player. The device charts an individual’s daily glucose activity especially during sleeping hours. With this information the health care team and the patient can modify the insulin regimen in order to achieve better control patterns. The device features a one point calibration per 48 hour monitoring period, wireless real-time display on instrument and PC, blind or displayed mode operation, alarm (buzzer or vibration) in case of hypoglycemia or hyperglycemia, less than 2 min delay in response time, long life on board biosensor (up to 6 months after the first use at room temperature) and an accessible data base. The system is based on a microdialysis” technique. GlucoDay consists of a micro-pump and a biosensor coupled with a microdialysis system. The micro-pump has a flow rate of 15-100 ul/min. Two flow rates can be used, one for cleaning or filling of the line and a slower rate for a continuous feed of the perfusion solution. The biosensor is made of an electrode which is covered by three separate membranes: a cellulose acetate membrane, an enzymatic membrane and a polycarbonate membrane. All held together by Teflon tubing. The device uses its peristalic pump to administer a continuous flow of perfusion solution from a storage bag in the device through the subject via a microfiber inserted under the skin. The microdialysis system is 2cm of a hallow fiber which is glued to two pieces of nylon tubing, a pair of twisted tungsten wires are inserted through the center to prevent a collapse of the membrane. The solution then carries a glucose sample from the microdialysis system to the biosensor in the device. The biosensor reacts continuously and a proportional current signal is detected and displayed every second. The solution continues through the biosensor and is dumped in another storage bag for disposal.
The 154 patient study is currently recruiting participants. The official title of the study is “Real Time Continuous Glucose Monitoring With Glucoday as an Assistant for Intensive Insulin Therapy in Diabetic Cardiothoracic Surgery Patients: a Randomized Study Comparing Blood Glucose Measurements Alone or Associated to Continue Glucose Monitoring”.