InsuLine Medical, an Israeli based company whose mission is to develop and market technologies for type 1 and type 2 diabetes, announced that it has completed a first stage clinical trial to examine the effectiveness of its InsuPatch for adults with type 1 diabetes.
InsuLine is developing two lines of products, the InsuPatch™ device for use with infusion pumps and the InsuPad™ device, to be used with insulin injections.
As of today, the company has conducted a series of over 100 human clinical studies demonstrating the safety and effectiveness of the first generation InsuPatch device. The product has received a CE mark enabling it to be marketed in the EU and the company is now seeking FDA approval.
In the first part of the trial, which has been completed, 55 diabetes patients were tested in a controlled setting, and InsuLine estimates that statistical results will be published within six weeks.The second part of the trial, examining safety issues of the InsuPatch, is being carried out in the US and in Israel. In this part of the study 100 patients are being tested by comparing quality of daily life during three months using the device with three months without the device. Upon completion of this stage of the trial, InsuLine will apply for FDA approval.