InsuLine Medical of Petach-Tikvah, Israel has begun a clinical trial to test the safety and efficacy of its InsuPatch catheter in type 1 diabetics. The InsuPatch catheter is designed to increase local blood flow by the application of controlled thermal energy to local tissue. Preliminary data has shown that participants using the device demonstrated more rapid delivery and clearance of insulin, as well as higher peak concentrations than controls.
The trial will take place in the US and in Israel, and will involve 100 participants. InsuLine Medical expects the trial to be complete in the third quarter of 2011, and following a successful outcome, anticipates that the device may receive FDA approval by the end of 2011. The US trial will take place at the Mills Peninsula Health Center, California.