Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device

The study is an open-label, randomized, two-period, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol. The study consists of two parts. Subject may participate in both parts or just in one part. The first part tests the effect of local heating on the post prandial glucose levels following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected 0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin measurements was taken from a venous line. The study was conducted twice with (test) and without (control) the use of the InsuPad device. The second part evaluate the safety and efficacy of the device use at daily life settings. Type I and type II diabetic patients enrolled to the study. They will be required to perform at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25 months. Up to one month run in period, up to 12 months with the device (test) and up to 12 months without the device (control).The subjects will be asked to record events of hypoglycemia, hyperglycemia and any adverse events related to diabetes or the study.