1.1.1 Safety The safety related objective of this study is to evaluate the incidence and severity of all adverse events. The primary safety parameter is the number of adverse events related to the device implantation and any other study related procedures from the time of device implantation until the end of the study (peri-operative complications including bleeding and infection, allergic reactions, occurrence of harm, tension or pressure on surrounding tissue etc.) 1.1.2 Performance To evaluate the technical stability of the Hyposafe hypoglycaemia alarm device during everyday activities.