SigiFIHSigi Insulin Management System - First-in-Human Study

The study focuses on testing a new device called the Sigi Insulin Management System, designed for people with diabetes who need to manage their insulin levels. This system is an advanced insulin patch pump that delivers insulin under the skin at controlled rates, both set and variable. It aims to provide more accurate and precise insulin delivery, quick detection of blockages, and includes features like pre-filled insulin cartridges and the ability to control it via a smartphone. This study, conducted in Lausanne University Hospital in Switzerland, is important as it could potentially make managing diabetes easier and more efficient for patients. Participants in the study will use the Sigi device, which is worn as a patch on the skin. The device administers insulin and is monitored using continuous glucose monitoring (CGM) to ensure safety and effectiveness. Data from the CGM is shared with the medical team throughout the study to keep track of participants' blood sugar levels and ensure their safety. The study does not specify particular outcomes, but it aims to assess the feasibility and performance of the device in a real-world setting.