What this Trial Is About

Researchers are evaluating the safety of an implantable continuous blood glucose monitoring device in adults with Diabetes Mellitus. This early first-in-man clinical trial aims to determine whether the insertion and use of the Sensor Lead cause any procedure or device-related adverse events and to assess the surgical procedure and device performance. Participants will have the investigational Sensor Lead inserted into a vein using a specific technique, allowing continuous blood glucose measurement. They will remain in the hospital for a 96-hour observation period during which glucose levels, medications, and food intake will be closely monitored. Two intensive 3-hour testing sessions with frequent glucose sampling will also occur. After approximately 96 hours, the Sensor Lead will be removed, followed by an additional hour of observation before discharge. A follow-up visit will take place about one week later to examine the removal site and officially conclude participation. During the study, participants will perform up to seven daily fingerstick blood glucose tests with provided meters and strips, wear a subcutaneous continuous glucose sensor, and carry an Android phone for data uploads. Researchers will record all safety events and monitor the device's safety by confirming no serious adverse events occur from enrollment through seven days after Sensor Lead removal. The study will track device performance and participant health throughout the process.

Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor