Feasibility Trial to Evaluate the Eclipse 3 Continuous Glucose Monitoring System - Australia (FREE - AU Trial)

This trial is designed to evaluate device tolerance and safety of the Eclipse 3 CGM System, a third-generation sensor design in a small group of participants. Additionally, this limited scope trial will help to determine whether the new design elements incorporating a smaller sensor (approximately 40% smaller than the prior design), modernized functionality and optimized sensor signal processing techniques have resulted in improved sensor performance. 6-8 participants are expected to be enrolled in this study and the sensor will be implanted into the participant’s lower abdominal area and remain there for a minimum of four and a half months and up to eight months, after which it will be removed. The sensor implant requires a minor 30 minute surgical operation usually achieved under local anaesthesia with some intravenous sedation in which the surgeon will complete a small incision in the lower abdomen to implant the sensor. At the end of the study, another minor surgical operation using the same technique is required to remove the sensor. Throughout the course of the trial, device properties and safety assessments will be made to determine device function. Participants will attend the clinical site weekly post device implant for up to 2 weeks to evaluate wound healing, and then at monthly intervals to undergo meal testing and frequent blood sampling. Blood samples taken during the monthly visits will assess device safety and determine if the protocol will be terminated at 4.5 months, or up to 8 months. Participants will be required to test their blood glucose daily by fingerprick a minimum of 4 times per day and fill out a diary each week to monitor adherence to the study requirements. The study diary will be reviewed at each visit.