Feasibility study of a novel glucose sensor in type 1 diabetes

A feasibility study to assess the accuracy and reliability of a novel continuous glucose monitoring (CGM) system in vivo in people with type 1 diabetes. For the duration of the study participants will concurrently wear two glucose sensors: 1) the investigational device - an electrochemical and optical fluorescence-based orthogonally redundant sensor (ORS), and 2) a non-redundant electrochemical sensor based on current CGM platforms. Each sensor will be inserted subcutaneously into the abdomen using a dedicated sensor inserter, a procedure which takes under 5 minutes. Immediately after sensor insertion, venous samples will be collected at 30 minute intervals for 4 hours for plasma glucose and glucose meter levels. After 48 or 72 hours +/- 4 hours of sensor wear participants will return to the clinical trials centre (CTC) and consume a standardised meal. Venous samples will be collected at 15 minutes intervals from 1 hour prior to the test meal until 3 hours post-meal for plasma glucose and glucose meter levels. Between visits to the CTC, finger prick glucose measurements will be performed a minimum of 6-8 times per day (spread throughout the day pre-meals and two hours post-meals) for the duration of the study. Glucose data from the study devices will not be available to the participants and will not impact on decisions involving their care. All participants will wear both sensors (investigational ORS and electrochemical) for up to 168 hours, with the first participant wearing the devices for 48 hours +/- 4 hours, followed by stepped increases in duration of wear up to 168 hours +/- 4 hours based on data analysis of prior data from participants.