Evaluation of the efficacy and safety of the novel Medtronic experimental automated insulin delivery system in adults with Type 1 Diabetes during exercise

- All eligible participants with Type 1 Diabetes will be transferred to the investigational Medtronic Experimental Automated Insulin Delivery (NMX7-AID) system in conjunction with the Simplera Sync™ sensor for the duration of the study. Details below are provided for both NMX7-AID and Simplera Sync sensor: a) The Simplera Sync sensor is a subcutaneously inserted continuous glucose monitor comparable in nature to widely available commercial continuous glucose monitors, measuring interstitial glucose every 5 minutes. The NMX7-AID system is comparable to widely available commercial automated insulin delivery systems. The system incorporates an insulin pump and a control algorithm, which use glucose levels measured by the continuous glucose monitor, processed by the algorithm to automatically and continuously adjust the delivery of rapid acting insulin via a subcutaneous canula under the skin. b) The CGM is applied via proprietary inserter into the subcutaneous tissue, while the insulin pump is attached via a tethered infusion line to a subcutaneous canula, via which is infuses rapid acting insulin. c) The participants must replace the sensor, infusion set and cannula at regular intervals (approximately weekly). They interact with the device via phone application to view their sensor glucose and modify insulin pump settings. d) Participants are provided the devices after screening, with education provided by a diabetes educator, in which they will swap from their regular commercial AID system to the interventional NMX7-AID system. Participants will use the devices continuously for the entire study duration. - Participation in the study will involve a total commitment of up to six months. - Exercise sessions will be scheduled at intervals ranging from a minimum of 48 hours to a maximum of two weeks apart. All exercise sessions must be completed within a 16-week period. - Following successful screening, participants will complete a four-week run-in period. During the run-in period participants will undertake their usual daily activities during the 4-week run-in period, with regular check-ins from the study team (device data will be reviewed daily for the first week, and every 2 days for the remainder). This is to ensure the device is functioning as anticipated. - Participants will subsequently complete a total of eight supervised, in-person exercise sessions, at the clinical site, organised into two blocks: Block 1 (exercise sessions 1–4) and Block 2 (exercise sessions 5–8). Each of the eight exercise sessions will be separated by at least 48 hrs (from commencement to commencement) and up to two weeks following the previous exercise session. This ensures no lingering effect of the previous exercise on insulin sensitivity influences results of subsequent sessions. - All exercise sessions will be supervised by qualified exercise physiologists in conjunction with the study physician. - Block 1 consists of four exercise sessions which consist of two moderate-intensity exercise (MIE) sessions and two high-intensity interval exercise (HIIE) sessions which are completed in the morning after overnight fast or in the afternoon having fasted for at least 3 hours before scheduled session with temporary targets set. - All Block 2 sessions are completed in the afternoon with the same temporary target set with varying regimes for consuming carbohydrates. - The exercise protocol will consist of six moderate-intensity exercise (MIE) sessions and two high-intensity interval exercise (HIIE) sessions to be completed using an exercise bike. - The order of exercise conditions, setting temporary targets on the study device and consuming food within each block will be randomised and participants advised of this order following completion of Run-in.. - For morning exercise sessions, participants will attend the clinical site between 6:00 and 10:00 a.m. following an overnight fast. - For afternoon exercise sessions, participants will attend the clinical site between 12:00 p.m. and 5:00 p.m. - Participants will be closely monitored throughout each exercise session using device data, continuous glucose monitoring, finger-stick blood samples for glucose and lactate measurement, and physical assessments to evaluate exercise intensity. -The study blocks differ in the comparisons made. In Block 1, each of the sessions will be compared with each of the other sessions for each of the outcomes. In Block 2, each of the sessions will be compared with the corresponding afternoon, moderate intensity session from Block 1. - Participants will consume a standardised meal approximately 30 minutes post-exercise at the clinical site. Commercially available frozen meals will provided to adhere to the study protocol as described below • Morning post-exercise meal: 30g carbohydrate, 10g protein, 10g fat • Afternoon post-exercise meal: 60g carbohydrate, 20g protein, 20g fat - A break in study activities of up to 12 weeks will occur between completion of Block 1 and start of Block 2. - Adherence to the study protocol will be continuously assessed throughout the study via review of device data and continuous glucose monitoring by the study team.