Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID)

This is an up to 92-week multiphase single site and single arm clinical trial with an expected duration of an individual’s study participation of up to 85 weeks. The trial consists of 4 study periods (described below). The co-primary objectives of this exploratory study are to investigate the safety and effectiveness of a Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID) system in children (2 – 17 years, inclusive) and adults (18 years and older) with type 1 diabetes. All study outcomes are exploratory. Period 1: For baseline data collection, participants will be trained in the use of MiniMed™ 780G AHCL system with Guardian 4 sensors and Guardian Link 4 transmitters (Medtronic) and wear this system for 3 weeks (NB: All participants in this study will have prior experience using the MiniMed 770G/780G system). Following the 3-week baseline data collection, participants will undergo NMX-AID system training (approx. 5 hours) and use the system for up to 9 weeks (duration dependent on participant age as described below). Enrollment will be staggered by age groups, with adults (aged 18 years and older) starting first, followed by children aged 7 to 17 and lastly children 2-6 years of age. - Adults (aged 18 years and older): Following training on the NMX-AID system, adult participants will use the system for 9 weeks at home. - Children 7 to 17 years of age (inclusive) will commence the study following study completion of adult participants and no detection of safety concerns (severe hypoglycaemia or diabetic ketoacidosis attributable to NMX-AID system wear). Immediately following training on the NMX-AID system, children aged 7-17 years (together with a parent/guardian) will enter a supervised hotel phase for 5 days/4 nights. Constant on-site supervision will be provided by health care professionals (HCP; medical and nursing staff), including overnight monitoring using CareLink™ Clinical App, which allows for remote data monitoring from a HCP's study smartphone. Following the supervised hotel phase, participants will use the NMX-AID system for 7 weeks at home, with support from their parent/guardian. - Children 2-6 years of age (inclusive) will commence the study following study completion of children aged 7-17 years when the system is considered ready for progression to this age group. This will be done in Period 3 (below). Period 2: After completion of Period 1, participants will enter an up to 35-week Observation Period, where they will transition back to the 780G AHCL system, including the Guardian 4 CGM system, provided through the study. The study team will be available for any questions or concerns by participants and adverse event collection will continue during the Observation Period. During this time, algorithm optimization based on Period 1 outcomes will be performed. Subsequently, use of the updated NMX-AID system will resume (detailed below). Period 3: Expected duration of an individual’s study participation during this period is up to 28 weeks. Following an up to 4-week baseline data collection, participants will undergo NMX-AID training (up to 4 hours) and use the system for up to 24 weeks at home. The study design for Period 3 will be similar to the staggered design described above for Period 1: First, adults (18 years and older) will commence. Once all adult participants have completed a minimum of 1 week (no upper limit) of the study and no safety concerns identified, then children aged 7-17 years will commence. Once these participants have completed a minimum of 2 weeks (no upper limit) of the study and no safety concerns identified, then children aged 2-6 years will commence. Period 4: Following completion of Period 3 as described above, a continuation of the study period using the NMX software in a novel pump housing, named NMX8, will commence for adults and children aged 7-17 years. Following NMX8 training (up to 3 hours), participants will use the system for up to 8 weeks at home. The study design for Period 4 will be similar to the staggered design described above for Period 1: First, adults (18 years and older) will commence. Once all adult participants have completed a minimum of 1 week (no upper limit) of the study and no safety concerns identified, then children aged 7-17 years will commence. The NMX-AID insulin pump is capable of continuous insulin delivery, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. When used with the continuous glucose monitoring (CGM) components (Simplera Sync), the pump system is capable of continuous or periodic monitoring of glucose levels via a sensor that is inserted in the interstitial fluid under the skin, including the detection of possible low or high blood glucose episodes. The pump also displays glucose values, storing the data so that it can be retrospectively analysed to track patterns and improve diabetes management. The NMX-AID system has the capability to operate in Manual Mode (also referred to as open loop) or in Auto Mode (also referred to as closed loop). While users have the option to manually announce meals to the system, the closed loop algorithm of the NMX-AID system enables the auto-delivery of meal insulin boluses without user input or acknowledgement. When Auto Mode is enabled, the sensor glucose (SG) value received by the pump from the CGM system will be used to automatically calculate the required insulin dose. It will then deliver insulin to the user, at five-minute intervals, to achieve glycaemic control. Basal rates are set for periods of Manual Mode (open loop) therapy. When Auto Mode is not enabled, the user may use the Low Management features. Here, basal rate delivery will be suspended either when the SG has reached a programmed low glucose threshold (Suspend on Low) or before the SG has reached the programmed low glucose threshold (Suspend before Low). Participants will receive face-to-face education at the study site by trained study staff (research nurses or diabetes educators with diabetes knowledge who are insulin pump trainers) based on the manufacturer's user guides. The initial educational session will take approximately 4-5 hours, including the device set-up of the pump. All participants will be monitored remotely by study staff during at-home NMX-AID system use. Monitoring will occur in form of review of system data uploads via CareLink™ software and phone calls with participants or parents/guardians (as applicable). During Periods 1, 2, and 3, participants’ pump data will be automatically uploaded to CareLink™ through the MiniMed™ Mobile phone app, which will be installed on participants’ phones and is connected with the pump via Bluetooth, every 24 hours, where study staff can review the data and give feedback to refine pump settings if necessary. These refinements are personalised based on the participant’s uploaded data and will happen after each review of the uploaded pump data. During Period 4, an identical process will be followed; however, participants’ pump data will be uploaded to CareLink™ through the Controller™ App, which will be installed on study phones. All participants will be provided with a study phone.