Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of a Combined Insulin-Delivery and Glucose Sensory System and Patch Pump System in Persons with Type 1 Diabetes

This is a prospective, non-randomised, single-centre, feasibility study. The participants will have an experimental combined insulin cannula and glucose sensor (Synergy) delivering insulin integrated with a novel Insulin Patch Pump (Pharmasens Niia Essential patch pump system). There is no control device. The participants will also have a Dexcom G6 Continuous glucose Monitor (CGM) system inserted. It is the first human clinical trial to be conducted with this system. Insulin delivery will be operated manually via the patch pump by trained study personnel. There will be no closed- or hybrid closed loop system in operation. The study will consist of two phases: Firstly a pilot phase, and secondly the main three day study phase. The device is inserted using sterile non-touch technique and with the assistance of an insertion device to ensure the glucose sensing cannula sits in the subcutaneous tissue. PILOT PHASE: Three participants will use the investigational device for 12 hours. The patch pump and integrated SynerG CGM Sensor will be inserted by trained study personnel. During this time there will be one meal test. The meal test will last 4-5 hours with 15 minutely interval blood sampling. Trained study staff will manually operate the insulin patch pump to administer insulin. After achieving stable glucose elves the systems will be removed and participants will resume their usual diabetes management. Participants involved in the pilot phase will not be involved in the main phase. MAIN PHASE 15 participants will wear the investigational devices for 72 hours spread across four consecutive calendar days. During this extended monitoring period, each participant will undergo two meal tests in the clinical trials centre on days 1 and 3, with free living days in between and until the end of the study period. During the free living period, participants will stay at a hotel near the clinic with study staff onsite. Study staff will manually operate insulin pumps to deliver insulin and CGM glucose levels will be monitored remotely by trained study staff. Participants will perform fingerpick glow glucose measurements throughout the day (fasting, preprandial/2-h postprandial at each meal, bedtime) or when required (suspected hypoglycaemia, suspected technical failure of CGM, etc.). The study staff will be available at the hotel promptly whenever needed.. MEAL TESTS The meal tests in both the pilot phase and the main phase, participants will arrive to the clinical trials centre at 7am after an overnight fast. After insertion of investigational devices (if required), participants will consume a standardised carbohydrate breakfast of 30-60g of carbohydrate. 15 minutely venous blood samples will be taken to monitor blood glucose levels. Meal tests will last over 4-5 hours. After 72 hours, all study devices will be removed, and participants will resume normal diabetes management with their personal devices. Experimental device CGM data will be collected throughout the study period. Experimental device CGM accuracy will be compared with reference Yellow Springs Instruments (YSI) blood glucose level (BGL) as well as commercially available Dexcom G6 CGM readings. Training of the device will be provided to study staff by Pharmasens with 2 hours of face to face practical training 1 week prior to enrolment of the first participant. Adherence to the intervention is assessed by direct observation of participants and measurement of blood glucose levels.