Assessment of closed loop technology in young children with Type 1 Diabetes Aged 2-7

The Randomised Controlled Trial (RCT) is a prospective multi-centre randomised controlled, two-arm unblinded, parallel study in free-living conditions, in young children with type 1 diabetes (T1D) on insulin pump therapy. Participants will be randomised in two groups; either the control group (standard therapy) or the intervention group (Advanced Hybrid Closed Loop, HCL). The control group will be participants on continuous subcutaneous insulin infusion (CSII) with or without CGM (continuous glucose monitoring). The study duration is for 3 months Intervention arm: Medtronic Advanced HCL system for 3 months OR Control arm: Standard care for 3 months The Medtronic Advanced HCL (AHCL) system comprises of the Medtronic MiniMed 780G insulin pump containing the closed loop algorithm, a next generation glucose sensor and a glucose sensor transmitter. The MiniMed 780G system has the capability to operate in Manual Mode or SmartGuard Mode (also referred to as AHCL or Auto Mode). After randomisation, participants in the intervention group and their parents will be educated on the use of Auto Mode (which will adjust the insulin delivery based on their determined set threshold of either 5.5 mmol/L, 6.1 mmol/L, or 6.7 mmol/L) during a 2-hour pump and CGM (continuous glucose monitoring) training. The information session will cover: - Instructions for pump upload - Instructions to log hypoglycaemia and hyperglycaemia in the record book provided - Instructions to link the participant's CGM to the Medtronic 780G pump Sensor naïve individuals will have familiarisation phase of 7 to 10 days to get used to wearing a sensor. The blood glucose threshold will be set at the discretion of the participant's endocrinologist. The AHCL algorithm will calculate the insulin dose at five-minute intervals based on their CGM data, in order to achieve glycaemic control throughout the day. Participants will still need to bolus for meals like standard pump therapy; hence described as a hybrid closed loop system. The advanced algorithm will be more robust in correcting hyperglycaemia as compared to the currently available Medtronic 670G system. The modifications to the closed loop algorithm include the addition of adjustable target set points (5.5 mmol/L, 6.1 mmol/L, and 6.7 mmol/L), an auto correction bolus without user input or acknowledgement and fine tuning of safeguards in order to reduce auto mode exits and improve user experience. The system will also have an additional Bluetooth capability which will make it possible to control the glucose level via a phone app and is therefore more suitable for this young cohort. 11 weeks after randomisation, participants in within the control group will attend the clinic for the insertion of a blinded CGM. This constitutes first of the two sensors, each sensor provides data for 7 days and parents will be instructed to test their children for a minimum of 3 to 4x /day using the study meter. Participants will return after 7 days to have the first sensor removed and the second sensor inserted. A minimum of 10 days of data will be requited from the 2 sensors. In participants who do not meet this requirement, repeat sensors will be offered till a maximum of 4 attempts of data collection. All visits will be conducted by a Diabetes educator with the supervision of an endocrinologist. Participants will have weekly communication via phone call or email for support in between clinic visits