The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control Aged 12-25

INTERVENTION: This is a prospective multicentre randomized controlled, two‐arm unblinded, parallel study in free‐living conditions, in adolescents with type 1 diabetes on insulin pump therapy. Participants are randomized in two groups; either the control group (standard therapy) or the intervention group (hybrid closed loop, HCL). The control group will be participants on insulin pump therapy with or without continuous glucose monitoring (CGM). Intervention arm: Medtronic Advanced HCL system for 6 months (8 in‐clinic visits in 6 months) OR Control arm: Standard care for 6 months (7 in‐clinic visits in 6 months) This will be followed by an optional extension phase for another 6 months when those in the control arm would crossover to the intervention arm. Study participants in the intervention arm will use the Medtronic Advanced HCL (AHCL) system. The system includes the advanced Medtronic insulin pump with the compatible transmitter and sensor. The pump works in Manual Mode (comparable to current insulin therapy with the Medtronic 640G pump) and Auto Mode (hybrid closed loop therapy). Participants will be educated on the use of Auto Mode, an option available in the pump, which will adjust the insulin delivery based on the sensor glucose level. The user will still need to bolus for meals like standard pump therapy and hence this is 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. CONDITION: Metabolic and Endocrine ‐ Diabetes Type 1 Diabetes;Poor Glycaemic Control; ; Type 1 Diabetes ; Poor Glycaemic Control PRIMARY OUTCOME: Glycaemic control as measured by HbA1c collected via blood test.[At baseline and 6 months post randomisation.] SECONDARY OUTCOME: Changes in retinal microvascular structure (arteriolar or venular dilation, increased vascular fractal dimension, branching and tortuosity) from retinal photography. This is a composite secondary outcome.[At randomisation ; Endpoint ‐ 6 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Changes in retinopathy scores from retinal photography.[At randomisation ; Endpoint ‐ 6 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes using Standard Deviation and Coefficient of Variation of CGM values[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time <2.8 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time <3.3 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time <3.9 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time >10.0 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time >13.9 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time >16.7 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time 3.9‐10.0mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Glycaemic outcomes via CGM data for % CGM time 3.9‐7.8 mmol/L[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Health economic impact of the AHCL system vs standard therapy by collecting the following data during the study: ; a) Calculate number of hypoglycaemic events ; b) Changes in HbA1c ; c) Amount of time spent by investigators with participants (training, education, support) ; d) Calculating amount of diabetes management consumables used by participants (glucose strips, ketone strips, batteries, sensors, site dressings, lancets, needles, insulin)[Baseline ; At randomisation ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Human factors: adherence patterns as measured by assessing AHCL system data upload completion.[At randomisation ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated diabetes distress scales: Problem Areas in Diabetes questionnaires[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated diabetes‐specific quality of life questionnaires: PedsQL[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated fear of hypoglycaemia scales: Hypoglycaemia Fear Survey II questionnaires[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated general anxiety scales: Generalized Anxiety Disorder‐7 and Patient Health Questionnaire‐9 questionnaires ; ; This is a composite secondary outcome.[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated health status questionnaires: EQ‐5D‐Y[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated hypoglycaemia awareness questionnaire: Gold Score Hypoglycaemic Awareness[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] Psychosocial well‐being measured via validated treatment satisfaction questionnaires: INSPIRE and Diabetes Technology Questionnaires ; ; This is a composite secondary outcome.[Baseline ; Midpoint ‐ 3 months post‐baseline ; Endpoint ‐ 6 months post‐baseline ; Midpoint optional extension phase ‐ 9 months post‐baseline ; Endpoint optional extension phase ‐ 12 months post‐baseline] INCLUSION CRITERIA: 1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago) 2. Fasting C peptide less than 0.1nmol/L (in the absence of hypoglycaemia) 3. Pump therapy for at least 6 months 4. Age 12 to 25 years 5. Recent HbA1c above 9% in the last 3 months 6. Mean HbA1c above 9% for 6 months 7. Willing to follow study instructions 8. Willing to perform at least 3 finger stick blood glucose measurements daily 9. Willing to perform required sensor calibrations 10.Capable of reading and understand instructions in English 11.Living in an area with internet and cellular phone coverage