Clinical Research Directory

Inclusion Criteria: 1. Age ≥6 and \<19 years 2. Type 1 diabetes as defined by WHO (51) for at least 1 year \[WHO definition: 'The aetiological type named type 1 encompasses the majority of cases with are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).'\] 3. Use of an insulin pump for at least 3 months, with good knowledge of insulin self-adjustment by subject or caregiver as judged by the investigator 4. Using U-100 rapid acting insulin analogues insulin Aspart or Lispro only 5. Willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements per day day 6. Screening HbA1c ≥ 7.0% (53 mmol/mol) and ≤10 % (86mmol/mol) based on analysis from local laboratory 7. Literate in English 8. Willing to wear glucose sensor 9. Willing to wear closed-loop system at home 10. Willing to follow study specific instructions 11. Willing to upload pump and CGM data at regular intervals 12. Access to WiFi. 13. Lives with someone who is trained to administer intramuscular glucagon and is able to seek emergency assistance Exclusion Criteria: 1. Living alone 2. Current use of any closed-loop system 3. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 4. Untreated coeliac disease, adrenal insufficiency, or untreated thyroid disease 5. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc. 6. Known or suspected allergy to insulin 7. Clinically significant nephropathy (eGFR \< 45ml/min) or on dialysis, neuropathy or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator 8. Recurrent incidents of severe hypoglycaemia (\>1 episode) during the previous 6 months (adolescents: severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital; children: severe hypoglycaemia is defined as an event associated with a seizure or loss of consciousness) 9. Recurrent incidents of diabetic ketoacidosis (\>1 episode) during previous 6 months 10. Unwilling to avoid regular use of acetaminophen 11. Lack of reliable telephone facility for contact 12. Total daily insulin dose ≥ 2 IU/kg/day 13. Total daily insulin dose \< 15 IU/day 14. Pregnancy, planned pregnancy, or breast feeding 15. Severe visual impairment 16. Severe hearing impairment 17. Seizure disorder 18. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement 19. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor) 20. Illicit drugs abuse 21. Subject is currently abusing prescription drugs 22. Alcohol abuse 23. Use of pramlintide (Symlin), or other non-insulin glucose lowering agents including sulphonylureas, biguanides, DPP4-Inhibitors, , GLP-1 analogues, SGLT-1/ 2 inhibitors at time of screening 24. Shift work with working hours between 10pm and 8am 25. Sickle cell disease, haemoglobinopathy, or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening 26. Eating disorder such as anorexia or bulimia 27. Employed by Medtronic Diabetes or with immediate family members employed by Medtronic Diabetes