This project will evaluate performance of 24/7 closed-loop in children and adolescents with type 1 diabetes in the laboratory and home settings. Traditionally, insulin is injected according to blood glucose levels measured with a spot glucose meter up to six times a day. However, insulin needs to be more accurately titrated to attain near-normal blood glucose levels and to reduce the risk of low blood glucose levels. This can be achieved by closed-loop insulin delivery. Glucose is measured on a minute-to-minute basis by a continuous glucose monitor. The signal is transmitted wirelessly to a handheld device, which calculates the right amount of insulin for a given glucose level. The information on the insulin rate is then transmitted wirelessly to an insulin pump. Utilising our knowledge and results obtained during testing of overnight closed-loop insulin delivery, we will develop and test a prototype of closed-loop system for 24/7 closed-loop insulin delivery. The clinical work will start by testing a prototype closed-loop system in controlled laboratory settings. Children and adolescents are known to have larger swings in insulin need than adults and laboratory experience is required to establish the feasibility and safety of closed-loop particularly after meals, during exercise, and following missed meal boluses and unannounced meals. We will proceed to testing 24/7 closed-loop insulin delivery at home settings over 30 days and compare with treatment by the continuous subcutaneous insulin infusion. It is anticipated that our results will contribute to the creation of medical, social, and regulatory acceptance of closed-loop control and will pave the way for its commercial exploitation and a widespread use of 24/7 closed-loop system.

Public Health Relevance

Treatment goals for subjects with type 1 diabetes are difficult to achieve due to an increased risk of hypoglycaemia associated with intensive insulin therapy. The overall objective of this project is to evaluate safety, efficacy, and utility of 24/7 closed-loop control with meal announcement in home settings in children and adolescents with type 1 diabetes. This will be preceded by evaluating 24/7 closed-loop control in compliant and non-compliant subjects in clinical research centre settings to collect data supporting regulatory submission for home testing.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Application #
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O2))
Program Officer
Arreaza-Rubin, Guillermo
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University of Cambridge
United Kingdom
Zip Code
CB2 1-TN
Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E et al. (2016) Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. Diabetes Care 39:2019-2025
Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E et al. (2016) Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial. Diabetes Care 39:1168-74
Thabit, Hood; Leelarathna, Lalantha; Wilinska, Malgorzata E et al. (2015) Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions. Diabetes Technol Ther 17:801-7
Thabit, H; Elleri, D; Leelarathna, L et al. (2015) Unsupervised home use of an overnight closed-loop system over 3-4 weeks: a pooled analysis of randomized controlled studies in adults and adolescents with type 1 diabetes. Diabetes Obes Metab 17:452-8
Tauschmann, Martin; Thabit, Hood; Leelarathna, Lalantha et al. (2015) Factors Associated With Glycemic Control During Free-Living Overnight Closed-Loop Insulin Delivery in Children and Adults With Type 1 Diabetes. J Diabetes Sci Technol 9:1346-7
Hovorka, R (2015) Artificial Pancreas Project at Cambridge 2013. Diabet Med 32:987-92
Elleri, D; Biagioni, M; Allen, J M et al. (2015) Safety, efficacy and glucose turnover of reduced prandial boluses during closed-loop therapy in adolescents with type 1 diabetes: a randomized clinical trial. Diabetes Obes Metab 17:1173-9
Hovorka, Roman; Nodale, Marianna (2014) Response to Mitre et al.: ""analysis of continuous glucose monitoring data to assess outpatient closed-loop studies: considerations for different sensors"". Diabetes Technol Ther 16:328-9
Thabit, Hood; Hovorka, Roman (2014) Bringing closed-loop home: recent advances in closed-loop insulin delivery. Curr Opin Endocrinol Diabetes Obes 21:95-101
Barnard, Katharine D; Wysocki, Tim; Allen, Janet M et al. (2014) Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents. BMJ Open Diabetes Res Care 2:e000025

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