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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.


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Authors

Thabit, H 
Elleri, D 
Leelarathna, L 
Allen, JM 
Lubina-Solomon, A 

Abstract

AIMS: To compare overnight closed-loop and sensor-augmented pump therapy in patients with type 1 diabetes by combining data collected during free-living unsupervised randomized crossover home studies. METHODS: A total of 40 participants with type 1 diabetes, of whom 24 were adults [mean ± standard deviation (s.d.) age 43 ± 12 years and glycated haemoglobin (HbA1c) 8.0 ± 0.9%] and 16 were adolescents (mean ± s.d. age 15.6 ± 3.6 years and HbA1c 8.1 ± 0.8%), underwent two periods of sensor-augmented pump therapy in the home setting, in combination with or without an overnight closed-loop insulin delivery system that uses a model predictive control algorithm to direct insulin delivery. The order of the two interventions was random; each period lasted 4 weeks in adults and 3 weeks in adolescents. The primary outcome was time during which sensor glucose readings were in the target range of 3.9-8.0 mmol/l. RESULTS: The proportion of time when sensor glucose was in the target range (3.9-8.0 mmol/l) overnight (between 24:00 and 08:00 hours) was 18.5% greater during closed-loop insulin delivery than during sensor-augmented therapy (p < 0.001). Closed-loop therapy significantly reduced mean overnight glucose levels by 0.9 mmol/l (p < 0.001), with no difference in glycaemic variability, as measured by the standard deviation of sensor glucose. Time spent above the target range was reduced (p = 0.001), as was time spent in hypoglycaemia (<3.9 mmol/l; p = 0.014) during closed-loop therapy. Lower mean overnight glucose levels during closed-loop therapy were brought about by increased overnight insulin delivery (p < 0.001) without changes to the total daily delivery (p = 0.84). CONCLUSION: Overnight closed-loop insulin therapy at home in adults and adolescents with type 1 diabetes is feasible, showing improvements in glucose control and reducing the risk of nocturnal hypoglycaemia.

Description

Keywords

clinical trial, closed-loop insulin delivery, glycaemic control, type 1 diabetes, Adolescent, Adult, Algorithms, Blood Glucose, Blood Glucose Self-Monitoring, Cross-Over Studies, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Time Factors, Treatment Outcome

Journal Title

Diabetes Obes Metab

Conference Name

Journal ISSN

1462-8902
1463-1326

Volume Title

17

Publisher

Blackwell Publishing Ltd
Sponsorship
Cambridge University Hospitals NHS Foundation Trust (CUH) (Roman Hovorka)
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085621)
Medical Research Council (G0600717)
Wellcome Trust (100574/Z/12/Z)
Diabetes UK (None)
Medical Research Council (G0600717/1)
Juvenile Diabetes Research Foundation (#22-2009-802) and Diabetes UK (BDA07/0003549) with additional support for the Artificial Pancreas work by National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK085621), and National Institute for Health Research Cambridge Biomedical Research Centre. Abbott Diabetes Care supplied continuous glucose delivery devices and sensors and modified devices to facilitate real-time connectivity.