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. Issue 5 (9th January 2015)

• Record Type: Journal Article
• Authors: Thabit, H.; Elleri, D.; Leelarathna, L.; Allen, J. M.; Lubina‐Solomon, A.; Stadler, M.; Walkinshaw, E.; Iqbal, A.; Choudhary, P.; Wilinska, M. E.; Barnard, K. D.; Heller, S. R.; Amiel, S. A.; Evans, M. L.; Dunger, D. B.; Hovorka, R.
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 5(2015:May)
• Page Start: 452
• Page End: 458
• Publication Date: 2015-01-09
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12427
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12427-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12427-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12427-para-0001">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.</p> </sec> <sec id="dom12427-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12427-para-0002">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.</p> </sec> <sec id="dom12427-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12427-para-0003">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).</p> </sec> <sec id="dom12427-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12427-para-0004">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.</p> </sec> </abstract>