Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes:crossover randomised controlled studies

Hovorka, Roman, Kumareswaran, Kavita, Harris, Julie, Allen, Janet M, Elleri, Daniela, Xing, Dongyuan, Kollman, Craig, Nodale, Marianna, Murphy, Helen R, Dunger, David B, Amiel, Stephanie A, Heller, Simon R, Wilinska, Malgorzata E and Evans, Mark L (2011) Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes:crossover randomised controlled studies. BMJ, 342. ISSN 1756-1833

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Abstract

OBJECTIVE: To compare the safety and efficacy of overnight closed loop delivery of insulin (artificial pancreas) with conventional insulin pump therapy in adults with type 1 diabetes. DESIGN: Two sequential, open label, randomised controlled crossover, single centre studies. SETTING: Clinical research facility. PARTICIPANTS: 24 adults (10 men, 14 women) with type 1 diabetes, aged 18-65, who had used insulin pump therapy for at least three months: 12 were tested after consuming a medium sized meal and the other 12 after consuming a larger meal accompanied by alcohol. INTERVENTION: During overnight closed loop delivery, sensor measurements of glucose were fed into a computer algorithm, which advised on insulin pump infusion rates at 15 minute intervals. During control nights, conventional insulin pump settings were applied. One study compared closed loop delivery of insulin with conventional pump therapy after a medium sized evening meal (60 g of carbohydrates) at 1900, depicting the scenario of "eating in." The other study was carried out after a later large evening meal (100 g of carbohydrates) at 2030, accompanied by white wine (0.75 g/kg ethanol) and depicted the scenario of "eating out." MAIN OUTCOME MEASURES: The primary outcome was the time plasma glucose levels were in target (3.91-8.0 mmol/L) during closed loop delivery and a comparable control period. Secondary outcomes included pooled data analysis and time plasma glucose levels were below target (≤ 3.9 mmol/L). RESULTS: For the eating in scenario, overnight closed loop delivery of insulin increased the time plasma glucose levels were in target by a median 15% (interquartile range 3-35%), P = 0.002. For the eating out scenario, closed loop delivery increased the time plasma glucose levels were in target by a median 28% (2-39%), P = 0.01. Analysis of pooled data showed that the overall time plasma glucose was in target increased by a median 22% (3-37%) with closed loop delivery (P < 0.001). Closed loop delivery reduced overnight time spent hypoglycaemic (plasma glucose ≤ 3.9 mmol/L) by a median 3% (0-20%), P=0.04, and eliminated plasma glucose concentrations below 3.0 mmol/L after midnight. CONCLUSION: These two small crossover trials suggest that closed loop delivery of insulin may improve overnight control of glucose levels and reduce the risk of nocturnal hypoglycaemia in adults with type 1 diabetes. Trial registration ClinicalTrials.gov NCT00910767 and NCT00944619.

Item Type: Article
Additional Information: This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
Uncontrolled Keywords: adolescent,adult,aged,algorithms,blood glucose,cross-over studies,type 1 diabetes mellitus,female,humans,hypoglycemic agents,insulin,insulin infusion systems,male,middle aged,treatment outcome,young adult
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School

Faculty of Science > School of Environmental Sciences
Depositing User: Pure Connector
Date Deposited: 25 May 2016 16:01
Last Modified: 22 Apr 2020 01:26
URI: https://ueaeprints.uea.ac.uk/id/eprint/59066
DOI: 10.1136/bmj.d1855

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