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

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...

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Autores principales: 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, Evans, Mark L
Formato: Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3077739/
https://www.ncbi.nlm.nih.gov/pubmed/21493665
http://dx.doi.org/10.1136/bmj.d1855
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author 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
Evans, Mark L
author_facet 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
Evans, Mark L
author_sort Hovorka, Roman
collection PubMed
description 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.
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spelling pubmed-30777392011-04-25 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 Evans, Mark L BMJ Research 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. BMJ Publishing Group Ltd. 2011-04-13 /pmc/articles/PMC3077739/ /pubmed/21493665 http://dx.doi.org/10.1136/bmj.d1855 Text en © Hovorka et al 2011 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.
spellingShingle Research
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
Evans, Mark L
Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title_full Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title_fullStr Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title_full_unstemmed Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title_short Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
title_sort overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3077739/
https://www.ncbi.nlm.nih.gov/pubmed/21493665
http://dx.doi.org/10.1136/bmj.d1855
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