Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints

Autores
Fushimi, Emilia; Rosales, Nicolás; de Battista, Hernán; Garelli, Fabricio
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Artificial pancreas (AP) systems for people with type 1 diabetes (T1DM) combine the use of a smart insulin pump with a Continuous Glucose Monitor (CGM) and a control algorithm to improve the regulation of glycaemia. Based on the extensive clinical evidence provided by the main research groups in the area, a hybrid control algorithm combining insulin meal boluses and glucose feedback action has been recently approved. However, this sort of algorithms should be refined especially during the postprandial period. In turn, fully closed-loop control strategies have to be further developed. In either case, intensive in vivo validation is necessary to ensure the viability of the proposed strategy as an effective method to treat T1DM patients. In this paper, a safety layer called SAFE loop [1] is reformulated to be employed during clinical trials in two different ways: the time enable mode to gradually activate the closed-loop control after an insulin meal bolus in hybrid configurations; and the amplitude enable mode to activate the full closed-loop control as long as the insulin infusion does not exceed the conventional therapy to a given extent. The SAFE module decides the activation of the controller as a function of a constraint on the insulin on board (IOB). In the case of the Time Enable, this results in the use of a constant restriction on the IOB, whereas in the amplitude enable it results in the use of a time-varying IOB constraint. Both operation modes are evaluated in silico using broadly accepted high-order models and the results contrasted with the ones obtained without the SAFE protection.
Fil: Fushimi, Emilia. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Rosales, Nicolás. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: de Battista, Hernán. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Garelli, Fabricio. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
ARTIFICIAL PANCREAS
CLINICAL TRIAL
GLUCOSE CONTROL
INSULIN-ON-BOARD
SLIDING MODE CONTROL
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/85562
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/85562
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraintsFushimi, EmiliaRosales, Nicolásde Battista, HernánGarelli, FabricioARTIFICIAL PANCREASCLINICAL TRIALGLUCOSE CONTROLINSULIN-ON-BOARDSLIDING MODE CONTROLhttps://purl.org/becyt/ford/2.2https://purl.org/becyt/ford/2Artificial pancreas (AP) systems for people with type 1 diabetes (T1DM) combine the use of a smart insulin pump with a Continuous Glucose Monitor (CGM) and a control algorithm to improve the regulation of glycaemia. Based on the extensive clinical evidence provided by the main research groups in the area, a hybrid control algorithm combining insulin meal boluses and glucose feedback action has been recently approved. However, this sort of algorithms should be refined especially during the postprandial period. In turn, fully closed-loop control strategies have to be further developed. In either case, intensive in vivo validation is necessary to ensure the viability of the proposed strategy as an effective method to treat T1DM patients. In this paper, a safety layer called SAFE loop [1] is reformulated to be employed during clinical trials in two different ways: the time enable mode to gradually activate the closed-loop control after an insulin meal bolus in hybrid configurations; and the amplitude enable mode to activate the full closed-loop control as long as the insulin infusion does not exceed the conventional therapy to a given extent. The SAFE module decides the activation of the controller as a function of a constraint on the insulin on board (IOB). In the case of the Time Enable, this results in the use of a constant restriction on the IOB, whereas in the amplitude enable it results in the use of a time-varying IOB constraint. Both operation modes are evaluated in silico using broadly accepted high-order models and the results contrasted with the ones obtained without the SAFE protection.Fil: Fushimi, Emilia. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Rosales, Nicolás. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: de Battista, Hernán. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Garelli, Fabricio. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaElsevier Science2018-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/85562Fushimi, Emilia; Rosales, Nicolás; de Battista, Hernán; Garelli, Fabricio; Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints; Elsevier Science; Biomedical Signal Processing and Control; 45; 8-2018; 1-91746-8094CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.bspc.2018.05.009info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1746809418301113info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:39:18Zoai:ri.conicet.gov.ar:11336/85562instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:39:18.952CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
title Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
spellingShingle Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
Fushimi, Emilia
ARTIFICIAL PANCREAS
CLINICAL TRIAL
GLUCOSE CONTROL
INSULIN-ON-BOARD
SLIDING MODE CONTROL
title_short Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
title_full Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
title_fullStr Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
title_full_unstemmed Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
title_sort Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints
dc.creator.none.fl_str_mv Fushimi, Emilia
Rosales, Nicolás
de Battista, Hernán
Garelli, Fabricio
author Fushimi, Emilia
author_facet Fushimi, Emilia
Rosales, Nicolás
de Battista, Hernán
Garelli, Fabricio
author_role author
author2 Rosales, Nicolás
de Battista, Hernán
Garelli, Fabricio
author2_role author
author
author
dc.subject.none.fl_str_mv ARTIFICIAL PANCREAS
CLINICAL TRIAL
GLUCOSE CONTROL
INSULIN-ON-BOARD
SLIDING MODE CONTROL
topic ARTIFICIAL PANCREAS
CLINICAL TRIAL
GLUCOSE CONTROL
INSULIN-ON-BOARD
SLIDING MODE CONTROL
purl_subject.fl_str_mv https://purl.org/becyt/ford/2.2
https://purl.org/becyt/ford/2
dc.description.none.fl_txt_mv Artificial pancreas (AP) systems for people with type 1 diabetes (T1DM) combine the use of a smart insulin pump with a Continuous Glucose Monitor (CGM) and a control algorithm to improve the regulation of glycaemia. Based on the extensive clinical evidence provided by the main research groups in the area, a hybrid control algorithm combining insulin meal boluses and glucose feedback action has been recently approved. However, this sort of algorithms should be refined especially during the postprandial period. In turn, fully closed-loop control strategies have to be further developed. In either case, intensive in vivo validation is necessary to ensure the viability of the proposed strategy as an effective method to treat T1DM patients. In this paper, a safety layer called SAFE loop [1] is reformulated to be employed during clinical trials in two different ways: the time enable mode to gradually activate the closed-loop control after an insulin meal bolus in hybrid configurations; and the amplitude enable mode to activate the full closed-loop control as long as the insulin infusion does not exceed the conventional therapy to a given extent. The SAFE module decides the activation of the controller as a function of a constraint on the insulin on board (IOB). In the case of the Time Enable, this results in the use of a constant restriction on the IOB, whereas in the amplitude enable it results in the use of a time-varying IOB constraint. Both operation modes are evaluated in silico using broadly accepted high-order models and the results contrasted with the ones obtained without the SAFE protection.
Fil: Fushimi, Emilia. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Rosales, Nicolás. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: de Battista, Hernán. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Garelli, Fabricio. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Electrotecnia. Laboratorio de Electrónica Industrial, Control e Instrumentación; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description Artificial pancreas (AP) systems for people with type 1 diabetes (T1DM) combine the use of a smart insulin pump with a Continuous Glucose Monitor (CGM) and a control algorithm to improve the regulation of glycaemia. Based on the extensive clinical evidence provided by the main research groups in the area, a hybrid control algorithm combining insulin meal boluses and glucose feedback action has been recently approved. However, this sort of algorithms should be refined especially during the postprandial period. In turn, fully closed-loop control strategies have to be further developed. In either case, intensive in vivo validation is necessary to ensure the viability of the proposed strategy as an effective method to treat T1DM patients. In this paper, a safety layer called SAFE loop [1] is reformulated to be employed during clinical trials in two different ways: the time enable mode to gradually activate the closed-loop control after an insulin meal bolus in hybrid configurations; and the amplitude enable mode to activate the full closed-loop control as long as the insulin infusion does not exceed the conventional therapy to a given extent. The SAFE module decides the activation of the controller as a function of a constraint on the insulin on board (IOB). In the case of the Time Enable, this results in the use of a constant restriction on the IOB, whereas in the amplitude enable it results in the use of a time-varying IOB constraint. Both operation modes are evaluated in silico using broadly accepted high-order models and the results contrasted with the ones obtained without the SAFE protection.
publishDate 2018
dc.date.none.fl_str_mv 2018-08
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/85562
Fushimi, Emilia; Rosales, Nicolás; de Battista, Hernán; Garelli, Fabricio; Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints; Elsevier Science; Biomedical Signal Processing and Control; 45; 8-2018; 1-9
1746-8094
CONICET Digital
CONICET
url http://hdl.handle.net/11336/85562
identifier_str_mv Fushimi, Emilia; Rosales, Nicolás; de Battista, Hernán; Garelli, Fabricio; Artificial pancreas clinical trials: Moving towards closed-loop control using insulin-on-board constraints; Elsevier Science; Biomedical Signal Processing and Control; 45; 8-2018; 1-9
1746-8094
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1016/j.bspc.2018.05.009
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1746809418301113
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier Science
publisher.none.fl_str_mv Elsevier Science
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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