Artificial pancreas: clinical study in Latin America without premeal insulin boluses

"Background: Emerging therapies such as closed-loop (CL) glucose control, also known as artificial pancreas (AP) systems, have shown significant improvement in type 1 diabetes mellitus (T1DM) management. However, demanding patient intervention is still required, particularly at meal times. To r...

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Autores principales: Sánchez-Peña, Ricardo, Colmegna, Patricio, Garelli, Fabricio, De Battista, Hernán, García Violini, Demián, Moscoso-Vásquez, Marcela, Rosales, Nicolás, Fushimi, Emilia, Campos-Náñez, Enrique, Breton, Marc, Beruto, Valeria, Scibona, Paula, Rodriguez, Cintia, Giunta, Javier, Simonovich, Ventura, Belloso, Waldo H., Cherñavvsky, Daniel, Grosembacher, Luis
Formato: Ponencias en Congresos acceptedVersion
Lenguaje:Inglés
Publicado: 2019
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Acceso en línea:http://ri.itba.edu.ar/handle/123456789/1653
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id I32-R138-123456789-1653
record_format dspace
spelling I32-R138-123456789-16532022-12-07T13:06:29Z Artificial pancreas: clinical study in Latin America without premeal insulin boluses Sánchez-Peña, Ricardo Colmegna, Patricio Garelli, Fabricio De Battista, Hernán García Violini, Demián Moscoso-Vásquez, Marcela Rosales, Nicolás Fushimi, Emilia Campos-Náñez, Enrique Breton, Marc Beruto, Valeria Scibona, Paula Rodriguez, Cintia Giunta, Javier Simonovich, Ventura Belloso, Waldo H. Cherñavvsky, Daniel Grosembacher, Luis PANCREAS ORGANOS ARTIFICIALES DIABETES INSULINA ENSAYOS CLINICOS CONTROL EN MODO DESLIZANTE GLUCOSA "Background: Emerging therapies such as closed-loop (CL) glucose control, also known as artificial pancreas (AP) systems, have shown significant improvement in type 1 diabetes mellitus (T1DM) management. However, demanding patient intervention is still required, particularly at meal times. To reduce treatment burden, the automatic regulation of glucose (ARG) algorithm mitigates postprandial glucose excursions without feedforward insulin boluses. This work assesses feasibility of this new strategy in a clinical trial. Methods: A 36-hour pilot study was performed on five T1DM subjects to validate the ARG algorithm. Subjects wore a subcutaneous continuous glucose monitor (CGM) and an insulin pump. Insulin delivery was solely commanded by the ARG algorithm, without premeal insulin boluses. This was the first clinical trial in Latin America to validate an AP controller. Results: For the total 36-hour period, results were as follows: average time of CGM readings in range 70-250 mg/dl: 88.6%, in range 70-180 mg/dl: 74.7%, <70 mg/dl: 5.8%, and <50 mg/dl: 0.8%. Results improved analyzing the final 15-hour period of this trial. In that case, the time spent in range was 70-250 mg/dl: 94.7%, in range 70-180 mg/dl: 82.6%, <70 mg/dl: 4.1%, and <50 mg/dl: 0.2%. During the last night the time spent in range was 70-250 mg/dl: 95%, in range 70-180 mg/dl: 87.7%, <70 mg/dl: 5.0%, and <50 mg/dl: 0.0%. No severe hypoglycemia occurred. No serious adverse events were reported. Conclusions: The ARG algorithm was successfully validated in a pilot clinical trial, encouraging further tests with a larger number of patients and in outpatient settings." 2019-07-15T20:16:23Z 2019-07-15T20:16:23Z 2018-09 Ponencias en Congresos info:eu-repo/semantics/acceptedVersion 1932-2968 http://ri.itba.edu.ar/handle/123456789/1653 en info:eu-repo/semantics/altIdentifier/doi/10.1177/1932296818786488 info:eu-repo/grantAgreement/CONICET/AR. Ciudad Autónoma de Buenos Aires info:eu-repo/grantAgreement/UNLP/AR. Buenos Aires. La Plata info:eu-repo/grantAgreement/UNQ/AR. Buenos Aires. Bernal info:eu-repo/grantAgreement/ITBA/AR. Ciudad Autónoma de Buenos Aires info:eu-repo/grantAgreement/JDRF/SRA/2-SRA-2016-291-Q-R/US. Nueva York, NY application/pdf América Latina
institution Instituto Tecnológico de Buenos Aires (ITBA)
institution_str I-32
repository_str R-138
collection Repositorio Institucional Instituto Tecnológico de Buenos Aires (ITBA)
language Inglés
topic PANCREAS
ORGANOS ARTIFICIALES
DIABETES
INSULINA
ENSAYOS CLINICOS
CONTROL EN MODO DESLIZANTE
GLUCOSA
spellingShingle PANCREAS
ORGANOS ARTIFICIALES
DIABETES
INSULINA
ENSAYOS CLINICOS
CONTROL EN MODO DESLIZANTE
GLUCOSA
Sánchez-Peña, Ricardo
Colmegna, Patricio
Garelli, Fabricio
De Battista, Hernán
García Violini, Demián
Moscoso-Vásquez, Marcela
Rosales, Nicolás
Fushimi, Emilia
Campos-Náñez, Enrique
Breton, Marc
Beruto, Valeria
Scibona, Paula
Rodriguez, Cintia
Giunta, Javier
Simonovich, Ventura
Belloso, Waldo H.
Cherñavvsky, Daniel
Grosembacher, Luis
Artificial pancreas: clinical study in Latin America without premeal insulin boluses
topic_facet PANCREAS
ORGANOS ARTIFICIALES
DIABETES
INSULINA
ENSAYOS CLINICOS
CONTROL EN MODO DESLIZANTE
GLUCOSA
description "Background: Emerging therapies such as closed-loop (CL) glucose control, also known as artificial pancreas (AP) systems, have shown significant improvement in type 1 diabetes mellitus (T1DM) management. However, demanding patient intervention is still required, particularly at meal times. To reduce treatment burden, the automatic regulation of glucose (ARG) algorithm mitigates postprandial glucose excursions without feedforward insulin boluses. This work assesses feasibility of this new strategy in a clinical trial. Methods: A 36-hour pilot study was performed on five T1DM subjects to validate the ARG algorithm. Subjects wore a subcutaneous continuous glucose monitor (CGM) and an insulin pump. Insulin delivery was solely commanded by the ARG algorithm, without premeal insulin boluses. This was the first clinical trial in Latin America to validate an AP controller. Results: For the total 36-hour period, results were as follows: average time of CGM readings in range 70-250 mg/dl: 88.6%, in range 70-180 mg/dl: 74.7%, <70 mg/dl: 5.8%, and <50 mg/dl: 0.8%. Results improved analyzing the final 15-hour period of this trial. In that case, the time spent in range was 70-250 mg/dl: 94.7%, in range 70-180 mg/dl: 82.6%, <70 mg/dl: 4.1%, and <50 mg/dl: 0.2%. During the last night the time spent in range was 70-250 mg/dl: 95%, in range 70-180 mg/dl: 87.7%, <70 mg/dl: 5.0%, and <50 mg/dl: 0.0%. No severe hypoglycemia occurred. No serious adverse events were reported. Conclusions: The ARG algorithm was successfully validated in a pilot clinical trial, encouraging further tests with a larger number of patients and in outpatient settings."
format Ponencias en Congresos
acceptedVersion
author Sánchez-Peña, Ricardo
Colmegna, Patricio
Garelli, Fabricio
De Battista, Hernán
García Violini, Demián
Moscoso-Vásquez, Marcela
Rosales, Nicolás
Fushimi, Emilia
Campos-Náñez, Enrique
Breton, Marc
Beruto, Valeria
Scibona, Paula
Rodriguez, Cintia
Giunta, Javier
Simonovich, Ventura
Belloso, Waldo H.
Cherñavvsky, Daniel
Grosembacher, Luis
author_facet Sánchez-Peña, Ricardo
Colmegna, Patricio
Garelli, Fabricio
De Battista, Hernán
García Violini, Demián
Moscoso-Vásquez, Marcela
Rosales, Nicolás
Fushimi, Emilia
Campos-Náñez, Enrique
Breton, Marc
Beruto, Valeria
Scibona, Paula
Rodriguez, Cintia
Giunta, Javier
Simonovich, Ventura
Belloso, Waldo H.
Cherñavvsky, Daniel
Grosembacher, Luis
author_sort Sánchez-Peña, Ricardo
title Artificial pancreas: clinical study in Latin America without premeal insulin boluses
title_short Artificial pancreas: clinical study in Latin America without premeal insulin boluses
title_full Artificial pancreas: clinical study in Latin America without premeal insulin boluses
title_fullStr Artificial pancreas: clinical study in Latin America without premeal insulin boluses
title_full_unstemmed Artificial pancreas: clinical study in Latin America without premeal insulin boluses
title_sort artificial pancreas: clinical study in latin america without premeal insulin boluses
publishDate 2019
url http://ri.itba.edu.ar/handle/123456789/1653
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