Artificial Pancreas: Clinical Study in Latin America Without Premeal Insulin Boluses

Peña, Ricardo; Colmegna, Patricio; Garelli, Fabricio; Battista, Hernán De; García-Violini, Demián; Moscoso-Vásquez, Marcela; Rosales, Nicolás; Fushimi, Emilia; Campos-Náñez, Enrique; Breton, Marc D.; Beruto, Valeria; Scibona, Paula; Rodríguez, Cintia; Giunta, Javier; Simonovich, Ventura; Cherñavvsky, Daniel R.; Grosembacher, Luis

doi:10.1177/1932296818786488

Cited by 29 publications

(25 citation statements)

References 73 publications

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“…4 Fujian Provincial Key Laboratory of Biochemical Technology, Huaqiao University, Xiamen 361021, China. 5 Internal Medicine Department, Xiamen Haicang Hospital, Xiamen 361000, Fujian, China. 6 • support for research data, including large and complex data types…”

Section: Supplementary Informationmentioning

confidence: 99%

Oral delivery of insulin with intelligent glucose-responsive switch for blood glucose regulation

Zhou

Long

et al. 2020

J Nanobiotechnol

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Background: The traditional treatment for diabetes usually requires frequent insulin injections to maintain normoglycemia, which is painful and difficult to achieve blood glucose control. Results: To solve these problems, a non-invasive and painless oral delivery nanoparticle system with bioadhesive ability was developed by amphipathic 2-nitroimidazole-l-cysteine-alginate (NI-CYS-ALG) conjugates. Moreover, in order to enhance blood glucose regulation, an intelligent glucose-responsive switch in this nanoparticle system was achieved by loading with insulin and glucose oxidase (GOx) which could supply a stimulus-sensitive turnover strategy. In vitro tests illustrated that the insulin release behavior was switched "ON" in response to hyperglycemic state by GOx catalysis and "OFF" by normal glucose levels. Moreover, in vivo tests on type I diabetic rats, this system displayed a significant hypoglycemic effect, avoiding hyperglycemia and maintaining a normal range for up to 14 h after oral administration. Conclusion: The stimulus-sensitive turnover strategy with bioadhesive oral delivery mode indicates a potential for the development of synthetic GR-NPs for diabetes therapy, which may provide a rational design of proteins, low molecular drugs, as well as nucleic acids, for intelligent releasing via the oral route.

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Section: Supplementary Informationmentioning

confidence: 99%

Oral delivery of insulin with intelligent glucose-responsive switch for blood glucose regulation

Zhou

Long

et al. 2020

J Nanobiotechnol

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“…El ensayo contaba con 5 participantes con DMT1. El protocolo aprobado por la ANMAT estipulaba 54hs de monitoreo con un monitor continuo de glucosa (CGM) utilizando la terapia tradicional de lazo abierto, seguido de 36hs de control a lazo cerrado utilizando el algoritmo ARG [20].…”

Section: Descripción Del Ensayo Clínico Y Tratamientosunclassified

“…La dosis de insulina que indica el SLQG es multiplicada por una señal γ calculada en el bloque Safety Auxiliary Feedback Element (SAFE), que tiene como función modular la infusión de insulina si esta llegara a implicar un riesgo para el paciente. Para una explicación más detallada del funcionamiento del algoritmo ARG referirse a [19], [20].…”

Section: Descripción Del Ensayo Clínico Y Tratamientosunclassified

Use of Change-Point Analysis Tools for Evaluating Performance in Artificial Pancreas Systems

Serafini

Fushimi

Battista

et al. 2018

2018 Argentine Conference on Automatic Control (AADECA)

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“…is layer is based on the sliding mode reference conditioning technique [21] and acts on the glucose reference signal when a specific constraint, related with the maximum IOB allowed (IOB), is violated. Such technique has already been applied in different control schemes [22][23][24][25], but so far it is not clear the best methodology to tune IOB. e selection of the constraint IOB is critical in the design of the closed-loop system.…”

Section: Introductionmentioning

confidence: 99%

Dynamic Rule-Based Algorithm to Tune Insulin-on-Board Constraints for a Hybrid Artificial Pancreas System

Bertachi

Biagi

Beneyto

et al. 2020

Journal of Healthcare Engineering

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The artificial pancreas (AP) is a system intended to control blood glucose levels through automated insulin infusion, reducing the burden of subjects with type 1 diabetes to manage their condition. To increase patients’ safety, some systems limit the allowed amount of insulin active in the body, known as insulin-on-board (IOB). The safety auxiliary feedback element (SAFE) layer has been designed previously to avoid overreaction of the controller and thus avoiding hypoglycemia. In this work, a new method, so-called “dynamic rule-based algorithm,” is presented in order to adjust the limits of IOB in real time. The algorithm is an extension of a previously designed method which aimed to adjust the limits of IOB for a meal with 60 grams of carbohydrates (CHO). The proposed method is intended to be applied on hybrid AP systems during 24 h operation. It has been designed by combining two different strategies to set IOB limits for different situations: (1) fasting periods and (2) postprandial periods, regardless of the size of the meal. The UVa/Padova simulator is considered to assess the performance of the method, considering challenging scenarios. In silico results showed that the method is able to reduce the time spent in hypoglycemic range, improving patients’ safety, which reveals the feasibility of the approach to be included in different control algorithms.

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Artificial Pancreas: Clinical Study in Latin America Without Premeal Insulin Boluses

Abstract: The ARG algorithm was successfully validated in a pilot clinical trial, encouraging further tests with a larger number of patients and in outpatient settings.

Cited by 29 publications

References 73 publications

Oral delivery of insulin with intelligent glucose-responsive switch for blood glucose regulation

Oral delivery of insulin with intelligent glucose-responsive switch for blood glucose regulation

Use of Change-Point Analysis Tools for Evaluating Performance in Artificial Pancreas Systems

Dynamic Rule-Based Algorithm to Tune Insulin-on-Board Constraints for a Hybrid Artificial Pancreas System

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