Artificial Pancreas: First Clinical Trials in Argentina

Peña, Ricardo; Colmegna, Patricio; Grosembacher, Luis; Breton, Marc D.; Battista, Hernán De; Garelli, Fabricio; Campos-Náñez, Enrique; Simonovich, Ventura; Beruto, Valeria; Scibona, Paula; Cherñavvsky, Daniel R.

doi:10.1016/j.ifacol.2017.08.1151

Cited by 8 publications

(3 citation statements)

References 25 publications

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“…The first AP clinical trials in Latin America were divided in two stages. First, the UVA algorithm (Patek et al (2012)) was tested following a hybrid closed-loop strategy in November 2016 (Sánchez-Peña et al (2017)). Then, the ARG algorithm was validated during the second clinical stage in June 2017 without premeal insulin boluses.…”

Section: Clinical Trialmentioning

confidence: 99%

See 1 more Smart Citation

Automatic regulatory control in type 1 diabetes without carbohydrate counting

Colmegna

Garelli

Battista

et al. 2018

Control Engineering Practice

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Section: Clinical Trialmentioning

confidence: 99%

“…This was the second phase of the first AP clinical trial campaign in Latin America. In the first phase a hybrid controller was tested in the same site and by the same team (Sánchez-Peña et al (2017)).…”

Section: Introductionmentioning

confidence: 99%

Automatic regulatory control in type 1 diabetes without carbohydrate counting

Colmegna

Garelli

Battista

et al. 2018

Control Engineering Practice

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“…A hybrid-loop algorithm developed by the University of Virginia, implemented in the Diabetes Assistant (DiAs) AP platform, was tested in five adult participants during 36 hours of hybrid-loop control. 8 These first trials provided our research group with valuable know-how regarding clinical trials and protocols, and familiarization with the DiAs platform. Then, in 2017, a second clinical trial involving five adult participants in the same hospital setting took place, but this time, the control algorithm evaluated was the so-called automatic regulation of glucose (ARG) algorithm, 9 implemented in the DiAs platform.…”

Section: Introductionmentioning

confidence: 99%

First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America

Garelli

Fushimi

Rosales

et al. 2022

J Diabetes Sci Technol

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Background: The first two studies of an artificial pancreas (AP) system carried out in Latin America took place in 2016 (phase 1) and 2017 (phase 2). They evaluated a hybrid algorithm from the University of Virginia (UVA) and the automatic regulation of glucose (ARG) algorithm in an inpatient setting using an AP platform developed by the UVA. The ARG algorithm does not require carbohydrate (CHO) counting and does not deliver meal priming insulin boluses. Here, the first outpatient trial of the ARG algorithm using an own AP platform and doubling the duration of previous phases is presented. Method: Phase 3 involved the evaluation of the ARG algorithm in five adult participants (n = 5) during 72 hours of closed-loop (CL) and 72 hours of open-loop (OL) control in an outpatient setting. This trial was performed with an own AP and remote monitoring platform developed from open-source resources, called InsuMate. The meals tested ranged its CHO content from 38 to 120 g and included challenging meals like pasta. Also, the participants performed mild exercise (3-5 km walks) daily. The clinical trial is registered in ClinicalTrials.gov with identifier: NCT04793165. Results: The ARG algorithm showed an improvement in the time in hyperglycemia (52.2% [16.3%] OL vs 48.0% [15.4%] CL), time in range (46.9% [15.6%] OL vs 50.9% [14.4%] CL), and mean glucose (188.9 [25.5] mg/dl OL vs 186.2 [24.7] mg/dl CL) compared with the OL therapy. No severe hyperglycemia or hypoglycemia episodes occurred during the trial. The InsuMate platform achieved an average of more than 95% of the time in CL. Conclusion: The results obtained demonstrated the feasibility of outpatient full CL regulation of glucose levels involving the ARG algorithm and the InsuMate platform.

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