First outpatient clinical trial of a full closed-loop artificial pancreas system in South America

GARELLI, FABRICIO; FUSHIMI, EMILIA; ROSALES, NICOLÁS; ARAMBARRI, DELFINA; MENDOZA, LEANDRO; SERAFINI, MARÍA CECILIA; MOSCOSO-VÁSQUEZ, MARCELA; STASI, MARIANELLA; DUETTE, PATRICIA; GARCÍA ARABEHETY, JULIA; GIUNTA, JAVIER; DE BATTISTA, HERNÁN; SÁNCHEZ-PEÑA, RICARDO; GROSEMBACHER, LUIS

Journal of Diabetes Science and Technology

SAGE Publications

Año: 2022

1932-3107

AbstractBackground: The first two studies of an artificial pancreas (AP) system carried out in Latin America took place in 2016 (phase one) and 2017 (phase two) in an inpatient setting, at the Hospital Italiano de Buenos Aires (HIBA). Phase one evaluated a hybrid-loop algorithm and AP platform developed by the University of Virginia (UVA). Next, phase two studied the performance of the so-called ARG algorithm, developed by researchers from the National University of La Plata (UNLP) and the Buenos Aires Institute of Technology (ITBA). The ARG algorithm is a full closed-loop algorithm, meaning that it does not require carbohydrate (CHO) counting and does not deliver meal priming insulin boluses. Method: Phase three involved the evaluation of the ARG algorithm in 5 adult participants (n=5) during 72 hours of closed-loop and 72 hours of open-loop 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 gCHO and included challenging meals like pasta. Also, the participants performed mild exercise (3 to 5 km walks) daily. The clinical trial is registered in ClinicalTrials.gov with identifier: NCT04793165. Results: The InsuMate platform achieved an average of over 95% of the time in closed-loop. The ARG algorithm showed an improvement in the time in hyperglycemia, time in range and mean glucose compared to the open-loop therapy. No severe hyper- or hypoglycemia episodes occurred during the trial. Conclusion: The ARG algorithm and the InsuMate platform demonstrated safe and effective behavior for future use in a supervised home study of an AP system.