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

Journal of Diabetes Science and Technology

SAGE Publications

Lugar: Thousand Oaks; Año: 2018

1932-2968

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%,