Control Automático

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Artificial pancreas: clinical study in Latin America without premeal insulin boluses
(2018-09) 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
"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."
Artificial Pancreas: first clinical trials in Argentina
(2017-07) Sánchez-Peña, Ricardo; Colmegna, Patricio; Grosembacher, Luis; Breton, Marc; De Battista, Hernán; Garelli, Fabricio; Belloso, Waldo H.; Campos-Náñez, Enrique; Simonovich, Ventura; Beruto, Valeria; Scibona, Paula; Cherñavvsky, Daniel
"The first clinical trials using an Artificial Pancreas (AP) in Latin America have been defined in 2 stages. The first stage was carried out in November 2016 with the UVA controller (developed by the Center for Diabetes Technology and already clinically tested), and the second will be performed during the first semester of 2017 with the ARG (Automatic Regulation of Glucose) algorithm (developed by ITBA, UNQ, and UNLP in Argentina). Both tests are based on the DiAs (Diabetes Assistant) from the UVA, and are performed in the HIBA on 5 patients with Type 1 Diabetes Mellitus (T1DM), for 36 hours. For the first stage, Open-Loop (OL) insulin boluses were applied before meals and patient's physical activity was included. On the other hand, for the second stage, patients will not be involved in physical activity, but no OL insulin boluses will be injected before meals. In this work, experimental results from the first stage with the UVA controller, and preliminary results with the ARG control algorithm tested on the UVA/Padova simulator are presented. Due to the final paper deadline, the experimental results from the second stage are not included here, but will be presented at the IFAC World Congress."

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