FIRST CLINICAL TRIALS IN LATIN AMERICA: THE ARG ALGORITHM WITHOUT CHO COUNTING

SANCHEZ PEÑA, RICARDO SALVADOR; PATRICIO COLMEGNA; FABRICIO GARELLI; HERNÁN DE BATTISTA; ENRIQUE CAMPOS-NÁÑEZ; MARC BRETON; VALERIA BERUTO; WALDO BELLOSO; LUIS GROSEMBACHER; DANIEL CHERÑAVVSKY

DIABETES TECHNOLOGY & THERAPEUTICS

MARY ANN LIEBERT INC

Lugar: New York; Año: 2018 vol. 20 p. 12 - 12

1520-9156

Background and Aims: This trial evaluated an Artificial Pancreas with the new Automatic Regulation of Glucose (ARG) algorithm for the first time in Latin America. The algorithmwas designed by a research team in Argentina from ITBA, UNQ, and UNLP. Method: Five subjects with T1DM participated in this study. Each patientwore a DEXCOMG4 CGMand a Roche Accu-Check Combo CSII during an open-loop (OL) period at home, and the same hardware connected to a Diabetes Assistant (DiAs) cellphone at Hospital. In this last case, the ARG algorithm was loaded in the DiAs cellphone to perform the closed-loop (CL) test. For comparison, both periods had a duration of 36 hrs. The OL procedure was performed with the usual basal-bolus method. The CL procedure did not require CHO counting for any of the five meals.Results: For the total 36 hr period, the CL results were: average glycaemia 88.6% in [70?250]mg/dl; 74.7% in [70?180] mg/dl; 5.8% <70 mg/dl and 0.8% <50 mg/dl, with LBGI = 2.3 and HBGI = 4.9. After a parameter tuning period, and considering the last 15hr, the results significantly improved: 94.7% in [70?250] mg/dl; 82.6% in [70?180] mg/dl; 4.1% <70 mg/dl and 0.2% <50 mg/dl, with LBGI =1.8 and HBGI = 2.8. The last night results were even better.No severe or nocturnal hypoglycemia occurred. No serious adverse events were reported.Conclusion: The novel ARG algorithm provided a good performance in its first clinical trial, particularly when comparing OL vs. CL results. Once the initial algorithm tuning wasachieved, the results become significantly better. This algorithm shows promising results and further tests will be performed with unannounced meals.