RESUMO
Background and Aims: After the artificial pancreas (AP) trials performed in 2016-7 with DiAs system, during the COVID-19 pandemic the first outpatient clinical trial was carried out in Argentina. The main objective was to evaluate the feasibility of running full closed-loop (FCL) algorithms in an own and free platform developed from open-source resources. Methods: The ARG project (Automatic Regulation of Glucose) aims at developing a robust AP algorithm prioritizing patient autonomy. The evolution of the project phases is summarized in the figure. The last step towards this objective was the implementation of a FCL algorithm in our InsuMate platform and its evaluation in an outpatient setting. Five adults with DMT1 completed one week of study, consisting in 3 days of open-loop (OL) followed by 3 days of FCL (i.e., without CHO counting and without delivering meal priming insulin boluses). Accu-Chek pumps and Dexcom G6 CGMs were used. Results: When analyzing the full duration of the trial, the time in range increased in FCL control vs. OL, while the time above range decreased, as did the mean BG. On the other hand, the time below range and the time in severe hypoglycemia remain similar across methods, both achieving the ADA recommended values. The FCL showed greater improvement by the end of the trial, particularly for daytime metrics. InsuMate properly operated in FCL for an average of 95.4% of time. Conclusions: It can be concluded from this experience that the outpatient automatic regulation of glucose levels using the ARG algorithm and Insumate platform is feasible, safe, and effective. (Figure Presented).
RESUMO
Objective: The first artificial pancreas (AP) ambulatory clinical trial in Argentina conducted in March 2021 in the COVID-19 pandemic context is reported. The main objective of this trial was to evaluate the feasibility of running advanced full closed-loop (FCL) algorithms for glycemic control in an own and free platform developed by the team at UNLP from open-source resources (www.insumate.com.ar). Method: The ARG algorithm, a FCL algorithm previously evaluated in-vivo [1], was implemented in InsuMate-AP. This platform was then connected to Dexcom G6 CGMs and Accu-Chek Spirit Combo insulin pumps. After configuring conventional open-loop (OL) treatment in the pumps, five adults with Type 1 Diabetes Mellitus completed one week of an ambulatory clinical trial, consisting in 3 days of OL treatment followed by 3 days of FCL glycemic control (i.e., without delivering meal priming insulin boluses). The participants performed regular activities in a hotel, including networking, eating without carbohydrates counting and extensive walking (3-5 km) around the neighborhood. Result: The last 24 hours of each phase were compared, finding a 25,3% increase in time in range (TIR, 70 mg/dl<G<180mg/dl), a 24,5% reduction of the time below range (TBR, G<70 mg/dl) and a 21,1% decrease in time above range (TAR, G>180 mg/dl) during FCL vs OL treatment. The InsuMate system performed reliably and showed good connectivity performance with both the multiple remote monitoring interface and the peripheral devices, achieving adequate FCL operation for 95.4% of time. Conclusion: The InsuMate system and the ARG algorithm were evaluated under challenging and patient-relaxed conditions showing safe and effective behaviour.