Prospective Open-Label, Single-Arm, Single-Center Follow-Up Study of the Application of the Advanced Hybrid Closed Loop System in Well-Controlled Children and Adolescents with Type 1 Diabetes.

Abstract

Background: The aim of this prospective open-label single-arm single-center follow-up study was to analyze glycemic control in children and adolescents with type 1 diabetes treated with the advanced hybrid closed loop (AHCL) system in relation to a sensor-augmented pump with low-glucose suspend (SAP-LGS) or predictive low-glucose suspend (SAP-PLGS). Materials and Methods: The data for 50 children and adolescents (age 5.5-19.6 years) with type 1 diabetes, receiving insulin through an AHCL system after being switched from SAP-LGS/PLGS systems, were included in the analysis. The SAP-LGS/PLGS records from 2 weeks preceding the AHCL connection were compared with the records from the first 4 weeks of AHCL use, represented as two separate 2-week intervals. Results: Significant improvements in most of the parameters, namely time spent in the range of 70-140 mg/dL (from 53.80% ± 12.35% to 61.70% ± 8.42%, P < 0.001) and 70-180 mg/dL (from 76.17% ± 10.28% to 81.32% ± 7.71%, P < 0.001), average sensor glucose (from 138.61 ± 16.66 to 130.02 ± 10.91 mg/dL, P < 0.001), and glucose management indicator (from 6.54% ± 0.45% to 6.27% ± 0.29%, P = 0.001), were observed within 2 weeks of switching to the AHCL. More evident improvements were observed for the parameters monitored at night than during the day. The potential limitations of this study were the short observation time, lack of glycated hemoglobin measurements, and no control arm. Conclusion: The AHCL system can significantly improve glycemic control even in well-controlled children and adolescents with type 1 diabetes by increasing the proportion of time spent in the narrower range of 70-140 mg/dL and decreasing the mean glucose concentration, especially during the night.