ABSTRACT
Background and Aims: Literature supports efficacy and safety of Hybrid Close loop (HCL) system in type 1 diabetes (T1D) patients. Limited data are available showing the short and long-term outcomes of telehealth. Our study described efficacy and safety of HCL system at one year of follow-up through telehealth during COVID-19 pandemic. Methods: A prospective observational cohort study including T1D patients previously treated with multiple doses of insulin or sensor augmented pump therapy started on HCL system during COVID-19 pandemic. Virtual training and follow-up were done through telehealth. CGM data were analyzed to compare the time in range (TIR), time below range (TBR) and glycemic variability, GMI at base line, 3,6,9 and 12 months of virtual follow-up. Use of automatic mode (AM) was also evaluated. Results: 134 patients were included (54.9% female, baseline A1c 7.66% ± 1.15). 48.8% hypoglycemia was the main indication of HCL therapy. 32.6% had hypoglycemia unawareness and 40.5% had ≥1 severe hypoglycemia event in the last year. TIR at the end of the virtual training was 78 ± 0.14%. After 3,6,9 and 12 months of follow-up TIR was 78.5%, 77.6%, 76.8% and 77%, respectively. Coefficient of variation was 31.4 ± 6.05% at 12 months. TBR <70mg/dl and <54mg/dl was 2.39 ± 0.14% and 0.54 ± 0.07%, respectively. Use of AM was 80.7 ± 24.7% and percentage of use of sensor was 90.3 ± 7.3%. No severe adverse events were reported. Conclusions: HCL systems allows T1D patients to improve TIR, TBR and glycemic variability independently of previous treatment. Long term follow-up through virtual modality allows to maintain TIR with low TBR and adherence to AM of 80%.