Efficacy, safety, and satisfaction with the Accu-Chek® Insight with Diabeloop™ closed-loop system in subjects with type 1 diabetes: a multicenter real-world study.

Aim To analyse evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek Insight with Diabeloop™ (DBLG1) in adults with type 1 diabetes (T1D) in real-world conditions. Methods Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analysed at baseline, 1, 2 and 3 months after starting DBLG1. HbA1c was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire. Results Sixty-two patients were included (43 women; age 44.2±11 years; diabetes duration 24.6±12 years; 40 used flash and 22 continuous glucose monitoring; 45 were on insulin pump therapy, 17 on multiple daily injections). A significant improvement was observed in all the CGM-derived glucose metrics eparameters early in the first month: %TIR (55.86±17 vs. 72.23±10.11); %TAR1 (26,26±13.3 vs. 19.48±6.78), %TAR2 (15.02±13.09 vs. 6.14±5.23), %TBR1 (5.73±11.5 vs. 1.67±1,3), %TBR2 (1,18±1.97 vs.0.44±0.49), %CV (38.66±7.53 vs. 29.63±3.74), median glucose (168.57 mg/dl±36 vs. 154.63±17.55), %GMI (7.37±0.91 vs. 7.02±0.42). HbA1c decreased significantly at 3 months (7.45%±1.05 vs. 6.95±0.7). No acute complications or serious adverse events occurred. The sameSimilar improvement was observed regardless of prior therapy or glucose monitoring system used. Three patients stopped discontinued use of using DBLG1 and 21 experienced some technical problemsissues. Overall, patientThe degree of satisfaction was high in most of the questions raised. Adjustments of the settingsThe configuration parameters were modified in general in the direction of greater aggressiveness. Conclusions A significant improvement in glycaemic control without serious adverse events and high degree of patient satisfaction was observed in this first real-world study evaluating the close-loop system Accu-Chek Insight with Diabeloop™.