RESUMO
Aim: To 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 analyzed 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 (CGM); 45 were on insulin pump and 17 on multiple daily injections). A significant improvement was observed in the CGM-derived glucose metrics early in the first month: Time in range (%TIR) 70-180 mg/dL (54.86 ± 17 vs. 72.23 ± 10.11); time above range level 1 (%TAR1) 180-250 mg/dL (26.26 ± 13.3 vs. 19.48 ± 6.78), time above range level 2 (%TAR2) > 250 mg/dL (12.02 ± 13.09 vs. 6.14 ± 5.23), time below range level 1 (%TBR 1) 54-70 mg/dL (5.73 ± 11.5 vs. 1.67 ± 1.3), time below range level 2 (%TBR2) < 54 mg/dL (1.18 ± 1.97 vs.0.44 ± 0.49), %CV (38.66 ± 7.53 vs. 29.63 ± 3.74), median glucose (168.57 ± 36 mg/dL vs. 154.63 ± 17.55 mg/dL), and %GMI (7.37 ± 0.91 vs. 7.02 ± 0.42). Also, HbA1c decreased significantly (7.45% ± 1.05% vs. 6.95% ± 0.7%). No acute complications or serious adverse events occurred. Similar improvement was observed regardless of prior therapy or the glucose monitoring system used. Three patients discontinued DBLG1 and 21 experienced technical issues. Overall, patient satisfaction was high. Adjustments of the settings were modified in general in the direction of greater aggressiveness. Conclusions: A significant improvement in glycemic control without serious adverse events and a high degree of patient satisfaction were observed in this first real-world study evaluating the closed-loop system, Accu-Chek Insight with Diabeloop.