We evaluated the efficacy and safety of a hybrid closed loop (HCL) system after its arrive in Italian market in October 2018 and during 1-year follow-up.
We prospectively analyzed data of all patients who started the Minimed 670G system, (Medtronic, CA, USA) after 1 year since its arrival. Main outcome is the time in range (TIR). Secondary outcomes are HbA1c change from baseline, time in hypo (70-54 and <54), time in hyper (>180 mg/dl and >250), coefficient of variation (CV).
After 1-year follow-up, 52 patients (mean age 11±5 yr s, range 6-20 yrs, diabetes duration 7±4 yrs) had a TIR of 71.3±17.6% when considering 70-180 mg/dl (range 32-97%), using the system in automatic mode for 84% of time. HbA1c significantly improved (7.12±0.87 vs 7.62±1.7, p=0.001). Time in hypo, in hyper and CV were respectively 1.8±1.9%, 0.63±1.0%, 18.2±8.0, 8.0 ±11.3 and 33±5.7% (n.v. <36%). A significant correlation has been observed between TIR and time in automatic mode (r=0.891, p=0.001). Considering the patients using the system >70% in automatic mode (n=42, 81%), TIR was 80.9±7.6%, using the system in automatic mode for 93% of time. Time in hypo, in hyper and CV were respectively 2±2.1%, 0.7±1.1%, 14.3±5.7, 2.1 ±1.4 and 31±5 %
670G system is effective to achieve a high TIR. A systematic educational pathway, as the one used by 640G users, could help reach recommended target even in pediatric population, overcoming some constrains observed using 670G system. A decalogue to help users will be proposed.