A hybrid closed-loop (HCL) insulin delivery system was initially evaluated to establish its safety for unsupervised use in patients ≥ 14 years in the US pre-market approval pivotal trial. The system included the Medtronic MiniMed 670G pump, 4th-generation sensors, and a control algorithm. Patients calibrated the sensor periodically and gave mealtime and correction boluses as needed. A 2-wk run-in (baseline) phase was followed by a 3-mo study phase of HCL at home and supervised hotel settings for 5 nights followed by an optional continued-access program. Data were available from 124 patients with T1D (55 male) with mean (± SD) age, 37.8 ± 16.46 yr (30 age ≤ 21) and duration of diabetes 21.7 ± 13.65 yr. Significant improvements in glycemic control (Time in ranges, % of Sensor Glucose) and A1C values from baseline and study phases were observed in time in ranges at SG ≤ 50 mg/dL (0.6%), SG ≤ 70 mg/dL (3.3%), 70 < SG ≤ 180 mg/dL (72.2%), and SG > 180 mg/dL (24.5%)) and a reduction in A1C from 7.4% to 6.9%. We also followed post to commercial launch using data from voluntary uploads of MiniMed 670G pump to CareLink personal Database. As of July 24, 2017, there were over 1700 patients with over 63,000 device days. The sensor usage was 89.2% and auto mode usage was 84.2%. The mean time in ranges at SG ≤ 50 mg/dL, SG ≤ 70 mg/dl, 70 < SG ≤ 180 mg/dL, and SG > 180 mg/dL were 0.41%, 2.5%, 72.8% and 24.7%. Sensor accuracy was also evaluated using SMBG as a reference. The Mean Absolute Relative Difference (%) was 10.5%, and 20/20 Agreement Rate (%) was 86.9%. So far, the HCL system seems safe, acceptable, and associated with improved glucose control during at-home use.