Safety and Effectiveness of MiniMed 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes.

Early feasibility studies have demonstrated safe and effective automated insulin delivery use in individuals with suboptimally controlled type 2 diabetes (T2D). The present study investigated MiniMed™ 780G advanced hybrid closed-loop (AHCL) therapy safety and effectiveness in adults with insulin-requiring T2D. This 13-site, single-arm, open-label study included 95 adults (mean ± standard deviation [SD] age of 60.3 ± 10.8 years and T2D duration of 18.6 ± 8.6 years) using basal-bolus insulin therapy. Participants underwent a run-in period (∼21 days) of open-loop or HCL followed by a study period (∼90 days) of AHCL. The primary safety end point was mean change in glycosylated hemoglobin (HbA1c) from baseline to the end of the 3-month study period. The primary and secondary effectiveness end points were noninferiority and superiority in the percentage of time in range (%TIR 70-180 mg/dL) during the last 6 weeks of the study period (computed by the Hodges-Lehmann method). Safety metrics, including the rates of severe hypoglycemia, diabetic ketoacidosis (DKA), and hyperosmolar hyperglycemic state (HHS), were summarized. HbA1c was reduced from 7.9% ± 1.0% (62.4 ± 10.4 mmol/mol) at baseline to 7.2 ± 0.7% (54.7 ± 8.0 mmol/mol) ( < 0.001). The %TIR estimate was 80.9% (95% confidence interval: 78.4%, 83.1%), and the significance criteria for both the primary and secondary effectiveness end points were met ( < 0.001). While total daily insulin dose was increased from run-in to the end of the study (77.4 ± 38.5 U vs. 91.8 ± 49.3 U, < 0.0001), announced carbohydrates were unchanged, and the number of daily user-initiated boluses was reduced (3.9 ± 1.9 vs. 3.2 ± 1.8, < 0.0001). There was no significant change in participant weight or body mass index, no severe hypoglycemia, DKA, or HHS, and no serious or unanticipated adverse device effects. These findings show that MiniMed 780G AHCL use provides safe insulin intensification in type 2 diabetes and significantly improves mean HbA1c and %TIR.