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

Abstract

Background: 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. Materials and Methods: 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. Results: 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) (P < 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 (P < 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, P < 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, P < 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. Conclusions: These findings show that MiniMed 780G AHCL use provides safe insulin intensification in type 2 diabetes and significantly improves mean HbA1c and %TIR.