Replacing or Supplementing Automated Insulin Delivery With Inhaled Insulin: A 90-Day Randomized Controlled Trial

Background: Technosphere insulin (TI) is an ultra-rapid-acting inhaled insulin approved for glucose management in adults with diabetes mellitus. Using a higher modified initial conversion dose than in the current United States Prescribing Information, this study assessed supplementing or replacing automated insulin delivery (AID) systems with TI. Methods: Adult participants with type 1 diabetes (glycated hemoglobin [HbA1c], 7%-11%) using an AID system were randomized into TI + AID (TI for meals and AID for basal and corrections), TI + insulin degludec (TI for meals and corrections and insulin degludec for basal), or control group (remaining on AID) and treated for 90 days. HbA1c, forced expiratory volume in 1 second (FEV 1 ), hypoglycemic events, and adverse events (AEs) were assessed. Results: Of 33 enrolled participants, 24 completed the study. All groups demonstrated comparable declines in HbA1c from baseline to end of treatment (statistically significant decline for control group). No within- or between-group statistical differences were observed in FEV 1 . Incidence and event rate of hypoglycemia <70 mg/dL and <54 mg/dL were similar between groups, and no severe hypoglycemic events were reported. No treatment-related serious AEs were reported, and 2 participants experienced AEs of special interest related to TI (clinically relevant decline in pulmonary function and wheezing). Conclusions: This proof-of-concept study demonstrated the safety and efficacy of TI, at a higher modified dose conversion, when added for mealtime control to an AID system or was used for glycemic control with basal insulin.