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 (FEV1), 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 FEV1. 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.