1805-PUB: Results of a Two-Part Feasibility Study Assessing Inhaled Insulin for Meals with MDI or Automated Insulin Delivery (AID) Compared with Standard AID Therapy

Background: Technosphere Insulin (TI) is an ultra-rapid acting inhaled insulin and when used with basal insulin may be a safe and effective alternative to AID systems in type 1 diabetes. Methods: During study part 1, subjects using an AID were given an in-clinic standardized meal with either all meal insulin as TI (n=21) at meal start or rapid-acting insulin given via an AID (n=5) 15 minutes prior. Capillary glucose was measured at intervals for 2 hours. During study part 2, HbA1c was compared for 3 groups at baseline and 90 days: AID control (n=5), TI+AID (TI for meals only; n=9), or TI+insulin degludec (TI for meals and corrections, degludec for daily basal; n=10). Results: The figure shows in study part 1, TI led to significantly lower post-prandial glucose than AID control for the standardized meal. In study part 2, comparable HbA1c reduction from baseline was observed in all 3 groups. No events of severe hypoglycemia and one episode of diabetic ketoacidosis not related to TI per investigator were reported. Conclusion: This initial evaluation indicates that 1) TI had a more favorable glycemic response for 2 hours after the meal compared to AID control, and 2) HbA1c baseline to 90 days was comparable for the AID and the TI arms without serious safety issues. Adding TI for meals or switching to TI and basal insulin may provide comparable safety and efficacy to AID alone. Disclosure K.Kaiserman: Employee; MannKind Corporation, Research Support; Medtronic, Stock/Shareholder; MannKind Corporation. J.Ulloa: Employee; MannKind Corporation. J.Pleitez: Employee; MannKind Corporation. J.Sylvan: Employee; MannKind Corporation. K.Codorniz: Research Support; Medtronic, MannKind Corporation. S.Lee: Consultant; MannKind Corporation. C.Jacobson: Advisory Panel; MannKind Corporation, Medtronic. T.Blevins: Other Relationship; Medtronic, Research Support; Lilly Diabetes, Novo Nordisk, Dexcom, Inc., Abbott Diabetes, Tandem Diabetes Care, Inc., Medtronic, Speaker's Bureau; Lilly Diabetes, Novo Nordisk A/S.