2158-P: Inhaled Technosphere Insulin (TI) Compared with Rapid-Acting Analog Insulin (RAA) in Gestational Diabetes (GDM)

Introduction and Objective: Postprandial (PP) hyperglycemia in pregnancy is a strong correlate for fetal overgrowth and adverse outcomes. The equivalence, efficacy, and safety of TI (Afrezza; inhaled human Regular insulin) in lowering PP hyperglycemia compared to RAA (lispro or aspart) have not been previously studied during pregnancy. We directly compared the glucose excursion and frequency of hypoglycemia (<63 mg/dL [3.5 mmol/L]) during two controlled breakfast visits utilizing TI versus RAA in GDM pregnancies. Methods: Consented pregnant participants with a diagnosis of GDM wearing at least one CGM, were randomized to complete two identical breakfast meal (~45 grams carbohydrate) sessions using either RAA or TI equivalent dosing (~2 times RAA dose) within a 10-day gestational window. Glucometer measures were performed every 15-30 mins for at least 3 hrs. This analysis compares the glucose metrics between the two treatments in the first 10 participants. Results: Mean maternal age was 33±6 yrs, 50% reported Hispanic or Latinx ethnicity, pre-pregnancy BMI was 35±6 kg/m2, and gestational age at screening was 29±4 weeks. There was a trend towards an overall lower glucose excursion (-2.8 mg/dL) and lower area under the curve >120 mg/dL [6.7 mmol/L] by -2.7 mg/dL and >140 mg/dL [7.8 mmol/L] by -1.3 mg/dL using TI vs RAA for the breakfast meal. The 1h- and 2h-PP blood glucose were 121±16 & 108±20 mg/dL for the TI and 129±25 & 107±25 mg/dL for the RAA meal. None of the TI meal sessions were complicated by hypoglycemia, whereas 3 of the RAA sessions were complicated by hypoglycemia following the meal. Conclusion: In this interim analysis of the first crossover RCT in GDM directly comparing PP glucose responses between TI vs RAA with a fixed breakfast meal, comparable effectiveness was demonstrated with a trend toward reduced glucose excursions and fewer hypoglycemic events with TI. Further investigation of a larger sample will further support safety and efficacy of TI as an alternative to RAA in GDM. Disclosure A. Valent: Research Support; Current; Dexcom, Inc. Advisory Panel; Current; MannKind Corporation. Research Support; Current; MannKind Corporation. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics. C. Durnwald: Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Abbott Diabetes. Research Support; Current; Dexcom, Inc., MannKind Corporation. C. Levy: Research Support; Current; Tandem Diabetes Care, Inc., Novo Nordisk, Abbott Diabetes, MannKind Corporation. Consultant; Current; MannKind Corporation, Tandem Diabetes Care, Inc. Research Support; Current; Deka/Sequel, Dexcom, Inc., Genti Bio. Consultant; Current; Deka/Sequel. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. G. O'Malley: Research Support; Ended; Dexcom, Inc. Research Support; Current; Abbott, MannKind Corporation. I. Hirsch: Research Support; Current; MannKind Corporation, Sequel Tech. Consultant; Current; Abbott Diabetes, Roche Diabetes Care, Hagar. D.Y. Gyalnub: None. A. Bradbury: None. C.M. Levister: Research Support; Ended; Capillary Biomedical, Inc., Tandem Diabetes Care, Inc. Research Support; Current; DEKA, Sequel. J.E. Phipers: Research Support; Current; Pfizer Inc., Myriad Genetics, Jaeb Center for Health Research, National Heart, Lung, and Blood Institute.