Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) Compared with Insulin Aspart in T1D Patients—STAT Study

Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by A1c values (<8.5% or ≥ 8.5%) to the control arm using aspart (n=34) vs. TI group (n=26). Patients in the TI arm were advised to take extra inhalations at 1 and 2 hours after meals based on post-prandial blood glucose (PPBG) values. Baseline characteristics and FEV1 were similar. Using per protocol (PPT) analysis, we examined outcomes over the 4-week period using linear regression with repeated measures. The primary outcomes were TIR (70-180 mg/dL) and PPBG excursions. Compliance with TI was based on its use when indicated at 1- and 2-hour PPBG. Patients with at least 80% compliance were included in PPT (n=15). Seven TI patients were non-compliant; 2 dropped out of the study; and 2 did not have CGM data. CGM glucose patterns and TIR for a patient with 100% or with 56% compliant with TI are shown (Figure 1a and 1b). TIR was significantly higher in the TI-compliant group compared to control or TI-non-compliant groups (Figure 1c). PPBG was also significantly lower in the TI-compliant compared to the control group at 1- and 2-hours post-prandial but not at 3 and 4 hours. PPBG was significantly lower in the compliant vs. non-compliant TI group at all time points (Figure 1d). We conclude that TI improves TIR and PPBG values, if patients use additional inhalations as directed. Disclosure J.K. Snell-Bergeon: Stock/Shareholder; Self; Abbott. Research Support; Self; Roche Diagnostics Corporation. H.K. Akturk: None. A. Rewers: None. B.W. Bode: Research Support; Self; Abbott. Advisory Panel; Self; ADOCIA. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Medtronic MiniMed, Inc., Novo Nordisk Inc., Diasome Pharmaceuticals, Inc., Sanofi US, Eli Lilly and Company, MannKind Corporation, Dexcom, Inc., OmniPod, Senseonics. L.J. Klaff: Research Support; Self; Abbott, Intarcia Therapeutics, Inc., MannKind Corporation, Dexcom, Inc., Novartis Pharmaceuticals Corporation, Gelesis, Novo Nordisk Inc., Eli Lilly and Company, Medtronic, Sanofi. A. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical. Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Eli Lilly and Company, Insulin Algorithms, JDRF, Lexicon Pharmaceuticals, Inc., Livongo Health. Research Support; Self; MannKind Corporation. Other Relationship; Self; Medscape. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Omada Health, Inc., Optum Rx, Inc., Sanofi. Research Support; Self; T1D Exchange. Advisory Panel; Self; The Endocrine Society. Research Support; Self; The Leona M. and Harry B. Helmsley Charitable Trust. Advisory Panel; Spouse/Partner; Johnson & Johnson Diabetes Institute, LLC. T.S. Bailey: Research Support; Self; Abbott. Consultant; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Ambra BioScience, Ascensia Diabetes Care, Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical. Consultant; Self; Calibra Medical. Research Support; Self; Companion Medical, Dexcom, Inc., Glooko, Inc., GlySens Incorporated, Lexicon Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Senseonics. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Versartis, Inc., Xeris Pharmaceuticals, Inc., MannKind Corporation. S.K. Garg: Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Sanofi US. Advisory Panel; Self; Sanofi US. Research Support; Self; MannKind Corporation, Diasome Pharmaceuticals, Inc., Labstyle Innovations, Lexicon Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Novo Nordisk A/S.