Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) Compared with Insulin Aspart in T1D Patients—STAT Study
Authors: SNELL-BERGEON JANET K. , AKTURK HALIS K. , REWERS AMANDA , BODE BRUCE W. , KLAFF LESLIE J. , PETERS ANNE , BAILEY TIMOTHY S. , GARG SATISH K. 
Published: June 2018

Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by A1c values (&lt;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.