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.


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