O-14: INHALE-1st: inhaled insulin safety and efficacy in youth with Newly-Diagnosed type 1 diabetes
C Berget, J Nguyen, S Watanabe, J Sylvan, J PleitezAbstract
Introduction
The American Diabetes Association recommends reassessing insulin management at every visit, using person-specific factors to guide changes in insulin delivery, including consideration of inhaled insulin. Technosphere Insulin (TI) is a rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes mellitus and offers an alternative to injectable mealtime insulin. However, inhaled insulin has not previously been evaluated in youth with newly diagnosed type 1 diabetes (T1D). Newly diagnosed T1D in youth is associated with marked glycemic variability and substantial treatment burden during early disease management.
Objectives
To assess safety and glycemic outcomes associated with inhaled insulin use in youth with newly diagnosed stage 3 T1D.
Methods
INHALE-1st is a multicenter, single-arm study enrolling up to 100 youth aged 10 to <18 years within 21 days of T1D diagnosis. Participants initiate inhaled insulin in combination with basal insulin and are followed for 13 weeks. The primary endpoint is the proportion of participants achieving ≥70% continuous glucose monitoring (CGM) time-in-range (70-180 mg/dL) during the two weeks preceding week 13. This abstract summarizes safety and efficacy data from participants with at least two weeks of follow-up as of April 13, 2026.
Results
Five participants aged 10-16 years at two sites initiated study treatment, contributing 4-9 weeks of follow-up. Median baseline HbA1c was 12.9% (range 11.1-15.2%). By week 4, participants achieved mean CGM time-in-range of approximately 80%. No serious adverse events were reported, and no new safety signals were identified.
Conclusions
INHALE-1st represents the first evaluation of inhaled prandial insulin initiated at diagnosis in youth with T1D. These findings support the feasibility of this treatment approach, demonstrate an acceptable short-term safety profile, and show glycemic patterns consistent with effective insulin coverage during the initial course of disease.