INHALE-1: A Multi-center Randomized Trial of Inhaled Technosphere Insulin in Children with Type 1 Diabetes

<p dir="ltr">Objective: To evaluate inhaled technosphere insulin (TI) in children with diabetes.</p><p dir="ltr">Research Design and Methods: Youth 4 to 17 years old with type 1 (98%) or type 2 (2%) diabetes treated with multiple daily injections of insulin were randomly assigned 1:1 to TI or rapid-acting analogue (RAA) insulin plus continuation of long-acting basal insulin and continuous glucose monitoring (CGM) for 26 weeks. The primary outcome was change in HbA1c, tested for non-inferiority with margin of 0.4%.</p><p dir="ltr">Results: In intent-to-treat analysis, mean HbA1c was 8.22±0.87% at baseline and 8.41±1.38% at 26 weeks with TI and 8.21±0.96% and 8.21±1.10%, respectively, with RAA (adjusted difference = 0.18%, 95% CI -0.07 to 0.43, non-inferiority p-value = 0.091). CGM-measured time-in-range 70-180 mg/dL was not significantly different between groups (adjusted difference -2.2%, 95% CI -7.0% to 2.7%, p=0.38). Two severe hypoglycemic events occurred in the TI group and one in the RAA group. Change in forced expiration volume in one second (FEV1) from baseline to 26 weeks did not differ comparing TI and RAA (p=0.53). The TI group reported greater treatment satisfaction (p=0.004) and had less gain in weight and body mass index percentile (p=0.009) than the RAA group.</p><p dir="ltr">Conclusions and Relevance: The primary analysis did not meet the pre-specified criteria for HbA1c non-inferiority. However, TI use was safe over 26 weeks without impacting pulmonary function and was associated with greater treatment satisfaction and less weight gain compared with RAA, supporting TI as a treatment option for some pediatric patients with type 1 diabetes.</p><p><br></p>