A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults with Type 1 Diabetes

<p dir="ltr"><b>Objective:</b> To evaluate a regimen of inhaled technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery system (AID) or multiple daily insulin injections (MDI) with continuous glucose monitoring (CGM).</p><p dir="ltr"><b>Research Design and Methods: </b>At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (TI group, N=62) or usual care with continuation of pre-study insulin delivery method (UC group, N=61) for 17 weeks.</p><p dir="ltr"><b>Results:</b> Prestudy, AID was being used by 48% and MDI by 45%. Mean HbA1c was 7.57<a href="" target="_blank">±</a>0.97% at baseline and 7.62±1.06% at 17 weeks in the TI group and 7.59±0.80% and 7.54±0.77%, respectively, in the UC group (adjusted difference = 0.11%, 95% CI -0.10 to 0.33, p-value for non-inferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; 8 participants discontinued TI due to side effects.</p><p dir="ltr"><b>Conclusions:</b> In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was non-inferior to usual care, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce post-prandial hyperglycemia.</p>