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

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posted on 2024-12-06, 16:37 authored by Irl B. Hirsch, Roy W. Beck, Martin C. Marak, Yogish Kudva, Halis K Akturk, Anuj Bhargava, Kevin Codorniz, Jamie Diner, Grazia Aleppo, Thomas Blevins, Carol J. Levy, Philip Raskin, Kristin Castorino, Anastasios Manessis, David Pickering, Devin W. Steenkamp, Ruth S. Weinstock, Bruce W Bode, Osama Hamdy, Quang T Nguyen, Mark Kipnes, Katrina J. Ruedy, Donna Desjardins, Zehra Haider, Christopher Jacobson, Scott Lee, John B. Buse, Klara Rachel Klein, Grenye O’Malley, Mei Mei Church, Adham Mottalib, Jesica D Baran, Corey Kurek, Shafaq Rizvi, Cassandra Donahue, Denisa Tamarez, Astrid Atakov Castillo, Sarah Borgman, Sarah Frey, Peter Calhoun

Objective: 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).

Research Design and Methods: 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.

Results: Prestudy, AID was being used by 48% and MDI by 45%. Mean HbA1c was 7.57±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.

Conclusions: 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.