A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes
Authors: 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, Bruce W. Bode, Jonathan Ownby, Joseph Johnson, Adriana Ruiz, Nashia Stephens, Amanda Maxson, Halis K. Akturk, Zehra Haider, Christie Beatson, Emma Mason, Devin W. Steenkamp, Howard Wolpert, Astrid Atakov-Castillo, Asya Sullivan, Mark Kipnes, Amna Salhin, Tina Copple, Stephanie Beltran, Terri Ryan, Carol J. Levy, Grenye O’Malley, Camilla Levister, Denisa Tamarez, Aslihan Ipek, Anuj Bhargava, Christine Burke, Christine Langel, Shannon Bauman, Cristina Haight, Allie Bohr, Osama Hamdy, Adham Mottalib, Tareq Salah, Marwa Al Badri, Shilton Dhaver, Quang T. Nguyen, Loida Nguyen, Kevin Codorniz, Scott Lee, Christopher Jacobson, Christian Cordero, Brittney Migliozzi, Yogish Kudva, Donna Desjardins, Corey Reid, Shafaq Rizvi, Ravinder Jeet Kaur, Daine Livingood, David Pickering, Dana Cruse, Grazia Aleppo, Jelena Kravarusic, Kasey Coyne, Stefanie Herrmann, Evelyn Fronczyk, Anastasios Manessis, Lorcan McKillop, Jamie Hyatt, Maria Patruno, Kristin Castorino, Mei Mei Church, Ashley Thorsell, Maggie Shuirman, Brandon Cobb, Olivia Watt, Ruth Weinstock, Suzan Bzdick, Thomas Blevins, Luis Casaubon, Valerie Espinosa, Keta Pandit, Jennifer Perez, Chloe Armstrong, Maritza Martinez-Arredondo, Ana Stewart, Olivia Johnson, Jamie Diner, John Buse, Klara Klein, Tahereh Ghorbani, Laura Young, Andrea D. Coviello, Cassandra Donahue, Alexander Kass, Karla Fulghum, Philip Raskin, Lin Jordan, Baomei Shao, Irl B. Hirsch, Jesica Baran, Patali Mandava, Rosanna Holod, Kevin Kaiserman, Johanna Ulloa, Jennifer Pleitez, Joey Sylvan, Lynn Badgett, Katrina Ruedy, Roy Beck, Sarah Borgman, Sarah Frey, Nnenna Mba-Oduwusi, Paige Miller, Ashleigh Fults, Martin Chase Marak, Peter Calhoun, Rosa Pritchard, Elizaveta Dolzhenko, Chris McCarthy, Deanna Gabrielson, Sue Brown, Andrew Ahmann, Richard Bergenstal
Journal: Diabetes Care (2024)

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 (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring. At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (N = 62) or usual care (UC) with continuation of prestudy insulin delivery method (N = 61) for 17 weeks. Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD 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 noninferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5 mmol/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; eight participants discontinued TI due to side effects. In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was noninferior to UC, 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 postprandial hyperglycemia.