A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes.
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 (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors
- Carol J. Levy (ORCID: https://orcid.org/0000-0002-3492-2578)
- Thomas Blevins (ORCID: https://orcid.org/0000-0003-3746-9606)
- Bruce W. Bode (ORCID: https://orcid.org/0000-0002-9998-055X)
- David Pickering
- Philip Raskin
- Halis Kaan Aktürk (ORCID: https://orcid.org/0000-0003-4518-5179)
- Quang Nguyen (ORCID: https://orcid.org/0009-0000-6309-855X)
- Anuj Bhargava (ORCID: https://orcid.org/0000-0002-5961-6171)
- Irl B. Hirsch (ORCID: https://orcid.org/0000-0003-1675-8417)
- Grenye O’Malley (ORCID: https://orcid.org/0000-0001-7940-2624)
- Shafaq Rizvi
- John B. Buse (ORCID: https://orcid.org/0000-0002-9723-3876)
- Kristin Castorino (ORCID: https://orcid.org/0000-0001-6386-9203)
- Mei Mei Church (ORCID: https://orcid.org/0000-0003-3393-2042)
- Astrid Atakov-Castillo (ORCID: https://orcid.org/0000-0001-9505-8528)
- Martin Marak
- Donna Desjardins
- Mark S. Kipnes
- Christopher Jacobson (ORCID: https://orcid.org/0009-0004-6492-6280)
- Devin Steenkamp (ORCID: https://orcid.org/0000-0001-7132-3657)
- Adham Mottalib (ORCID: https://orcid.org/0000-0002-8573-6329)
- Katrina J. Ruedy
- Yogish C. Kudva (ORCID: https://orcid.org/0000-0003-0285-6622)
- Jamie Diner
- Anastasios Manessis (ORCID: https://orcid.org/0000-0002-5473-0573)
- Kevin Codorniz
- Grazia Aleppo (ORCID: https://orcid.org/0000-0003-1644-5947)
- Sarah Frey
- Zehra Haider
- Ruth S. Weinstock (ORCID: https://orcid.org/0000-0001-5859-5666)
- Klara R. Klein (ORCID: https://orcid.org/0000-0002-5894-9054)
- Jesica D Baran
- Osama Hamdy (ORCID: https://orcid.org/0000-0002-1919-0268)
- Scott Lee (ORCID: https://orcid.org/0000-0002-2913-3777)
- Peter Calhoun (ORCID: https://orcid.org/0000-0003-3688-578X)
- Denisa Tamarez
- Cassandra Donahue
- Sarah Borgman
- Corey Kurek
- Roy W. Beck
Institutions
- University of North Carolina at Chapel Hill (US)
Publication Details
- Journal
- UNC Libraries
- Published
- 2024-12-17
- DOI
- https://doi.org/10.17615/345c-z826
- Primary Topic
- Diabetes Management and Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- Sanofi
- Gilead Sciences
- Vertex Pharmaceuticals
- Ionis Pharmaceuticals
- Insulet Corporation
- MannKind Corporation
- Dexcom
- Kowa Company
- Tandem Diabetes Care
- Moderna
- Novo Nordisk
- Abbott Diabetes Care