Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Mar 1;48(3):353-360.
doi: 10.2337/dc24-1832.

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

Collaborators, Affiliations
Randomized Controlled Trial

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

Irl B Hirsch et al. Diabetes Care. .

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Duality of Interest. I.B.H. reports consulting for Abbott, Roche, Hagar, and Vertex Pharmaceuticals and research support from MannKind, Dexcom, and Tandem Diabetes Care. R.W.B. reports that his institution has received funding on his behalf as follows: grant funding, study supplies, and consulting fees from Insulet, Tandem Diabetes Care, and Beta Bionics; grant funding and study supplies from Dexcom; grant funding from Bigfoot Biomedical; study supplies from Medtronic, Ascencia, and Roche; consulting fees and study supplies from Eli Lilly and Novo Nordisk; and consulting fees from embecta, Sequel Med Tech, Vertex Pharmaceuticals, Hagar, Ypsomed, Sanofi, and Zucara Therapeutics. Y.K. reports receiving product support from Tandem Diabetes Care, Insulet, and Abbott and acting on the advisory board for Tandem Diabetes Care, Novo Nordisk, and Vertex Pharmaceuticals. H.K.A. received grant payments for research from the following companies: Boehringer Ingelheim, Abbott Diabetes Care, AbbVie, Covance, Dexcom, Eli Lilly, Madrigal Pharmaceuticals, Medtronic, Novo Nordisk, MannKind, Carmot Therapeutics, Quintiles, Akero Therapeutics, 89bio, Viking Therapeutics, PPD, Zydus, Kowa Pharmaceuticals America, Insulet, and VtV Therapeutics. G.A. has received consulting fees from Dexcom and Insulet. G.A. has received research support to her institution, Northwestern University, from Fractyl Health, Insulet, Tandem Diabetes Care, and Welldoc. T.B. reports participating in the speakers bureau for Eli Lilly, Novo Nordisk, Boehringer Ingelheim, AstraZeneca, and Dexcom; receiving research support from Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Roche, Abbott, Tandem Diabetes Care, MannKind, Insulet, Medtronic, AbbVie, VtV Therapeutics, and Biomea Fusion; and acting on advisory boards for Insulet and MannKind. C.J.L. reports research support paid to her institution from Dexcom, Tandem Diabetes Care, Insulet, Novo Nordisk, and Abbott Diabetes Care and consulting fees from Dexcom and Tandem Diabetes Care. K.C. receives research support provided to her institution from Dexcom, Abbott, Medtronic, Eli Lilly, MannKind, and Insulet and receives consulting fees from Dexcom. A.M. reports acting on the scientific advisory board and participating in speaking engagements for MannKind; acting as a clinical trial principal investigator and participating in speaking engagements for Novo Nordisk, Sanofi, Eli Lilly, Boehringer Ingelheim, and AstraZeneca; participating in speaking engagements for Janssen Pharmaceuticals; acting as a chief clinical principal investigator, acting on the scientific advisory board, and participating in speaking engagements for Medtronic; acting on the scientific advisory board and acting as a principal investigator for AbbVie; and participating in speaking engagements for Intuity Medical. D.P. reports support from Novo Nordisk, Eli Lilly, MannKind, AstraZeneca, and Boehringer Ingelheim. D.W.S. reports consulting for Abbott Diabetes Care and research support to his institution from the National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Novo Nordisk, and Abbott Diabetes Care. R.S.W. reports participation in multicenter clinical trials, through her institution, sponsored by Tandem Diabetes Care, Insulet, Diasome, Eli Lilly, and Amgen, and use of DexCom devices obtained at reduced cost for clinical research. B.W.B. reports stock ownership in Aseko (Glytec); consulting for Beta Bionics, Biomea Fusion, Eli Lilly, Medtronic, MannKind, Novo Nordisk, and Sensorics; participating in the speakers bureau of Abbott, Eli Lilly, Medtronic, MannKind, Novo Nordisk, Sanofi, and Xeris; and receiving grant and research support through his employer from Abvance Therapeutics, Abbott, Dexcom, Diasome, Dompé farmaceutici, Insulet, Eli Lilly, MannKind, Medtronic, Novo Nordisk, Sanofi, Senseonics, REMD Biotherapeutics, Xeris, and vTv Therapeutics. O.H. reports research support from Novo Nordisk, Eli Lilly, and MannKind and acting on an advisory board for Abbott Nutrition. M.K. reports participating in clinical trials for the following sponsor companies: 89bio, AbbVie, Akero Therapeutics, Amgen, AstraZeneca, Biolinq, Biomea Fusion, Boehringer Ingelheim, Corcept Therapeutics, Diamyd Medical, Dexcom, Eli Lilly, Endogenex, Fractyl Health, Gilead, Insulet, Ionis Pharmaceuticals, Kowa, MannKind, Medtronic, Novo Nordisk, Pfizer, Reata Pharmaceuticals, Sinocare, Tandem Diabetes Care, vTv Therapeutics, Zucara Therapeutics, and Zydus. M.K. participates in an advisory board for Corcept Therapeutics and a clinical events committee for Capillary Biomedical. C.J. reports consulting, acting on an advisory board for, and speaking on insulin pumps for Medtronic. J.B.B. reports research support from Bayer, Boehringer Ingelheim, Carmot Therapeutics, Corcept Therapeutics, Dexcom, Eli Lilly, Insulet, MannKind, Novo Nordisk, and vTv Therapeutics; consulting fees from Alkahest, Altimmune, Anji Pharmaceuticals, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Eli Lilly, embecta, GentiBio, Glyscend, Insulet, Mediflix, Medscape, Medtronic, Mellitus Health, Metsera, Moderna, Novo Nordisk, Pendulum Therapeutics, Praetego, ReachMD, Stability Health, Tandem Diabetes Care, Terns Pharmaceuticals, and Vertex Pharmaceuticals; and stock options from Glyscend, Mellitus Health, Pendulum Therapeutics, Praetego, and Stability Health. K.R.K. has received consulting fees from Novo Nordisk. K.R.K. has received research-related contracts (paid to the institution) from Bayer, Boehringer Ingelheim, Carmot Therapeutics, Diasome, Eli Lilly, Novo Nordisk, Rhythm Pharmaceuticals, and vTv Therapeutics. G.O. has received research support paid to her institution from Dexcom, Abbott Diabetes Care, Tandem Diabetes Care, Insulet, and Novo Nordisk. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
CGM-measured mean glucose by hour at 17 weeks. Lines represent means, and shaded bands represent 95% CIs.

Comment in

References

    1. American Diabetes Association Professional Practice Committee . 6. Glycemic goals and hypoglycemia: Standards of Care in Diabetes—2024. Diabetes Care 2024;47(Suppl. 1):S111–S125 - PMC - PubMed
    1. Pettus JH, Zhou FL, Shepherd L, et al. . Incidences of severe hypoglycemia and diabetic ketoacidosis and prevalence of microvascular complications stratified by age and glycemic control in U.S. adult patients with type 1 diabetes: a real-world study. Diabetes Care 2019;42:2220–2227 - PubMed
    1. Foster NC, Beck RW, Miller KM, et al. . State of type 1 diabetes management and outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther 2019;21:66–72 - PMC - PubMed
    1. Forlenza GP, Lal RA. Current status and emerging options for automated insulin delivery systems. Diabetes Technol Ther 2022;24:362–371 - PMC - PubMed
    1. Heinemann L, Parkin CG. Rethinking the viability and utility of inhaled insulin in clinical practice. J Diabetes Res 2018;2018:4568903. - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources