INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes

Haller, MJ; Kanapka, L; Monzavi, R; Mouse, TJ; Prakasam, G; Dewan, AK; DiMeglio, LA; Laffel, LM; Willi, SM; Tansey, MJ; Nelson, BA; Kashmiri, H; Wood, JR; Latif, K; White, P; Kipnes, M; Rodriguez, H; Smith, J; Sparling, DP; Malik, FS; Cymbaluk, A; Bhargava, A; Ekhlaspour, L; Beasley, S; Cossen, K; Wintergerst, KA; Fiallo-Scharer, R; Maahs, DM; Bethin, KE; Wood, MA; Hanley, PC; Mulukutla, SN; Van Name, M; Blackman, SM; Gallagher, MP; Clements, MA; Sheanon, N; Reddy, K; Reiner, BJ; Gal, R; Beck, RW; INHALE-1 Study Group*

doi:10.2337/dc25-1994

Diabetes technology

INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes

Diabetes CarePublished 12 Nov 2025Randomised controlled trial

Primary result · HbA1cResultAdjusted difference 0.18 95% CI −0.07 to 0.43

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Authors' conclusion

The primary analysis did not meet the prespecified criteria for HbA1c noninferiority. However, TI use was safe over 26 weeks without affecting pulmonary function and was associated with greater treatment satisfaction and less weight gain compared with RAA, supporting TI as a treatment option for some pediatric patients with type 1 diabetes.

Study context

Population: Youth 4–17 years old with T1D (98%) or T2D (2%) treated with MDIrandomized 1:1
Participants: 230 participants

Comparison: Inhaled technosphere insulin (TI) vs rapid-acting analog (RAA) insulin, plus continued long-acting basal insulin and continuous glucose monitoring (CGM)
Primary endpoint: Change in HbA1c, tested for noninferiority with margin of 0.4%
Follow-up: 26 weeks

Methodological detailsmulticenter, noninferiority

Multicenter
Noninferiority

Primary result

HbA1c

Adjusted difference

0.18

95% CI −0.07 to 0.43

noninferiority P = 0.091

By group

TI8.41mean · SD 1.38 · %

RAA8.21mean · SD 1.10 · %

TIvs RAA

adjusted difference 0.18 (95% CI −0.07 to 0.43); noninferiority P = 0.091

Non-inferiority margin 0.4 as printed, not drawn

As reported in the abstract

Further findings

HbA1c at baseline

TImean 8.22 %SD 0.87

RAAmean 8.21 %SD 0.96

Outcome		Adjusted difference (%) (95% CI)	P value
CGM-measured TIR 70-180 mg/dL	−10−505	−2.2 (−7.0 to 2.7)	P = 0.38
	−10−505Difference, % (linear scale)

Treatment satisfaction · greater with TI: P = 0.004
Gain in weight and BMI percentile · less gain with TI: P = 0.009

Safety

Events

Outcome	TI	RAA
Severe hypoglycemic events	2	1

Change in forced expiration volume in 1 s · baseline to 26 weeks · did not differ: P = 0.53

Reference

Authors: Haller MJ, Kanapka L, Monzavi R, Mouse TJ, Prakasam G, Dewan AK, et al.
All 42 authors
Haller MJ, Kanapka L, Monzavi R, Mouse TJ, Prakasam G, Dewan AK, DiMeglio LA, Laffel LM, Willi SM, Tansey MJ, Nelson BA, Kashmiri H, Wood JR, Latif K, White P, Kipnes M, Rodriguez H, Smith J, Sparling DP, Malik FS, Cymbaluk A, Bhargava A, Ekhlaspour L, Beasley S, Cossen K, Wintergerst KA, Fiallo-Scharer R, Maahs DM, Bethin KE, Wood MA, Hanley PC, Mulukutla SN, Van Name M, Blackman SM, Gallagher MP, Clements MA, Sheanon N, Reddy K, Reiner BJ, Gal R, Beck RW, INHALE-1 Study Group*
Journal: Diabetes Care
Published: 12 Nov 2025
DOI: 10.2337/dc25-1994
PubMed: 41223151

Topic: Diabetes technology
Also indexed: Type 1 diabetes

Intervention details

TI: inhaled technosphere insulin plus continuation of long-acting basal insulin and CGM
RAA: rapid-acting analog insulin plus continuation of long-acting basal insulin and CGM

Key notes

Noninferiority margin 0.4%; not met
Intent-to-treat analysis

Original publication

INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes. Diabetes Care. Published 12 November 2025. doi:10.2337/dc25-1994

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