Evidence map›Paper›PMID 41223151›Full record

Trial reportDiabetes care2026

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

Michael J Haller, Lauren Kanapka, Roshanak Monzavi, Thomas J Mouse, Gnanagurudasan Prakasam, Asheesh K Dewan, Linda A DiMeglio, Lori M Laffel, Steven M Willi, Michael J Tansey and 32 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Diabetes care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. AFREZZAPaediatric drugs · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Michael J HallerDepartment of Pediatrics, University of Florida, Gainesville, FL.ORCID 0000-0002-2803-1824
Lauren KanapkaJaeb Center for Health Research, Tampa, FL.
Roshanak MonzaviChildren's Hospital Los Angeles, Los Angeles, CA.
Thomas J MouseJaeb Center for Health Research, Tampa, FL.
Gnanagurudasan PrakasamSutter Valley Medical Foundation Pediatric Endocrinology, Sacramento, CA.
Asheesh K DewanThe Diabetes, Obesity, Cardiovascular Specialists (DOCS), Las Vegas, NV.
Linda A DiMeglioIndiana University School of Medicine, Indianapolis, IN.
Lori M LaffelJoslin Diabetes Center, Boston, MA.
Steven M WilliChildren's Hospital of Philadelphia, Philadelphia, PA.
Michael J TanseyUniversity of Iowa, Iowa City, IA.
Bryce A NelsonVirginia Commonwealth University, Richmond, VA.
Himala KashmiriChildren's Hospital Orange County, Orange, CA.
Jamie R WoodUniversity Hospitals Cleveland, Cleveland, OH.
Kashif LatifAM Diabetes and Endocrinology Center, Bartlett, TN.
Perrin WhiteUniversity of Texas Southwestern Medical Center, Dallas, TX.
Mark KipnesDiabetes & Glandular Disease Clinic, San Antonio, TX.
Henry RodriguezUniversity of South Florida, Tampa, FL.
Joshua SmithRocky Mountain Clinical Research, Idaho Falls, ID.
David P SparlingUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK.
Faisal S MalikSeattle Children's Research Institute, Seattle, WA.
Anna CymbalukRady's Children's Hospital, San Diego, CA.
Anuj BhargavaIowa Diabetes and Endocrinology, West Des Moines, IA.
Laya EkhlaspourUniversity of California, San Francisco, Madison Clinic for Pediatric Diabetes, San Francisco, CA.
Shannon BeasleyUniversity of Minnesota, Minneapolis, MN.
Kristina CossenEmory University, Atlanta, GA.
Kupper A WintergerstNorton Children's Hospital, University of Louisville, Louisville, KY.
Rosanna Fiallo-ScharerThe Medical College of Wisconsin, Milwaukee, WI.
David M MaahsStanford University, Stanford, CA.
Kathleen E BethinUBMD Pediatrics, Buffalo, NY.
Michael A WoodMichigan Pediatric Endocrine & Diabetes Services, Ypsilanti, MI.
Patrick C HanleyNemours Children's Hospital Delaware, Wilmington, DE.
Surya N MulukutlaDHR Health Institute for Research and Development, Edinburg, TX.
Michelle Van NameYale School of Medicine, New Haven, CT.
Scott M BlackmanJohns Hopkins Pediatric Endocrinology, Baltimore, MD.
Mary Pat GallagherPediatric Diabetes Center, Hassenfeld Children's Hospital at NYU Langone, New York, NY.
Mark A ClementsChildren's Mercy Clinics, Kansas City, MO.
Nicole SheanonCincinnati Children's Hospital, Cincinnati, OH.
Konda ReddyAdventHealth, Orlando, FL.
Barry J ReinerBarry J. Reiner, MD LLC, Baltimore, MD.
Robin GalJaeb Center for Health Research, Tampa, FL.
Roy W BeckJaeb Center for Health Research, Tampa, FL.ORCID 0000-0002-5194-8446
INHALE-1 Study Group*

Funding

SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI Alessandro Doria · 1986 to 2026
$50.5M
Modeling and modulating insulin delivery in automated insulin delivery systems to accommodate for meal compositionsK23DK121942 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI EKHLASPOUR, LAYA · 2020 to 2024
$964k
MannKind CorporationNIDDK NIH HHS K23 DK121942NIDDK NIH HHS P30 DK036836
6 · The paper itself

Abstract

objectiveTo evaluate inhaled technosphere insulin (TI) in children with diabetes. RESEARCH DESIGN AND

methodsA total of 230 youth 4-17 years old with type 1 (98%) or type 2 (2%) diabetes treated with multiple daily injections of insulin were randomly assigned 1:1 to TI or rapid-acting analog (RAA) insulin plus continuation of long-acting basal insulin and continuous glucose monitoring (CGM) for 26 weeks. The primary outcome was change in HbA1c, tested for noninferiority with margin of 0.4%.

resultsIn intent-to-treat analysis, mean HbA1c (% ± SD) was 8.22 ± 0.87 at baseline and 8.41 ± 1.38 at 26 weeks with TI and 8.21 ± 0.96 and 8.21 ± 1.10, respectively, with RAA (adjusted difference = 0.18; 95% CI -0.07, 0.43; noninferiority P = 0.091). CGM-measured time in range 70-180 mg/dL was not significantly different between groups (adjusted difference -2.2%; 95% CI -7.0, 2.7; P = 0.38). Two severe hypoglycemic events occurred in the TI group and one in the RAA group. Change in forced expiration volume in 1 s from baseline to 26 weeks did not differ comparing TI and RAA (P = 0.53). The TI group reported greater treatment satisfaction (P = 0.004) and had less gain in weight and BMI percentile (P = 0.009) than did the RAA group.

conclusionsThe 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.

Indexed as

Diabetes Mellitus, Type 1Hypoglycemic AgentsInsulinAdministration, InhalationAdolescentBlood GlucoseChildChild, PreschoolFemaleGlycated HemoglobinHumansMaleBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID41223151
PMCPMC12818954

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.