Evidence map›Paper›PMID 26884472›Full record

Trial reportDiabetes care2016

Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.

Jennifer L Sherr, Katrina J Ruedy, Nicole C Foster, Claude A Piché, Hélène Dulude, Michael R Rickels, William V Tamborlane, Kathleen E Bethin, Linda A DiMeglio, Larry A Fox and 8 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05206149 (Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes), which is not on this map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
9.9field-weighted citation impact, top 1% of its field
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.

NCT05206149 phase4completednot on this mapstarted 2021, after this paper: background citation

Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes

TypeinterventionalSponsorA.O.U. Città della Salute e della ScienzaRan2021 to 2021Enrolled10ConditionsHypopituitarismArmsIntranasal glugagon, Intranasal placebo
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 121 citations in OpenAlex.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Out of Sight, Out of Mind: A Call to Action for the Treatment of Hypoglycemia.Clinical diabetes : a publication of the American Diabetes Association · 2024
    Article
  14. Review
  15. Article
  16. Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  17. Article
  18. Article
  19. Nasal Glucagon.Hospital pharmacy · 2022
    Review
  20. Article
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

18 authors at 8 institutions in 2 countries.

Jennifer L SherrYale School of Medicine, New Haven, CT.
Katrina J RuedyJaeb Center for Health Research, Tampa, FL.
Nicole C FosterJaeb Center for Health Research, Tampa, FL t1dstats@jaeb.org.
Claude A PichéLocemia Solutions ULC, Montreal, Canada.
Hélène DuludeLocemia Solutions ULC, Montreal, Canada.
Michael R RickelsUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
William V TamborlaneYale School of Medicine, New Haven, CT.
Kathleen E BethinUniversity at Buffalo School of Medicine and Biomedical Sciences, The State University of New York, Buffalo, NY.
Linda A DiMeglioIndiana University School of Medicine, Indianapolis, IN.
Larry A FoxNemours Children's Specialty Care, Jacksonville, FL.
R Paul WadwaBarbara Davis Center for Childhood Diabetes, Aurora, CO.
Desmond A SchatzUniversity of Florida, Gainesville, FL.
Brandon M NathanUniversity of Minnesota, Minneapolis, MN.
Santica M MarcovinaNorthwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA.
Emmanouil RampakakisJSS Medical Research, Saint-Laurent, Canada.
Linyan MengJSS Medical Research, Saint-Laurent, Canada.
Roy W BeckJaeb Center for Health Research, Tampa, FL.
T1D Exchange Intranasal Glucagon Investigators
Jaeb Center for Health Research · USCentre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent · CAYale University · USIndiana University – Purdue University Indianapolis · USUniversity at Buffalo, State University of New York · USUniversity of Florida · USUniversity of Minnesota · USUniversity of Pennsylvania · US

Funding

Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR001427NCATS NIH HHS UL1 TR002529
6 · The paper itself

Abstract

objectiveTreatment of severe hypoglycemia outside of the hospital setting is limited to intramuscular glucagon requiring reconstitution prior to injection. The current study examined the safety and dose-response relationships of a needle-free intranasal glucagon preparation in youth aged 4 to <17 years. RESEARCH DESIGN AND

methodsA total of 48 youth with type 1 diabetes completed the study at seven clinical centers. Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon. Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session. Glucagon was given after glucose was lowered to <80 mg/dL (mean nadir ranged between 67 and 75 mg/dL).

resultsAll 24 intramuscular and 58 of the 59 intranasal doses produced a ≥25 mg/dL rise in glucose from nadir within 20 min of dosing. Times to peak plasma glucose and glucagon levels were similar under both intramuscular and intranasal conditions. Transient nausea occurred in 67% of intramuscular sessions versus 42% of intranasal sessions (P = 0.05); the efficacy and safety of the 2- and 3-mg intranasal doses were similar in the youngest cohorts.

conclusionsResults of this phase 1, pharmacokinetic, and pharmacodynamic study support the potential efficacy of a needle-free glucagon nasal powder delivery system for treatment of hypoglycemia in youth with type 1 diabetes. Given the similar frequency and transient nature of adverse effects of the 2- and 3-mg intranasal doses in the two youngest cohorts, a single 3-mg intranasal dose appears to be appropriate for use across the entire 4- to <17-year age range.

Indexed as

Administration, IntranasalAdolescentBlood GlucoseChildChild, PreschoolCohort StudiesCross-Over StudiesDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleGlucagonHumansHypoglycemiaInjections, IntramuscularBlood GlucoseGlucagonInsulinPowders

Identifiers

PMID26884472
PMCPMC4806770
OpenAlexW2276228986

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.