Evidence map›Paper›PMID 26681725›Full record

Trial reportDiabetes care2016

Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

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

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized 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 NCT01994746 (Efficacy and Safety of Nasal Glucagon for Treatment of Insulin Induced Hypoglycemia in Adults With Diabetes), which is not on this map. Cited by 52 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 4% 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.

NCT01994746 phase3completednot on this map

Efficacy and Safety of Nasal Glucagon for Treatment of Insulin Induced Hypoglycemia in Adults With Diabetes

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2015Enrolled77ConditionsDiabetes Mellitus, Type 1ArmsNasal Glucagon, Intramuscular Glucagon
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 4 syntheses or guidelines pooled it, 125 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Pooled it
  4. Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
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  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Article
  16. Article
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  18. Article
  19. 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
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

Michael R RickelsUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
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, QC, Canada.
Hélène DuludeLocemia Solutions ULC, Montreal, QC, Canada.
Jennifer L SherrYale School of Medicine, New Haven, CT.
William V TamborlaneYale School of Medicine, New Haven, CT.
Kathleen E BethinJacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY.
Linda A DiMeglioIndiana University School of Medicine, Indianapolis, IN.
R Paul WadwaBarbara Davis Center for Childhood Diabetes, Aurora, CO.
Andrew J AhmannHarold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
Michael J HallerUniversity 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, St. Laurent, QC, Canada.
Linyan MengJSS Medical Research, St. Laurent, QC, Canada.
Roy W BeckJaeb Center for Health Research, Tampa, FL.
T1D Exchange Intranasal Glucagon Investigators
Jaeb Center for Health Research · USYale University · USIndiana University – Purdue University Indianapolis · USOregon Health & Science University · USUniversity at Buffalo, State University of New York · USUniversity of Florida · USUniversity of Minnesota · USUniversity of Pennsylvania · US

Funding

Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
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
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 UL1TR000003NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1TR000064NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1TR001108NCATS NIH HHS UL1 TR001427NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

objectiveTreatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia. RESEARCH DESIGN AND

methodsAt eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33 ± 12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin. Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon.

resultsMean plasma glucose at time of glucagon administration was 48 ± 8 and 49 ± 8 mg/dL at the intranasal and intramuscular visits, respectively. Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7% vs. 100%; difference 1.3%, upper end of 1-sided 97.5% CI 4.0%). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P < 0.001). Head/facial discomfort was reported during 25% of intranasal and 9% of intramuscular dosing visits; nausea (with or without vomiting) occurred with 35% and 38% of visits, respectively.

conclusionsIntranasal glucagon was highly effective in treating insulin-induced hypoglycemia in adults with type 1 diabetes. Although the trial was conducted in a controlled setting, the results are applicable to real-world management of severe hypoglycemia, which occurs owing to excessive therapeutic insulin relative to the impaired or absent endogenous glucagon response.

Indexed as

Administration, IntranasalAdultBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 1FemaleGlucagonHormonesHumansHypoglycemiaInsulinMaleMiddle AgedYoung AdultBlood GlucoseGlucagonHormonesInsulin

Identifiers

PMID26681725
PMCPMC4722945
OpenAlexW2213182784

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.