Generated Narrative: Citation 267499

url: Citation 26681725 Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

identifier: FEvIR Object Identifier/267499, https://pubmed.ncbi.nlm.nih.gov/26681725, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.35

version: 2.0.0-ballot

title: 26681725 Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

status: Active

date: 2024-11-01 10:20:00+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

UseContexts

jurisdiction: World

copyright:

approvalDate: 2016-07-26

lastReviewDate: 2022-03-30

author: Computable Publishing®: MEDLINE-to-FEvIR Converter:

classification

type: Citation Source

classifier: MEDLINE

classification

type: MEDLINE Citation Owner

classifier: National Library of Medicine, Index Section

currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish

statusDate

activity: PubMed Pubstatus of Received

period: ?? --> 2015-07-09

statusDate

activity: PubMed Pubstatus of Accepted

period: ?? --> 2015-10-20

statusDate

activity: PubMed Pubstatus of Entrez

period: ?? --> 2015-12-19 06:00:00+0000

statusDate

activity: PubMed Pubstatus of Pubmed

period: ?? --> 2015-12-19 06:00:00+0000

statusDate

activity: PubMed Pubstatus of Medline

period: ?? --> 2016-07-28 06:00:00+0000

statusDate

activity: PubMed Pubstatus of PMC release

period: ?? --> 2017-02-01

citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/26681725, https://www.ncbi.nlm.nih.gov/pmc//PMC4722945, https://doi.org/10.2337/dc15-1498, pii/dc15-1498

Titles

-	Type	Language	Text
*	Primary title	English	Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

Abstracts

-	Text	Copyright
*	OBJECTIVE: Treatment 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. <AbstractText Label="RESEARCH DESIGN AND METHODS" NlmCategory="METHODS">At 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. RESULTS: Mean 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. CONCLUSIONS: Intranasal 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.	© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

relatesTo

type: cites

classifier: Journal Article

citation:

Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes 2008;57:3169–3176

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/19033403/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/19033403

relatesTo

type: cites

classifier: Journal Article

citation:

Brodows RG, Williams C, Amatruda JM. Treatment of insulin reactions in diabetics. JAMA 1984;252:3378–3381

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/6389915/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/6389915

relatesTo

type: cites

classifier: Journal Article

citation:

Slama G, Traynard PY, Desplanque N, et al. . The search for an optimized treatment of hypoglycemia. Carbohydrates in tablets, solutin, or gel for the correction of insulin reactions. Arch Intern Med 1990;150:589–593

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/2310277/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/2310277

relatesTo

type: cites

classifier: Journal Article

citation:

Gold AE, MacLeod KM, Deary IJ, Frier BM. Hypoglycemia-induced cognitive dysfunction in diabetes mellitus: effect of hypoglycemia unawareness. Physiol Behav 1995;58:501–511

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/8587958/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/8587958

relatesTo

type: cites

classifier: Journal Article

citation:

Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP Jr, Selby JV. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009;301:1565–1572

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/19366776/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/19366776

relatesTo

type: cites

classifier: Journal Article

citation:

McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Increased mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care 2012;35:1897–1901

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/22699297/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/22699297

relatesTo

type: cites

classifier: Journal Article

citation:

Weinstock RS, Xing D, Maahs DM, et al. .; T1D Exchange Clinic Network . Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange clinic registry. J Clin Endocrinol Metab 2013;98:3411–3419

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/23760624/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/23760624

relatesTo

type: cites

citation:

Cariou B, Lièvre M, Huet D, Charbonnel B, Sert C, Gouet D. Hypoglycemia among 3048 insulin-treated patients in real life: frequency and predictive factors: results from the prospective DIALOG study. Presented at European Association for the Study of Diabetes (Abstract). Barcelona, Spain, EASD, 2013. Available from http://www.easdvirtualmeeting.org/resources/hypoglycaemia-among-3048-insulin-treated-patients-in-real-life-frequency-and-predictive-factors-results-from-the-prospective-dialog-study--2. Accessed 3 December 2015

relatesTo

type: cites

citation:

Khunti K, Alsifri S, Aronson R, et al. . Self-reported hypoglycemia: A global study of 24 countries with 27,585 insulin-treated patients with diabetes: the HAT study. Diabetes Res Clin Pract 2014;106:S105–S106

relatesTo

type: cites

classifier: Journal Article

citation:

Gerich JE, Langlois M, Noacco C, Karam JH, Forsham PH. Lack of glucagon response to hypoglycemia in diabetes: evidence for an intrinsic pancreatic alpha cell defect. Science 1973;182:171–173

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/4581053/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/4581053

relatesTo

type: cites

classifier: Journal Article

citation:

Holstein A, Hammer C, Plaschke A, et al. . Hormonal counterregulation during severe hypoglycaemia under everyday conditions in patients with type 1 and insulin-treated type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes 2004;112:429–434

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/15372362/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/15372362

relatesTo

type: cites

citation:

Harrism G, Diment A, Sulway M, Wilkinson M. Glucagon administration - underevaluated and undertaught. Pract Diabetes Int 2001;18:22–25

relatesTo

type: cites

classifier: Journal Article

citation:

Pontiroli AE, Alberetto M, Pozza G. Metabolic effects of intranasally administered glucagon: comparison with intramuscular and intravenous injection. Acta Diabetol Lat 1985;22:103–110

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/3907228/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/3907228

relatesTo

type: cites

classifier: Journal Article

citation:

Freychet L, Rizkalla SW, Desplanque N, et al. . Effect of intranasal glucagon on blood glucose levels in healthy subjects and hypoglycaemic patients with insulin-dependent diabetes. Lancet 1988;1:1364–1366

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/2898045/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/2898045

relatesTo

type: cites

classifier: Journal Article

citation:

Pontiroli AE, Calderara A, Pajetta E, Alberetto M, Pozza G. Intranasal glucagon as remedy for hypoglycemia. Studies in healthy subjects and type I diabetic patients. Diabetes Care 1989;12:604–608

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/2676430/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/2676430

relatesTo

type: cites

classifier: Journal Article

citation:

Slama G, Alamowitch C, Desplanque N, Letanoux M, Zirinis P. A new non-invasive method for treating insulin-reaction: intranasal lyophylized glucagon. Diabetologia 1990;33:671–674

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/2076798/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/2076798

relatesTo

type: cites

classifier: Journal Article

citation:

Rosenfalck AM, Bendtson I, Jørgensen S, Binder C. Nasal glucagon in the treatment of hypoglycaemia in type 1 (insulin-dependent) diabetic patients. Diabetes Res Clin Pract 1992;17:43–50

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/1511660/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/1511660

relatesTo

type: cites

classifier: Journal Article

citation:

Beck RW, Tamborlane WV, Bergenstal RM, Miller KM, DuBose SN, Hall CA; T1D Exchange Clinic Network . The T1D Exchange clinic registry. J Clin Endocrinol Metab 2012;97:4383–4389

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/22996145/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/22996145

relatesTo

type: cites

citation:

Novo Nordisk. GlucaGen prescribing information [Internet]. Available from http://www.novonordiskmedicalinformation.com//file_upload/GlucaGen%20HypoKit%20Prescribing%20Information,April%202014%20.pdf. Accessed 9 September 2015

relatesTo

type: cites

citation:

Locemia Solutions ULC. Safety and efficacy of a novel glucagon formulation in type 1 diabetic patients following insulin-induced hypoglycemia (AMG102) [Internet]. Available from https://clinicaltrials.gov/ct2/show/study/NCT01556594?term=amg+medical&rank=1. Accessed 23 June 2015

relatesTo

type: cites

classifier: Journal Article

citation:

Hepburn DA, Deary IJ, Frier BM, Patrick AW, Quinn JD, Fisher BM. Symptoms of acute insulin-induced hypoglycemia in humans with and without IDDM. Factor-analysis approach. Diabetes Care 1991;14:949–957

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/1797507/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/1797507

relatesTo

type: cites

citation:

Yale JF, Piche C, Lafontaine M, et al. Needlefree nasal delivery of glucagon is superior to injectable delivery in simulated hypoglycaemia rescue. Poster presented at European Association for the Study of Diabetes (Abstract). Stockholm, Sweden, September 2015. Available from http://www.easdvirtualmeeting.org/resources/needle-free-nasal-delivery-of-glucagon-is-superior-to-injectable-delivery-in-simulated-hypoglycaemia-rescue--3. Accessed 3 December 2015

relatesTo

type: cites

classifier: Journal Article

citation:

Pacchioni M, Orena C, Panizza P, Cucchi E, Del Maschio A, Pontiroli AE. The hypotonic effect of intranasal and intravenous glucagon in gastrointestinal radiology. Abdom Imaging 1995;20:44–46

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/7894298/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/7894298

relatesTo

type: comment-in

classifier: Comment

citation:

Diabetes Care. 2016 Oct;39(10):e192. doi: 10.2337/dc16-0955

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/27660134/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/27660134

relatesTo

type: comment-in

classifier: Comment

citation:

Diabetes Care. 2016 Oct;39(10):e193-4. doi: 10.2337/dci16-0025

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/27660135/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/27660135

publicationForm

publishedIn

type: Periodical

identifier: Electronic ISSN Type/1935-5548, ISOAbbreviation/Diabetes Care, ISSN Linking/0149-5992, Medline Title Abbreviation/Diabetes Care, NLM Unique ID/7805975

title: Diabetes care

publisherLocation: United States

citedMedium: Internet

volume: 39

issue: 2

articleDate: 2016-02

publicationDateText: 2016-Feb

language: English

pageString: 264-70

publicationForm

citedMedium: Internet without issue

articleDate: 2015-12-17

webLocation

classifier: Abstract

url: https://pubmed.ncbi.nlm.nih.gov/26681725/

webLocation

classifier: DOI Based

url: https://doi.org/10.2337/dc15-1498

classification

type: Publishing Model

classifier: Print Electronic

classification

type: Chemical

classifier: Blood Glucose, Hormones, Insulin, Glucagon

classification

type: MeSH heading

artifactAssessment: ArtifactAssessment: artifact[x] = this resource

classification

type: Publication type

classifier: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't

classification

type: Knowledge Artifact Type

classifier: Journal Article

artifactAssessment: Classifier added by Computable Publishing LLC

classification

type: Citation subset

classifier: IM

contributorship

complete: true

entry

contributor: Rickels MR

forenameInitials: MR

affiliation: University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

entry

contributor: Ruedy KJ

forenameInitials: KJ

affiliation: Jaeb Center for Health Research, Tampa, FL.

entry

contributor: Foster NC

forenameInitials: NC

affiliation: Jaeb Center for Health Research, Tampa, FL t1dstats@jaeb.org.

entry

contributor: Piché CA

forenameInitials: CA

affiliation: Locemia Solutions ULC, Montreal, QC, Canada.

entry

contributor: Dulude H

forenameInitials: H

affiliation: Locemia Solutions ULC, Montreal, QC, Canada.

entry

contributor: Sherr JL

forenameInitials: JL

affiliation: Yale School of Medicine, New Haven, CT.

entry

contributor: Tamborlane WV

forenameInitials: WV

affiliation: Yale School of Medicine, New Haven, CT.

entry

contributor: Bethin KE

forenameInitials: KE

affiliation: Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY.

entry

contributor: DiMeglio LA

forenameInitials: LA

affiliation: Indiana University School of Medicine, Indianapolis, IN.

entry

contributor: Wadwa RP

forenameInitials: RP

affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.

entry

contributor: Ahmann AJ

forenameInitials: AJ

affiliation: Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.

entry

contributor: Haller MJ

forenameInitials: MJ

affiliation: University of Florida, Gainesville, FL.

entry

contributor: Nathan BM

forenameInitials: BM

affiliation: University of Minnesota, Minneapolis, MN.

entry

contributor: Marcovina SM

forenameInitials: SM

affiliation: Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA.

entry

contributor: Rampakakis E

forenameInitials: E

affiliation: JSS Medical Research, St. Laurent, QC, Canada.

entry

contributor: Meng L

forenameInitials: L

affiliation: JSS Medical Research, St. Laurent, QC, Canada.

entry

contributor: Beck RW

forenameInitials: RW

affiliation: Jaeb Center for Health Research, Tampa, FL.

entry

contributor: T1D Exchange Intranasal Glucagon Investigators

Generated Narrative: Practitioner #contributor0

name: Michael R Rickels

Generated Narrative: Practitioner #contributor1

name: Katrina J Ruedy

Generated Narrative: Practitioner #contributor2

name: Nicole C Foster

Generated Narrative: Practitioner #contributor3

name: Claude A Piché

Generated Narrative: Practitioner #contributor4

name: Hélène Dulude

Generated Narrative: Practitioner #contributor5

name: Jennifer L Sherr

Generated Narrative: Practitioner #contributor6

name: William V Tamborlane

Generated Narrative: Practitioner #contributor7

name: Kathleen E Bethin

Generated Narrative: Practitioner #contributor8

name: Linda A DiMeglio

Generated Narrative: Practitioner #contributor9

name: R Paul Wadwa

Generated Narrative: Practitioner #contributor10

name: Andrew J Ahmann

Generated Narrative: Practitioner #contributor11

name: Michael J Haller

Generated Narrative: Practitioner #contributor12

name: Brandon M Nathan

Generated Narrative: Practitioner #contributor13

name: Santica M Marcovina

Generated Narrative: Practitioner #contributor14

name: Emmanouil Rampakakis

Generated Narrative: Practitioner #contributor15

name: Linyan Meng

Generated Narrative: Practitioner #contributor16

name: Roy W Beck

Generated Narrative: Organization #contributor17

name: T1D Exchange Intranasal Glucagon Investigators

Generated Narrative: ArtifactAssessment #meshHeading0

artifact: Citation 26681725 Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Administration, Intranasal

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Adult

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Blood Glucose

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: drug effects

Components

-	Type	Classifier
*	is Major topic	No

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Cross-Over Studies

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Diabetes Mellitus, Type 1

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: blood

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: drug therapy

Components

-	Type	Classifier
*	is Major topic	Yes

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Female

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Glucagon

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: administration & dosage

Components

-	Type	Classifier
*	is Major topic	Yes

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Hormones

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: therapeutic use

Components

-	Type	Classifier
*	is Major topic	Yes

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Humans

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Hypoglycemia

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: chemically induced

Components

-	Type	Classifier
*	is Major topic	No

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Insulin

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: therapeutic use

Components

-	Type	Classifier
*	is Major topic	No

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Male

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Middle Aged

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Young Adult

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic