Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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Generated Narrative: Citation 267499
version: 1; Last updated: 2024-08-05 19:55:53+0000
Profile: JournalArticleCitation
identifier: FEvIR Object Identifier/267499, https://pubmed.ncbi.nlm.nih.gov
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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: 2024-11-21 14:09:14+0000
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description:
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
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https://creativecommons.org/licenses/by-nc-sa/4.0/
approvalDate: 2016-07-26
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citedArtifact
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https://pubmed.ncbi.nlm.nih.gov
/26681725,https://www.ncbi.nlm.nih.gov/pmc/
/PMC4722945,https://doi.org
/10.2337/dc15-1498, pii/dc15-1498Titles
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
/19033403relatesTo
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
/6389915relatesTo
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
/2310277relatesTo
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
/8587958relatesTo
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
/19366776relatesTo
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
/22699297relatesTo
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
/23760624relatesTo
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
/4581053relatesTo
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
/15372362relatesTo
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
/3907228relatesTo
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
/2898045relatesTo
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
/2676430relatesTo
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
/2076798relatesTo
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
/1511660relatesTo
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
/22996145relatesTo
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
/1797507relatesTo
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
/7894298relatesTo
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Diabetes Care. 2016 Oct;39(10):e192. doi: 10.2337/dc16-0955
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Diabetes Care. 2016 Oct;39(10):e193-4. doi: 10.2337/dci16-0025
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affiliation: Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY.
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contributor: DiMeglio LA
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affiliation: Indiana University School of Medicine, Indianapolis, IN.
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contributor: Wadwa RP
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affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
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affiliation: Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
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