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: 2; Last updated: 2024-11-22 19:28:54+0000
Profile: JournalArticleCitation
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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: 2024-12-19 14:29:51+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.
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Diabetes Care. 2016 Oct;39(10):e192. doi: 10.2337/dc16-0955
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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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contributor: Ahmann AJ
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affiliation: Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
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contributor: Haller MJ
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affiliation: University of Florida, Gainesville, FL.
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