Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
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
| Active as of 2024-11-01 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 267499</b></p><a name="267499"> </a><a name="hc267499"> </a><a name="267499-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 1; Last updated: 2024-08-05 19:55:53+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>url</b>: <a href="Citation-267499.html">Citation 26681725 Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.</a></p><p><b>identifier</b>: FEvIR Object Identifier/267499, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26681725, <a href="http://terminology.hl7.org/6.0.2/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
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This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.35</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 26681725 Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-01 10:20:00+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
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</div><p><b>approvalDate</b>: 2016-07-26</p><p><b>lastReviewDate</b>: 2022-03-30</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-received}">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --> 2015-07-09</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --> 2015-10-20</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2015-12-19 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --> 2015-12-19 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --> 2016-07-28 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pmc-release}">PubMed Pubstatus of PMC release</span></p><p><b>period</b>: ?? --> 2017-02-01</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26681725, <code>https://www.ncbi.nlm.nih.gov/pmc/</code>/PMC4722945, <code>https://doi.org</code>/10.2337/dc15-1498, pii/dc15-1498</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td><div><p><strong>OBJECTIVE:</strong> 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.
<strong>RESULTS:</strong> 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.
<strong>CONCLUSIONS:</strong> 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.</p>
</div></td><td><div><p>© 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.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes 2008;57:3169–3176</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/19033403/">https://pubmed.ncbi.nlm.nih.gov/19033403/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/19033403</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Brodows RG, Williams C, Amatruda JM. Treatment of insulin reactions in diabetics. JAMA 1984;252:3378–3381</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/6389915/">https://pubmed.ncbi.nlm.nih.gov/6389915/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/6389915</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2310277/">https://pubmed.ncbi.nlm.nih.gov/2310277/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2310277</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/8587958/">https://pubmed.ncbi.nlm.nih.gov/8587958/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/8587958</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
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</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>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</p>
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</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2898045/">https://pubmed.ncbi.nlm.nih.gov/2898045/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2898045</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
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</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/2076798/">https://pubmed.ncbi.nlm.nih.gov/2076798/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/2076798</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
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</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/22996145/">https://pubmed.ncbi.nlm.nih.gov/22996145/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/22996145</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>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</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>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</p>
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</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/1797507/">https://pubmed.ncbi.nlm.nih.gov/1797507/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/1797507</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>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</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>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</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/7894298/">https://pubmed.ncbi.nlm.nih.gov/7894298/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/7894298</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Diabetes Care. 2016 Oct;39(10):e192. doi: 10.2337/dc16-0955</p>
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value="**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 &lt; 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."/>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-01
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