Evidence Based Medicine on FHIR Implementation Guide
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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

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

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Generated Narrative: Citation 267499

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Profile: JournalArticleCitation

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/https://fevir.net/FOI/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: 2024-12-19 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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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

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

Abstracts

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*

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

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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

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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

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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

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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: Indiana University School of Medicine, Indianapolis, IN.

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

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contributor: T1D Exchange Intranasal Glucagon Investigators


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

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