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Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation

Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen™; Xeris Ph...

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Autores principales: Valentine, Virginia, Newswanger, Brett, Prestrelski, Steve, Andre, Anthony D., Garibaldi, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708285/
https://www.ncbi.nlm.nih.gov/pubmed/31219349
http://dx.doi.org/10.1089/dia.2019.0148
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author Valentine, Virginia
Newswanger, Brett
Prestrelski, Steve
Andre, Anthony D.
Garibaldi, Mark
author_facet Valentine, Virginia
Newswanger, Brett
Prestrelski, Steve
Andre, Anthony D.
Garibaldi, Mark
author_sort Valentine, Virginia
collection PubMed
description Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen™; Xeris Pharmaceuticals, Inc., Chicago, IL) versus marketed glucagon emergency kits (GEKs) for managing severe hypoglycemia. Methods: A simulated-use human factors usability study was conducted with the GAI versus marketed GEKs in 16 participants, including adult caregivers and first responders, experienced with glucagon administration. A summative human factors validation study of the GAI was conducted with 75 volunteers. Participants were (1) trained on the device and procedure or (2) given time to individually read the instructions and familiarize themselves with the device. Participants returned a week later to perform an unaided rescue attempt that simulated rescue of patients with diabetes suffering a hypoglycemia emergency. Participant actions were recorded for critical rescue tasks and use errors. Results: In the usability study, 88% (14) successfully administered a rescue injection using the GAI versus 31% (5) using GEKs (P < 0.05). Mean total rescue time of use was 47.9 s with the GAI versus 109.0 s with GEKs (P < 0.05). In the validation study, 98.7% successfully administered the rescue injection using the GAI. Overall, there were no patterns of differences between trained versus untrained participants, between caregivers versus first responders or between adults versus adolescents. Conclusion: The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs.
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spelling pubmed-67082852019-08-26 Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation Valentine, Virginia Newswanger, Brett Prestrelski, Steve Andre, Anthony D. Garibaldi, Mark Diabetes Technol Ther Original Articles Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen™; Xeris Pharmaceuticals, Inc., Chicago, IL) versus marketed glucagon emergency kits (GEKs) for managing severe hypoglycemia. Methods: A simulated-use human factors usability study was conducted with the GAI versus marketed GEKs in 16 participants, including adult caregivers and first responders, experienced with glucagon administration. A summative human factors validation study of the GAI was conducted with 75 volunteers. Participants were (1) trained on the device and procedure or (2) given time to individually read the instructions and familiarize themselves with the device. Participants returned a week later to perform an unaided rescue attempt that simulated rescue of patients with diabetes suffering a hypoglycemia emergency. Participant actions were recorded for critical rescue tasks and use errors. Results: In the usability study, 88% (14) successfully administered a rescue injection using the GAI versus 31% (5) using GEKs (P < 0.05). Mean total rescue time of use was 47.9 s with the GAI versus 109.0 s with GEKs (P < 0.05). In the validation study, 98.7% successfully administered the rescue injection using the GAI. Overall, there were no patterns of differences between trained versus untrained participants, between caregivers versus first responders or between adults versus adolescents. Conclusion: The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs. Mary Ann Liebert, Inc., publishers 2019-09-01 2019-08-19 /pmc/articles/PMC6708285/ /pubmed/31219349 http://dx.doi.org/10.1089/dia.2019.0148 Text en © Virginia Valentine, et al., 2019; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Original Articles
Valentine, Virginia
Newswanger, Brett
Prestrelski, Steve
Andre, Anthony D.
Garibaldi, Mark
Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title_full Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title_fullStr Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title_full_unstemmed Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title_short Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
title_sort human factors usability and validation studies of a glucagon autoinjector in a simulated severe hypoglycemia rescue situation
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708285/
https://www.ncbi.nlm.nih.gov/pubmed/31219349
http://dx.doi.org/10.1089/dia.2019.0148
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