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Expert Opin Drug Deliv. 2019 Sep;16(9):1015-1025. doi: 10.1080/17425247.2019.1653278.

Human factors studies of a prefilled syringe with stable liquid glucagon in a simulated severe hypoglycemia rescue situation.

Author information

1
Xeris Pharmaceuticals, Inc ., Chicago , IL , USA.
2
Interface Analysis Associates , Saratoga , CA , USA.

Abstract

Background: Two human factors studies evaluated whether a stable liquid formulation of glucagon in a prefilled syringe (G-PFS) could be safely and effectively administered and evaluated the effectiveness of the product label guide and instructions-for-use (IFU). Research design and methods: In a formative study, 11 participants received orientation with the G-PFS instructional materials and performed a single unaided rescue attempt. In the validation study, 75 adult and adolescent participants received training or familiarized themselves with the G-PFS IFU, Label Guide, and device. All participants returned 1 week later to perform a single unaided rescue attempt of a simulated person with diabetes suffering from an emergency severe hypoglycemic event. Results: The formative study resulted in a 100% success rate across all rescue dose attempts. The validation study resulted in 74/75 (99%) of participants successfully using the G-PFS to administer the full glucagon rescue dose, and validated that intended users could learn from, comprehend, and recall the G-PFS instructions to successfully use the product. Conclusion: The G-PFS provides a familiar, easy-to-use alternative to currently marketed lyophilized glucagon kits for treating severe hypoglycemia. The G-PFS IFU and Label Guide enable even untrained users to successfully administer a full rescue dose of stable liquid glucagon.

KEYWORDS:

Liquid glucagon; human factors; hypoglycemia; prefilled syringe; rescue; validation

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