2017
DOI: 10.1177/1932296817736316
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Dose Accuracy, Injection Force, and Usability Assessment of a New Half-Unit, Prefilled Insulin Pen

Abstract: Background:This study examines the utility of the first prefilled, rapid-acting insulin pen that can be dialed in half-unit increments. Dose accuracy and injection force were examined through a series of design-verification tests, and usability was established by human factors validation testing.Methods:Devices were tested for dose accuracy at 3 different doses and temperatures and under free fall, vibration, and cold storage conditioning. Injection force was measured at the maximum dose (30 units). Both exper… Show more

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Cited by 8 publications
(6 citation statements)
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“…As another step toward characterizing the potential injectability of granular hydrogels, the force required to extrude NorHA MD, BE, and EF granular hydrogels through an 18G and 23G needle was measured. Across the three fabrication methods, the extrusion force was well within acceptable clinical standards. For example, it has been reported that injection forces for commercially available insulin pens can range from ∼5 to 20 N, , and 30 N has been considered a maximum force for manual injection . In both needle diameters, NorHA EF granular hydrogels exhibited a significantly higher extrusion force required when compared to NorHA MD and BE granular hydrogels.…”
Section: Results and Discussionmentioning
confidence: 60%
“…As another step toward characterizing the potential injectability of granular hydrogels, the force required to extrude NorHA MD, BE, and EF granular hydrogels through an 18G and 23G needle was measured. Across the three fabrication methods, the extrusion force was well within acceptable clinical standards. For example, it has been reported that injection forces for commercially available insulin pens can range from ∼5 to 20 N, , and 30 N has been considered a maximum force for manual injection . In both needle diameters, NorHA EF granular hydrogels exhibited a significantly higher extrusion force required when compared to NorHA MD and BE granular hydrogels.…”
Section: Results and Discussionmentioning
confidence: 60%
“…Pacientes com DM1 sejam eles crianças, jovens e adultos, podem necessitar de uma dose menor de insulina, seja ela por motivo de uma alta sensibilidade à insulina ou por atividade física. As canetas que possuem capacidade para aplicar meia unidade de insulina são extremamente importantes para esses pacientes, pois conseguem aplicar doses precisas (KAPPES et al, 2018). Portanto, a caneta de insulina é de grande importância para ajudar no autocuidado e na adesão do paciente ao tratamento, não somente para o paciente, mas também para os cuidadores, pois muitos pacientes ainda são crianças e precisam do auxílio dos pais ou outros adultos (OLSEN et al, 2010).…”
Section: Caneta De Insulinaunclassified
“…All pens except the JuniorSTAR Ò have demonstrated accuracy at 0.5 U of insulin. [27][28][29] The newer pens have evolved to be lighter, and in one case, disposable ( Table 2): features that can make the devices more portable and user friendly.…”
Section: Review Of Precision Half-unit Insulin Devicesmentioning
confidence: 99%