Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements

OBJECTIVE: The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy. METHODS: Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the n...

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Detalles Bibliográficos
Autores principales: Abdel-Tawab, Mona, Schmitz, Mario, Kamlot, Stefan, Schubert-Zsilavecz, Manfred
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2015
Materias:
Technology Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4738205/
https://www.ncbi.nlm.nih.gov/pubmed/26187635
http://dx.doi.org/10.1177/1932296815595983
Descripción
Sumario:OBJECTIVE: The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy. METHODS: Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Statistical analysis was performed using Student’s t test. RESULTS: Both pens delivered all doses within ISO limits. The difference between the average measured dose and the target dose was significantly smaller for SoloSTAR than FlexTouch at 40 U (P = .009) and 80 U (P = .008), but not at 1 U (P = .417). CONCLUSION: Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.

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