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 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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Author:Mona Abdel TawabORCiDGND, Mario Schmitz, Stefan Kamlot, Manfred Schubert-ZsilaveczGND
Pubmed Id:
Parent Title (English):Journal of diabetes science and technology
Place of publication:Thousand Oaks, Calif.
Document Type:Article
Date of Publication (online):2016/11/11
Date of first Publication:2015/07/17
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2016/11/11
Tag:FlexTouch; SoloSTAR; disposable insulin pens; dosing accuracy
Page Number:5
First Page:157
Last Page:161
Institutes:Biochemie, Chemie und Pharmazie / Pharmazie
Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (English):License LogoCreative Commons - Namensnennung-Nicht kommerziell 4.0