Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1-Reference-Cited by-同舟云学术

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

Published:2015-07-17 Issue:1 Volume:10 Page:157-161
ISSN:1932-2968
Container-title:Journal of Diabetes Science and Technology
language:en
Short-container-title:J Diabetes Sci Technol

Author:

Abdel-Tawab Mona¹,Schmitz Mario²,Kamlot Stefan²,Schubert-Zsilavecz Manfred³

Affiliation:

1. Central Laboratory of German Pharmacists, Eschborn, Germany

2. sanofi-aventis Deutschland GmbH, Site Frankfurt Devices, Frankfurt, Germany

3. Institute of Pharmaceutical Chemistry, J.W. Goethe-University, Frankfurt, Germany

Abstract

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.

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/1932296815595983

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