Dose accuracy comparison between SoloSTAR and FlexPen at three different dose levels

Diabetes Technology & Therapeutics
Alfred Penfornis, Kristian Horvat

Abstract

The convenience and accuracy of insulin pens have led to their extensive use in patients with diabetes. Although all insulin pens go through extensive testing as part of the regulatory process, it is important that both the patient and clinician can be assured of the accuracy of the dose delivered. This study compared the dosing accuracy of two commonly available insulin pens, the SoloSTAR (sanofi-aventis Deutschland GmbH, Frankfurt, Germany) and FlexPen (Novo Nordisk A/S, Bagsvaerd, Denmark) devices. Doses of 5, 10, and 30 units of insulin were investigated for SoloSTAR and FlexPen, and specific units of accuracy were based on International Organization of Standards for insulin injection pens (+/-1 unit for the 5 and 10-unit doses, +/-5% for the 30-unit dose). A total of 30 pens were tested for both the SoloSTAR and FlexPen, and a total of 2,280 measurement values were taken for each pen type (5 units, 1,260; 10 units, 750; and 30 units, 270 doses). Both devices were shown to be accurate at all three doses, and all doses were delivered within the limits proposed by the International Standard of Organization, which is used as part of the regulatory approval process when introducing an insulin injection device to the market. Our...Continue Reading

References

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Citations

Sep 22, 2009·Diabetes Technology & Therapeutics·Arnd Friedrichs
Jun 28, 2011·Diabetes Technology & Therapeutics·Alfred PenfornisSophie Borot
Jun 15, 2012·Diabetes Technology & Therapeutics·Meike KrzywonMona Abdel-Tawab
Mar 21, 2009·Expert Review of Medical Devices·Andreas Pfützner
Sep 8, 2010·Current Medical Research and Opinion·L Niskanen
Feb 16, 2010·Current Medical Research and Opinion·M KrzywonM Schubert-Zsilavecz
Mar 10, 2009·Diabetes/metabolism Research and Reviews
Apr 13, 2011·Pediatric Diabetes·Ragnar HanasBarbara Anderson
Jul 19, 2015·Journal of Diabetes Science and Technology·Mona Abdel-TawabManfred Schubert-Zsilavecz
Jan 5, 2010·Journal of Diabetes Science and Technology·Alexander WeiseAndreas Pfützner
Jun 2, 2010·Journal of Diabetes Science and Technology·Teresa L Pearson
Jul 20, 2011·American Journal of Therapeutics·Robert M Cuddihy, Sarah K Borgman
Aug 6, 2013·Journal of Diabetes Science and Technology·Janine BohnetMona Abdel-Tawab

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