Dosing accuracy with a novel pen device (SoloSTAR) as performed by patients with diabetes in a clinical setting

Diabetes Technology & Therapeutics
Norbert HermannsThomas Haak

Abstract

Pen devices can help to overcome some of the barriers associated with insulin therapy. The present study evaluated the accuracy of dose delivery by people with diabetes using the novel prefilled, disposable SoloSTAR device with insulin glargine (Lantus) and insulin glulisine (Apidra) (all from sanofi-aventis, Paris, France). People with type 1 or type 2 diabetes (insulin users or insulin naive) were eligible to participate in this randomized, single-center, open-label study. Each participant delivered six separate insulin doses into a sponge using SoloSTAR (three with glargine [10, 40, and 80 units] and three with glulisine [5, 15, and 30 units]). Pens were weighed before and after each test dose to determine the dose delivered. Thresholds for dosing accuracy were calculated according to the 2000 International Organization for Standardization (ISO) recommendations (Guideline 11608-1). All doses of glargine and glulisine delivered (60 participants; 360 individual doses) were within the ISO limits. Mean (standard deviation) glargine doses delivered were 9.87 (0.24), 39.63 (0.36), and 79.02 (0.62) units for 10, 40, and 80 units, respectively. Insulin glulisine doses delivered were 4.98 (0.20), 14.87 (0.29), and 29.67 (0.34) units ...Continue Reading

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Citations

Jan 1, 2010·Medical Devices : Evidence and Research·Estella M DavisPamela A Foral
Mar 21, 2009·Expert Review of Medical Devices·Andreas Pfützner
Feb 17, 2009·Diabetes/metabolism Research and Reviews
Jun 2, 2010·Journal of Diabetes Science and Technology·Ann S Williams, Patrick A Schnarrenberger
Jun 6, 2009·Drugs·Karly P Garnock-Jones, Greg L Plosker
May 10, 2011·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Stephen N DavisSatish Garg

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