Validation of the SoloSTAR insulin pen

Diabetes Technology & Therapeutics
S L Schwartz, A Vlajnic

Abstract

This study was designed to validate the use of SoloSTAR (sanofi-aventis Deutschland GmbH, Frankfurt, Germany), a new disposable pen developed for use with insulin glargine by patients with type 1 or type 2 diabetes. This single-center, open-label, single-arm, sequential trial enrolled subjects with type 1 or type 2 diabetes, 21-78 years old. After face-to-face training (Part 1) or self-training (Part 2), subjects performed three dose-delivery repetitions into an injection pad using separate pens; pens were weighed before and after each dose delivery. The primary outcome was the proportion of subjects delivering successful doses (target dose, 40 units) with all three repetitions. Secondary outcomes included pen accuracy and precision. Validation population included 50 (Part 1) and 54 (Part 2) subjects. In Part 1, 100% of the subjects delivered a successful dose on all three repetitions. In Part 2, 98% of subjects delivered a successful dose on all three repetitions, with five cases of dose-delivery failures reported in the study population. The mean dose delivered was 40.2 units (95% confidence interval [CI], 40.1-40.3 units) in Part 1 and 38.0 units (95% CI, 36.7-39.3 units) in Part 2; 99% and 88% of dose repetitions in Parts 1...Continue Reading

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Citations

Mar 12, 2008·Expert Review of Medical Devices·Samita GargSatish Garg
Mar 10, 2009·Diabetes/metabolism Research and Reviews
Jun 2, 2010·Journal of Diabetes Science and Technology·Ann S Williams, Patrick A Schnarrenberger
Dec 12, 2013·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Stacey A SeggelkeBoris Draznin
Dec 21, 2017·Postgraduate Medicine·Sarah L AndersonRobert J Tanenberg
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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