Evaluation of a New Reusable Insulin Pen (ClikSTAR) in Canadian Patients with Type 1 and Type 2 Diabetes Mellitus Receiving Insulin Glargine

Abstract Background: The objective of this Canadian observational study was to assess the safety and patient satisfaction with the ClikSTAR® (sanofi-aventis, Frankfurt am Main, Germany) reusable insulin pen in clinical practice. Subjects and Methods: Patients with diabetes (n=2,517) were recruited from 103 sites, provided with the ClikSTAR pen, and instructed to report product technical complaints (PTCs), product technical failures (PTFs), and adverse events (AEs) over 6–12 weeks of use. A patient subgroup (n=301) completed a pen use questionnaire at 12 weeks. The risk acceptance criterion was that no validated PTF led to a serious AE (SAE). PTFs were PTCs having a confirmed technical deficiency. Results: Patients (68.5% with type 2 diabetes) had a mean age of 56.2 years, and 92.5% were insulin pen users. In total, 84 PTCs were reported by 79 (3.1%) patients. Most PTCs were due to pen handling errors. PTCs from 12 patients were possibly related to AEs, three of which were SAEs; none was confirmed to be du...