Abstract
BACKGROUND: Insulin pen devices are currently being used by approximately half of insulin users worldwide. ClikSTAR® (sanofi-aventis) is a novel reusable insulin pen for injecting either long-acting insulin glargine or short-acting insulin glulisine. The objective of this study was to demonstrate that individuals with diabetes could use the ClikSTAR pen correctly. METHODS: In this open-label, single-center study, people with diabetes delivered three 40 U insulin doses after receiving training from a diabetes specialist (group A, n = 256) or after self-training (group B, n = 47). Administration of a dose of 75-115% of the intended dose was considered successful. Adverse events (AEs) and product technical complaints (PTCs) were recorded. RESULTS: In group A (68% females, 93% Hispanic ethnicity, 97% type 2 diabetes mellitus, mean ± standard deviation age 52 ± 11 years, diabetes duration 11 ± 7 years), half of the participants had prior experience in using insulin pen devices. All except one participant (99.6%) in group A successfully delivered three insulin doses. The lower one-tailed 95% confidence limit for the success rate (98.2%) was higher than the predefined target of 90%. Demographic/baseline characteristics were similar in group B, but 70% had not previously used an injection pen. Group B also showed success; 93.6% of participants successfully completed three dose deliveries. No AEs were reported, although one participant (0.4%) in group A reported one PTC during the training period that was due to a blocked needle. CONCLUSIONS: This study successfully validated the ClikSTAR pen for use by individuals with diabetes.