Sherwyn Schwartz1. 1. Diabetes and Glandular Disease Research Associates, San Antonio, Texas 78229, USA. slschwartz@dgdclinic.com
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.
BACKGROUND:Insulinpen devices are currently being used by approximately half of insulin users worldwide. ClikSTAR® (sanofi-aventis) is a novel reusable insulinpen for injecting either long-acting insulinglargine or short-acting insulinglulisine. 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 insulinpen 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.
Authors: Debra A Ignaut; Michael R Opincar; Paula E Clark; Melanie K Palaisa; Sheila M Lenox Journal: Curr Med Res Opin Date: 2009-12 Impact factor: 2.580
Authors: H Yki-Järvinen; R Kauppinen-Mäkelin; M Tiikkainen; M Vähätalo; H Virtamo; K Nikkilä; T Tulokas; S Hulme; K Hardy; S McNulty; J Hänninen; H Levänen; S Lahdenperä; R Lehtonen; L Ryysy Journal: Diabetologia Date: 2006-02-03 Impact factor: 10.122