Dosing Accuracy with a Novel Pen Device (SoloSTAR ® ) as Performed by Patients with Diabetes in a Clinical Setting

BACKGROUND: 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). METHODS: 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). RESULTS: 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 for 5, 15, and 30 units, respectively. CONCLUSIONS: The SoloSTAR pen allows people with diabetes to achieve a dosing accuracy with glargine and glulisine similar to that achieved in laboratory conditions. The dosing accuracy and ease of use of SoloSTAR may provide greater confidence in the precision and accuracy of the device while titrating glargine and/or glulisine to goal.