Abstract
This multi‐national study was designed to examine the acceptability and safety of a new 3.0 ml pre‐filled insulin pen in clinical use. There were 74 patients (60 with type 1 and 14 with type 2 diabetes) who completed the eight week study during which all insulin injections were administered using the new pens. Patients were familiar with the use of insulin pens before the study and they maintained their pre‐study insulin regimens during the study. At the final visit each patient completed a questionnaire which assessed the ease of use of the new pen and compared it with the pre‐study delivery system. Features of the new pen which were ranked highly included: dose correction, re‐setting after dose delivery, cartridge visibility and dialling the insulin dose. More than 50% said that they would prefer to use the new pen in the future and 74% said that they would recommend the pen to other people with diabetes. Safety was assessed from adverse events, the vast majority of which were mild. Such clinical testing is important to ensure that technical improvements result in real patient benefits and this study demonstrated that the new pen had a high patient acceptability with a clinically acceptable safety profile.