Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle

Study Summary

This is a multi-site, prospective, open-label, randomized, 2 period cross over study comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus pen needle. The study will consist of two 15 day periods ( in which the subject will use each pen needle \[BD Nucleus pen needle or subject's current pen needle, order randomized\] for injection. At the end of the last study period, each subject will be asked to evaluate his or her perceptions using a 150mm relative VAS scale.

Primary Outcome

This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).

Interventions

• DEVICE BD Nano™ vs Nucleus
• DEVICE NovoFine® vs Nucleus
• DEVICE NovoTwist®/NovoFine® Plus vs Nucleus
• DEVICE Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus