NCT03267264

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BD Nano™ vs Nucleus	Subjects will be randomized to 1. Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or 2. subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
DEVICE	NovoFine® vs Nucleus	Subjects will be randomized to 1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or 2. subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
DEVICE	NovoTwist®/NovoFine® Plus vs Nucleus	Subjects will be randomized to 1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or 2. subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
DEVICE	Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus	Subjects will be randomized to 1. Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or 2. subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-04-24
• Completion: 2018-05-24
• First posted: 2017-08-30
• Last updated: 2019-07-16
• Results posted: 2019-07-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study