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

NCT03267264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2019-07-16

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-04-24
Completion
2018-05-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267264 on ClinicalTrials.gov