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

NCT03267264 | Completed Results FDA Device

• 1 other identifier: DBC-17NUCL07
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall User Preference -Combined Groups

  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).

  30 Days

Secondary Outcomes (3)

• Overall User Preference - Each Comparator Group

  30 Days

• User Experience - All Study Groups Combined

  30 Days

• User Experience - Each Individual Study Group

  30 Days

Study Arms (4)

Group 1

EXPERIMENTAL

Device: BD Nano™ vs Nucleus

Group 2

EXPERIMENTAL

Device: NovoFine® vs Nucleus

Group 3

EXPERIMENTAL

Device: NovoTwist®/NovoFine® Plus vs Nucleus

Group 4

EXPERIMENTAL

Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus

Interventions

BD Nano™ vs Nucleus DEVICE

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

Group 1

NovoFine® vs Nucleus DEVICE

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

Group 2

NovoTwist®/NovoFine® Plus vs Nucleus DEVICE

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

Group 3

Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus DEVICE

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

Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 - 75 inclusive)
• Diagnosed Type 1 or Type 2 diabetes
• Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)
• Every effort will be made to recruit a minimum of 30 subjects with Asian ethnicity (of the total population, not of each subgroup). Ideally, 60 Asian subjects are needed for the study
• Minimum within the last 4 months experience self-injecting insulin with a pen injector
• Minimum within the last 2 months experience self-injecting consistently with one of the following available pen needles OR a subject may be enrolled that is using a 31G/32G pen needle that is not longer than 6mm in length who is willing to transfer to one of the following 32G pen needle with a 14 day wash-in period:
• BD Nano™ 32Gx4mm
• NovoFine® 32Gx6mm
• NovoTwist® 32Gx5mm or
• NovoFine® Plus 32Gx4mm
• Owen Mumford PenTips 32Gx4mm or
• Perrigo / Ypsomed ClickFine 32Gx4mm or
• Other 32G such as UltiMed, MHC, or other private label.
• Able and willing to provide informed consent/participant form
• Able and willing to complete all study procedures

You may not qualify if:

• Self-injecting insulin with a pen injector for less than 3 months
• Planned changes in insulin regimen (increasing or decreasing number of injections per day).
• Positive pregnancy test (urine)
• Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).
• History of a bleeding disorder or easy bruising
• Blood borne infection(s)
• History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)
• Gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations, tattoos, superficial masses, acne, inflammation) located at or very close to the injection sites
• Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
• Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.
• A current or previous medical or physical condition that, in the opinion of the investigator, would place the patient at risk or make them unable to perform study procedures or has the potential to confound interpretation of the study results.
• Currently participating in another study
• Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (4)

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Corporation Lane Internal Medicine and Research Center

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (2)

• Whooley S, Briskin T, Gibney M, Blank L, Berube J, Pflug B. Evaluation the User Performance and Experience of a New Pen Needle with Advanced Hub Face Geometry. Poster presented at: American Association of Diabetes Education Annual Conference; 2018 Aug 17-20; Baltimore, MD.

  BACKGROUND

• Whooley S, Briskin T, Gibney MA, Blank LR, Berube J, Pflug BK. Evaluating the User Performance and Experience with a Re-Engineered 4 mm x 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles. Diabetes Ther. 2019 Apr;10(2):697-712. doi: 10.1007/s13300-019-0585-7. Epub 2019 Feb 27.

  PMID: 30809762 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michael Gibney
• Organization: Becton Dickinson

michael_gibney@bd.com

201-847-6170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 30, 2017
• Study Start: September 1, 2017
• Primary Completion: April 24, 2018
• Study Completion: May 24, 2018
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)