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

NCT ID: NCT03267264

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-05-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

BD Nano™ vs Nucleus

Intervention Type: 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 2

Group Type: EXPERIMENTAL

NovoFine® vs Nucleus

Intervention Type: 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 3

Group Type: EXPERIMENTAL

NovoTwist®/NovoFine® Plus vs Nucleus

Intervention Type: 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 4

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults (18 - 75 inclusive)

2. Diagnosed Type 1 or Type 2 diabetes

3. Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)

4. 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

5. Minimum within the last 4 months experience self-injecting insulin with a pen injector

6. 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.

7. Able and willing to provide informed consent/participant form

8. Able and willing to complete all study procedures

Exclusion Criteria

1. Self-injecting insulin with a pen injector for less than 3 months

2. Planned changes in insulin regimen (increasing or decreasing number of injections per day).

3. Positive pregnancy test (urine)

4. Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).

5. History of a bleeding disorder or easy bruising

6. Blood borne infection(s)

7. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)

8. 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

9. Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.

10. Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.

11. 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.

12. Currently participating in another study

13. Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

East West Medical Research Institute

Honolulu, Hawaii, United States

PMG Research of Raleigh

Raleigh, North Carolina, United States

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Corporation Lane Internal Medicine and Research Center

Virginia Beach, Virginia, United States

Countries

United States

References

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 30809762 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DBC-17NUCL07

Identifier Type: -

Identifier Source: org_study_id