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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East West Medical Research Institute
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Corporation Lane Internal Medicine and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1	Device: BD Nano™ vs Nucleus; Subjects will be randomized to; Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or; subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
EXPERIMENTAL: Group 2	Device: NovoFine® vs Nucleus; Subjects will be randomized to; Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or; subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
EXPERIMENTAL: Group 3	Device: NovoTwist®/NovoFine® Plus vs Nucleus; Subjects will be randomized to; Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or; subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
EXPERIMENTAL: Group 4	Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus; Subjects will be randomized to; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall User Preference - Each Comparator Group	This endpoint analyzes data for individual groups. 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
User Experience - All Study Groups Combined	This is a combined endpoint for all study subjects. User experience is assessed through a series of questions 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). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.	30 Days
User Experience - Each Individual Study Group	This endpoint analyzes data for individual groups. User experience is assessed through a series of questions 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). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.	30 Days

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Diabetes Ther. 2019 Apr 17;:

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): April 24, 2018
• Study Completion (ACTUAL): May 24, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (ACTUAL): August 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DBC-17NUCL07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes