CClinicalTrials.gg
Sign In
CompletedNCT03267264Updated Jul 16, 2019Results posted

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

An interventional study of BD Nano™ vs Nucleus and NovoFine® vs Nucleus in Diabetes, sponsored by Becton, Dickinson and Company. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    Group 1

    Device: BD Nano™ vs Nucleus

  • Experimental
    Group 2

    Device: NovoFine® vs Nucleus

  • Experimental
    Group 3

    Device: NovoTwist®/NovoFine® Plus vs Nucleus

  • Experimental
    Group 4

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

Interventions

  • DeviceBD 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

  • DeviceNovoFine® 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

  • DeviceNovoTwist®/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

  • DeviceOther 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

05

What researchers measure

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).

    Time frame: 30 Days

Secondary outcomes

  1. 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).

    Time frame: 30 Days

  2. 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.

    Time frame: 30 Days

  3. 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.

    Time frame: 30 Days

06

Results

Posted Jul 16, 2019

Participant flow

Participant flow — Overall Study
MilestoneGroup 1Group 2Group 3Group 4
Started66496865
Sequence a(nucleus)34253333
Sequence b(comparator)32243332
Completed65496661
Not completed1024
Withdrew: Withdrawal by subject1024

Outcome measures

PrimaryOverall 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).

Time frame:
30 Days
Reported as:
Mean · mm
Overall User Preference -Combined Groups
mmCombined Groups
Overall User Preference -Combined Groups17.5 (10.3 to 24.7)
Statistical analysis
  • Combined Groups · Overall mean: 17.5 · 95% CI 10.3 to 24.7
SecondaryOverall 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).

Time frame:
30 Days
Reported as:
Mean · mm
Overall User Preference - Each Comparator Group
mmGroup 1Group 2Group 3Group 4
Overall User Preference - Each Comparator Group30.5 (16.8 to 44.3)20.6 (4.1 to 37.1)6.2 (-7.2 to 19.5)12.8 (-1.1 to 26.7)
Statistical analysis
  • Group 1 · Overall mean: 30.5 · 95% CI 16.8 to 44.3
  • Group 2 · Overall: 20.6 · 95% CI 4.1 to 37.1
  • Group 3 · Overal mean: 6.2 · 95% CI -7.2 to 19.5
  • Group 4 · Overall mean: 12.8 · 95% CI -1.1 to 26.7
SecondaryUser 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.

Time frame:
30 Days
Reported as:
Mean · mm
User Experience - All Study Groups Combined
mmAll Groups Combined
Overall Comfort18.0 (11.3 to 24.7)
Anxiety Associated with a Needle Stick Injury15.9 (9.9 to 21.8)
Injection Pain15.5 (8.9 to 22.1)
Ease of Use19.7 (13.8 to 25.7)
Statistical analysis
  • All Groups Combined · Overall mean: 18.0 · 95% CI 11.3 to 24.7
  • All Groups Combined · Overall mean: 15.9 · 95% CI 9.9 to 21.8
  • All Groups Combined · Overall mean: 15.5 · 95% CI 8.9 to 22.1
  • All Groups Combined · Overall mean: 19.7 · 95% CI 13.8 to 25.7
SecondaryUser 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.

Time frame:
30 Days
Reported as:
Mean · mm
User Experience - Each Individual Study Group
mmGroup 1Group 2Group 3Group 4
Overall Comfort27.8 (14.9 to 40.7)20.7 (5.3 to 36.1)8.4 (-4 to 20.9)15.1 (2.1 to 28.1)
Anxiety Associated with a Needle Stick Injury20.2 (8.9 to 31.6)19.4 (6 to 32.8)12.9 (1.9 to 23.8)11.0 (-0.5 to 22.4)
Injection Pain16.1 (3.4 to 28.8)18.6 (3.6 to 33.7)7.0 (-5.3 to 19.4)20.2 (7.4 to 33.1)
Ease of Use30.7 (19.3 to 42.1)18.4 (4.9 to 31.9)17.7 (6.7 to 28.8)12.0 (0.5 to 23.5)
Statistical analysis
  • Group 1 · Overall mean: 27.8 · 95% CI 14.9 to 40.7
  • Group 1 · Overall mean: 20.2 · 95% CI 8.9 to 31.6
  • Group 1 · Overall mean: 16.1 · 95% CI 3.4 to 28.8
  • Group 1 · Overall mean: 30.7 · 95% CI 19.3 to 42.1
  • Group 2 · Overall mean: 20.7 · 95% CI 5.3 to 36.1
  • Group 2 · Overall mean: 19.4 · 95% CI 6 to 32.8
  • Group 2 · Overall mean: 18.6 · 95% CI 3.6 to 33.7
  • Group 2 · Overall mean: 18.4 · 95% CI 4.9 to 31.9
  • Group 3 · Overall mean: 8.4 · 95% CI -4.0 to 20.9
  • Group 3 · Overall mean: 12.9 · 95% CI 1.9 to 23.8
  • Group 3 · Overall mean: 7.0 · 95% CI -5.3 to 19.4
  • Group 3 · Overall mean: 17.7 · 95% CI 6.7 to 28.8
  • Group 4 · Overall mean: 15.1 · 95% CI 2.1 to 28.1
  • Group 4 · Overall mean: 11.0 · 95% CI -0.5 to 22.4
  • Group 4 · Overall mean: 20.2 · 95% CI 7.4 to 33.1
  • Group 4 · Overall mean: 12.0 · 95% CI 0.5 to 23.5

Adverse events

Collected over Adverse Events were collected over 6 week period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nucleus0/241 (0%)1/241 (0.4%)50/241 (20.7%)
BD Nano0/65 (0%)0/65 (0%)5/65 (7.7%)
NovoFine®0/49 (0%)1/49 (2%)4/49 (8.2%)
NovoTwist®/NovoFine®0/66 (0%)0/66 (0%)4/66 (6.1%)
Other Commercially Available Pen Needles (Unifine® Pentips®/M0/61 (0%)1/61 (1.6%)5/61 (8.2%)
Most frequent serious events
Most frequent serious events
EventNucleusBD NanoNovoFine®NovoTwist®/NovoFine®Other Commercially Available Pen Needles (Unifine® Pentips®/M
Infection of L Hand LacerationInfections and infestations0/2410/651/490/660/61
InfluenzaRespiratory, thoracic and mediastinal disorders0/2410/650/490/661/61
Broken Right AnkleSurgical and medical procedures1/2410/650/490/660/61
Most frequent other events
Showing 10 of 12
Most frequent other events
EventNucleusBD NanoNovoFine®NovoTwist®/NovoFine®Other Commercially Available Pen Needles (Unifine® Pentips®/M
BleedingInjury, poisoning and procedural complications21/2414/651/492/662/61
BruisingInjury, poisoning and procedural complications14/2411/650/490/662/61
Swelling/Pain at injection siteInjury, poisoning and procedural complications10/2410/650/490/661/61
HypoglycemiaEndocrine disorders0/2410/651/492/660/61
DiarrheaGastrointestinal disorders0/2410/651/490/660/61
L hand LacerationSurgical and medical procedures0/2410/651/490/660/61
Abcess under chinInfections and infestations1/2410/650/490/660/61
Common ColdRespiratory, thoracic and mediastinal disorders1/2410/650/490/660/61
CoughRespiratory, thoracic and mediastinal disorders1/2410/650/490/660/61
Respiratory IllnessRespiratory, thoracic and mediastinal disorders1/2410/650/490/660/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1Group 2Group 3Group 4Total
Mean55.5 ± 13.356.6 ± 12.855.4 ± 12.255.2 ± 11.255.6 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Group 1Group 2Group 3Group 4Total
Female34253633128
Male32243232120
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1Group 2Group 3Group 4Total
Hispanic or Latino343111
Not Hispanic or Latino63456564237
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1Group 2Group 3Group 4Total
American Indian or Alaska Native00000
Asian101013942
Native Hawaiian or Other Pacific Islander01102
Black or African American2315152376
White26173228103
More than one race667524
Unknown or Not Reported10001
07

Study locations

4 sites
  • East West Medical Research Institute
    Honolulu, Hawaii 96814, United States
  • PMG Research of Raleigh
    Raleigh, North Carolina 27609, United States
  • Rapid Medical Research, Inc.
    Cleveland, Ohio 44122, United States
  • Corporation Lane Internal Medicine and Research Center
    Virginia Beach, Virginia 23462, United States
08

References and documents

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 Jun;10(3):1175. doi: 10.1007/s13300-019-0623-5. PubMed 30809762 ↗

Study documents

  • Study protocol · Dec 20, 2017
  • Statistical analysis plan · Mar 22, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03267264
Lead sponsor
Becton, Dickinson and Company
Responsible party
Sponsor
First posted
Aug 30, 2017
Start date
Sep 1, 2017
Primary completion
Apr 24, 2018
Completion
May 24, 2018
Results posted
Jul 16, 2019
Last update
Jul 16, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Becton, Dickinson and Company

Start the discussion