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Completed

NCT Number: NCT03267264

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East West Medical Research Institute, Honolulu, Hawaii, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BD Nano™ vs Nucleus

Device

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

NovoFine® vs Nucleus

Device

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

NovoTwist®/NovoFine® Plus vs Nucleus

Device

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

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

Device

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

Primary outcomes

  1. Overall User Preference -Combined Groups

    Time frame: 30 Days

    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).

Secondary outcomes

  1. Overall User Preference - Each Comparator Group

    Time frame: 30 Days

    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).

  2. User Experience - All Study Groups Combined

    Time frame: 30 Days

    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.

  3. User Experience - Each Individual Study Group

    Time frame: 30 Days

    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.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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