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

June 24, 2019 updated by: Becton, Dickinson and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group 1
Device: 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
EXPERIMENTAL: Group 2
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
EXPERIMENTAL: Group 3
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
EXPERIMENTAL: Group 4
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
30 Days
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.
30 Days
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.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Becton, Dickinson and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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