DiabetesNCT03267264
Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
A study testing BD Nano™ vs Nucleus, NovoFine® vs Nucleus and NovoTwist®/NovoFine® Plus vs Nucleus in people with Diabetes, run by Becton, Dickinson and Company at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- BD Nano™ vs Nucleus, NovoFine® vs Nucleus and NovoTwist®/NovoFine® Plus vs Nucleus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2017to 24 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
East West Medical Research Institute
Honolulu, Hawaii, 96814
PMG Research of Raleigh
Raleigh, North Carolina, 27609
Corporation Lane Internal Medicine and Research Center
Virginia Beach, Virginia, 23462
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- BD Nano™ vs Nucleus, NovoFine® vs Nucleus, NovoTwist®/NovoFine® Plus vs Nucleus, Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Nano™ vs NucleusDevice
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 NucleusDevice
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 NucleusDevice
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 NucleusDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Device: BD Nano™ vs Nucleus |
| Group 2 | Experimental | Not described Receives: Device: NovoFine® vs Nucleus |
| Group 3 | Experimental | Not described Receives: Device: NovoTwist®/NovoFine® Plus vs Nucleus |
| Group 4 | Experimental | Not described Receives: Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 Days
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Sep 2017
- Primary completion24 Apr 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267264
- Sponsor's protocol ID
- DBC-17NUCL07
- Status last verified
- Jun 2019
- First submitted
- 22 Aug 2017
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 30809762
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nucleus Claims Study: Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
- ClinicalTrials.gov ID
- NCT03267264
- Acronym / sponsor ID
- DBC-17NUCL07
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: BD Nano™ vs Nucleus |
| Group 2 | Experimental | Device: NovoFine® vs Nucleus |
| Group 3 | Experimental | Device: NovoTwist®/NovoFine® Plus vs Nucleus |
| Group 4 | Experimental | Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Nano™ vs NucleusSubjects 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 | Device | Group 1 |
| NovoFine® vs NucleusSubjects 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 | Device | Group 2 |
| NovoTwist®/NovoFine® Plus vs NucleusSubjects 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 | Device | Group 3 |
| Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs NucleusSubjects 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 | Device | Group 4 |
Primary outcome
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).
3 secondary outcomes
Overall User Preference - Each Comparator Group
Time frame: 30 Days
User Experience - All Study Groups Combined
Time frame: 30 Days
User Experience - Each Individual Study Group
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWhooley 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.
- Derived from this study: PubMed 30809762Whooley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD Nano™ vs Nucleus, NovoFine® vs Nucleus and NovoTwist®/NovoFine® Plus vs Nucleus in people with Diabetes, run by Becton, Dickinson and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall User Preference -Combined Groups (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267264, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.