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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Device: BD Nano™ vs Nucleus<br>* 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<br>|
| Experimental: Group 2<br> | Device: NovoFine® vs Nucleus<br>* 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<br>|
| Experimental: Group 3<br> | Device: NovoTwist®/NovoFine® Plus vs Nucleus<br>* 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<br>|
| Experimental: Group 4<br> | Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus<br>* 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<br>|

What is the study measuring?
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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 |