Diabetes
Conditions
Brief 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.
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
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall User Preference -Combined Groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall User Preference - Each Comparator Group | 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). |
| User Experience - All Study Groups Combined | 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. |
| User Experience - Each Individual Study Group | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 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 | 66 |
| Group 2 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 | 49 |
| Group 3 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 (NovoTwist®/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period | 68 |
| Group 4 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 | 65 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Group 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 13.3 | 56.6 years STANDARD_DEVIATION 12.8 | 55.4 years STANDARD_DEVIATION 12.2 | 55.2 years STANDARD_DEVIATION 11.2 | 55.6 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 45 Participants | 65 Participants | 64 Participants | 237 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 10 Participants | 13 Participants | 9 Participants | 42 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 15 Participants | 15 Participants | 23 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 6 Participants | 7 Participants | 5 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 17 Participants | 32 Participants | 28 Participants | 103 Participants |
| Sex: Female, Male Female | 34 Participants | 25 Participants | 36 Participants | 33 Participants | 128 Participants |
| Sex: Female, Male Male | 32 Participants | 24 Participants | 32 Participants | 32 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 241 | 0 / 65 | 0 / 49 | 0 / 66 | 0 / 61 |
| other Total, other adverse events | 50 / 241 | 5 / 65 | 4 / 49 | 4 / 66 | 5 / 61 |
| serious Total, serious adverse events | 1 / 241 | 0 / 65 | 1 / 49 | 0 / 66 | 1 / 61 |
Outcome results
Primary
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
Population: Per-protocol population; note that one VAS data point was missing.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Groups | Overall User Preference -Combined Groups | 17.5 mm |
95% CI: [10.3, 24.7]
Secondary
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
Population: Per-protocol population; note that one VAS data point was missing
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Groups | Overall User Preference - Each Comparator Group | 30.5 mm |
| Group 2 | Overall User Preference - Each Comparator Group | 20.6 mm |
| Group 3 | Overall User Preference - Each Comparator Group | 6.2 mm |
| Group 4 | Overall User Preference - Each Comparator Group | 12.8 mm |
95% CI: [16.8, 44.3]
95% CI: [4.1, 37.1]
95% CI: [-7.2, 19.5]
95% CI: [-1.1, 26.7]
Secondary
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
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Combined Groups | User Experience - All Study Groups Combined | Overall Comfort | 18.0 mm |
| Combined Groups | User Experience - All Study Groups Combined | Anxiety Associated with a Needle Stick Injury | 15.9 mm |
| Combined Groups | User Experience - All Study Groups Combined | Injection Pain | 15.5 mm |
| Combined Groups | User Experience - All Study Groups Combined | Ease of Use | 19.7 mm |
Comparison: Overall Comfort95% CI: [11.3, 24.7]
Comparison: Anxiety Associated with a Needle Stick Injury95% CI: [9.9, 21.8]
Comparison: Injection Pain95% CI: [8.9, 22.1]
Comparison: Ease of Use95% CI: [13.8, 25.7]
Secondary
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
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Combined Groups | User Experience - Each Individual Study Group | Overall Comfort | 27.8 mm |
| Combined Groups | User Experience - Each Individual Study Group | Anxiety Associated with a Needle Stick Injury | 20.2 mm |
| Combined Groups | User Experience - Each Individual Study Group | Injection Pain | 16.1 mm |
| Combined Groups | User Experience - Each Individual Study Group | Ease of Use | 30.7 mm |
| Group 2 | User Experience - Each Individual Study Group | Anxiety Associated with a Needle Stick Injury | 19.4 mm |
| Group 2 | User Experience - Each Individual Study Group | Injection Pain | 18.6 mm |
| Group 2 | User Experience - Each Individual Study Group | Ease of Use | 18.4 mm |
| Group 2 | User Experience - Each Individual Study Group | Overall Comfort | 20.7 mm |
| Group 3 | User Experience - Each Individual Study Group | Injection Pain | 7.0 mm |
| Group 3 | User Experience - Each Individual Study Group | Anxiety Associated with a Needle Stick Injury | 12.9 mm |
| Group 3 | User Experience - Each Individual Study Group | Ease of Use | 17.7 mm |
| Group 3 | User Experience - Each Individual Study Group | Overall Comfort | 8.4 mm |
| Group 4 | User Experience - Each Individual Study Group | Ease of Use | 12.0 mm |
| Group 4 | User Experience - Each Individual Study Group | Anxiety Associated with a Needle Stick Injury | 11.0 mm |
| Group 4 | User Experience - Each Individual Study Group | Overall Comfort | 15.1 mm |
| Group 4 | User Experience - Each Individual Study Group | Injection Pain | 20.2 mm |
Comparison: Overall Comfort95% CI: [14.9, 40.7]
Comparison: Anxiety Associated with a needle stick injury95% CI: [8.9, 31.6]
Comparison: Injection Pain95% CI: [3.4, 28.8]
Comparison: Ease of Use95% CI: [19.3, 42.1]
Comparison: Overall Comfort95% CI: [5.3, 36.1]
Comparison: Anxiety Associated with a needle stick95% CI: [6, 32.8]
Comparison: Injection Pain95% CI: [3.6, 33.7]
Comparison: Ease of Use95% CI: [4.9, 31.9]
Comparison: Overall Comfort95% CI: [-4, 20.9]
Comparison: Anxiety Associated with a Needle stick injury95% CI: [1.9, 23.8]
Comparison: Injection Pain95% CI: [-5.3, 19.4]
Comparison: Ease of Use95% CI: [6.7, 28.8]
Comparison: Overall Comfort95% CI: [2.1, 28.1]
Comparison: Anxiety Associated with a Needle Stick Injury95% CI: [-0.5, 22.4]
Comparison: Injection Pain95% CI: [7.4, 33.1]
Comparison: Eae of Use95% CI: [0.5, 23.5]