Adults 18 to 75, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall User Preference -Combined GroupsPrimary· 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).
Group
Value
95% CI
Combined Groups
17.5
10.3 – 24.7
Overall User Preference - Each Comparator GroupSecondary· 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).
Group
Value
95% CI
Group 1
30.5
16.8 – 44.3
Group 2
20.6
4.1 – 37.1
Group 3
6.2
-7.2 – 19.5
Group 4
12.8
-1.1 – 26.7
User Experience - All Study Groups CombinedSecondary· 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, Inj
Overall Comfort
Group
Value
95% CI
All Groups Combined
18.0
11.3 – 24.7
Anxiety Associated with a Needle Stick Injury
Group
Value
95% CI
All Groups Combined
15.9
9.9 – 21.8
Injection Pain
Group
Value
95% CI
All Groups Combined
15.5
8.9 – 22.1
Ease of Use
Group
Value
95% CI
All Groups Combined
19.7
13.8 – 25.7
User Experience - Each Individual Study GroupSecondary· 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, Inje
Overall Comfort
Group
Value
95% CI
Group 1
27.8
14.9 – 40.7
Group 2
20.7
5.3 – 36.1
Group 3
8.4
-4 – 20.9
Group 4
15.1
2.1 – 28.1
Anxiety Associated with a Needle Stick Injury
Group
Value
95% CI
Group 1
20.2
8.9 – 31.6
Group 2
19.4
6 – 32.8
Group 3
12.9
1.9 – 23.8
Group 4
11.0
-0.5 – 22.4
Injection Pain
Group
Value
95% CI
Group 1
16.1
3.4 – 28.8
Group 2
18.6
3.6 – 33.7
Group 3
7.0
-5.3 – 19.4
Group 4
20.2
7.4 – 33.1
Ease of Use
Group
Value
95% CI
Group 1
30.7
19.3 – 42.1
Group 2
18.4
4.9 – 31.9
Group 3
17.7
6.7 – 28.8
Group 4
12.0
0.5 – 23.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected over 6 week period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nucleus
Serious: 1/241 (0%)
Deaths: 0/241
BD Nano
Serious: 0/65 (0%)
Deaths: 0/65
NovoFine®
Serious: 1/49 (2%)
Deaths: 0/49
NovoTwist®/NovoFine®
Serious: 0/66 (0%)
Deaths: 0/66
Other Commercially Available Pen Needles (Unifine® Pentips®/M
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Becton, Dickinson and Company
Last refreshed: 16 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03267264.