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.
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)Primary· Scores were collected immediately after each paired injection
Injection pain as measured by a relative 150mm visual analog scale. Injection pain as measured by a relative visual analog scale. s. User preference is assessed through a single question reported on a 150mm relative VAS scale with the BD Nano™ PRO pen needle Pen labeled at +75 mm and the Comparator 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 forBD Nano™ PRO and negative scores reflect preference for the comparator.
Scores from each of the paired injections (330
Group
Value
95% CI
All Study Participants
7.30
2.2 – 12.39
BD Nano™ PRO vs Terumo Nanopass® (Force)Secondary· Scores were collected immediately after each paired injection
Subject perceived force required to deliver dose measured by a relative 5 point Likert scale. The scale ranged from -2 to 2, where positive scores indicated less thumb force required for the BD Nano™ PRO, and negative scores indicated less thumb force for Terumo Nanopass®. Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated.
Group
Value
95% CI
All Study Participants
0.210
0.07 – 0.35
BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)Secondary· Immediately after injections were completed
Participants reported a visual score of needle bending. A score of at least 2, corresponding to \>10 degrees of bending, was considered an event of a bent needle. The percentage of of bending events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Group
Value
95% CI
BD Nano™ PRO
0.6
0.2 – 2.5
Terumo Nanopass
0.6
0.2 – 2.2
BD Nano™ PRO vs Terumo Nanopass® (Leakage)Secondary· Immediately after injection
After saline delivery equivalent to 30U of U100 insulin (0.3mL) and subject removal of pen needle from body, study staff used the provided materials and scale to absorb leakage from the pen needle tip and injection site to measure the amount of leakage. Leakage over 0.015g was counted as an event. The percentage of of leakage events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Group
Value
95% CI
BD Nano™ PRO
0.3
0 – 1.7
Terumo Nanopass
1.8
0.8 – 3.9
Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time)Secondary· Immediately after injections were completed
Time from when injection button fully depressed to when pen needle removed from body. Mean total injection time was calculated for both the BD Nano™ PRO and the Terumo Nanopass®. Scores from each injection (330 for each needle type) were pooled and a mean was calculated. The total injection time for the BD Nano™ PRO and Terumo Nanopass® were compared and the mean difference reported with a 95% confidence interval.
BD NANO
Group
Value
95% CI
All Study Participants
7.55
± 4.75
Terumo
Group
Value
95% CI
All Study Participants
7.80
± 4.62
Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)Secondary· Immediately after injections were completed
Needle breakage was defined as the patient-end metal cannula being separated into two pieces. The percentage of of breaking events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Group
Value
95% CI
BD Nano™ PRO
0
0 – 1.1
Terumo Nanopass
0
0 – 1.1
Subject Satisfaction SurveySecondary· Immediately after injections were completed
Each subject was asked to fill out a 4 question survey on the general importance of Injection Pain, Thumb pressure, Leakage and Needle Bending, each question was tabulated. Each participant answered 1 survey about their general preferences and opinions, not regarding either product used in the study.
Injection Pain affects my level of satisfaction
Group
Value
95% CI
All Study Participants
16
All Study Participants
16
All Study Participants
16
All Study Participants
3
Thumb pressure needed affects my level of satisfac
Group
Value
95% CI
All Study Participants
10
All Study Participants
21
All Study Participants
14
All Study Participants
7
Post injection leakage increases level of concern
Group
Value
95% CI
All Study Participants
18
All Study Participants
16
All Study Participants
16
All Study Participants
4
A bent needle increases my level of concern
Group
Value
95% CI
All Study Participants
23
All Study Participants
13
All Study Participants
17
All Study Participants
1
Sponsor's own description
This is a subject single blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially available Terumo Nanopass® pen needle. The study will include a minimum of 55 Japanese American study subjects with Type 1 or Type 2 diabetes.
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: 19 May 2020
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/NCT03878745.