Trial Outcomes & Findings for Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles (NCT NCT03878758)

Last Updated: 2020-03-09

Results Overview

Injection pain as measured by a relative visual analog scale. This endpoint analyzes data for individual groups. 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 (308 pairs for all participants) were pooled and a mean was calculated. The two-sided 95% confidence interval was calcuated for the average relative rating. A linear model was used to adjust for the order effect. If the lower bound of the 95% CI is \> -10cm, non-inferiority could be concluded. If the lower bound of the 95% CI is \>0, superiority can also be concluded.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

Scores were collected immediately after each paired injection

Results posted on

2020-03-09

Participant Flow

Each subject received more than one treatment

Participant milestones

Participant milestones
Measure	All Study Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
Overall Study STARTED	158
Overall Study COMPLETED	154
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
Overall Study Withdrawal by Subject	1
Overall Study Protocol defined	2
Overall Study Improper consent documentation	1

Baseline Characteristics

Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=157 Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G
Age, Continuous	56.2 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	12 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Scores were collected immediately after each paired injection

Population: Per-protocol population

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators	17.55 mm Interval 11.43 to 23.67	17.39 mm Interval 11.28 to 23.51	9.13 mm Interval 3.01 to 15.25

SECONDARY outcome

Timeframe: Scores were collected immediately after each paired injection

Population: Per protocol population

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. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of bent needle events in the BD Nano™ PRO and each competitor were compared and the mean difference reported with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles	-0.39 Difference in incidence Interval -1.82 to 1.04	0.13 Difference in incidence Interval -2.8 to 3.06	0.42 Difference in incidence Interval -1.91 to 2.75

SECONDARY outcome

Timeframe: Leakage was measured directly after each injection

Population: Per protocol population

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 incidence of leakage (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval. A positive score indicates fewer leakage events with the BD Nano™ PRO and a negative score indicates fewer leakage events with the competitor. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of needle leakage in the BD Nano™ PRO and each comparator were compared and the mean difference reported with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=308 Pen Needles Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me n=308 Pen Needles Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ n=308 Pen Needles Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage)	-5.70 Difference in incidence Interval -9.0 to -3.5	-14.09 Difference in incidence Interval -26.49 to -1.69	-0.20 Difference in incidence Interval -1.9 to 0.6

SECONDARY outcome

Timeframe: Immediately after injection Pair

Population: Subjects protocol population with non-missing data

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 the comparator. Scores from each of the paired injections were pooled and a mean was calculated.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=306 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me n=305 paired injections Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ n=307 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force)	0.8 Score on a scale Interval 0.62 to 0.98	1.0 Score on a scale Interval 0.8 to 1.16	0.3 Score on a scale Interval 0.13 to 0.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Time of injection

Population: Per Protocol Population

Time from when subject when is depressed and time when removed from body.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=1848 Pen needles Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) BD NANO	8.39 seconds Standard Deviation 5.26	—	—
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) Artsana 33G	10.98 seconds Standard Deviation 2.64	—	—
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) Arstana 34G	9.93 seconds Standard Deviation 5.16	—	—
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) Comfort EZ 33G	8.63 seconds Standard Deviation 5.30	—	—

POST_HOC outcome

Timeframe: Immediately after injection

Population: Per Protocol Population

A needle was considered broken if the patient end and canula was separated into 2 pieces. The number and proportion of needle breaking occurrence for each pen needle type were summarized. The incidence of broken needle events for the BD Nano PRO was compared to each of the 3 comparator products and the mean difference reported with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me n=308 paired injections Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ n=308 paired injections Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking)	0 Difference in incidence Interval -0.4 to 1.2	0 Difference in incidence Interval -0.4 to 1.2	0 Difference in incidence Interval -0.4 to 1.2

POST_HOC outcome

Timeframe: At the end of study

Population: Each subject was provided a 4 question survey of their general experience with pen needles. The questions were based on a a 5 point type of Likert scale.

Each subject was given a non-comparative 4-question survey on Pen needle characteristics.

Outcome measures

Outcome measures
Measure	BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me n=154 Participants Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO: Insulin Pen needle 34G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle 33G Artsana Insupen Extr3me: Insulin Pen Needle	BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle
Subject Satisfaction Survey Post injection leakage affects my level of concern · Somewhat Agree	31 Participants	—	—
Subject Satisfaction Survey Post injection leakage affects my level of concern · Neutral	23 Participants	—	—
Subject Satisfaction Survey Injection pain affects my level of satisfaction · Agree	56 Participants	—	—
Subject Satisfaction Survey Injection pain affects my level of satisfaction · Somewhat Agree	46 Participants	—	—
Subject Satisfaction Survey Injection pain affects my level of satisfaction · Neutral	27 Participants	—	—
Subject Satisfaction Survey Injection pain affects my level of satisfaction · Somewhat disagree	8 Participants	—	—
Subject Satisfaction Survey Injection pain affects my level of satisfaction · Disagree	17 Participants	—	—
Subject Satisfaction Survey Thumb pressure affects my level of satisfaction · Agree	54 Participants	—	—
Subject Satisfaction Survey Thumb pressure affects my level of satisfaction · Somewhat Agree	51 Participants	—	—
Subject Satisfaction Survey Thumb pressure affects my level of satisfaction · Neutral	26 Participants	—	—
Subject Satisfaction Survey Thumb pressure affects my level of satisfaction · Somewhat disagree	9 Participants	—	—
Subject Satisfaction Survey Thumb pressure affects my level of satisfaction · Disagree	14 Participants	—	—
Subject Satisfaction Survey Post injection leakage affects my level of concern · Agree	76 Participants	—	—
Subject Satisfaction Survey Post injection leakage affects my level of concern · Somewhat disagree	8 Participants	—	—
Subject Satisfaction Survey Post injection leakage affects my level of concern · Disagree	16 Participants	—	—
Subject Satisfaction Survey A bend needle increases my level of concern · Agree	100 Participants	—	—
Subject Satisfaction Survey A bend needle increases my level of concern · Somewhat Agree	28 Participants	—	—
Subject Satisfaction Survey A bend needle increases my level of concern · Neutral	13 Participants	—	—
Subject Satisfaction Survey A bend needle increases my level of concern · Somewhat disagree	2 Participants	—	—
Subject Satisfaction Survey A bend needle increases my level of concern · Disagree	11 Participants	—	—

Adverse Events

BD Nano™ PRO Pen Needle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

34G Artsana Insupen Extr3me

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

33G Artsana Insupen Extr3me

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Simple Diagnostics Comfort EZ™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Gibney

Becton Dickinson

Phone: 201-847-6170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place