Trial Outcomes & Findings for Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle (NCT NCT03878745)

Last Updated: 2020-05-19

Results Overview

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 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

55 participants

Primary outcome timeframe

Scores were collected immediately after each paired injection

Results posted on

2020-05-19

Participant Flow

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 Terumo
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=55 Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo
Age, Continuous	60.3 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	55 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Are you of Japanese descent Yes	55 Participants n=5 Participants
Are you of Japanese descent No	0 Participants n=5 Participants
Born in Japan Yes	9 Participants n=5 Participants
Born in Japan No	46 Participants n=5 Participants
At Least one(1) Parent born in Japan Yes	12 Participants n=5 Participants
At Least one(1) Parent born in Japan No	43 Participants n=5 Participants
At Least one(1) Grandparent born in Japan Yes	51 Participants n=5 Participants
At Least one(1) Grandparent born in Japan No	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Scores were collected immediately after each paired injection

Population: Per protocol population

Outcome measures

Outcome measures
Measure	All Study Participants n=330 paired injections Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass All participants received 6 paired injections
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)	7.30 mm Interval 2.2 to 12.39	—

SECONDARY outcome

Timeframe: Scores were collected immediately after each paired injection

Population: Per-protocol population

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=330 paired injections Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass All participants received 6 paired injections
BD Nano™ PRO vs Terumo Nanopass® (Force)	0.210 score on a scale Interval 0.07 to 0.35	—

SECONDARY outcome

Timeframe: Immediately after injections were completed

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. The percentage of of bending events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	All Study Participants n=330 pen needles Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass n=330 pen needles All participants received 6 paired injections
BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)	0.6 percentage of needles with bending Interval 0.2 to 2.5	0.6 percentage of needles with bending Interval 0.2 to 2.2

SECONDARY outcome

Timeframe: Immediately after 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 percentage of of leakage events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	All Study Participants n=330 Pen Needles Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass n=330 Pen Needles All participants received 6 paired injections
BD Nano™ PRO vs Terumo Nanopass® (Leakage)	0.3 percentage of participants with leakage Interval 0.0 to 1.7	1.8 percentage of participants with leakage Interval 0.8 to 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately after injections were completed

Population: Per Protocol population

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=660 pen needles Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass All participants received 6 paired injections
Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time) BD NANO	7.55 seconds Standard Deviation 4.75	—
Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time) Terumo	7.80 seconds Standard Deviation 4.62	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately after injections were completed

Population: Per-protocol population

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=330 pen needles Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass n=330 pen needles All participants received 6 paired injections
Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)	0 percentage of needles with breaking Interval 0.0 to 1.1	0 percentage of needles with breaking Interval 0.0 to 1.1

POST_HOC outcome

Timeframe: Immediately after injections were completed

Population: Each subject was asked to fill out a 4 question survey on the importance of Injection Pain, Thumb pressure, Leakage and Needle Bending

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=55 Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo	Terumo Nanopass All participants received 6 paired injections
Subject Satisfaction Survey Injection Pain affects my level of satisfaction · Agree	16 Participants	—
Subject Satisfaction Survey Injection Pain affects my level of satisfaction · Somewhat Agree	16 Participants	—
Subject Satisfaction Survey Injection Pain affects my level of satisfaction · Neutral	16 Participants	—
Subject Satisfaction Survey Injection Pain affects my level of satisfaction · Somewhat Disagree	3 Participants	—
Subject Satisfaction Survey Injection Pain affects my level of satisfaction · Disagree	4 Participants	—
Subject Satisfaction Survey Thumb pressure needed affects my level of satisfac · Agree	10 Participants	—
Subject Satisfaction Survey Thumb pressure needed affects my level of satisfac · Somewhat Agree	21 Participants	—
Subject Satisfaction Survey Thumb pressure needed affects my level of satisfac · Neutral	14 Participants	—
Subject Satisfaction Survey Thumb pressure needed affects my level of satisfac · Somewhat Disagree	7 Participants	—
Subject Satisfaction Survey Thumb pressure needed affects my level of satisfac · Disagree	3 Participants	—
Subject Satisfaction Survey Post injection leakage increases level of concern · Agree	18 Participants	—
Subject Satisfaction Survey Post injection leakage increases level of concern · Somewhat Agree	16 Participants	—
Subject Satisfaction Survey Post injection leakage increases level of concern · Neutral	16 Participants	—
Subject Satisfaction Survey Post injection leakage increases level of concern · Somewhat Disagree	4 Participants	—
Subject Satisfaction Survey Post injection leakage increases level of concern · Disagree	1 Participants	—
Subject Satisfaction Survey A bent needle increases my level of concern · Agree	23 Participants	—
Subject Satisfaction Survey A bent needle increases my level of concern · Somewhat Agree	13 Participants	—
Subject Satisfaction Survey A bent needle increases my level of concern · Neutral	17 Participants	—
Subject Satisfaction Survey A bent needle increases my level of concern · Somewhat Disagree	1 Participants	—
Subject Satisfaction Survey A bent needle increases my level of concern · Disagree	1 Participants	—

Adverse Events

BD Nano™ PRO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Terumo Nanopass

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