Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Terumo Nanopass® 34G pen needle

+ BD Nano™ PRO 32G pen needle

Device
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: February 2019
See protocol details

Summary

Principal SponsorBecton, Dickinson and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 11, 2019

Actual date on which the first participant was enrolled.

Study conduct will consist of one 60 to 120-minute Site visit in which pre-set doses of saline will be abdominally delivered by Subjects via a reusable insulin pen device. All pen needles will be attached by Study Staff and pen needle outer cover and inner shield will be removed for subjects. Subjects are to perform 12 injections into the abdomen (6 pairs of injections). Pairs of injections will be evaluated and each pair will contain one BD Nano™ PRO and one Terumo Nanopass® pen needle. The order of the two pen needles in each pair will be randomized. The intent of this comparative use study is to determine whether Japanese American patients' experiences are different when using the BD Nano™ PRO 4mm x 32G extra thin wall, 5-bevel pen needle vs the Terumo Nanopass® 4mm x 34G pen needle in the Japanese American population. These experiences include the perceived force to deliver dose, the ability to deliver the full dose (measured by leakage), injection pain and bending.

Official TitleComparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
NCT03878745
Principal SponsorBecton, Dickinson and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

8 inclusion criteria required to participate
Self-attesting Japanese American adults 18 to 75 years of age (inclusive).

Self-attest to Japanese descent.

Diagnosed with Type 1 or Type 2 diabetes.

Self-injecting using an injection pen for ≥3 months with any pen needle.

Show More Criteria

15 exclusion criteria prevent from participating
Currently participating in another pen needle study.

Not self-injecting (for example injections completed by a family member).

Self-injecting with a pen injector for less than 3 months.

Unwilling to inject into abdomen.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants are to perform 6 pairs of injections.

Group II

Active Comparator
Participants are to perform 6 pairs of injections.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute

San Mateo, United StatesOpen Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute in Google Maps
Suspended

East West Medical Research Institute

Honolulu, United States
Completed2 Study Centers