NCT03878758

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

Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs the Artsana Insupen® Extr3me 4mm x 33G, Artsana Insupen® Extr3me 3.5mm x 34G and the Simple Diagnostics Comfort EZ™ 4mm x 33G Pen Needles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a subject partially blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. three (3) thinner commercially available comparator pen needles (Artsana Insupen Extr3me 33G, Artsana Insupen Extr3me 34G and the Simple Diagnostics Comfort EZ™ 33G Pen Needles). The study will include up to 146 study subjects having Type 1 or Type 2 diabetes.

Detailed description

The study will consist of one 60 to 120 minute 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. The pen needle outer cover and inner shield will be removed prior to subject use so that they will not be able to identify which device they are using. 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 comparator pen needle. Within the 12 injections, each comparator will be injected twice, therefore each subject will experience 2 of each of the following pairs: BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G Each Subject will evaluate pain after completion of each pair of injections using a 15 cm relative Visual Analog Scale (VAS).

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BD Nano™ PRO	Insulin Pen needle
DEVICE	33G Artsana Insupen Extr3me	Insulin Pen Needle
DEVICE	34G Artsana Insupen Extr3me	Insulin Pen Needle
DEVICE	Simple Diagnostics Comfort EZ™	Insulin Pen Needle

Timeline

• Start date: 2019-02-07
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-03-18
• Last updated: 2020-03-09
• Results posted: 2020-03-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study