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

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT03878758

Run by

Becton, Dickinson and Company

People needed

158

Starts

2019-02-07

Expected to finish

2019-04-30

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 75 years of age (inclusive)
• Diagnosed with Type 1 or Type 2 diabetes
• Self-injecting using an injection pen for ≥3 months with any pen needle
• Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day
• Able to demonstrate proficiency using an injection pen into an injection model
• Able and willing to provide informed consent
• Able and willing to complete all study procedures

You may not qualify if…

• a. Not self-injecting (example, injections completed by a family member) b. Self-injecting with a pen injector for less than 3 months c. Unwilling to inject into abdomen d. Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation e. Failure to confirm which pen needle (gauge and needle length) subject is currently using. To confirm, subject may be asked to bring their pen and pen needles to the site or site staff may confirm via medical record or pharmacy.
• f. Pregnant (self-attestation) g. Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted).
• h. History of a bleeding disorder i. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema) j. Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space.
• k. History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections l. Use of any analgesic medications (prescription or OTC) within 24 hours of first study injection, and during the study (up to 162 mg per day of aspirin is permitted).
• m. A current or previous medical or physical condition that, in the opinion of the investigator, would place the patient at risk or make them unable to perform study procedures or has the potential to confound interpretation of the study results n. Currently participating in another pen needle study o. Employed by, or currently serving as a contractor or consultant to BD or any diabetes injectable medication, injection pen, or pen needle manufacturer

Where it is running

• East West Medical Research Institute — Honolulu, Hawaii, United States
• TKL Research Inc. — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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