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

Completed · Not applicable

Conditions studied: Diabetes

In brief

This is a subject single blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially available Terumo Nanopass® pen needle. The study will include a minimum of 55 Japanese American study subjects with Type 1 or Type 2 diabetes.

Key facts

Study ID

NCT03878745

Run by

Becton, Dickinson and Company

People needed

55

Starts

2019-02-11

Expected to finish

2019-06-14

Last updated by the study team

2020-05-19

Who can join

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

You may qualify if…

• 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.
• 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…

• 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.
• Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation.
• 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.
• Pregnant (self-attestation).
• Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted).
• History of a bleeding disorder.
• History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema).
• Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space.
• History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
• Use of any analgesic medications within 24 hours of first study injection, and during the study (up to 162 mg per day of aspirin is permitted).
• 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.
• Currently participating in another pen needle study.
• 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

• Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute — San Mateo, California, United States
• East West Medical Research Institute — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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