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

Last updated: May 6, 2020
Sponsor: Becton, Dickinson and Company
Overall Status: Completed

Phase

N/A

Condition

Diabetic Vitreous Hemorrhage

Diabetic Neuropathy

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT03878745
DBC-18PENDL01
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Self-attesting Japanese American adults 18 to 75 years of age (inclusive).

  2. Self-attest to Japanese descent.

  3. Diagnosed with Type 1 or Type 2 diabetes.

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

  5. Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day.

  6. Able to demonstrate proficiency using an injection pen into an injection model.

  7. Able and willing to provide informed consent.

  8. Able and willing to complete all study procedures.

Exclusion

Exclusion Criteria:

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

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

  3. Unwilling to inject into abdomen.

  4. Unwilling to have hair at the injection area reduced with an electric razor if it isdetermined the hair will interfere with leakage evaluation.

  5. Failure to confirm which pen needle (gauge and needle length) subject is currentlyusing. To confirm, subject may be asked to bring their pen and pen needles to the siteor site staff may confirm via medical record or pharmacy.

  6. Pregnant (self-attestation).

  7. Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day ofaspirin is permitted).

  8. History of a bleeding disorder.

  9. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis,eczema).

  10. Gross skin anomalies and abnormalities located at or very close to the injection sitesthat would significantly limit available injection space.

  11. History of symptomatic low blood pressure or history of fainting (syncope) duringhypodermic injections.

  12. Use of any analgesic medications within 24 hours of first study injection, and duringthe study (up to 162 mg per day of aspirin is permitted).

  13. A current or previous medical or physical condition that, in the opinion of theinvestigator, would place the patient at risk or make them unable to perform studyprocedures or has the potential to confound interpretation of the study results.

  14. Currently participating in another pen needle study.

  15. Employed by, or currently serving as a contractor or consultant to BD or any diabetesinjectable medication, injection pen, or pen needle manufacturer.

Study Design

Total Participants: 55
Study Start date:
February 11, 2019
Estimated Completion Date:
June 14, 2019

Study Description

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.

Connect with a study center

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

    San Mateo, California 94401
    United States

    Site Not Available

  • East West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

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