Status:
COMPLETED
Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 availab...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03878758
Start Date
February 7 2019
End Date
April 30 2019
Last Update
March 9 2020
Active Locations (2)
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1
East West Medical Research Institute
Honolulu, Hawaii, United States, 96814
2
TKL Research Inc.
Fair Lawn, New Jersey, United States, 07410