Clinical trial NCT03878758: Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BD Nano (Test Device) will be compared to other currently marketed devices (controls) through a series of abdominal saline injections
Primary purpose: OTHER

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 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators
timeFrame: Scores were collected immediately after each paired injection
Secondary outcomes:
measure: Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles
timeFrame: Scores were collected immediately after each paired injection
measure: Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage)
timeFrame: Leakage was measured directly after each injection
measure: Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force)
timeFrame: Immediately after injection Pair
Other outcomes:
measure: Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time)
timeFrame: Time of injection
Locations:
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Fair Lawn
country: United States
facility: TKL Research Inc.
state: New Jersey
Study officials:
References:
citation: Gibney MA, Fitz-Patrick D, Klonoff DC, Whooley S, Lu B, Yue W, Glezer S. User experiences with second-generation 32-gauge x 4 mm vs. thinner comparator pen needles: prospective randomized trial. Curr Med Res Opin. 2020 Oct;36(10):1591-1600. doi: 10.1080/03007995.2020.1803248. Epub 2020 Aug 18.