Clinical trial NCT03878745: Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
Official title: Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
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: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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 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 is determined the hair will interfere with leakage evaluation.
5. 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.
6. Pregnant (self-attestation).
7. Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin 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 sites that would significantly limit available injection space.
11. History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
12. 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).
13. 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.
14. Currently participating in another pen needle study.
15. 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: BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)
timeFrame: Scores were collected immediately after each paired injection
Secondary outcomes:
measure: BD Nano™ PRO vs Terumo Nanopass® (Force)
timeFrame: Scores were collected immediately after each paired injection
measure: BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)
timeFrame: Immediately after injections were completed
measure: BD Nano™ PRO vs Terumo Nanopass® (Leakage)
timeFrame: Immediately after injection
Other outcomes:
measure: Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time)
timeFrame: Immediately after injections were completed
measure: Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)
timeFrame: Immediately after injections were completed
Locations:
city: San Mateo
country: United States
facility: Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute
state: California
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
Study officials:
References:
citation: Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
citation: Watson PJ, Latif RK, Rowbotham DJ. Ethnic differences in thermal pain responses: a comparison of South Asian and White British healthy males. Pain. 2005 Nov;118(1-2):194-200. doi: 10.1016/j.pain.2005.08.010. Epub 2005 Oct 3.
citation: Palmer B, Macfarlane G, Afzal C, Esmail A, Silman A, Lunt M. Acculturation and the prevalence of pain amongst South Asian minority ethnic groups in the UK. Rheumatology (Oxford). 2007 Jun;46(6):1009-14. doi: 10.1093/rheumatology/kem037. Epub 2007 Mar 31.
citation: Komiyama O, Kawara M, De Laat A. Ethnic differences regarding tactile and pain thresholds in the trigeminal region. J Pain. 2007 Apr;8(4):363-9. doi: 10.1016/j.jpain.2006.12.002. Epub 2007 Feb 1.
citation: Hobara M. Beliefs about appropriate pain behavior: cross-cultural and sex differences between Japanese and Euro-Americans. Eur J Pain. 2005 Aug;9(4):389-93. doi: 10.1016/j.ejpain.2004.09.006.
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.