Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
NCT ID: NCT03878745
Last Updated: 2020-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2019-02-11
2019-06-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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BD Nano™ PRO 32G pen needle
Participants are to perform 6 pairs of injections.
Terumo Nanopass® 34G pen needle
Insulin pen needle
BD Nano™ PRO 32G pen needle
Insulin pen needle
Terumo Nanopass® 34G pen needle
Participants are to perform 6 pairs of injections.
Terumo Nanopass® 34G pen needle
Insulin pen needle
BD Nano™ PRO 32G pen needle
Insulin pen needle
Interventions
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Terumo Nanopass® 34G pen needle
Insulin pen needle
BD Nano™ PRO 32G pen needle
Insulin pen needle
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Becton, Dickinson and Company
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DBC-18PENDL01
Identifier Type: -
Identifier Source: org_study_id
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