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

NCT03878745 | Completed Results FDA Device

• 1 other identifier: DBC-18PENDL01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)

  Injection pain as measured by a relative 150mm visual analog scale. Injection pain as measured by a relative visual analog scale. s. User preference is assessed through a single question reported on a 150mm relative VAS scale with the BD Nano™ PRO pen needle Pen labeled at +75 mm and the Comparator pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference forBD Nano™ PRO and negative scores reflect preference for the comparator. Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated. The two-sided 95% confidence interval was calcuated for the average relative rating. A linear model was used to adjust for the order effect. If the lower bound of the 95% CI is \> -10cm, non-inferiority could be concluded. If the lower bound of the 95% CI is \>0, superiority can also be concluded.

  Scores were collected immediately after each paired injection

Secondary Outcomes (3)

• BD Nano™ PRO vs Terumo Nanopass® (Force)

  Scores were collected immediately after each paired injection

• BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)

  Immediately after injections were completed

• BD Nano™ PRO vs Terumo Nanopass® (Leakage)

  Immediately after injection

Other Outcomes (2)

• Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time)

  Immediately after injections were completed

• Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)

  Immediately after injections were completed

Study Arms (2)

BD Nano™ PRO 32G pen needle

EXPERIMENTAL

Participants are to perform 6 pairs of injections.

Device: Terumo Nanopass® 34G pen needle; Device: BD Nano™ PRO 32G pen needle

Terumo Nanopass® 34G pen needle

ACTIVE COMPARATOR

Participants are to perform 6 pairs of injections.

Device: Terumo Nanopass® 34G pen needle; Device: BD Nano™ PRO 32G pen needle

Interventions

Terumo Nanopass® 34G pen needle DEVICE

Insulin pen needle

BD Nano™ PRO 32G pen needle; Terumo Nanopass® 34G pen needle

BD Nano™ PRO 32G pen needle DEVICE

Insulin pen needle

BD Nano™ PRO 32G pen needle; Terumo Nanopass® 34G pen needle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not self-injecting (for example injections completed by a family member).
• Self-injecting with a pen injector for less than 3 months.
• Unwilling to inject into abdomen.
• Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation.
• 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.
• Pregnant (self-attestation).
• Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted).
• History of a bleeding disorder.
• History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema).
• Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space.
• History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
• 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).
• 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.
• Currently participating in another pen needle study.
• Employed by, or currently serving as a contractor or consultant to BD or any diabetes injectable medication, injection pen, or pen needle manufacturer.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (2)

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

San Mateo, California, 94401, United States

Location

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Related Publications (6)

• 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.

  PMID: 11690726 BACKGROUND

• 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.

  PMID: 16202529 BACKGROUND

• 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.

  PMID: 17401133 BACKGROUND

• 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.

  PMID: 17275416 BACKGROUND

• 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.

  PMID: 15979019 BACKGROUND

• 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.

  PMID: 32723109 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michael Gibney
• Organization: Becton Dickinson

Michael.gibney@bd.com

201-847-6170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants will not see any labeling for the pen needles used for injections
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: February 11, 2019
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)