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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Terumo Nanopass® 34G pen needle; Device: BD Nano™ PRO 32G pen needle

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94401
      • Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East West Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BD Nano™ PRO 32G pen needle; Participants are to perform 6 pairs of injections.	Device: Terumo Nanopass® 34G pen needle; Insulin pen needle; Device: BD Nano™ PRO 32G pen needle; Insulin pen needle
Active Comparator: Terumo Nanopass® 34G pen needle; Participants are to perform 6 pairs of injections.	Device: Terumo Nanopass® 34G pen needle; Insulin pen needle; Device: BD Nano™ PRO 32G pen needle; Insulin pen needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BD Nano™ PRO vs Terumo Nanopass® (Force)	Subject perceived force required to deliver dose measured by a relative 5 point Likert scale. The scale ranged from -2 to 2, where positive scores indicated less thumb force required for the BD Nano™ PRO, and negative scores indicated less thumb force for Terumo Nanopass®. Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated.	Scores were collected immediately after each paired injection
BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)	Participants reported a visual score of needle bending. A score of at least 2, corresponding to >10 degrees of bending, was considered an event of a bent needle. The percentage of of bending events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.	Immediately after injections were completed
BD Nano™ PRO vs Terumo Nanopass® (Leakage)	After saline delivery equivalent to 30U of U100 insulin (0.3mL) and subject removal of pen needle from body, study staff used the provided materials and scale to absorb leakage from the pen needle tip and injection site to measure the amount of leakage. Leakage over 0.015g was counted as an event. The percentage of of leakage events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.	Immediately after injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time)	Time from when injection button fully depressed to when pen needle removed from body. Mean total injection time was calculated for both the BD Nano™ PRO and the Terumo Nanopass®. Scores from each injection (330 for each needle type) were pooled and a mean was calculated. The total injection time for the BD Nano™ PRO and Terumo Nanopass® were compared and the mean difference reported with a 95% confidence interval.	Immediately after injections were completed
Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)	Needle breakage was defined as the patient-end metal cannula being separated into two pieces. The percentage of of breaking events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.	Immediately after injections were completed

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): June 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DBC-18PENDL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No