Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles

NCT03878758 | Completed Results FDA Device

• 1 other identifier: DBC-18PENDL02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators

  Injection pain as measured by a relative visual analog scale. This endpoint analyzes data for individual groups. 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 (308 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)

• Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles

  Scores were collected immediately after each paired injection

• Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage)

  Leakage was measured directly after each injection

• Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force)

  Immediately after injection Pair

Other Outcomes (1)

• Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time)

  Time of injection

Study Arms (3)

BD Nano™ PRO pen needle vs 33G Artsana Insupen Extr3me

EXPERIMENTAL

Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2

Device: BD Nano™ PRO; Device: 33G Artsana Insupen Extr3me

BD Nano™ PRO pen needle vs 34G Artsana Insupen Extr3me

EXPERIMENTAL

Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2

Device: BD Nano™ PRO; Device: 34G Artsana Insupen Extr3me

BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™

EXPERIMENTAL

Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2

Device: BD Nano™ PRO; Device: Simple Diagnostics Comfort EZ™

Interventions

BD Nano™ PRO DEVICE

Insulin Pen needle

BD Nano™ PRO pen needle vs 33G Artsana Insupen Extr3me; BD Nano™ PRO pen needle vs 34G Artsana Insupen Extr3me; BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™

33G Artsana Insupen Extr3me DEVICE

Insulin Pen Needle

BD Nano™ PRO pen needle vs 33G Artsana Insupen Extr3me

34G Artsana Insupen Extr3me DEVICE

Insulin Pen Needle

BD Nano™ PRO pen needle vs 34G Artsana Insupen Extr3me

Simple Diagnostics Comfort EZ™ DEVICE

Insulin Pen Needle

BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™

Eligibility Criteria

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

You may qualify if:

• Adults 18 to 75 years of age (inclusive)
• 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:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (2)

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Related Publications (1)

• 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not see any labeling for the Pen Needles used for the injections
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BD Nano (Test Device) will be compared to other currently marketed devices (controls) through a series of abdominal saline injections

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: February 7, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)