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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-07

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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The study will consist of one 60 to 120 minute 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. The pen needle outer cover and inner shield will be removed prior to subject use so that they will not be able to identify which device they are using. 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 comparator pen needle. Within the 12 injections, each comparator will be injected twice, therefore each subject will experience 2 of each of the following pairs:

BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G Each Subject will evaluate pain after completion of each pair of injections using a 15 cm relative Visual Analog Scale (VAS).

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will not see any labeling for the Pen Needles used for the injections

Study Groups

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

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

Group Type EXPERIMENTAL

BD Nano™ PRO

Intervention Type DEVICE

Insulin Pen needle

33G Artsana Insupen Extr3me

Intervention Type DEVICE

Insulin Pen Needle

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

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

Group Type EXPERIMENTAL

BD Nano™ PRO

Intervention Type DEVICE

Insulin Pen needle

34G Artsana Insupen Extr3me

Intervention Type DEVICE

Insulin Pen Needle

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

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

Group Type EXPERIMENTAL

BD Nano™ PRO

Intervention Type DEVICE

Insulin Pen needle

Simple Diagnostics Comfort EZ™

Intervention Type DEVICE

Insulin Pen Needle

Interventions

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BD Nano™ PRO

Insulin Pen needle

Intervention Type DEVICE

33G Artsana Insupen Extr3me

Insulin Pen Needle

Intervention Type DEVICE

34G Artsana Insupen Extr3me

Insulin Pen Needle

Intervention Type DEVICE

Simple Diagnostics Comfort EZ™

Insulin Pen Needle

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults 18 to 75 years of age (inclusive)
2. Diagnosed with Type 1 or Type 2 diabetes
3. Self-injecting using an injection pen for ≥3 months with any pen needle
4. Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day
5. Able to demonstrate proficiency using an injection pen into an injection model
6. Able and willing to provide informed consent
7. Able and willing to complete all study procedures

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No