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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Terumo Nanopass® 34G pen needle
* Device: BD Nano™ PRO 32G pen needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
Masking: None (Open Label)


Arms and Interventions

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

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 |