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

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).

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