Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle

Exclusion Criteria

• •1. Self-injecting insulin with a pen injector for less than 3 months
• •2. Planned changes in insulin regimen (increasing or decreasing number of injections per day).
• •3. Positive pregnancy test (urine)
• •4. Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).
• •5. History of a bleeding disorder or easy bruising
• •6. Blood borne infection(s)
• •7. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)
• •8. Gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations, tattoos, superficial masses, acne, inflammation) located at or very close to the injection sites
• •9. Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
• •10. Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.
• •11. 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.
• •12. Currently participating in another study
• •13. Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer