Clinical trial NCT03267264: Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
Official title: Nucleus Claims Study: Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a multi-site, prospective, open-label, randomized, 2 period cross over study comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus pen needle. The study will consist of two 15 day periods ( in which the subject will use each pen needle \[BD Nucleus pen needle or subject's current pen needle, order randomized\] for injection. At the end of the last study period, each subject will be asked to evaluate his or her perceptions using a 150mm relative VAS scale.


Eligibility criteria: Inclusion Criteria:

1. Adults (18 - 75 inclusive)
2. Diagnosed Type 1 or Type 2 diabetes
3. Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)
4. Every effort will be made to recruit a minimum of 30 subjects with Asian ethnicity (of the total population, not of each subgroup). Ideally, 60 Asian subjects are needed for the study
5. Minimum within the last 4 months experience self-injecting insulin with a pen injector
6. Minimum within the last 2 months experience self-injecting consistently with one of the following available pen needles OR a subject may be enrolled that is using a 31G/32G pen needle that is not longer than 6mm in length who is willing to transfer to one of the following 32G pen needle with a 14 day wash-in period:

   * BD Nano™ 32Gx4mm
   * NovoFine® 32Gx6mm
   * NovoTwist® 32Gx5mm or
   * NovoFine® Plus 32Gx4mm
   * Owen Mumford PenTips 32Gx4mm or
   * Perrigo / Ypsomed ClickFine 32Gx4mm or
   * Other 32G such as UltiMed, MHC, or other private label.
7. Able and willing to provide informed consent/participant form
8. Able and willing to complete all study procedures

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

Primary outcomes:
measure: Overall User Preference -Combined Groups
timeFrame: 30 Days
Secondary outcomes:
measure: Overall User Preference - Each Comparator Group
timeFrame: 30 Days
measure: User Experience - All Study Groups Combined
timeFrame: 30 Days
measure: User Experience - Each Individual Study Group
timeFrame: 30 Days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Virginia Beach
country: United States
facility: Corporation Lane Internal Medicine and Research Center
state: Virginia
Study officials:
References:
citation: Whooley S, Briskin T, Gibney M, Blank L, Berube J, Pflug B. Evaluation the User Performance and Experience of a New Pen Needle with Advanced Hub Face Geometry. Poster presented at: American Association of Diabetes Education Annual Conference; 2018 Aug 17-20; Baltimore, MD.
citation: Whooley S, Briskin T, Gibney MA, Blank LR, Berube J, Pflug BK. Evaluating the User Performance and Experience with a Re-Engineered 4 mm x 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles. Diabetes Ther. 2019 Apr;10(2):697-712. doi: 10.1007/s13300-019-0585-7. Epub 2019 Feb 27.