Nucleus Claims Study: Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 8
- 主要终点
- Overall User Preference -Combined Groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 - 75 inclusive)
- •Diagnosed Type 1 or Type 2 diabetes
- •Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)
- •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
- •Minimum within the last 4 months experience self-injecting insulin with a pen injector
- •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.
- •Able and willing to provide informed consent/participant form
- •Able and willing to complete all study procedures
排除标准
- •Self-injecting insulin with a pen injector for less than 3 months
- •Planned changes in insulin regimen (increasing or decreasing number of injections per day).
- •Positive pregnancy test (urine)
- •Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).
- •History of a bleeding disorder or easy bruising
- •Blood borne infection(s)
- •History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)
- •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
- •Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
- •Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.
- •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 study
- •Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer
研究组 & 干预措施
Group 1
干预措施: BD Nano™ vs Nucleus (Device)
Group 2
干预措施: NovoFine® vs Nucleus (Device)
Group 3
干预措施: NovoTwist®/NovoFine® Plus vs Nucleus (Device)
Group 4
干预措施: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus (Device)
结局指标
主要结局
Overall User Preference -Combined Groups
时间窗: 30 Days
This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
次要结局
- User Experience - All Study Groups Combined(30 Days)
- Overall User Preference - Each Comparator Group(30 Days)
- User Experience - Each Individual Study Group(30 Days)