Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants will not see any labeling for the pen needles used for injections
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
- •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.
排除标准
- •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.
结局指标
主要结局
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)
时间窗: Scores were collected immediately after each paired injection
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.
次要结局
- BD Nano™ PRO vs Terumo Nanopass® (Force)(Scores were collected immediately after each paired injection)
- BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)(Immediately after injections were completed)
- BD Nano™ PRO vs Terumo Nanopass® (Leakage)(Immediately after injection)