Whooley Shahista, Briskin Toby, Gibney Michael A, Blank Lydia R, Berube Julie, Pflug Brian K
BD (Becton, Dickinson and Company), Andover, MA , USA.
Rapid Medical Research, Cleveland, OH, USA.
Diabetes Ther. 2019 Apr;10(2):697-712. doi: 10.1007/s13300-019-0585-7. Epub 2019 Feb 27.
Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its "PRO" brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN's hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips.
This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using 31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of > - 10 mm or > 0 mm, respectively.
At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined.
Clinicaltrials.gov (NCT03267264).
BD (Becton, Dickinson, and Company).
自1985年胰岛素笔首次问世以来，笔用针头（PNs）已取得了许多进展。在本研究中，我们评估了一种新设计的4毫米×32G研究用PN（BD Nano™ 2代，在美国以外的许多市场也以其“PRO”品牌名称销售）的患者报告结局。该研究用PN的针座取代了传统的圆柱形带贴边针座，其轮廓设计增加了表面积。该研究用PN还包括重新设计的内护套，带有触觉脊，以及重新设计的外针帽，其比例和握持处有所改进。
这是一项多中心、前瞻性、开放标签、两阶段交叉试验。1型和2型糖尿病患者，使用长度≤6毫米的32G PNs且时间≥4个月者符合条件。使用类似长度31G PNs的受试者，经过2周的导入期后符合条件。受试者被分为四组，每组使用一种市售PN，并与研究用PN进行比较。两个研究阶段各为15天：一个阶段使用研究用PN，另一个阶段使用对照PN。完成两个研究阶段后，受试者比较两种PN的使用体验。使用150毫米比较视觉模拟量表（VAS）评估总体偏好（主要终点）和几个次要终点，包括总体舒适度、注射疼痛和易用性。在验证数据可合并性后，将四个PN组的数据合并。对每个PN组也进行了亚组分析。对于VAS反应，计算平均评分的双侧95%置信区间（CI）。非劣效性或优越性的阈值分别设定为下限CI > -10毫米或> 0毫米。
在基线时，受试者的平均年龄为55.6岁；51.6%为女性；85.1%患有2型糖尿病。糖尿病平均病程为14.2年，平均注射时间为7.8年。对于所有合并组，研究用PN在主要和次要所有结局方面均显示出优越性（p < 0.05）。
在所有合并组中，与类似规格和长度的对照PN相比，研究用PN在总体偏好、更舒适、疼痛更少和使用更方便方面的评分更高。
Clinicaltrials.gov（NCT03267264）。
BD（碧迪医疗器械有限公司）。
