Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles

Abstract

Introduction 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. Methods 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. Results 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). Conclusions 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. Clinical Trial Registration Clinicaltrials.gov (NCT03267264). Funding BD (Becton, Dickinson, and Company).

Insulin Injection Practices in a Population of Canadians with Diabetes: An Observational Study

“…Technological advances in needle design have observed that a 4 mm pen needle injected at a 90°angle results in optimal needle depth penetration, therefore reducing the risk of intramuscular injections [29]. New-generation pen needles have also been associated with more positive patient reviews and improved ease of use [30], and in general, shorter needles are the preferred choice for most patients [25]. Pen needle hub design may also support proper injection force [29,30].…”

“…New-generation pen needles have also been associated with more positive patient reviews and improved ease of use [30], and in general, shorter needles are the preferred choice for most patients [25]. Pen needle hub design may also support proper injection force [29,30].…”

User experiences with second-generation 32-gauge × 4 mm vs. thinner comparator pen needles: prospective randomized trial

“…There were no significant differences in occurrence of needle bending for any PN comparisons. In a prior study, the investigational BD 32 G Â 4 mm PN was compared with PNs of similar gauge and was rated as being more comfortable, less painful and easier to use, and preferred overall 27 . In our investigation, the investigational BD 32 G PN was compared with PNs of thinner gauge and similar or shorter length, and our findings of significantly less participant-reported injection pain and force to deliver the dose were in line with those prior study results.…”

“…For the primary endpoint of participant-reported injection pain in both studies, we calculated that a sample size from 266-300 pairs per comparator was required to provide >90% power for the noninferiority criterion of À10 mm, using an SD for relative VAS of 50 mm from a prior study 27 and assuming no true difference in pain (based on a twosided 95% CI for the mean).…”

“…For these reasons, a 32 G extra-thin-wall, 5-bevel cannula PN has been re-engineered with a contoured hub with expanded surface area to improve the injection experience and injection depth consistency 21,[25][26][27] . The aim of this investigation, conducted as two separate studies, was to compare user experiences with this redesigned, second generation 32 G Â 4 mm PN (investigational BD 32 G PN: BD Nano i 2nd Gen, also known as BD Nano PRO) versus four thinner and similar length, commercially available PNs (33 G Â 4 mm, 34 G Â 4 mm, and 34 G Â 3.5 mm).…”