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).

Keywords: Comfort; Diabetes; Hub; Injection; Pain; Pen; Pen needle; Preference.

Fig. 1

Comparison of components of a conventional posted pen needle (PN) (left) and those of the re-engineered investigational PN (right)

Fig. 2

Study design including visits and crossover periods

Fig. 3

Flow diagram of subjects through enrollment, randomization, and visits

Fig. 4

Visual analog scale (VAS). A single vertical line placed by the subject on the horizontal VAS scale indicates perceived preference (or lack of) for one of the two PNs used in each study period. The order of needle use was adjusted in the analysis

Fig. 5

Mean VAS score with 95% confidence interval (CI) for all survey questions. Solid red vertical line indicates threshold for non-inferiority, dotted vertical line indicates threshold for superiority. No differences were observed between the per-protocol (PP) and intent-to-treat (ITT) analyses. NSI Needlestick injuries

Fig. 6

a–d Mean VAS score with 95% CI score for all survey questions for each PN group (Groups 1–4) separately. For detailed description of groups, see Table 1 and Fig. 3. a–d Solid red vertical line indicates threshold for non-inferiority, dotted vertical line indicates threshold for superiority. a Group 1. No differences were observed between the PP and ITT analyses. b Group 2. The PP analysis (shown above) did not indicate superiority for “Easier to Remove from Pen,” whereas the result based on the ITT analysis showed superiority. c Group 3. The PP analysis (shown above) did not indicate superiority for “More Comfortable Against Skin,” whereas the result based on the ITT analysis showed superiority. d Group 4. The PP analysis (shown above) indicated superiority for “More User-Friendly,” whereas the result based on the ITT analysis did not

Fig. 7

A breakdown of preference for the comparator PN (black), no preference (gray), and preference for the investigational PN (white), in all groups combined, in all VAS questions