Impact of a modified needle tip geometry on penetration force as well as acceptability, preference, and perceived pain in subjects with diabetes

Abstract

Background: Multiple factors impact subcutaneous insulin injection pain. Injection devices [e.g., syringe or pen needle (PN)] affect pain due to needle length, diameter, needle polishing and lubrication, and needle tip geometry.

Methods: We evaluated a modified 5-bevel PN tip in 32 G × 4 mm 31 G × 5 mm and 8 mm PNs vs the equivalent marketed 3-bevel PNs in laboratory penetration force testing, as well as in insulin-taking subjects for overall acceptability, comparative pain, and preference. The clinical tests were done in three ways: paired insertions with the subjects blinded to PN tip geometry, after brief at-home use of 5-bevel PNs, and again with subjects informed about each needle's tip geometry in paired insertions.

Results: Average penetration force in a skin substitute was 23% lower with the 5-bevel PNs vs similar 3-bevel PNs (p ≤ 0.01). In blinded testing and after at-home use, patients rated the 5-bevel needle as acceptable. After shortterm home use, patients rated the 5-bevel PN less painful and preferable to their usual PN (both p < 0.01). In paired, informed testing, the 5-bevel PN was less painful and preferred to subjects' currently used needles (p ≤ 0.01) and to other marketed PNs (p < 0.01).

Conclusions: Needle tip geometry affects penetration force. When blinded, patients did not distinguish differences in PN tip geometry with fine-gauge PN insertions. A 5-bevel needle tip is perceived as less painful and is preferred by subjects following home use for usual injections. Similar results occurred when patients were informed that they were using a needle with a modified tip.

© 2012 Diabetes Technology Society.

Figures

Figure 1

(A) 3-bevel tip. (B) 5-bevel tip.

Figure 2

Study flow/conduct diagram.

Figure 3

A 15-cm visual analog scale used for comparative pain perception. After each pair of insertions, subjects placed a vertical line indicating comparative pain. Pain scores ranged from –7.5 cm (2nd insertion much less painful than 1st insertion) to +7.5 cm (2nd insertion much more painful than 1st insertion), with a score of 0 cm representing no difference. Study scale did not have centimeter indicators.

Figure 4

Mean percent (with 95% CI) reduced penetration force of 5-bevel compared to similar 3-bevel pen needles. * = p < 0.001, ^ = p < 0.01, # = p < 0.05, 0 = p ≥ 0.05 (NS).

Figure 5

Ease of insertion, comfort, and preference for 3- and 5-bevel pen needles; same manufacturer usual 3-bevel vs 5-bevel after home use (A), same manufacturer 3-bevel vs 5-bevel (B), and comparator 3-bevel vs 5-bevel (C).