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J Diabetes Sci Technol · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyImpact of a modified needle tip geometry on penetration force as well as acceptability, preference, and perceived pain in subjects with diabetes.
- Laurence Hirsch, Michael Gibney, Julie Berube, and John Manocchio.
- BD (Becton, Dickinson and Company), Franklin Lakes, New Jersey, USA. laurence_hirsch@bd.com
- J Diabetes Sci Technol. 2012 Mar 1;6(2):328-35.
BackgroundMultiple 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.MethodsWe 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.ResultsAverage 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).ConclusionsNeedle 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.
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