Comparison Between Shorter Straight and Thinner Microtapered Insulin Injection Needles.
Diabetes Technol Ther. 2013 Jul;15(7):550-555.
Nagai Y, Ohshige T, Arai K, Kobayashi H, Sada Y, Ohmori S, Furukawa K, Kato H, Kawata T, Ohta A, Tanaka Y.
Department of Internal Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine, Kawasaki, Japan.
Background: Many diabetes patients who require insulin perform multiple subcutaneous injections every day that often cause pain, discomfort, and anxiety. We compared efficacy (glycemic control) and patient preference for two types of needle: a shorter straight needle (32 gauge ´ 4mm, straight wall; Nippon Becton Dickinson Co., Ltd., Tokyo, Japan; hereafter referred to as BD32S4) and a thinner microtapered needle (33-gauge tip and 28-gauge base ´ 5mm, double-tapered wall; Terumo Corp., Tokyo, Japan; hereafter referred to as TR33T5) in a single-center study.
Patients and Methods: Eighty-four patients with diabetes were enrolled in a randomized, open-label crossover trial. The patients injected their usual insulin dosage with one type of needle for 4 weeks and then switched to the other type for the next 4 weeks. The serum glycated albumin level was measured before and after each 4-week period. Each patient assessed pain during injection on a 150-mm visual analog scale (VAS). Needle preference, perceptions of handling, and acceptance were assessed by the patients, who completed a questionnaire after using each type of needle for 4 weeks.
Results: In total, 79 patients completed the study. There was no difference of glycemic control between the two needles. The mean VAS score was – 14.5mm (95% confidence interval, -20.9, -8.0 mm), indicating that the patients perceived less pain with the BD32S4 needle. In the overall evaluation, a significantly higher percentage of patients selected the BD32S4 as the better needle compared with the TR33T5 (60.3% vs. 19.2%; P < 0.0001).
Conclusions: The BD32S4 needle was more highly evaluated and was preferred by the patients with respect to pain during injection, usability, and visual impression, without having a negative impact on glycemic control. The overall preference of patients for the shorter needle in this study suggests that needle length may be one of the major contributing factors for patients’ comfort in insulin injection, although the other relevant factors of needles still need to be considered.
Figure 2. Mean visual analog scale scores for pain after use of both needles. CI, confidence interval.
Figure 3. Comparison of the usability of the two needles.
The present study demonstrated that needle length may be one of the major contributing factors to improve patients’ comfort at insulin injection and there was no difference of glycemic control (glycated albumin) between BD32S4 and TR33T5. We can safely say that use of 4mm pen needle for insulin injection causes no negative impact on glycemic control in the clinical setting. However, to investigate this more exactly, it is necessary to evaluate insulin pharmacokinetic properties with 4mm needle and confirm that 4mm needle provides the similar properties of injected insulin as the existing longer pen needles. A recent study1 showed that the pharmacokinetic properties of insulin using 4mm needle are bioequivalent to 6mm and 8mm needles. Therefore, it also supported that 4mm pen needle can be safely and effectively used for insulin injection.
Further, a new 32G ´ 4mm needle, BD Ultra-FineTM pen needle (Becton, Dickinson and Company, NJ), has been newly introduced. This needle is the improved one of BD32S4 which we investigated in the present study. The improvements are its modified needle tip from 3-bevel to 5-bevel to create a flatter and thinner needle tip surface, and its wider inner diameter with the “EasyFlowTM Technology” to secure sufficient insulin flow rate. Aronson2 demonstrated that it provided an easier-to-use, more convenient injection experience, with significantly better overall patient preference, lower thumb button force, reduced time to inject, and greater patient confidence in completing the full injection with type1 and 2 diabetes mellitus.
Race for new technologies has been intensified for insulin pen needles and it seems to require the timely and comprehensive investigation to evaluate them, in order to appropriately assess the impact of pen needles on diabetic patients’ quality of life.
- Identification and comparison of insulin pharmacokinetics injected with a new 4-mm needle vs 6- and 8-mm needles accounting for endogenous insulin and C-peptide secretion kinetics in non-diabetic adult males. J Diabetes Invest. 2013 May;4(3):287-296. Hirose T, Ogihara T, Tozaka S, Kanderian S, Watada H.
- Insulin pen needles: effects of extra-thin wall needle technology on preference, confidence, and other patient ratings. Clin Ther. 2013 Jul;35(7):923-933. Aronson R, Gibney MA, Oza K, Bérubé J, Kassler-Taub K, Hirsch L.