title: Usability of a microtapered needle (TN3305) for insulin treatment in japanese patients with diabetes mellitus: a comparative clinical study with a standard thin wall needle.
abstract: BACKGROUND
  We evaluated the clinical usability of a microtapered needle (TN3305, "Needle T," Terumo Corp., Tokyo, Japan) by comparing it with a standard needle (Micro-Fine +, 31 gauge, 5 mm, thin wall, "Needle B," Nippon Becton Dickinson Co., Ltd., Tokyo) in a multicenter study.
  
  
  METHODS
  Ninety-nine patients with diabetes mellitus being treated in 11 Japanese hospitals were enrolled in the study. Written consent was obtained from all patients. They were allocated randomly to two groups by an envelope (crossover) method. Injections were performed using one needle first, followed by the other needle 4 or 5 days later. Pain caused by injection was evaluated using a visual analogue scale (VAS).
  
  
  RESULTS
  In the overall evaluation, Needle T was chosen by 40 patients (44.4%) and Needle B by 17 (18.8%); 33 patients (36.7%) expressed no preference. VAS scores for Needles T and B were 1.48 +/- 0.18 and 2.47 +/- 0.24 cm, respectively (P < 0.001). In this study, lower VAS indicated less pain.
  
  
  CONCLUSIONS
  The preferences and VAS scores suggested that Needle T caused less pain than Needle B. The incidence of adverse events and safety were equivalent for both needles. We believe that usability of Needle T by patients for self-injection is better.
authors.affiliation: Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. asa-mac@m7.dion.ne.jp
authors.forename: Toshinari
authors.initials: T
authors.lastname: Asakura
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Seino
authors.forename: Kiyohide
authors.initials: K
authors.lastname: Nunoi
authors.forename: Kazuyo
authors.initials: K
authors.lastname: Hashimoto
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Mutou
authors.forename: Katsuya
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Minako
authors.initials: M
authors.lastname: Kakutani
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Toraishi
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kitaoka
authors.forename: Harumi
authors.initials: H
authors.lastname: Daikoku
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Sugiyama
authors.forename: Koushi
authors.initials: K
authors.lastname: Narasaki
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tsuji
authors.forename: Shinsaku
authors.initials: S
authors.lastname: Ohnishi
authors.forename: Kazushige
authors.initials: K
authors.lastname: Oto
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tsujimoto
authors.forename: Reiko
authors.initials: R
authors.lastname: Nakano
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007271:Injections, Intradermal / Q000009:adverse effects / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008875:Middle Aged; D009339:Needles; D010146:Pain / Q000209:etiology; D010147:Pain Measurement; D012646:Self Administration
chemical_list: D007328:Insulin