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.
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.
Asakura
Toshinari
T
Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. asa-mac@m7.dion.ne.jp
Seino
Hiroaki
H
Nunoi
Kiyohide
K
Hashimoto
Kazuyo
K
Mutou
Tatsuya
T
Yamazaki
Katsuya
K
Kakutani
Minako
M
Toraishi
Ken-Ichi
K
Kitaoka
Masafumi
M
Daikoku
Harumi
H
Sugiyama
Kazuhiko
K
Narasaki
Koushi
K
Tsuji
Kazuo
K
Ohnishi
Shinsaku
S
Oto
Kazushige
K
Tsujimoto
Tsutomu
T
Nakano
Reiko
R
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
D007328:Insulin