• Diabetes Technol. Ther. · Aug 2006

    Randomized Controlled Trial Comparative Study

    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.

    • Toshinari Asakura, Hiroaki Seino, Kiyohide Nunoi, Kazuyo Hashimoto, Tatsuya Mutou, Katsuya Yamazaki, Minako Kakutani, Ken-Ichi Toraishi, Masafumi Kitaoka, Harumi Daikoku, Kazuhiko Sugiyama, Koushi Narasaki, Kazuo Tsuji, Shinsaku Ohnishi, Kazushige Oto, Tsutomu Tsujimoto, and Reiko Nakano.
    • Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. asa-mac@m7.dion.ne.jp
    • Diabetes Technol. Ther. 2006 Aug 1;8(4):489-94.

    BackgroundWe 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.MethodsNinety-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).ResultsIn 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.ConclusionsThe 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.

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