Document Detail


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.
MedLine Citation:
PMID:  16939373     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
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; Reiko Nakano
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Diabetes technology & therapeutics     Volume:  8     ISSN:  1520-9156     ISO Abbreviation:  Diabetes Technol. Ther.     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-08-30     Completed Date:  2006-11-02     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100889084     Medline TA:  Diabetes Technol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  489-94     Citation Subset:  IM    
Affiliation:
Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. asa-mac@m7.dion.ne.jp
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Cross-Over Studies
Diabetes Mellitus / drug therapy*
Female
Humans
Injections, Intradermal / adverse effects,  instrumentation*
Insulin / administration & dosage*
Japan
Male
Middle Aged
Needles*
Pain / etiology
Pain Measurement
Self Administration
Chemical
Reg. No./Substance:
11061-68-0/Insulin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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