BACKGROUND: This study was designed to evaluate two pen needles (PNs) with the same diameter but different lengths (4 mm and 6 mm) and different needle tip shapes (straight and tapered) to compare their effects on glycemic control, perceived pain, safety, patients' ease of use and preferences, and visual impression. SUBJECTS AND METHODS: In this prospective, open-label, controlled crossover study, 41 insulin-treated patients with type 1 or type 2 diabetes were randomized into either Group 1 (the 32-gauge × 4-mm PN was used during Study Period 1, then the 32-gauge × 6-mm PN was used during Study Period 2) or Group 2 (the order for using the PNs was reversed). RESULTS: The 32-gauge × 4-mm PN provided an equivalent glycemic control in diabetes patients as the 32-gauge × 6-mm PN, with an equivalent occurrence rate of adverse events. The 32-gauge × 4-mm PN was perceived as significantly less painful and rated as significantly more favorable than the 32-gauge × 6-mm PN according to the survey results on patients' ease of use and preferences and on their visual impressions. CONCLUSIONS: The 32-gauge × 4-mm PN was not only as safe and efficacious as the 32-gauge × 6-mm PN, but also was perceived as less painful, easier to use, and more favorable to Japanese adult patients with diabetes.
RCT Entities:
BACKGROUND: This study was designed to evaluate two pen needles (PNs) with the same diameter but different lengths (4 mm and 6 mm) and different needle tip shapes (straight and tapered) to compare their effects on glycemic control, perceived pain, safety, patients' ease of use and preferences, and visual impression. SUBJECTS AND METHODS: In this prospective, open-label, controlled crossover study, 41 insulin-treated patients with type 1 or type 2 diabetes were randomized into either Group 1 (the 32-gauge × 4-mm PN was used during Study Period 1, then the 32-gauge × 6-mm PN was used during Study Period 2) or Group 2 (the order for using the PNs was reversed). RESULTS: The 32-gauge × 4-mm PN provided an equivalent glycemic control in diabetespatients as the 32-gauge × 6-mm PN, with an equivalent occurrence rate of adverse events. The 32-gauge × 4-mm PN was perceived as significantly less painful and rated as significantly more favorable than the 32-gauge × 6-mm PN according to the survey results on patients' ease of use and preferences and on their visual impressions. CONCLUSIONS: The 32-gauge × 4-mm PN was not only as safe and efficacious as the 32-gauge × 6-mm PN, but also was perceived as less painful, easier to use, and more favorable to Japanese adult patients with diabetes.