Randomized Trial on the Influence of the Length of Two Insulin Pen Needles on Glycemic Control and Patient Preference in Obese Patients with Diabetes

Abstract

Objective: This study determined the influence of needle length for insulin administration on metabolic control and patient preference in obese patients with diabetes mellitus. Methods: In this multicenter, open-label crossover study, insulin pen needles of two different lengths (5 mm and 8 mm) were compared. A total of 130 insulin-treated type 1 and type 2 diabetes patients with a body mass index !30 kg/m 2 were randomized, and 126 patients completed the study. Patients started using the 5-mm needle for 3 months, after which they switched to injecting insulin with the 8-mm needle for another 3 months, or vice versa. Hemoglobin A1c (A1C), fructosamine, and 1,5-anhydroglucitol were measured, and self-reported side effects and patient preference were recorded. Results: No within-group changes were observed with respect to A1C, serum fructosamine, 1,5-anhydroglucitol, hypoglycemic events, bruising, and pain. When data of all 126 subjects were pooled, there was a small, but significant, difference between needle lengths (5-mm, A1C 7.47 AE 0.9%; 8-mm, 7.59 AE 1.0%; P ¼ 0.02). Patients reported less bleeding with the 5-mm needle (P ¼ 0.04) and less insulin leakage from the skin with the 8-mm needle (P ¼ 0.01). There were no significant differences in patient preference, with 46% of the patients preferring the 5-mm needle, 41% the 8-mm needle, and 13% not preferring a particular needle length. Conclusions: A 5-mm needle is similar to an 8-mm needle in obese patients with diabetes with respect to metabolic control, injection-related complaints, or patient preference and can be used safely.

Impact of a Modified Needle Tip Geometry on Penetration Force as Well as Acceptability, Preference, and Perceived Pain in Subjects with Diabetes

“…1,2 For injection delivery devices [e.g., syringes and pen needles (PNs)], important contributors include needle diameter (gauge), needle length, needle smoothness, and lubrication. [3][4][5][6][7] Additionally, sharpness or bluntness of a needle directly affects pain. 8 Needle tips vary in terms of bevel design, e.g., the number and angularity of the tip facets.…”

AMD-OSDI Consensus on Injection Techniques for People with Diabetes Mellitus

“…Injecting insulin by shorter and thinner pen needles (4 mm and 32G) with triple bevels, in compliance with the UNI EN ISO 7864 standards, cause less pain and discomfort [14,36,[39][40] and ensure better therapy acceptance and adherence. In fact, the greater the outer diameter, the greater the resistance the needle has to face to penetrate the skin and, vice versa, the smaller the outer diameter, the less the feeling of discomfort at injection.…”

“…Appropriate education on injection techniques is obviously essential, nevertheless it is often lacking [4], as shown by the high rate of skin lesions caused by incorrect injecting habits [11,36,[38][39][40][41][42][43][44][45][46][47][48][49][50].…”

“…Also needle gauge (G) and sharpness are important factors in terms of patient acceptance and satisfaction [32][33][34][35]. 4 mm × 32G needles provide both obese and non-obese patients with comparable degrees of metabolic control as 5 mm × 31G and 8 mm × 31G needles but are perceived as less painful and better accepted [34,[36][37][38][39].Injecting insulin by shorter and thinner pen needles (4 mm and 32G) with triple bevels, in compliance with the UNI EN ISO 7864 standards, cause less pain and discomfort [14,36,[39][40] and ensure better therapy acceptance and adherence. In fact, the greater the outer diameter, the greater the resistance the needle has to face to penetrate the skin and, vice versa, the smaller the outer diameter, the less the feeling of discomfort at injection.…”

The injection technique: results of a questionnaire study of diabetic patients in Russia. New international guidelines on the injectiontechnique

“…Проведенные исследования подтвердили, что даже у па-циентов, страдающих ожирением, короткие иглы (5 и 6 мм) и длинные иглы (8 и 12,7 мм) характеризуются сопоставимыми эффективностью и безопасностью / переносимостью [29,30]. На сегодняшний день нет данных о значимом вытекании инсу-лина, усилении болевых ощущений, ухудшении контроля над течением СД, увеличении выраженности липогипертрофии или других осложнений в популяции пациентов, использующих ко-роткие (4, 5 и 6 мм) иглы [29][30][31][32][33][34][35]. Последние исследования с иглами длинной 4 мм показали, что они безопасны и эффек-тивны у взрослых пациентов с любой массой тела и что такие осложнения, как боль или вытекание инсулина, одинаковы или даже менее выражены по сравнению с более длинными и боль-шего диаметра иглами.…”