A Randomized Trial of the Efficacy and Acceptability of a Pen Injector

Abstract

A controlled trial of pen injection of insulin was performed in 78 patients, with assessment of metabolic control and lifestyle. After a 6‐week run‐in period, during which control was optimized, the patients were randomized, either to stay on a twice daily insulin regimen (n = 37), or to change to a three times daily pen regimen with human ultralente at night (n = 41). Over the 20 weeks, there was no significant change in mean glycosylated haemoglobin (syringe, mean ± SD, 11.1±2.5% to 10.9±2.0%; pen, 11.3±2.6% to 11.2±2.0%), in blood glucose profiles or in frequency of hypoglycaemic attacks in either group. A self‐completed questionnaire demonstrated high patient satisfaction with the pen injector (NovoPen), 78% for effect on lifestyle and 81% for increased flexibility. Ninety‐five percent preferred the pen injector regimen to conventional treatment and stayed on it.