A randomized trial of the efficacy and acceptability of a pen injector.

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.