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.
Murray
D P
DP
Department of Medicine, Adelaide Hospital, Dublin, Ireland.
Keenan
P
P
Gayer
E
E
Salmon
P
P
Tomkin
G H
GH
Drury
M I
MI
O'Sullivan
D J
DJ
D000328:Adult; D002986:Clinical Trials as Topic; D003258:Consumer Behavior; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007279:Injections, Subcutaneous / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D049528:Insulin, Long-Acting; D061389:Insulin, Regular, Pork; D008297:Male; D011897:Random Allocation; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000627:therapeutic use; D011795:Surveys and Questionnaires
D006442:Glycated Hemoglobin; D007328:Insulin; D049528:Insulin, Long-Acting; D061389:Insulin, Regular, Pork; D011994:Recombinant Proteins; C023501:Insulin, Ultratard; C000006:insulin, neutral