SAFETY, EFFICACY, ACCEPTABILITY OF A PRE-FILLED INSULIN PEN IN DIABETIC-PATIENTS OVER 60 YEARS OLD

The aim of the study was to evaluate safety, efficacy and acceptabilit y of a pre-filled insulin pen device (NovoLet) in diabetic patients ov er 60 years old already treated with insulin administered with convent ional syringes. After a run-in period of 2 weeks, 60 patients particip ated in a randomized cross-over study with two 6-week treatment period s using the insulin pen or conventional syringes, Insulin regimens did not change during the study. Hypoglycaemic episodes did not differ si gnificantly between both kinds of treatment and no severe hypoglycaemi a was registered, Hb(Alc) (%) was (mean +/- S.D.) 7.7 +/- 1.2 and 7.9 +/- 1.1 during pen and syringe treatment, respectively. Blood glucose profiles were similar during both treatment modalities except for pre- lunch blood glucose values (mmol/l) lower during pen treatment (8.7 +/ - 2.9 vs, 9.2 +/- 2.7, P < 0.01). The insulin dose (U/day) was 31.9 +/ - 8.9 (pen) and 32.3 +/- 9 (syringe). 54 patients found the functionin g of the insulin pen easy to understand and preferred it for future tr eatment because the conditions of insulin administration are faster an d easier than with conventional syringes. We concluded that the prefil led insulin pen is safe, efficacious and is highly accepted in over 60 years old diabetic patients.