Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus.
OBJECTIVE
To study whether post-prandial insulin lispro (PL) could be used as a part of insulin therapy instead of premeal human regular insulin (HR) in prepubertal children with Type 1 diabetes mellitus (Type 1 DM).


METHODS
In this open, randomized cross-over study patients used either PL or HR at breakfast and at dinner. After a 1-month screening period, patients were randomized to treatment with PL or HR for 3 months and then they crossed over to the other insulin for an additional 3 months. The patients were 24 prepubertal children with Type 1 DM (median age 6.2 years, duration of diabetes 37 months). Home monitoring of 1-day glucose profiles at meals (premeal, 1 h and 2 h after breakfast and after dinner) and HbA1c were measured before randomization, before cross-over, and at the last visit. Data on hypoglycaemic episodes were collected at each of the seven visits. The variables were compared between the two treatments.


RESULTS
Of the patients 22/24 completed the study. There were no major differences in the glucose excursions between PL and HR after breakfast (mean +/- SD: 1-h PL 3.7 +/- 4.7 vs. HR 2.9 +/- 3.9 mmol/l, P = 0.3; 2-h -0.9 +/- 5.4 vs. 0.3 +/- 4.5 mmol/l, P = 0.2, respectively) or after dinner (1-h PL -2.5 +/- 4.8 vs. HR -0.4 +/- 3.7 mmol/l, P = 0.07, 2-h -4.1 +/- 5.2 vs. -0.7 +/- 5.0 mmol/l, P = 0.05, respectively). Mean change of HbA1c was similar in both treatment groups (PL 0.2 +/- 0.8% vs. HR -0.4 +/- 0.7%, P = 0.1). The frequency of hypoglycaemic episodes was 4.9 per patient per month during treatment with PL, and 4.4 during HR (P = 0.3).


CONCLUSIONS
Treatment with post-prandial lispro as a meal insulin is as effective and safe as traditional treatment with regular insulin in young children.
Tupola
S
S
Hospital for Children and Adolescents, University of Helsinki, Helsinki, Finland. sarimari.tupola@hus.fi
Komulainen
J
J
Jääskeläinen
J
J
Sipilä
I
I
D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D005190:Family; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061268:Insulin Lispro; D017060:Patient Satisfaction; D019518:Postprandial Period; D011627:Puberty; D013997:Time Factors
D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro