Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus
Article first published online: 20 DEC 2001
Volume 18, Issue 8, pages 654–658, August 2001
How to Cite
Tupola, S., Komulainen, J., Jääskeläinen, J. and Sipilä, I. (2001), Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus. Diabetic Medicine, 18: 654–658. doi: 10.1046/j.1464-5491.2001.00564.x
- Issue published online: 20 DEC 2001
- Article first published online: 20 DEC 2001
- Accepted 8 April 2001
- insulin lispro;
- Type 1 diabetes mellitus
Aims 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).
Patients and 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).
Conclusion Treatment with post-prandial lispro as a meal insulin is as effective and safe as traditional treatment with regular insulin in young children.
Diabet. Med. 18, 654–658 (2001)