Post‐prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus

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Abstract
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)