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Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus
S Tupola1, J Komulainen, J Jääskeläinen
1Hospital for Children and Adolescents, University of Helsinki, Helsinki, Finland. sarimari.tupola@hus.fi
Insights
Post-prandial insulin lispro (PL) is as effective and safe as regular insulin (HR) for managing Type 1 diabetes in young children. This study found no significant differences in glucose control or hypoglycemia between the two insulin types.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Diabetes Mellitus Research
Background:
- Type 1 diabetes mellitus (Type 1 DM) management in prepubertal children requires effective insulin regimens.
- Traditional insulin therapy often involves premeal human regular insulin (HR).
- Exploring alternative rapid-acting insulins like post-prandial insulin lispro (PL) may offer improved glycemic control.
Purpose of the Study:
- To evaluate the efficacy and safety of using post-prandial insulin lispro (PL) versus premeal human regular insulin (HR) in prepubertal children with Type 1 DM.
- To compare glucose excursions and HbA1c levels between PL and HR treatments.
- To assess the frequency of hypoglycemic episodes associated with each insulin regimen.
Main Methods:
- An open-label, randomized cross-over study design was employed.
- Twenty-four prepubertal children with Type 1 DM participated.
- Patients received either PL or HR for 3-month periods, with a crossover to the alternative insulin, and underwent glucose monitoring and HbA1c measurements.
Main Results:
- No significant differences in glucose excursions were observed between PL and HR after breakfast or dinner.
- Mean changes in HbA1c levels were similar across both treatment groups.
- The frequency of hypoglycemic episodes did not differ significantly between PL and HR treatments.
Conclusions:
- Post-prandial insulin lispro (PL) demonstrates comparable efficacy and safety to traditional human regular insulin (HR) for mealtime insulin therapy in young children with Type 1 DM.
- PL can be considered a viable alternative for insulin therapy in this pediatric population.
- The study supports the use of rapid-acting insulin analogs in managing Type 1 DM in prepubertal children.
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.