OBJECTIVE: This study compared the glucose-lowering effect of insulin lispro, given before or after meals, with regular human insulin given before meals in prepubertal children with diabetes. RESEARCH DESIGN AND METHODS: A 3-way crossover, open-label study involving 61 prepubertal children (ages 2.9-11.4 years) with type 1 diabetes. The children were randomly assigned to receive regular human insulin 30 to 45 minutes before meals, insulin lispro within 15 minutes before or immediately after meals, combined with basal insulin. Each treatment lasted 3 months. Hemoglobin A(1c) levels and home glucose monitoring profiles were measured at the end of each treatment period. RESULTS: Treatment with insulin lispro before breakfast resulted in lower 2-hour postprandial glucose values than regular human insulin (11.7 +/- 4.4 mmol/L vs 15.0 +/- 5.4 mmol/L). Similarly, insulin lispro given before dinner resulted in lower blood glucose values 2 hours postprandially (8.8 +/- 5.0 mmol/L vs 10.8 +/- 5.4 mmol/L) than regular human insulin. When insulin lispro was administered after meals, the 2-hour glucose levels were between those seen with either insulin lispro or regular human insulin given before meals. The number and types of adverse events, the rates of hypoglycemia, and the HbA(1c) levels did not differ among the 3 therapies. CONCLUSIONS: In prepubertal children, insulin lispro given before meals is safe and significantly lowers postprandial glucose levels after breakfast and dinner compared with regular human insulin, and insulin lispro given after the meal provides similar benefits as regular human insulin before the meal.
RCT Entities:
OBJECTIVE: This study compared the glucose-lowering effect of insulin lispro, given before or after meals, with regular humaninsulin given before meals in prepubertal children with diabetes. RESEARCH DESIGN AND METHODS: A 3-way crossover, open-label study involving 61 prepubertal children (ages 2.9-11.4 years) with type 1 diabetes. The children were randomly assigned to receive regular humaninsulin 30 to 45 minutes before meals, insulin lispro within 15 minutes before or immediately after meals, combined with basal insulin. Each treatment lasted 3 months. Hemoglobin A(1c) levels and home glucose monitoring profiles were measured at the end of each treatment period. RESULTS: Treatment with insulin lispro before breakfast resulted in lower 2-hour postprandial glucose values than regular humaninsulin (11.7 +/- 4.4 mmol/L vs 15.0 +/- 5.4 mmol/L). Similarly, insulin lispro given before dinner resulted in lower blood glucose values 2 hours postprandially (8.8 +/- 5.0 mmol/L vs 10.8 +/- 5.4 mmol/L) than regular humaninsulin. When insulin lispro was administered after meals, the 2-hour glucose levels were between those seen with either insulin lispro or regular humaninsulin given before meals. The number and types of adverse events, the rates of hypoglycemia, and the HbA(1c) levels did not differ among the 3 therapies. CONCLUSIONS: In prepubertal children, insulin lispro given before meals is safe and significantly lowers postprandial glucose levels after breakfast and dinner compared with regular humaninsulin, and insulin lispro given after the meal provides similar benefits as regular humaninsulin before the meal.
Authors: Karishma A Datye; Claire T Boyle; Jill Simmons; Daniel J Moore; Sarah S Jaser; Nicole Sheanon; Julie M Kittelsrud; Stephanie E Woerner; Kellee M Miller Journal: J Diabetes Sci Technol Date: 2017-09-12