Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial

Pediatrics. 2003 Sep;112(3 Pt 1):559-64. doi: 10.1542/peds.112.3.559.

Abstract

Objective: To compare the efficacy and feasibility of continuous subcutaneous insulin infusion (CSII) with multiple daily insulin injections (MDI) in children with type 1 diabetes.

Methods: The study sample included 23 children (10 males) aged 9.4 to 13.9 years with type 1 diabetes. An open randomized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables: diabetic control, incidence of adverse events, daily insulin requirement, body mass index standard deviation scores, treatment satisfaction, and quality of life.

Results: The changes in HbA(1c) and fructoseamine values were similar in the 2 arms over time. At the end of the study, mean HbA(1c) level measured 8.05 +/- 0.78%. There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events. There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI, yielding a rate of 0.26 events per patient-year. There were no episodes of diabetic ketoacidosis. Body mass index standard deviation scores decreased during CSII and increased during MDI, as did mean insulin dose. Patients expressed a higher treatment satisfaction from CSII than MDI, although there was no difference in quality of life between the 2 modes.

Conclusions: Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes, with similar diabetes control and a very low rate of adverse events. We suggest that both modes be available to the diabetic team to better tailor therapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Blood Glucose / metabolism
  • Body Mass Index
  • Child
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Drug Administration Schedule
  • Female
  • Glycated Hemoglobin / metabolism
  • Humans
  • Infusion Pumps, Implantable / adverse effects
  • Infusion Pumps, Implantable / statistics & numerical data
  • Injections, Subcutaneous / adverse effects
  • Injections, Subcutaneous / statistics & numerical data
  • Insulin / administration & dosage*
  • Insulin Infusion Systems* / adverse effects
  • Insulin Infusion Systems* / statistics & numerical data
  • Male
  • Treatment Outcome

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Insulin