title: A randomized, controlled study of insulin pump therapy in diabetic preschoolers.
abstract: OBJECTIVE
  To compare glycemic control, safety, and parental satisfaction in preschool-aged diabetic children randomized to treatment either with continuous subcutaneous insulin infusion (CSII) or intensive insulin injection therapy.
  
  
  METHODS
  This clinical trial enrolled 42 patients <5 years of age who had been diagnosed with diabetes for at least 12 months. Children were randomly assigned to CSII (n = 21) or intensive insulin injection therapy (n = 21). Hemoglobin A1c (HbA1c) level was measured at baseline, 3, and 6 months. Secondary outcomes included severe hypoglycemic events, meter-detected hypoglycemia, blood sugar variability, body mass index (BMI), and satisfaction with therapy.
  
  
  RESULTS
  Thirty-seven patients completed 6 months of therapy. There was a significant decrease in HbA1c during the study period for both groups (from 8.9% +/- 0.6% to 8.6% +/- 0.6% at 3- and 6-month visits). At 3 months, children using pumps had a significantly lower HbA1c than the injection group (8.4% vs 8.8%); however, by 6 months the two groups were similar (8.5% vs 8.7%). No differences in pre-meal blood sugar variabilities were seen between groups. Children on pumps had increases in the number of meter-detected episodes of hypoglycemia. Pump therapy was safe and well tolerated. No episodes of ketoacidosis occurred in either group, whereas one hypoglycemic seizure occurred in each group. Parents reported satisfaction with CSII, with 95% of families continuing on CSII beyond the 6-month study period.
  
  
  CONCLUSIONS
  Pump therapy in preschool-aged children was not associated with clinically significant differences in glycemic control as compared with intensive injection therapy. The rationale for initiating CSII in this age group should be based on patient selection and lifestyle preference.
authors.affiliation: Pediatric Endocrinology and Diabetology, Indiana University, 702 Barnhill Drive, Indianapolis, IN 46202, USA. dimeglio@iupui.edu
authors.forename: Linda A
authors.initials: LA
authors.lastname: DiMeglio
authors.forename: Tina M
authors.initials: TM
authors.lastname: Pottorff
authors.forename: Sheryl R
authors.initials: SR
authors.lastname: Boyd
authors.forename: Lisa
authors.initials: L
authors.lastname: France
authors.forename: Naomi
authors.initials: N
authors.lastname: Fineberg
authors.forename: Erica A
authors.initials: EA
authors.lastname: Eugster
mesh_terms: D015992:Body Mass Index; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007260:Infusion Pumps / Q000523:psychology*; D007275:Injections, Intravenous; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D017060:Patient Satisfaction
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin