title: A randomized prospective study of insulin pump vs. insulin injection therapy in very young children with type 1 diabetes: 12-month glycemic, BMI, and neurocognitive outcomes.
abstract: OBJECTIVE
  To compare glycemic control, body mass index (BMI), neurocognitive function, and parenting stress for preschool-aged diabetic children randomized to treatment either with continuous subcutaneous insulin infusion (CSII) or with intensive insulin injection therapy (IIT).
  
  
  METHODS
  Children <5 yr of age diagnosed with type 1 diabetes mellitus for at least 12 months were randomized to either CSII (n = 21) or IIT (n = 21) for 6 months. After 6 months, the IIT group began CSII therapy and the CSII group continued on pumps. Hemoglobin A1c (HbA1c) and BMI percent were collected at baseline, 3, 6, 9, and 12 months. Neurocognitive assessments (Developmental Test of Visual-Motor Integration and Stanford-Binet Intelligence Scale: Fourth Edition) were administered to children, and parenting and child behavior assessments (Parenting Stress Index and Child Behavior Checklist) were completed by parents and at baseline, 6, and 12 months.
  
  
  RESULTS
  Thirty-five children completed the study. Mean HbA1c decreased significantly over the study period (8.9% +/- 0.6 vs. 8.5% +/- 0.7, p = 0.006). Initiation of CSII resulted in an HbA1c decrease of 0.4% after 3 months (p = 0.002); however, in the CSII first group, the HbA1c at 12 months was not significantly different from study start (8.8% +/- 0.6 vs. 8.5% +/- 0.6; p = 0.4). There were no significant changes in BMI%, neurocognitive, parenting, and child behavior measures between groups.
  
  
  CONCLUSIONS
  Initiation of CSII vs. continuing IIT does not significantly influence HbA1c, BMI, neurocognitive, or parenting stress parameters in a research study setting.
authors.affiliation: Section of Pediatric Endocrinology and Diabetology, Department of Pediatrics, James Whitcomb Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN 46202, USA. znabhan@iupui.edu
authors.forename: Zeina M
authors.initials: ZM
authors.lastname: Nabhan
authors.forename: Nerissa C
authors.initials: NC
authors.lastname: Kreher
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Greene
authors.forename: Erica A
authors.initials: EA
authors.lastname: Eugster
authors.forename: William
authors.initials: W
authors.lastname: Kronenberger
authors.forename: Linda A
authors.initials: LA
authors.lastname: DiMeglio
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002652:Child Behavior; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000503:physiopathology* / Q000523:psychology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D010287:Parent-Child Relations; D016487:Parenting; D010353:Patient Education as Topic; D011446:Prospective Studies; D012054:Reinforcement, Psychology; D012917:Social Adjustment; D013315:Stress, Psychological / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin