A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes.

Objective: This study assesses the effects of insulin pump therapy on diabetes control and family life in children 1-6 years old with type 1 diabetes.

Research Design And Methods: Twenty-six children with type 1 diabetes for >/=6 months were randomly assigned to current therapy (two or three shots per day using NPH insulin and rapid-acting analog) or continuous subcutaneous insulin infusion (CSII) for 6 months. After 6 months, current therapy subjects were offered CSII. Changes in HbA(1c), mean blood glucose (MBG), hypoglycemia frequency, diabetes-related quality of life (QOL), and parental adjustment were recorded.

Results: Eleven subjects from each group completed the trial (age 46.3 +/- 3.2 months [means +/- SE]). At baseline, there were no differences between groups in HbA(1c), MBG, age, sex, diabetes duration, or parental QOL. Mean HbA(1c), MBG, and parental QOL were similar between groups at 6 months. Mean HbA(1c) and MBG did not change from baseline to 6 months in either group. The frequency of severe hypoglycemia, ketoacidosis, or hospitalization was similar between groups at any time period. Subjects on CSII had more fasting and predinner mild/moderate hypoglycemia at 1 and 6 months. Diabetes-related QOL improved in CSII fathers from baseline to 6 months. Psychological distress increased in current therapy mothers from baseline to 6 months. All subjects continued CSII after study completion.

Conclusions: CSII is safe and well tolerated in young children with diabetes and may have positive effects on QOL. CSII did not improve diabetes control when compared with injections, despite more mild/moderate hypoglycemia. The benefits and realistic expectations of CSII should be thoroughly examined before starting this therapy in very young children.