1 Pediatric Endocrinology and Metabolism Section, Texas Children’s Hospital, Baylor College of Medicine; and 2 The Children’s Nutrition Research Center, Houston, Texas. The contents of this publication do not necessarily reflect the views of policies of the U.S. Department of Agricul- ture, nor does mention of trade names, commercial products, or organizations imply endorsement from the U.S. Gov- ernment. DIABETES TECHNOLOGY & THERAPEUTICS Volume 7, Number 6, 2005 © Mary Ann Liebert, Inc. Insulin Pump Therapy in Preschool Children with Type 1 Diabetes Mellitus Improves Glycemic Control and Decreases Glucose Excursions and the Risk of Hypoglycemia GEORGE S. JEHA, M.D., 1 LEFKOTHEA P. KARAVITI, M.D., Ph.D., 1 BARBARA ANDERSON, Ph.D., 1 E. O’BRIAN SMITH, Ph.D., 2 SUSAN DONALDSON, R.N., 1 TONIEAN S. MCGIRK, R.N., 1 and MOREY W. HAYMOND, M.D. 1,2 ABSTRACT Background: Hypoglycemia in preschool children limits the effectiveness of insulin therapy. Continuous subcutaneous insulin infusion (CSII) is not widely used in this group. Objectives: This study was designed (1) to test the hypothesis that compared with twice-daily insulin injection, CSII decreases the SD of the mean daily blood glucose (BG) and improves gly- cemic control and (2) to evaluate the effect of CSII on parental anxiety using the Parental Stress Index (PSI) scale. Methods: Ten subjects 6 years of age and receiving insulin injections were recruited. Each underwent two 72-h CGMS ® (Medtronic Minimed, Northridge, CA) monitoring periods and then was started on CSII and re-monitored 3 and 6 months later. We assessed the effects of CSII on the mean BG and SD of BG values, A 1c , PSI scores, and number, distribution, and duration of hypoglycemic episodes. Results: Pooled pre- and post-CSII data were compared. There was a 22% decrease in the BG variability (mean SD 93 19 mg/dL vs. 72 5 mg/dL; P = 0.02) and a 13% decrease in A 1c (8.6 0.8% vs. 7.5 0.7%; P = 0.01). There was a decrease in the 24-h median number and du- ration of hypoglycemic episodes [1.16 vs. 0 episodes/24 h (P = 0.01) and 1.19 vs. 0.05 h/24 h (P = 0.01), respectively], as well as the median number and duration of nighttime episodes [0.83 vs. 0 episode/night (P = 0.008) and 0.98 vs. 0 h/night (P = 0.008), respectively]. We found no statistically significant change in the PSI score. Conclusions: CSII in preschool children is feasible and safe. Pump therapy reduced the gly- cemic excursions and decreased hypoglycemia duration and frequency. 876 INTRODUCTION H YPOGLYCEMIA IS A SIDE EFFECT of tight con- trol in subjects with type 1 diabetes mel- litus with an increased risk of hypoglycemia, specifically in adolescents and younger pa- tients. 1,2 This is of greater concern in preschool children with type 1 diabetes than for any other group. 2 Very young children, at a time of rapid rate of brain development, have the most un-