Objective: To examine the efficacy and safety of using continuous subcutaneous insulin infusion (CSII) therapy in a large group of patients 18 months to 18 yr from a single pediatric diabetes program.
Research design and methods: All patients < or = 18 yr of age starting on CSII from 1 January 1997 to 31 March 2000 at the Yale Children's Diabetes Program were included. Clinical data were collected prospectively before and during pump treatment. HbA1c was the primary efficacy outcome and rates of diabetes-related adverse events were the primary safety measures.
Results: One hundred and sixty-one children ranging in age from 18 months to 18 yr received CSII for an average of 32 +/- 9 months when data collection was closed on 31 October 2001, including 26 preschoolers (< 7 yr), 76 school-agers (7-11 yr) and 59 adolescents (12-18 yr). Mean HbA1c levels were 7.1% in the preschoolers, 7.8% in the school-agers and 8.1% in the adolescents prior to the start of CSII. There was a significant and consistent reduction in mean HbA1c levels after 12 months of CSII (to 6.5% in preschoolers, 7.3% in school-agers and 7.4% in adolescents, p < 0.02 vs. prepump) that was maintained at the most recent visit. Improved diabetes control was achieved with CSII without increasing daily insulin doses and in association with a decrease in the frequency of severe hypoglycemic events (p < 0.05 vs. prepump, all three age groups combined).
Conclusions: CSII is an effective alternative to injection therapy in a large pediatric diabetes clinic setting. Even very young patients can utilize CSII to safely lower HbA1c levels.