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A Randomized, Prospective Trial Comparing the Efficacy of Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections Using Insulin Glargine

From the Department of Pediatrics and the Children’s Clinical Research Center, Yale University School of Medicine, New Haven, Connecticut

Address correspondence and reprint requests to Elizabeth Doyle, MSN APRN, CDE, Yale Diabetes Research Program, 2 Church St. South, Suite 312, New Haven, CT 06519. E-mail: elizabeth.doyle{at}yale.edu

OBJECTIVE—The efficacy of the insulin analogs now available for multiple daily injection (MDI) and continuous subcutaneous insulin infusion (CSII) therapy in type 1 diabetes has not yet been established in pediatric patients. Our principal aim in this short-term study was to compare the efficacy of CSII to MDI with glargine in lowering HbA_1c levels in children and adolescents with type 1 diabetes.

RESEARCH DESIGN AND METHODS—Thirty-two youth with type 1 diabetes (age 8–21 years) were randomly assigned to receive either MDI treatment with once-daily glargine and premeal/snack insulin aspart or CSII with insulin aspart. Dose titration in both groups was based on home self-monitored blood glucose measurements and monthly HbA_1c. HbA_1c, total daily insulin dose (TDD), self-monitored blood glucose readings, and adverse events were compared after 16 weeks of therapy.

RESULTS—While there was no significant change in the glargine group (HbA_1c 8.2% at baseline vs. 8.1% at 16 weeks), youth randomized to CSII had a sharp reduction in HbA_1c levels, from 8.1 to 7.2% after 16 weeks of therapy (P < 0.02 vs. baseline and <0.05 vs. glargine group). TDD was unchanged in the glargine group, but significantly dropped with CSII (1.4 units/kg at baseline vs. 0.9 units/kg at 16 weeks, P < 0.01). Both groups had similar basal doses and insulin-to-carbohydrate ratios. Fasting self-monitored blood glucose was similar in both groups, but lunch, dinner, and bedtime readings were significantly lower in the CSII group (P < 0.01).

CONCLUSIONS—Lower HbA_1c and premeal glucose levels were more achievable in this short-term study with CSII than with glargine-based MDI treatment. CSII is an efficacious treatment to improve metabolic control in youth with type 1 diabetes.

Abbreviations: CSII, continuous subcutaneous insulin infusion • DQOL-Y, Diabetes Quality of Life-Youth • MDI, multiple daily injection • TDD, total daily insulin dose

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