A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents with Newly Diagnosed Type I Diabetes on Insulin Resistance, Beta-Cell Function & the Honeymoon Period

Larry Fox, Principal Investigator
Nelly Mauras, Co-Investigator

Funding: Nemours Research Programs

Several prior studies indicate that prolonging the honeymoon phase in type 1 diabetes mellitus has beneficial effects on diabetes control. This protocol evaluates how insulin pump therapy (CSII) compares to multiple daily injections (MDI) in affecting the honeymoon period. The study assesses the differences in insulin sensitivity and beta-cell function imposed by the two modes of therapies. We hypothesize that early initiation of CSII will improve insulin sensitivity and beta cell function when compared with MDI, and therefore allow an earlier and more prolonged honeymoon period. The protocol assesses whether CSII, when compared with insulin injections, improves insulin sensitivity, improves ß-cell function, and alters the time of onset and duration of the honeymoon phase. Other outcomes include serum adiponectin concentrations, glycemic control and body composition. In this pilot trial, subjects will be randomized to receive either MDI or CSII, starting within four weeks after diagnosis. Insulin sensitivity and beta cell function will be assessed at baseline and at 12 and 24 months, using euglycemic-hyperinsulinemic clamp studies and mixed meal tolerance testing, respectively. The results of these studies may have important therapeutic implications that could influence the standard of care in pediatric diabetes. The data generated in these studies will offer a unique insight into the role of modern insulin delivery systems on beta cell function in adolescents with diabetes that start using pumps at diagnosis.