Healthcare and associated costs related to type 2 diabetes in youth and adolescence: the TODAY clinical trial experience.

The economic issues related to medical treatments in youth with type 2 diabetes (T2D) are rarely reported and thus not fully understood. The Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial of youth recently diagnosed with T2D collected healthcare and related cost information from the largest cohort studied to date. Costs related to medical treatments and expenses faced by caregivers were identified over a 2-year period from 496 participants. Data were collected by surveys and diaries to document frequency of use of diabetes care (excluding study laboratory tests), non-diabetes care services and treatments, caregiver time, and expenses related to exercise and dietary activities recommended for patients. Economic costs were derived by applying national cost values to the reported utilization frequency data. Annual medical costs in the first year varied by the treatment group, averaging $1798 in those assigned to metformin alone (M), $2971 to combination drug therapy with metformin + rosiglitazone (M + R), and $2092 to metformin + an intensive lifestyle and behavior change program (M + L). Differences were primarily due to costs related to combination drug therapy. Adult caregiver support costs were higher for participants in the lifestyle program, which was delivered in weekly sessions in the first 6 months. Expenses for purchases to enhance diet and exercise change did not vary by treatment assignment. In year 2, medication costs increased in M and M + L due to the initiation of insulin in subjects who failed to maintain glycemic control on the assigned treatment. Data are reported for use by researchers and those providing healthcare to this vulnerable patient population.