Insulin dependent diabetes mellitus (IDDM) is one of the most common chronic diseases of childhood. While daily insulin injections have prolonged life, mortality rates remain high. By age 30, many patients face retinopathy, nephropathy, neuropathy, or cardiovascular disease. Annual diabetes care and disability costs are greater than $20 billion. In 1982, the Diabetes Complications and Control Trial (DCCT) was initiated to test whether intensive therapy (IT) (a rigorous regimen of increased injection frequency, blood glucose testing, insulin adjustment, and frequent provider contact) could result in improved health status. The trial was terminated early when the marked advantages of IT over conventional therapy became apparent. The costs of IT included increased hypoglycemia and weight gain. Since the DCCT was conducted with carefully selected, highly motivated, predominantly adult IDDM patients, its impact on every day clinical practice remains to be seen. Although IDDM is typically diagnosed in childhood, adolescents were under represented in the DCCT.
Specific aims of the current proposal include: (1) to access the acceptability and success of IT when introduced to a general population of adolescent patients; (2) to identify the characteristics of those adolescents who succeed and fail with IT; (3) to document risks associated with IT in this population, including hypoglycemia and weight gain; (4) to describe psychological sequelae (if any) associated with IT, including fear of hypoglycemia, body image concerns, and impact on quality of life; (5) to assess whether increased health provider contact can result in glycemic control comparable to that achieved by IT; and (6) to assess whether frequent provider contact can be successfully tapered without a reduction in IT success. The study design includes a Treatment Comparison Phase in which adolescent patients will be randomized to IT, standard care (SC3), or standard care with frequent provider contact (SC1). In the Replication Phase, patients will be permitted to self-select IT, SC3, or SC1, in an effort to replicate effects documented under random assignment in a group of patients representing more usual, self-selected patient care. In the Maintenance Phase, compliant IT or SC1 patients will be randomly assigned to a Taper (provider contact will be gradually reduced to that of SC3) or a No-Taper condition (frequent provider contact will continue). Approximately 240 adolescent patients will be recruited across two different sites. Outcome measures include: glycemic control (glycosylated hemoglobin levels, blood glucose testing results); risk of severe hypoglycemia and weight gain, psychosocial status (fear of hypoglycemia, attitudes toward eating and physical appearance, quality of life); and direct/indirect costs as well as projected savings associated with treatment.
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