Introduction to the TODAY Study
The TODAY study group brought together investigators in a collaborative effort involving institutions across the country to design and conduct a prospective, randomized trial to evaluate treatment regimens and the clinical course of type 2 diabetes in youth. In order to be eligible to be in the study, participants had to have type 2 diabetes diagnosed according to American Diabetes Association criteria within the previous 2 years, absence of islet autoantibodies, BMI >= 85th percentile, age 10-17 years, and a family member willing to participate in the child's treatment. A total of 699 participants were enrolled from 2004-2009 and followed for 2 to 6 years.
All participants received the TODAY Standard Diabetes Education (TSDE) program. Each participant was randomly assigned to one of three treatment arms:
- Metformin alone.
- Metformin plus Rosiglitazone.
- Metformin plus the TODAY Lifestyle Program (TLP), an intensive lifestyle program incorporating nutrition, physical activity, and behavior modification.
The primary outcome was time to treatment failure due to loss of glycemic control, defined as hemoglobin A1c >= 8% for 6 months. Secondary outcomes included measures of beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes. The influence of individual and family behaviors on treatment response and the relative cost effectiveness of the three treatment arms were also evaluated.
This national study is likely to provide information fundamental to improving treatments and outcomes for youth with type 2 diabetes.
Click on the ‘Publications' tab to download publications by the TODAY study group, including design and rationale of the TODAY study, development of the TSDE, and development of the TLP.