There is a new epidemic of Type 2 Diabetes (DM2) in children and adolescents which is coincident with increased prevalence of obesity in the same age group. The growing epidemic of DM2 will likely lead to the largest public health crisis of the next generation. To date, no effective treatment strategy has been demonstrated. The U.S. National Institute of Diabetes & Digestive & Kidney Diseases has sponsored TODAY to address this need.

Experts in diabetes treatment from all over the country collaborated to develop a randomized clinical trial seeking to recruit 750 patients at 13 sites across the nation, including, Children’s Hospital Los Angeles, University of Colorado Health Sciences Center, University
of Oklahoma Health Science Center, University of Texas Health Sciences Center—San Antonio, Baylor University, St. Louis/Washington Universities, Case Western Reserve
University, Children’s Hospital Pittsburgh, Children’s Hospital Philadelphia, State University of New York—Syracuse, Columbia University, Joslin Diabetes Center/Massachusetts
General Hospital, and Yale University. Recruitment of TODAY patients began in May, 2004 and will continue through November, 2008.

Metformin is currently the only medication approved by the U.S. Food and Drug Administration in the treatment of DM2 in youth. The primary aim of TODAY is to compare the safety and efficacy of three treatment regimens for DM2 in this age cohort: metformin + placebo, metformin + rosiglitazone (approved for DM2 in adults), and metformin + intensive lifestyle intervention. All patients must meet eligibility criteria, must complete a run-in period (which includes standard diabetes education) prior to randomization, and will be followed post- randomization for a total of 2-6 years.

Major study inclusion criteria for TODAY includes:

• Age 10 to 17 years
  
• Duration of DM2 less than two years
  
• BMI > 85th percentile
  
• Willingness to participate (parental consent and child assent)
  
• Parent or other adult agrees to participate in the intervention
  
• Absence of pancreatic autoimmunity
  
• Fasting C-peptide > 0.6 mmol/L

The Standard Diabetes Education Program was newly developed for children and adolescents with DM2 with input from national diabetes experts. Patients will receive the most up-to-date diabetes education from Certified Diabetes Educators, which includes: Diabetes Self-Management, Weight Management, Exercise, and Living with Diabetes.




The TODAY Lifestyle Program is an intensive intervention to facilitate behavioral changes in
healthy eating and physical choices, as well as other supportive behaviors. Each patient randomized to the lifestyle arm will, for the remainder of the study, utilize regular sessions with a Physical Activity/Nutrition Leader (PAL) who supervised by a psychologist. Patients will receive extensive materials to assist in the lifestyle change process.

Potential Benefits of Participation:

Free diabetes-related medical care, medication, supplies Close monitoring of patients beyond ADA recommended Standards of Care Incentives “Tool box” items to overcome barriers preventing adherence Mileage reimbursement or arranged round round-trip transportation, hotel rooms for overnight stays, meals, and compensation provided for medical visits

For more information, visit: www.todaystudy.org.