Phase 1 - Intervention
Some have speculated that the growing epidemic of Type 2 Diabetes (DM2) in children and adolescents may 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 (NIDDK) sponsored TODAY (Treatment Options for Type 2 Diabetes inAdolescents and Youth) to address this need. The Pediatric Diabetes and Endocrinology Section was one of 15 sites in the nation awarded this grant to participate, along with Children's Hospital of Los Angeles, the University of Colorado Health Sciences Center, the 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 lasted from March, 2004 through February 2009, and the intervention phase of the study continued through February 28, 2011.
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 was 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 had to meet eligibility criteria, complete a run-in period (which includes standard diabetes education) prior to randomization, and to receive treatment post-randomization for a total of 2-6 years.
Study results appear in the New England Journal of Medicine here. You may view the official news release from the NIH here. You may also view links from other TODAY study publications here.
Major study inclusion criteria for TODAY included:
- 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
Benefits of participation included:
- Free diabetes-related medical care, medication, supplies
- Close monitoring of patients beyond ADA recommended Standards of Care
- "Tool box" items to overcome barriers preventing adherence
- Mileage reimbursement or arranged round-trip transportation,
hotel rooms for overnight stays, meals, and compensation provided for medical visits
|The Standard Diabetes Education Program was newly developed for children and adolescents with DM2 with input from national diabetes experts. Patients 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 was 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, for the duration of the study, utilized regular sessions with a Physical Activity/Nutrition Leader (PAL) who was supervised by a psychologist. Patients received extensive materials to assist in the lifestyle change process.
Phase 2 - Long-term Outcomes
Recognizing the potential for a fuller understanding of the treatment for DM2 that began in youth, the NIDDK secured funding to transition participants to non-blinded, non-randomized standard diabetes care and management with follow-up through February 28, 2014. Thanks to ongoing committment from the NIDDK, participants will be observed beyond March 1, 2014, with close monitoring of the long-term effects of the different treatments from TODAY, description of the continued evolution of beta cell function, and description of the development of vascular complications and risk factors for vascular complications.
A separate set of TODAY study protocols relate to collecting blood and phenotypic information from more than 3,200 paticipants diagnosed with DM2 before age 18. Our Section is one of 24 sites collecting this data, which will be used to explore relationships between candidate genes and DM2, obesity, insulin resistance, and cardiovascular complications of insulin resistance.
For information about the studies, call 405 271-7755 or visit the TODAY Study website.