The Children’s Hospital Participates in a Pediatric Type 2 Diabetes Study

from Practice Update, Fall 2004

TODAY, Treatment Options for Type 2 Diabetes in Adolescents and Youth, is a nationwide study funded by the National Institutes of Health (NIH) to explore treatment of type 2 diabetes in children and adolescents. The Children’s Hospital is one of 12 participating sites. The primary objective of the TODAY trial is to compare the efficacy of three treatment alternatives to prolong glycemic control, as reflected by HbA1c, a measure that correlates with both glycemic control and long-term diabetes outcome.

Primary Inclusion Criteria

  • confirmed diagnosis of type 2 diabetes less than two years ago
  • no evidence for pancreatic autoimmunity
  • fasting C-peptide > 0.6 ng/ml
  • BMI ≥ 85th percentile
  • age 10-17 years
  • availability of an adult caregiver who agrees to participate with the child

Patients who meet eligibility criteria will be invited to proceed with pre-randomization, a pre-study period designed to get participants on the maximum tolerable dose of metformin, safely discontinue all other diabetic medications, and present a standard diabetes education program. Patients who successfully complete pre-randomization will be randomly assigned to one of three treatment regimens:

  1. metformin alone
  2. metformin plus rosiglitazone
  3. metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP)

Patients assigned to the TODAY Lifestyle Program (TLP) will receive an evidence-supported, family-based, behaviorally-oriented comprehensive weight management program that is developmentally and culturally appropriate. The goals of the intervention include modification of eating and activity behaviors so that new, healthier behaviors develop and replace less healthy behaviors. The approach to behavior change is positive and successive changes toward desired outcomes are modeled, practiced, and reinforced.

Patients enrolled in the study will receive diabetes supplies and medication, as well as diabetes care from the TODAY team at no charge.

To learn more about the TODAY study, please go to: www.todaystudy.org/index.cgi or contact the TODAY study team directly TODAY@tchden.org

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