Results
The study enrollment, randomization, and retention
are shown in Figure 1. Of the 1211 children
and adolescents who were screened, 927 (76.5%)
entered the run-in phase and 699 (75.4%) were
randomly assigned to a treatment group, for an
overall enrollment rate of 57.7%. The mean duration
of diagnosed type 2 diabetes was 7.8 months.
The baseline demographic and clinical characteristics
of this cohort have been reported in detail
previously12 and are summarized in Section C in
the Supplementary Appendix. Randomly assigned
persons were not significantly different from those
who were screened but not enrolled, in regard to
sex, race or ethnic group, age, and BMI, but the
glycated hemoglobin level was significantly lower
among those who were not enrolled (7.5% vs. 8.0%,
P