We found no evidence of a benefit
with respect to reducing the risk for islet
autoantibodies. Similar to the TRIGR
(Trial to Reduce Insulin-Dependent Diabetes
Mellitus in the Genetically at Risk)
pilot study (18), the BABYDIET study was
not powered for efficacy. The power of
the study was ~40% to detect a 50% reduction
in the probability of islet autoantibodies.
Increasing the power to 80%
would require at least three times the
number of participants, and in view of
the difficulty with compliance, it appears
justified to have conducted a pilot feasibility
study first. Nevertheless, even with
the limited power of the study, we do not
recommend altering current pediatric
guidelines with respect to the introduction
of gluten into the diet of children who are
genetically at risk for type 1 diabetes.