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.