The BABYDIET study is a pilot study to determine whether delaying the introduction of gluten to the diet of neonates until 12 months of age is a feasible strategy to reduce the risk of islet autoimmunity in children with a high genetic risk for type1 diabetes. The study found that 30% of families reported that they did not adhere to the gluten introduction protocol for their randomization group. Nevertheless, late gluten introduction, whether by randomization group or as reported by families, did not increase the risk for tTGCAs and did not affect growth,suggesting that it is relatively safe.Al though the study was not powered to examine efficacy other than for major differences between intervention and control groups, the number of islet autoantibody–positive children and the number of cases of diabetes in the late-exposure group and the control group were very similar. These data suggest that delaying gluten exposure until the age of 12 months is safe but will not substantially reduce the prevalence of islet autoimmunity in genetically at-risk children.