Previous observations showed an increased risk of islet autoimmunity when gluten-containing cereals (6) or any cereals (7) were introduced during the first 3 months of life in children with increased genetic risk for type 1 diabetes. Because Germany and many other countries recommend introducing gluten at 6 months of age,we were unable to design a study to formally compare intervention with 3 months versus later gluten introduction. Hence, our design was to extend the gluten-free exposure to 12 months of age. Recruitment was not problematic,with the majority of eligible families consenting to participate in the intervention. Retention, despite the intensive follow-up of the protocol, also was high (80%). Families were well instructed as to the foods that contain gluten.In addition,study members were in contact with families weekly to discuss issues related to feeding during the study.