The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched controls. Primary objective of the trial is the change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet.

Secondary objectives are:

• Changes in immune parameters between gluten-free diet group and control group;
• Differences in fecal microbiome between children on normal diet and children on GFD;

Inclusion Criteria:

• Type 1 Diabetes (T1D) diagnosed according to the American Diabetes Association criteria

Exclusion Criteria:

• negativity of the three diabetes-related autoantibodies at T1D onset;
• negativity of celiac-disease high risk Human Leucocyte Antigen DQB1 (HLA-DQB1) and Human Leucocyte Antigen DQA1 (HLA-DQA1) genotype HLA-DQB1*03:02-DQA1*03 nor DQB1*02-DQA1*05 molecules;
• celiac disease or positive transglutaminase antibody test;
• body mass index over two standard deviations of the age and height standard;
• any concomitant disease potentially influencing immune response or gluten sensitivity

15 months

Specific AE questionnaire given at each visit (i.e. in 3 months periods).

The main limitation is the lack of randomization. Second, the study did not achieve the sample size needed for sufficient power according to the pre-study power analysis. Furthermore, the duration of the study might have been too short for the assessment of the long-term effect of the GFD on the course of T1D.