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. 2023 Oct 5;3:130. doi: 10.1038/s43856-023-00357-y

Table 1.

Primary prevention studies.

Trial acronym Population Intervention Multi-center? Blinding Primary outcome Follow-up duration Positive? Hazard ratio (95%CI) vs. control
Hummel 201122 (BABYDIET) 150 infants with a first-degree family history of T1D and high-risk HLA genotypes Late (12 months) vs. early (6 months) gluten exposure No None Aabs 3 years (range 3.0–10.0) No 1.3 (0.6‚3.0)
Vaarala 201230 (FINDIA) 1113 infants with high-risk HLA genotypes • Whey-based hydrolyzed vs. cow’s milk formula Yes Double Aabs n/a • No • 0.82 (0.38–1.7)
• Insulin-free whey-based vs. cow’s milk formula • Yes • 0.24 (0.08–0.72)
Knip 201823 (TRIGR) 2159 infants with a first-degree family history of T1D and high-risk HLA genotypes Extensively hydrolyzed casein formula vs. conventional formula Yes Double Time to diabetes 11.5 years (Q1–Q3, 10.2–12.8 No 1.1 (0.8 to 1.5)

T1D type 1 diabetes, HLA human leukocyte antigen, Aab autoantibody, FINDIA Finnish Dietary Intervention Trial for the Prevention of Type 1 Diabetes, n/a not applicable, TRIGR trial to reduce IDDM in the genetically at risk, Aab+ autoantibody positive.