Table 1.
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.