Table 2.

Strategies to identify individuals for clinical trials in the U.S.

Population	Estimated N of population	Estimated average number of relatives	Estimated number to be screened annually	Estimated number with multiple AAb+	Estimated number willing to enroll*	Theoretical number of trials with N = 300
Relatives: incidence cases	40,000 per year	3 relatives, each age <50 years	120,000	3,000 (120,000 × 2.5%)	If 20% of those eligible enroll, 600 individuals annually	2 per year
Relatives: prevalence cases	1,500,000 unique families	2 relatives, each age <50 years	3,000,000	>75,000 (3,000,000 × 2.5%)	If 20% of those eligible enroll, 15,000 individuals	50
General population	350,000,000 U.S.	N/A	200,000,000 age <50 years	800,000 (200,000,000 × 0.4%)	If 10% of those eligible enroll, 80,000 individuals	>260

Theoretical number of trials requiring 300 people that could be conducted with different approaches to screening.

*Assumes that fewer individuals without knowledge of T1D will enroll in a prevention trial in comparison with those with family members.