Patients who have a biological relative with T1D; those who have certain autoimmune diseases (e.g., Hashimoto’s disease, Grave’s disease, Celiac disease); or adult patients with abnormal glucose levels level between 5.7% to 6.4% AND are in Stage 1 or Stage 2 T1D.  Specifically,

• Stage 1 patients have 2 or more T1D autoantibodies, but no dysglycemia.
• Stage 2 patients have 2 or more T1D autoantibodies and some level of dysglycemia.

— Stage 1 and Stage 2 T1D patients are not dependent on exogenous insulin.—

• Stage 3 patients, clinical T1D, have 2 or more autoantibodies, hyperglycemia and are dependent on exogenous insulin.