Environmental Determinants of Type 1 Diabetes Risk

Prior treatment

• Current systemic immunosuppressive therapy.
• Current systemic glucocorticoid therapy.
• Participation in another drug or medical device trial during recruitment or the study period.

Other illness

• Individuals with type 1 diabetes
  • Gestational diabetes.
  • Confirmed monogenic diabetes.
  • Secondary diabetes.
  • Type 2 diabetes.
  • Other specific types of diabetes.
• Severe active disease or a condition likely to substantially affect life expectancy, including malignancy or severe cardiac, pulmonary, hepatic, or renal disease.
• A condition that may require immunosuppressive therapy during the study period.
• History of major surgery or severe trauma.

Lab values

• First-degree relatives:
  • Diagnosed with diabetes before screening;
  • Previous or current use of glucose-lowering drugs.
  • Common exclusion criteria:

• Individuals with type 1 diabetes (no age restriction):
  • Clinically diagnosed with T1D by a specialist.
  • Meeting any one of the following conditions:(1) Age of onset \< 15 years;(2) No overweight or obesity at onset;(3) History of ketoacidosis.
  • Insulin-dependent since disease onset;
  • Positive for at least one islet autoantibody (GADA, IA-2A, ZnT8A, IAA, ICA);
  • Disease duration ≤ 3 years.
• First-degree relatives:
  • Parents, siblings, or children of an individual with T1D.
  • Age ≤ 45 years.