Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes

Prior treatment

• History of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs.
• Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.

Other illness

• Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to:
• History of type 2 diabetes
• Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes)
• History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
• History of organ transplant
• History of HIV, active Hepatitis B or C, or Tuberculosis
• Psychiatric disease prohibiting adherence to study protocol
• Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits

Lab values

• Use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], prescribed medications for weight loss, etc.)

Other

• Pregnancy, lactation or 6 months postpartum from the scheduled date of collection

• Type 1 Diabetes (T1D)
• Age 12-18 years inclusive
• Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history.
• T1D duration of ≤ 3 months from the diagnosis
  • Healthy Normal Volunteers (HNV)
• Age 12-18 years inclusive
• No personal history of diabetes according to ADA criteria
• No history of T1D or insulin treated diabetes in first degree relatives (FDR)