Overview
More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and/or other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.
Eligibility
Inclusion Criteria:
- Documented informed consent/ assent from the subject
- ONE of the following:
- Type 1 diabetes patients (including pediatric patients) -OR-
- Adult type 2 diabetes patients -OR-
- Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-
- Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-
- Adult control subjects with HbA1cc ≤ 5.6%
- Weight ≥ 30 kg
- Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review
Exclusion Criteria:
- Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant
- Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)
- Active infection
- Active malignancy (i.e., currently undergoing treatment)
- Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines/ growth factors (e.g. interferons, interleukins)
- Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy
- Bleeding disorder
- Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing)
- Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood
- An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
- A direct study team member