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Circulating Biomarkers in the Development of Type 1 Diabetes

Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for biomarkers—signs in blood that may help show how diabetes starts and gets worse. It includes people with diabetes, people with certain blood test results, and adults without diabetes for comparison.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent or age-appropriate agreement to join.
  • Weigh at least 30 kg (about 66 pounds).
  • Agree to give blood samples and, if needed, allow review of medical records and lab results. You must also fit one of the five groups below.
  • Have type 1 diabetes. Children may join.
  • Be an adult with type 2 diabetes.
  • Have antibodies that target the pancreas cells that make insulin, and an HbA1c of 5.6% or less. HbA1c measures average blood sugar. Children may join.
  • Be an adult diagnosed with high blood sugar, with an HbA1c of 5.7% to 6.4%.
  • Be an adult in the comparison group with an HbA1c of 5.6% or less.

Who can't join

  • For the comparison group: any long-term health condition or a past cell, tissue, or organ transplant.
  • Sickle cell disease or anemia (low red blood cells). Anemia is allowed if treatment corrected it and records from within 6 months before the blood draw confirm this.
  • An active infection, cancer currently being treated, or a bleeding disorder.
  • Treatment that changes how the immune system works within 1 year before the planned blood draw.
  • For people with type 1 diabetes: treatment with certain immune cells called polyclonal regulatory T cells or dendritic cells.
  • Pregnant or breastfeeding. Joining may be delayed based on blood donation timing rules.
  • For people with diabetes: any health problem that could get worse after giving up to 100 mL of blood.
  • Being a study team member or an employee supervised directly or indirectly by a study investigator or the study manager.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA