Indiividuals who are found to have autoantibodies will be offered confirmational testing. Those that are found to be autoantibody positive will be offered participation in the monitoring portion of the study.

Monitoring

Annual Monitoring for those with Autoantibodies at Screening

Individuals with one autoantibody will have an Oral Glucose Tolerance Test (OGTT) and HbA1c at the first monitoring visit to determine their monitoring plan. If these results confirm a lower 5-year risk for diabetes, Annual Monitoring will be offered. 

Annual Monitoring visits include testing for autoantibodies and HbA1c. If the HbA1c increases or a participant develops two or more autoantibodies they will be asked to come for Semi-Annual Monitoring so that they can be followed more closely for possible progression towards type 1 diabetes.

Semi-Annual Monitoring for those with Autoantibodies at Screening

Individuals in this group have a higher 5-year risk of diabetes. They will be asked to come in for Semi-Annual Monitoring. This includes individuals found to have two or more autoantibodies as well as individuals that have one autoantibody and other test results that indicate a higher 5-year risk for diabetes. Semi-Annual Monitoring visits include blood tests for autoantibodies, HbA1c, as well as an (OGTT).

Based on these test results, the study team may recommend continuous monitoring as a part of the Natural History Study or discuss the opportunity to participate in a TrialNet Prevention Trial.

Prevention Trials

Oral Insulin Prevention Trial: (For individuals at moderate risk)

In a prior study (completed by the Diabetes Prevention Trial-Type 1 group) there was a suggestion that oral insulin may help delay type 1 diabetes by four or more years in individuals with higher levels of insulin antibodies. This follow up study is testing if this is the case. Study participants take one capsule each day (insulin or placebo) and visit a study site for blood tests every 6 months and return at other times as needed.

CTLA-4Ig (Abatacept) Prevention Trial: (For individuals at moderate risk)

Prior to being diagnosed with type 1 diabetes, patients progress from normal glucose tolerance to abnormal glucose tolerance. Subsequent progression to clinical diabetes occurs in 80% of this population within 5 years. It is hypothesized that treatment with abatacept may delay or prevent the onset of abnormal glucose tolerance in those with normal glucose tolerance by blocking co-stimulation of immune cells involved in destruction of pancreatic beta cells.

AntiCD3 (Teplizumab) Prevention Trial: (For individuals at high risk)

Teplizumab is a medication that has shown promise in preserving insulin secretion in people with newly diagnosed type 1 diabetes. This study is testing whether teplizumab can help to delay or prevent the onset of diabetes in individuals at high risk. Participants receive the two-week study treatment (drug or placebo) and then return for follow-up tests and monitoring approximately every six months.

Follow-Up Trials

Long-Term Investigative Follow-Up in TrialNet (LIFT)

The LIFT study is for participants that have previously participated in a TrialNet prevention or intervention study and have been diagnosed with type 1 diabetes. The purpose of the study is to continue to gather information from participants and learn whether there are any long term effects of participating in TrialNet. In particular, TrialNet is interested in finding out about the participant's general health, diabetes mangement and insulin secretion over time post-diagnosis. Participation involves semi-annual visits for blood tests.