TrialNet Natural History Study (TrialNet)

To participate in the screening phase of the Natural History Study, you must be: (1) 1 to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes; OR (2) 1 to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandparent with type 1 diabetes. In general, type 1 diabetes is assumed if it developed before age 40 and required insulin injections within a year of diagnosis.

TrialNet is a network of 18 Clinical Centers working in cooperation with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes. The Natural History Study is one of the studies TrialNet will perform. This study will screen individuals who are close relatives of people with type 1 diabetes to identify those at risk for developing the disease. Individuals at risk will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes. Participants in the Natural History Study may be offered the opportunity to enter into prevention or early treatment studies when these become available.

The goal of this study is to learn more about how type 1 diabetes develops in “at-risk” individuals. Relatives of people with type 1 diabetes are being studied because they have a 10 to 15 times greater risk of developing the disease than people with no family history.

The Natural History Study is conducted in three phases: Phase 1 - Screening, Phase 2 - Baseline Risk Assessment, and Phase 3 - Follow-Up Risk Assessments. In Phase 1 (Screening), a blood test is done to screen for the presence of diabetes-related autoantibodies. To do the screening test, a small sample of blood is taken. If autoantibodies are present (positive result) and confirmed by repeat testing, you will be asked to continue on to Phase 2 ( Baseline Risk Assessment). In this phase, your risk for the development of type 1 diabetes over the next 5 years will be determined. As part of the Baseline Risk Assessment, you will have a several tests performed. The first test is called an Oral Glucose Tolerance Test (OGTT). For this test, you will drink a special sugar drink after an overnight fast. Several blood samples will be taken over 2 hours. We will also take blood samples for HbA1c and HLA tests. The HbA1c blood test will measure your average blood glucose level for the past 2-3 months. HLA is an area on your chromosomes (part of your DNA) that contains a group of genes. Some people who have certain kinds of HLA genes have a higher risk of developing type 1 diabetes. Your HLA genes will only be tested to determine your risk of type 1 diabetes. For a few individuals, we may need to do an additional test called an Intravenous Glucose Tolerance Test (IVGTT). For this test, several blood samples are drawn over a period of about 20 minutes to measure how the cells in your pancreas that make insulin respond to an intravenous injection of glucose. About 4 to 6 weeks after Phase 2 testing is completed, we will notify you by telephone of your estimated risk for developing type 1 diabetes in the next five years. As part of the Follow-up Risk Assessments (Phase 3), you will be invited back to the clinic every 6 months for the next 5 years to be closely monitored for the development of diabetes. The tests performed in Phase 3 are very similar to the ones performed in Phase 2. You will again be asked to drink a special sugar drink after an overnight fast for the Oral Glucose Tolerance Test (OGTT). Several blood samples will be taken over 2 hours. We will also take blood samples for an HbA1c test.

Yes, you can participate in other TrialNet prevention or new onset studies if you are eligible.

Please call the toll free number below or visit the TrialNet website for more information.