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TrialNet Natural History Study

WHAT IS TYPE 1 DIABETES?

Type 1 diabetes is a life-long condition that can affect both children and adults. It occurs when the body attacks and destroys the cells in the pancreas that make insulin. The body needs insulin, a hormone, to turn food into energy.

WHAT IS TYPE 1 DIABETES TRIALNET?

Type 1 Diabetes TrialNet is a network of clinical centres dedicated to conducting diabetes prevention research and studying new therapies for people with newly diagnosed diabetes. TrialNet centres in Australia and New Zealand work in cooperation with centres located throughout the United States, Canada, and Europe. TrialNet researchers are experts in both diabetes and the body’s immune system. They share common scientific goals related to the study, treatment and prevention of type 1 diabetes.

TrialNet is supported by the National Institutes of Health, which is part of the United States federal government. It is also supported by two major diabetes organizations, the Juvenile Diabetes Research Foundation and the American Diabetes Association.

TrialNet is conducting 3 types of research:

Natural History Studies
These studies will enable us to learn more about risk factors associated with the development of type 1 diabetes. This page provides more information about the Natural History Study being conducted currently.

Diabetes Prevention Studies
These studies will test therapies that may delay or prevent the onset of type 1 diabetes.

Diabetes Intervention Studies
These studies will test therapies to preserve insulin secretion in people recently diagnosed with type 1 diabetes.

 

INFORMATION ABOUT THE NATURAL HISTORY STUDY

The goal of this study is to increase our understanding of how type 1 diabetes develops over time. Better understanding may help to prevent diabetes or develop a cure.

Relatives of people with type 1 diabetes have a 10 to 15 times greater risk for the disease than people without a family history. Therefore, TrialNet is screening first- and second-degree relatives of people with this type of diabetes. The study is being conducted in three phases.

Information about Phase 1 (Screening)
A screening test is done to see if you have antibodies in your blood. Antibodies are a sign that your immune system may be attacking the insulin-producing cells in your pancreas. Antibodies are proteins made by the immune system. If present in the blood they indicate you may be at risk for developing type 1 diabetes. About 4 percent of family members of people with type 1 diabetes have antibodies detected in the blood. To do the test, a small sample of blood is taken from your arm and sent to a laboratory for analysis.

If the test results are negative, you will be notified by letter. Testing negative for antibodies doesn't mean you will never get diabetes. It does mean that the chances are much lower than if you tested positive. If you are under 18 years of age, we will recommend that you be re-tested every year.

If the results are positive, you will be notified by telephone. Testing positive doesn't mean that you will get type 1 diabetes. It means that your chances are greater than if you tested negative. We will ask you to return to the centre for further tests to confirm these results. We may also invite you to participate in Phase 2 but you will not be obliged to continue.

Information about Phase 2 (Baseline Risk Assessment)
In Phase 2 you have additional tests to determine your risk for developing diabetes. These tests provide an estimate of the likelihood of developing diabetes over the next 5 years. Your risk level may be indicated as less than 25%, 25-50%, or greater than 50%. These risk categories are our best estimates based on current knowledge and may not be completely accurate. As there is much more to be learned, we cannot tell you for sure if and when you will develop diabetes.

Information about Phase 3 (Follow-up Risk Assessments)

After the Phase 2 assessment, we will invite you to have risk assessments every 6 months for 5 years. We do this to check if your risk level changes. You are not obliged to continue to Phase 3.

When a diabetes prevention study becomes available for which you are eligible, you may be invited to participate.

What happens first?

Before you enrol in each of the three Phases, you will be asked to sign a Consent Form. Parents must give permission for children under 18 years of age to participate.

Who is eligible to participate?

To participate in Phase 1 you must be:

45 years of age or younger and have a brother, sister, child, or parent with type 1 diabetes, or
20 years of age or younger and have a cousin, aunt, uncle, niece, nephew, half sibling, or grandparent with type 1 diabetes.
Children under 1 year are not eligible.

Note: Your relative probably has type 1 diabetes if he/she:

developed diabetes before age 40 years of age AND
started taking insulin injections within a year of diagnosis

Who do I contact to find out more about the Natural History Study?

Please contact Fiona Williams (TrialNet Coordinator) at The Royal Melbourne Hospital on: Ph: (03) 9345-2562 or 9345-2555

You can also visit the TrialNet Website at www.diabetestrialnet.com

Return to TrialNet Natural History Study Page

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