What is Type 1 Diabetes TrialNet?

Type 1 Diabetes TrialNet is an international network of researchers who are exploring ways to prevent, delay and reverse the progression of type 1 diabetes.

TrialNet was established in response to the Surgeon General's Report Healthy People 2010. This report identified diabetes as a national health objective for the Nation. In response to the report, Congress created the Diabetes Research Working Group (DRWG) to develop a plan for diabetes research. One recommendation of the DRWG was to conduct additional research studies (clinical trials) to prevent type 1 diabetes.

TrialNet is jointly funded by:

• The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• The National Institute of Allergy and Infectious Diseases (NIAID)
• The National Institute of Child Health and Human Development (NICHD)
• The National Center for Research Resources at the NIH, which provides support through its General Clinical Research Centers (GCRC) Program.
• Juvenile Diabetes Research Foundation International (JDRF).
• American Diabetes Association (ADA)

TrialNet is conducting clinical trials with researchers from 18 Clinical Centers in the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia and New Zealand. In addition, more than 150 medical centers and physician offices are participating in the TrialNet network. Studies are available for people newly diagnosed with type 1 diabetes, as well as for relatives of people with type 1 diabetes who are at greater risk of developing the disease.

There are two types of studies:

• The Natural History Study provides information about risk factors associated with developing type 1 diabetes
• Diabetes Intervention Studies test either treatments to delay or prevent the onset of type 1 diabetes, or test treatments to preserve remaining insulin secretion in people recently diagnosed with type 1 diabetes.

What is the Goal of TrialNet?

The goal of TrialNet is to perform intervention studies to preserve insulin-producing cells in individuals at risk for type 1 diabetes and in those with new onset type 1 diabetes. TrialNet will focus on identifying individuals "at risk" for developing type 1 diabetes. Risk is based on having autoantibodies or other markers and results of certain tests. These tests include Oral and Intravenous Glucose Tolerance Tests.

Specific study interventions are determined by TrialNet investigators. Every study in TrialNet follows a protocol that tells exactly how the research study is carried out. Each protocol is thoroughly reviewed by an Institutional Review Board (IRB) before approval is given to start recruitment to make sure the participant is fully protected and not exposed to unnecessary risks.

Natural History Studies

TrialNet is screening relatives of people with type 1 diabetes to find out if these family members are "at risk" for developing type 1 diabetes. Screening involves a simple blood test from your arm to look for diabetes-related autoantibodies that may appear years before type 1 diabetes develops.

Relatives of people with type 1 diabetes have about a 3 to 4 percent chance of having autoantibodies in their blood associated with type 1 diabetes.

The following relatives may be screened at no charge to determine their risk:

• relatives between 1 and 45 years of age who have a sibling, child, or parent with type 1 diabetes
• relatives between 1 and 20 years of age who have cousin, aunt, uncle, niece, nephew, half sibling or grandparent with type 1 diabetes

In general, your relative may have type 1 diabetes if it developed before age 40 and required insulin injections within a year of diagnosis.

Natural History Studies are being done to learn more about what causes type 1 diabetes and to find out what might predict the development of the disease. These studies provide close monitoring to individuals "at risk" for developing type 1 diabetes. Individuals at greater risk may be offered an opportunity to participate in a prevention study.

Diabetes Intervention Studies

Two types of Diabetes Intervention Studies are being planned.

The first type will determine whether new treatments can delay, or prevent, the onset of type 1 diabetes in individuals at greater risk. If you are found to be at greater risk in the Natural History Study, you may be offered enrollment in a diabetes prevention study. If you are enrolled in a prevention study, your development of type 1 diabetes may be delayed, or prevented, if the treatment being tested is successful. All research volunteers will be closely monitored for early detection of type 1 diabetes. Early detection of type 1 diabetes may improve your blood sugar (glucose) control and reduce your chances of developing complications. You will be part of a research program that may help other people at risk for type 1 diabetes.

The second type of intervention study is for people with new onset type 1 diabetes. The goal of these research studies is to preserve insulin production in people newly diagnosed with type 1 diabetes. Eligible participants will be randomly (like the flip of a coin) put into either an experimental treatment group or a control group. The experimental group will receive the new treatment and the control group will receive an "inactive" treatment. Differences between the two groups will help researchers know if the experimental treatment is successful. Ongoing intervention studies will be available at specific TrialNet sites located at medical institutions in the United States and at the international sites.

You may be eligible to participate in a diabetes intervention study if you are:

• 12 to 35 years of age (Age range may vary with the interventions).
• Diagnosed with type 1 diabetes within the last 3 months.

If you participate in an intervention study, you will be a part of a research study to learn if it is possible to save remaining insulin production after a diagnosis of diabetes. If the intervention is successful, your diabetes may be easier to manage, possibly reducing your risks of abnormal blood sugar (glucose) levels and long- term complications.