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What is Type 1 Diabetes TrialNet?

Type 1 Diabetes TrialNet (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 2000. 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.

What does participating in the Natural History Study involve?

The TrialNet Pathway to Prevention Study is divided into two parts or phases: Screening and Monitoring.

Screening involves drawing blood and shipping the specimen to a core laboratory for assessments of autoantibodies that are predictive of the development of type 1 diabetes (T1D).

Those who test positive are eligible to enter the monitoring phase which includes a baseline monitoring visit at a TrialNet site to estimate the level of risk of developing T1D. Participants are followed-up either annually or semi-annually depending on their risk level.

All participants will have repeat testing for autoantibodies and HbA1c; those in the higher risk will be closely monitored with Oral Glucose Tolerance Tests (OGTT). Participants who initially receive annual monitoring will be followed with semi-annual monitoring if their risk level for developing T1D increases. Participants who develop diabetes may be invited to enroll in an early treatment study aimed at preservation of islet cell function.

Diabetes Intervention Studies

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. Two types of diabetes intervention studies are being planned.

The first type will determine whether new treatments can delay or prevent the onset of T1D in individuals at greater risk. Those found to be at greater risk in the Pathway to Prevention Study may be offered enrollment in a diabetes prevention study. For those enrolled in a prevention study, the development of T1D may be delayed or prevented, if the treatment being tested is successful. All research volunteers will be closely monitored for early detection ofT1D. Early detection of T1D may improve blood sugar (glucose) control and reduce the chances of developing complications. Participants 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 T1D. The goal of these studies is to preserve insulin production in people newly diagnosed with T1D. 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.

 

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