Trial Information

TrialNet TN-01: Trialnet Natural History Study of the Development of Type I Diabetes

Phase 1 - You/your child have/has been asked to participate in this research study because you/your child are/is a close blood relative of someone with type 1 diabetes. This includes brothers, sisters, parents, children, cousins, aunts, uncles, and grandchildren of people with type 1 diabetes. The purpose of this study is to learn more about how type 1 diabetes occurs, what the risk is for relatives of persons with type 1 diabetes to also develop diabetes, and what other factors contribute to the development of diabetes. The goal is to develop studies to learn more about prevention of type 1 diabetes. This first phase of the TrialNet Natural History Study of the Development of Type 1 Diabetes will do preliminary tests to evaluate the risk of developing type 1 diabetes. Your/your child’s participation in this study is expected to last anywhere from one visit to five years or until the end of the study.

Phase 2 - You/your child have/has been asked to participate in this research study because the results of your/your child’s test in Phase 1 show that you/your child are/is more likely to develop type 1 diabetes than most other people, but we still do not know just how likely. The purpose of this study is to learn more about how type 1 diabetes occurs, what the risk is for relatives of persons with type 1 diabetes to also develop diabetes, and what other factors contribute to the development of diabetes. The goal is to develop studies to learn more about the prevention of type 1 diabetes. This is the second phase of the TrialNet Natural History Study of the Development of Type 1 Diabetes. This phase will include additional tests to more accurately predict the risk of developing type 1 diabetes. Your participation in this study is expected to last anywhere from one visit to five years or until the end of the study.

Phase 3 - You/your child have/has been asked to participate in this research study because the results of your/your child’s tests in Phase 1 and Phase 2 show that you are/your child is more likely to develop type 1 diabetes than most other people. The purpose of this study is to learn more about how type 1 diabetes occurs, what the risk is for relatives of persons with type 1 diabetes to also develop diabetes, and what other factors contribute to the development of diabetes. The goal is to develop studies to learn more about prevention of type 1 diabetes. This third phase of the TrialNet Natural History Study of the Development of Type 1 Diabetes will follow people who have been shown to be more likely to develop type 1 diabetes. Your/your child’s participation in this study is expected to last anywhere from one visit to five years or until the end of the study.

Turning 18 - You have been asked to participate in this research study because the results of your tests in Phase 1 and Phase 2 show that you are more likely to develop type 1 diabetes than most other people. You started in this study before you were 18 years of age. Either one or both of your parents or a guardian gave permission for you to be in this study. This was because individuals who participate in research cannot give their own legal consent until they are 18. Now that you are 18, you have the opportunity to decide whether you want to give your legal consent to continue participation in this study. The purpose of the third phase of the study is to follow people like you who are at risk for type 1 diabetes. Your participation in this study is expected to last anywhere from one visit to five years or the end of the study.

Former DPT-1 Participants - You/your child have/has been asked to participate in this research study because you/your child are/is a former Diabetes Prevention Trial participant and although you/your child didn’t get type 1 diabetes during that study you/your child are/is still at higher risk than most people. Because you/your child have/has this increased risk for type 1 diabetes, you/your child are/is now being asked to participate in a research study called the TrialNet Natural History Study of the Development of Type 1 Diabetes. The purpose of this study is to learn more about how type 1 diabetes occurs, what the risk is for relatives of persons with type 1 diabetes to also develop diabetes, and what other factors contribute to the development of diabetes. The goal is to develop studies to learn more about prevention of type 1 diabetes. Your/your child’s participation is expected to last anywhere from one visit to five years or when the study ends.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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