NATURAL HISTORY STUDY
Phase
1
Screening
Welcome to Type 1 Diabetes TrialNet and Phase 1 Screening of the Natural History Study of the Development of Type 1 Diabetes We appreciate your interest in our study
WHAT IS TRIALNET?
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 TrialNet is supported by the National Institutes of Health, which is part of the United States federal government It is also supported by other major diabetes organizations
lose the ability to produce insulin and need to take insulin injections
WHO IS
AT
RISK
FOR
TYPE 1 DIABETES?
TrialNet will screen relatives of people with type 1 diabetes because they have a 10 to 15 times greater risk for developing the disease than people with no family history
WHAT IS
THE
NATURAL HISTORY STUDY?
WHO CAN PARTICIPATE HISTORY STUDY?
IN THE
NATURAL
The Natural History Study is part of the TrialNet Type 1 Diabetes studies The goal of this study is to learn more about how type 1
diabetes develops in at-risk individuals Close relatives of people with type 1 diabetes are being studied in three steps phases: Screening, Baseline Risk Assessment, and Follow-Up Risk Assessments Participants in the Natural History Study may be offered the opportunity to enter into prevention or early treatment studies when these become available The purpose of screening is to identify people at risk for developing type 1 diabetes Individuals at greater risk may be offered the opportunity to continue on to other phases of the Natural History Study to receive close monitoring for the development of diabetes They may also participate in studies testing new treatments to delay or prevent the onset of diabetes If participants develop diabetes during the Natural History Study, they may be eligible to participate in studies aimed at slowing the progression of type 1 diabetes
To participate in Phase 1 of the Natural History Study, you must be: 1 to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes, OR 1 to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandparent with type 1 diabetes In general, your relative may have
type 1 diabetes if they were diagnosed before age 40 and required insulin injections within a year of diagnosis
WHAT IS
THE
SCREENING TEST?
WHAT IS TYPE 1 DIABETES?
Type 1 diabetes is a life-long disease that occurs in both children and adults It develops when the body attacks and destroys insulin-producing cells in the pancreas Insulin is a hormone the body needs to use food for energy Patients with type 1 diabetes
The screening test is a blood test to see if you have autoantibodies associated with a risk of developing diabetes Autoantibodies are a sign that your immune system may be attacking the insulin-producing cells in your pancreas Autoantibodies are proteins made by the immune system About 3 to 4 percent of family members of people with type 1 diabetes have autoantibodies The presence of some autoantibodies indicates you may be at risk for developing type 1 diabetes To do the test, a small sample of blood is drawn from your arm It is sent to the TrialNet central laboratory for analysis You can have the blood sample drawn in a TrialNet clinic or you can have a test kit sent to you You can then take this test kit to a local laboratory or your own physician to have your
blood drawn
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Phase
1
Screening
Continued
You will be notified of your test results in one of two ways: By letter if the antibody test shows NO autoantibodies are present negative result Testing negative for autoantibodies does not 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, you can be tested every year since antibody levels can change By phone if autoantibodies are present positive result We will call you to discuss your results and future testing options Testing positive does not mean that you will get type 1 diabetes It means you have a greater chance than if you tested negative You may return to the clinic for more tests to confirm these results If the repeat tests indicate the presence of at least one of the same autoantibodies, you may have additional tests to determine your risk for developing diabetes Additional tests to further determine your risk of developing type 1 diabetes are done in Phase 2 Baseline Risk Assessment and will estimate your chances of developing type 1 diabetes over the next 5 years Your estimated risk level may be indicated as
being less than 25, 25-50, or greater than 50 If you wish to continue the testing, you may participate in Phase 3 Follow-Up Risk Assessments In Phase 3 you will be closely monitored for the development of type 1 diabetes You may also be offered enrollment in diabetes prevention studies as they become available
You may also learn about TrialNet at
Individuals that develop type 1 diabetes while participating in the Natural History Study may be offered enrollment in a TrialNet study to save your ability to produce insulin All of these study options Phase 2 and 3, and diabetes prevention studies would require that you visit a TrialNet clinical center or Affiliate clinic You would not be able to have a test kit sent to you for testing at a local physicians office or laboratory as can be done in Phase 1
HOW DO YOU GIVE CONSENT AUTOANTIBODY TEST?
FOR THE
Before you have the autoantibody screening test, you will be asked to sign an Informed Consent form This form gives your permission to take the test Parents must give permission for children under 18 years of age to be tested Although a representative of the study will speak to you about the study, it is important that you read the
consent form carefully If you have questions or concerns, you should contact your TrialNet health professional If you participate in Phase 1, you are not required to participate in any other phase of the Natural History Study If you choose to participate in Baseline Risk Assessment Phase 2 or Follow-Up Risk Assessments Phase 3 of the study, we will ask you to sign a separate consent form for each phase Even if you do not wish to take part in Phase 2 or Phase 3, we might contact you in the future by phone or mail to see if you are interested in taking part in another diabetes-related research study We would also like to learn if you have developed type 1 diabetes
wwwDiabetesTrialNetorg
OTHER TRIALNET FACT SHEETS AVAILABLE INCLUDE:
TrialNet Natural History Study, Phase 2: Baseline Risk Assessment TrialNet Natural History Study, Phase 3: Follow-Up Risk Assessments
TRIALNET IS SPONSORED BY:
National Institute of Diabetes Digestive Kidney Diseases National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Center for Research Resources National Institutes of Health United States Department of Health Human Services
Juvenile Diabetes Research Foundation International American Diabetes Association
July 2004
NATURAL HISTORY STUDY
Phase
2
Baseline Risk Assessment
Welcome to Phase 2 of the TrialNet Natural History Study of the Development of Type 1 Diabetes This phase is called Baseline Risk Assessment You were screened in Phase 1 of the Natural History Study and learned that your blood sample tested positive for the presence of at least one autoantibody associated with type 1 diabetes These results show that you are more likely to develop type 1 diabetes than most other people, but we do not know your actual risk
WHAT IS THE PURPOSE OF BASELINE RISK ASSESSMENT PHASE 2?
The purpose of Phase 2 is to estimate your risk for the development of type 1 diabetes over the next 5 years
WHAT HAPPENS IN BASELINE RISK ASSESSMENT PHASE 2?
As part of Phase 2, you will have the following tests performed: Oral Glucose Tolerance Test OGTT After an overnight fast, a needle wil 
l be inserted into your arm and then removed, leaving a small plastic tube You will be asked to drink a special sugar drink We will look at your blood sugar glucose levels before and after you have the drink Blood samples will be taken
over a period of 2 hours HLA test HLA is an area on your chromosomes part of your DNA that contains a group of genes Some people with certain kinds of HLA genes may have a higher risk of developing type 1 diabetes Your HLA genes will only be tested to determine your risk of type 1 diabetes HbA1c test This test measures your average blood sugar glucose level over the past 2 to 3 months Blood samples will be stored for possible later use, if you agree to this
HOW DO YOU START TESTING FOR BASELINE RISK ASSESSMENT PHASE 2?
Before you have any Phase 2 tests done, you will be asked to sign an Informed Consent form This form gives your permission to take the tests Parents must give permission for children under 18 years of age to be tested The Informed Consent for the Baseline Risk Assessment study is different from the one that you signed for Phase 1 of the study A TrialNet representative will speak to you about the study, but it is very important that you read the consent form carefully You must have participated in Phase 1 to be eligible for Phase 2 but you are not required to participate in Phase 2
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Phase
2
Baseline Risk Assessment
Continued
In some
cases we will ask to do an additional test called an Intravenous Glucose Tolerance Test IVGTT This test will be done on a different day to learn more about your risk of developing type 1 diabetes For this test, several blood samples are drawn over 20 minutes to measure how your pancreas responds to receiving glucose into your vein At the end of Phase 2, we will provide you with an estimate about your risk for developing type 1 diabetes in the next five years Your risk may be estimated as less than 25, 25-50, or greater than 50 You will be notified of your estimated risk by telephone in 4 to 6 weeks You will also be provided with feedback from your other testing unless you do not wish to know this information Since there is still more to be learned about predicting who will develop type 1 diabetes, we cannot tell you for sure if and when you might develop type 1 diabetes However, Phase 2 should provide more information about your risk for developing type 1 diabetes than can be determined in Phase 1
WHAT
IS THE
NEXT STEP?
The next phase is Follow-up Risk Assessments Phase 3 If you participate in Phase 2, you are automatically eligible for Phase 3, but you are not required to
participate in Phase 3 If you choose to participate in Phase 3, we will ask you to sign a separate consent form Depending on your risk for type 1 diabetes, you could be asked to take part in a prevention trial if one is available If you qualify, we will ask you to sign a consent form for that specific trial If a trial is not immediately available for you, and you do not wish to participate in Phase 3, you might be asked to return for repeat testing when a prevention study becomes available Even if you do not want to take part in Phase 3, we might contact you in the future to see if you are interested in taking part in another diabetes related research study We would also like to learn if you have developed type 1 diabetes
You may also learn about TrialNet at
wwwDiabetesTrialNetorg
OTHER TRIALNET FACT SHEETS AVAILABLE INCLUDE:
TrialNet Natural History Study, Phase 1: Screening TrialNet Natural History Study, Phase 3: Follow-Up Risk Assessments
TRIALNET IS SPONSORED BY:
National Institute of Diabetes Digestive Kidney Diseases National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Center for Research Resources
National Institutes of Health United States Department of Health Human Services Juvenile Diabetes Research Foundation International American Diabetes Association
July 2004
NATURAL HISTORY STUDY
Phase
3
Follow-Up Risk Assessments
Welcome to Phase 3 of the TrialNet Natural History Study of the Development of Type 1 Diabetes This phase is called Follow-Up Risk Assessments At this point, you have been through Phase 1 and Phase 2 of the study During Phase 1, your blood sample had autoantibodies present You had additional tests in Phase 2 which provided an estimate of your risk for developing type 1 diabetes over the next 5 years
WHAT IS THE PURPOSE OF FOLLOW-UP RISK ASSESSMENTS PHASE 3?
The purpose of Phase 3 is to see if your risk level for developing diabetes has changed You will also be monitored closely for the possible development of type 1 diabetes If you were to develop diabetes, it is possible it would be found earlier and that you might qualify for research studies of people with new-onset type 1 diabetes
WHAT HAPPENS IN FOLLOW-UP RISK ASSESSMENTS PHASE 3?
As part of Phase 3, you will be invited back to the clinic every 6 months for the next 5 years to have tests
performed The tests performed in Phase 3 are similar to the ones performed in Phase 2 the Intravenous Glucose Tolerance Test is not repeated You will again be asked to drink a special sugar drink after an overnight fast A needle will be inserted into your arm and then removed, leaving a small plastic tube Several blood samples will be taken from this tube over a period of 2 hours to perform the Oral Glucose Tolerance Test OGTT We will also take blood for a HbA1c test The HbA1c blood test measures your average blood sugar glucose level over the past 2 to 3 months You will be offered feedback on your test results With your consent, we will also take blood to be stored for possible later use The blood samples will be sent to a TrialNet central laboratory for analysis Continued on reverse side
HOW DO YOU START TESTING FOR FOLLOW-UP RISK ASSESSMENTS PHASE 3?
Before you have any Phase 3 tests done, you will be asked to sign an Informed Consent form This form gives your permission to take the tests Parents must give permission for children under 18 years of age to be tested This Informed Consent is different from the ones that you signed in Phase 1 and 2 of the study A TrialNet
representative will speak to you about the study, but it is very important that you read the consent form carefully If you have questions or concerns you should contact your TrialNet health professional
Phase
3
Follow-Up Risk Assessments
Cont
WHAT HAPPENS AFTER FOLLOW-UP RISK ASSESSMENTS PHASE 3?
The results of the follow-up tests performed in Phase 3 will help us learn more about risk factors associated with the development of type 1 diabetes These results will also be used to see if you qualify for any of the following research studies: Prevention Studies, which will test different treatments to prevent or delay the onset of type 1 diabetes If you qualify and choose to take part in a prevention trial, you will have no further visits for the TrialNet Natural History Study You will also be asked to sign a separate Informed Consent form
New Onset Studies, which will test various treatments to preserve insulin production in people with newly diagnosed type 1 diabetes These studies will test treatments that might help the pancreas to continue producing some insulin
If you participated in the Diabetes Prevention Trial DPT-1, you will probably be entering the Natural History
Study at Phase 3
You may also learn about TrialNet at
wwwDiabetesTrialNetorg
OTHER TRIALNET FACT SHEETS AVAILABLE INCLUDE:
TrialNet Natural History Study, Phase 1: Screening TrialNet Natural History Study, Phase 2: Baseline Risk Assessment
TRIALNET IS SPONSORED BY:
National Institute of Diabetes Digestive Kidney Diseases National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Center for Research Resources National Institutes of Health United States Department of Health Human Services Juvenile Diabetes Research Foundation International American Diabetes Association
July 2004
Source:diabetesnd.org
