Leading Researchers Respond to Type 1 Diabetes Increase

This truly an exciting time for finding a cure for type 1 diabetes. Never has their been as much research going on at the same time that looks so promising. This week we have a feature from Martha Halsey-Lyda, FNP-BC, CDE, TrialNet Coordinator, discussing some of the current trials. Also, items 1 and 2 discuss some of the inroads we are making. See if you have any patients who might be able to take advantage of the research. TrialNet Research

 

Martha Halsey-Lyda, FNP-BC, CDE
TrialNet Research Coordinator                   Contact: Lisa Rafkin-Mervis: 305-243-6146
Leading Researchers Respond to Type 1 Diabetes Increase

The world is experiencing an alarming increase in type 1 diabetes among children and adolescents. In the U.S., 1 child in every 300 develops type 1 diabetes before 15 years of age. It is one of the most common chronic diseases in school-aged children. In other parts of the world, prevalence of the disease among children and adolescents is even greater. Universally, the rate of increase is growing, especially in children below the age of five.

Funded by the National Institutes of Health (NIH), Type 1 Diabetes TrialNet has brought together top diabetes researchers from the United States, United Kingdom, Italy, Germany, Finland, Canada and Australia to respond to this disturbing trend and to work toward a better understanding of the disease process. TrialNet researchers are screening and following high risk individuals, and investigating promising treatments for intervening in the disease process before and after diagnosis. In the U.S. alone, more than 150 medical centers are testing ways to prevent the disease, as well as ways to detect and treat it in its earliest stages.

Participating TrialNet medical centers offer a simple blood test that can predict a person’s risk for type 1 diabetes up to 10 years before diagnosis. Using this test, one TrialNet study is screening relatives of people with type 1 diabetes to determine their risk of developing the disease. Screening and follow-up of at-risk persons allow for earlier diagnosis if the disease develops. Earlier diagnosis may mean that ketoacidosis, a life-threatening complication of diabetes, can be prevented. Intervening shortly after diagnosis may also prevent complete beta cell destruction and help retain an individual’s ability to make some level of insulin. This is very important because it may make their diabetes easier to manage and lessen the likelihood of serious long-term complications.

Participating medical centers are screening relatives who are:

• Between 1 and 45 years of age and have a sibling, child, or parent with type 1 diabetes

• Between 1 and 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling or grandparent with type 1 diabetes

Those who are screened and identified as being at risk may be eligible to join clinical studies that are testing ways to prevent and delay the disease.

Benefits of joining a research study include:

• Regular monitoring, medical exams and blood tests—free of charge

• The potential to prevent or delay the onset of type 1 diabetes (for those who join prevention studies)
• Possible early detection and treatment of diabetes, which can help lessen short- and long-term complications

• The opportunity to make a personal contribution to diabetes research

Type 1 Diabetes TrialNet offers clinical trials for two types of people:

• Those at increased risk:  Studies for people who have family members with type 1 diabetes and, therefore, are at increased risk:
• The Natural History Study of the Development of Type 1 Diabetes is screening and observing relatives of people with type 1 diabetes to learn more about how the disease occurs.
• The Oral Insulin for Prevention of Type 1 Diabetes Study is seeking to prevent or delay type 1 diabetes in a specific group of at-risk people with the use of a single, daily oral insulin capsule.
• The Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Study is seeking to prevent or delay type 1 diabetes in at-risk newborns by adding a nutritional supplement, an omega-3 fatty acid (DHA), to their diet.
• Teplizumab for Prevention of Type 1 Diabetes will evaluate the use of Teplizumab therapy (mAb hOKT3gamma1 [Ala-Ala]) to delay or prevent type 1 diabetes onset in high-risk individuals. This study is expected to start enrolling participants this summer (2008).

 Those newly diagnosed: Intervention studies for people recently diagnosed with type 1 diabetes that are testing ways to help people continue to make their own insulin for as long as possible:

• Abatacept (CTLA4-lg) in New Onset Type 1 Diabetes is testing the drug abatacept, already approved for the treatment of rheumatoid arthritis (another autoimmune disease) to see if it can prevent loss of insulin production.
• GAD in New Onset Type 1 Diabetes will explore whether treatment with multiple injections of the GAD protein will help preserve insulin production. This study is expected to start enrolling participants this spring (2008).
• Metabolic Control in New Onset Diabetes is looking at whether early intensive metabolic control can help to preserve insulin production. This study is expected to start enrolling participants this summer (2008).

Type 1 Diabetes TrialNet studies are underway in communities across the U.S. and around the world. To locate the medical center closest to you that is conducting screenings and clinical trials, call Type 1 Diabetes TrialNet at 1-800-HALT-DM1 (1-800-425-8361) or visit www.DiabetesTrialNet.org.
Type 1 Diabetes TrialNet is also collaborating with the following NIH-funded groups that are conducting research in type 1 diabetes:

• The Type 1 Diabetes Genetics Consortium (T1DGC) is collecting blood samples and health information from African American and Mexican American individuals with type 1 diabetes, as well as from people who do not have type 1 or type 2 diabetes in their immediate family (www.t1dgc.org).
• The Immune Tolerance Network is offering additional intervention studies (www.immunetolerance.org).
• The Clinical Islet Transplant Consortium, an international network of centers offering islet cell transplantation studies in individuals with type 1 diabetes (www.citisletstudy.org).

Physicians can join TrialNet as an affiliate or a participating physician. Affiliates offer screening and refer patients into clinical studies. Participating physicians offer screening and take part in TrialNet studies. To learn more about joining TrialNet, please contact the TrialNet Coordinating Center at 1-800-805-3705 or by e-mail at TrialNet@biostat.bsc.gwu.edu.
Type 1 Diabetes TrialNet is additionally supported by the Juvenile Diabetes Research Foundation and the American Diabetes Association.
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