Worldwide Research Network Fights Type 1 Diabetes

Type 1 diabetes has a formidable new enemy: A global network of diabetes researchers, immunology experts, and specialized laboratories and facilities is pooling resources to understand—and hopefully prevent—type 1 diabetes.

“This group of centers works in a collaborative fashion to undertake therapies aimed at, first, preventing type 1 diabetes and, second, doing studies aimed not only at understanding the natural history of the disease, but also gaining insight into the actual mechanisms leading to the disease,” explains Desmond Schatz, MD, professor and associate chair of the department of pediatrics and the clinical center director for TrialNet at the University of Florida.

“We really want any primary care physician who has a patient who is eligible to refer those people to a center,” Schatz says, noting that the National Institutes of Health will assist with the costs of enrolling.

Type 1 Diabetes TrialNet is a consortium of 18 diabetes research centers in the U.S., Canada, Europe, and Australia. In one study, the investigators are screening family members of people who have type 1 in search of antibodies in the blood associated with a risk of developing the disease. The Natural History Study seeks to identify which biological mechanisms put a person at risk for type 1 diabetes.

In phase 1, thousands of relatives will be followed through screening, baseline risk assessment, and follow-up risk assessments.

In phase 2, the baseline risk assessment, participants who test positive for the presence of at least one antibody will undergo an additional intravenous glucose tolerance test to estimate their chances of developing diabetes over the next 5 years.

Phase 3, the follow-up risk assessments, will be used to determine if participants qualify for TrialNet's two other types of research—new onset and prevention studies.

The first intervention study will test two immunosuppressive agents approved by the Food and Drug Administration for organ transplant recipients: mycophenolate mofetil (CellCept, Roche) used alone or in combination with daclizumab (Zenapax, Roche).

The study seeks to discover if these agents can preserve insulin secretion by delaying or stopping further destruction of insulin-secreting cells in people with newly diagnosed type 1 diabetes. Eligible patients need to have been diagnosed with type 1 diabetes within the past 3 months, be 12–35 years old, and be willing to comply with intensive diabetes management. TrialNet is also developing diabetes prevention studies that will test therapies that could delay or prevent the onset of type 1 diabetes.

“We need every primary care physician and all new patients to participate in fostering the understanding of the disease process and to participate in studies leading to its prevention,” Schatz says. “If we don't do the studies, we'll never learn. If patients don't participate, we just can't do the studies. It requires the participation of everybody—every nurse, patient, physician, pediatrician, endocrinologist—anybody involved in taking care of people with diabetes or anyone who has diabetes.” ▪