Early results from TRIGR study released

Initial results from the study, published recently in the New England Journal of Medicine, found some evidence that infants at risk for developing type 1 diabetes who were fed the specialized formula after being weaned from breast milk were less likely to develop autoantibodies associated with the progression to type 1 diabetes, when compared with those who received conventional formula made with cow’s milk.  The evidence found was not statistically significant to show the prevention of type 1 diabetes, however, and the study was not powered to determine whether different infant formulas played a definitive role in the prevention of the disease.  These findings will need to be confirmed by a larger ongoing clinical trial that evaluates the role of diet in infants at risk for type 1 diabetes. Also, neither study is designed to replace breastfeeding, which was strongly encouraged by the investigators. 

In the study, the research group led by Dr. Michael Knip of University of Helsinki gave formula that was “hydrolyzed,” or broken down into smaller proteins that make it easier to digest, to half of the 230 infants participating in the study, while the other half were fed with the conventional cow’s milk formula.  Infants in the study were monitored for 10 years.  Those who received the specialized formula showed that it reduced the presence of diabetes-related autoantibodies, suggesting that the hydrolyzed formula may ultimately be shown to have a role in the prevention of type 1 diabetes. 

The study published in NEJM is the pilot for a larger, on-going international trial called TRIGR (Trial to reduce Insulin-dependent diabetes in the Genetically at-Risk), which is designed to determine whether weaning to a specialized formula decreases the risk of developing type 1 diabetes.  The larger study involves more than 2,160 infants in 15 countries (including those featured in the Finland study) and tracks the children up until their 10th birthday for the development of diabetes and the presence of diabetes-related antibodies.  All of the participants in the study have a genetic susceptibility to diabetes, and had at least one family member with type 1 diabetes.

“The preliminary results from this study could shed additional light on a possible way to prevent the onset of type 1 diabetes in individuals who have been identified at risk for the disease,” Dr. Insel added. “It is important to note that these results are not statistically significant in showing the prevention of type 1 diabetes.  Breastfeeding should still be encouraged, and it shouldn’t change how parents wean their infants.  Furthermore, it is unknown whether similar results would be observed in infants from the general population.”   “I look forward to seeing the results of the larger TRIGR study, which will provide further insight and evidence into the role that cow’s milk formula is a risk factor for developing type 1 diabetes,” he added. Final results of the TRIGR study are expected to be completed in 2017.

TRIGR is the largest type 1 diabetes prevention trial to date, and is one of many important developments in diabetes research that is currently being supported by the Special Diabetes Program (SDP), a federal-funded program that is up for renewal before Congress.  Without continued funding for the SDP, support for much-needed clinical research, like TRIGR, will be in jeopardy. 

Established by Congress in 1997, SDP currently funds $150 million annually for type 1 diabetes research, representing 35 percent of the federal government’s support for type 1 diabetes research.  JDRF, also committed to funding research toward a cure for type 1 diabetes, is calling for the multi-year renewal of the program before Congress adjourns for the year.  “If the SDP is renewed, this would ensure that the discoveries and advancements made based on this study can continue uninterrupted to further our mission of treating and curing type 1 diabetes,” added Dr. Insel.

Key highlights:


  • While not definitive, early evidence provides clues on a possible link between the diet of at-risk infants and prevention of type 1 diabetes.
  • The study is the pilot for a larger, on-going trial called TRIGR, which is designed to determine whether weaning to a highly hydrolyzed formula decreases the risk of developing type 1 diabetes. 
  • Renewal of the Special Diabetes Program will help ensure that the research for TRIGR study continues until its completion in 2017.  

About JDRF
JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million last year.