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More than 250,000 people have learned their risk of developing type 1 diabetes (T1D) through TrialNet screening. TrialNet and Breakthrough T1D (formerly JDRF) announced the research milestone as part of National Diabetes Month, observed each November to raise awareness about diabetes and encourage families to take action to protect their health.

Kathryn Sumpter, MD

Le Bonheur’s Endocrinology division is a participant in this screening study, led by Le Bonheur Chief of Endocrinology Kathryn Sumpter, MD. As part of the study, children and adolescents 2 years or older with a parent, sibling, niece, nephew, aunt, uncle, cousin or half-sibling who has T1D can be screened for their risk to develop the disease. Since joining the initiative,        Le Bonheur has screened 669 individuals. The most frequent participants in the screening are those with a child, sister or brother with T1D who is seen at Le Bonheur’s Endocrinology Clinic.

“TrialNet has been instrumental in broadening our understanding of how T1D develops and improving our ability to predict who will develop T1D in the future,” said Sumpter. “Because of TrialNet’s years of research, we can screen anyone and determine their risk for T1D. Knowing someone is at high risk to develop T1D allows patients and families to watch for symptoms of diabetes, such as increased urination and thirst, and reduces the chances of severe illness at the time of diabetes diagnosis.

Research shows that people who have a relative with T1D are 15 times more likely to develop the disease than the general population. The general risk of developing T1D is about one in 300. For people who have a relative with T1D, they have a risk of one in 20.

TrialNet offers families personal risk screening to identify the autoantibodies that signal the early stages of T1D. During screening, a blood sample is collected, and TrialNet tests it for up
to five autoantibodies. These autoantibodies are often detectable years before a person starts to develop symptoms. Early detection and monitoring of people with autoantibodies reduces the risk of diabetic ketoacidosis — a serious and potentially life-threatening condition.

TrialNet’s research was instrumental in developing the concept of stages that occur before T1D diagnosis, which are used in eligibility criteria for treatment or clinical trials that hope to delay disease progression. For example, the stages of T1D were used to identify participants in TrialNet’s Teplizumab Prevention Study, which led to the first FDA-approved immune therapy to delay T1D in people at risk of progressing to a clinical diagnosis. On average, teplizumab delays the onset of T1D by an average of three years.

Breakthrough T1D and TrialNet are spearheading worldwide initiatives to increase T1D screening, and to provide guidance for monitoring and treating those with early stage T1D. Research shows that people with early stage T1D — two or more persistent T1D-related autoantibodies — have an almost 100% chance of a clinical diagnosis (Stage 3) in their lifetime. Due to this elevated risk, TrialNet also offers screening and monitoring to people in the general population found to have one or more T1D-related autoantibodies outside of TrialNet.