Sanford Health receives grant to enhance PLEDGE Study

Helmsley Charitable Trust awards $3.4 million for kids' diabetes and celiac screening

A 5-year-old girl sits in an exam room, holding out her finger to a medical provider.

Sanford Health, the largest rural health system in the country, has received an additional grant to expand its PLEDGE Study. PLEDGE centers on a blood test to identify children at risk of developing type 1 diabetes (T1D) and celiac disease and is integrated into routine pediatric care at Sanford clinics.

The $3.4 million grant from The Leona M. and Harry B. Helmsley Charitable Trust will support continued screening to identify children at risk of developing T1D or celiac disease. The Helmsley Charitable Trust made an initial $1.3 million grant when the PLEDGE (Population Level Estimate of type 1 Diabetes risk Genes in children) Study first launched in 2020.

Links between diabetes and celiac disease

In T1D, the immune system makes antibodies that destroy the cells in the pancreas that produce insulin, which the body uses to turn food into energy. Some of the genetic risk factors for T1D are shared with celiac disease, in which eating foods containing gluten triggers the immune system, causing inflammation in the small intestine.

Enroll in the PLEDGE Study: Early detection of type 1 diabetes and celiac disease in children

Children with celiac disease start with few, if any, symptoms, and progress to more typical gastrointestinal issues. Left untreated, more serious complications can develop including impacts on growth and physical development.

“The goal of the PLEDGE study is to be able to catch those children who are on the path towards type 1 diabetes (T1D) so that we can prevent diabetic ketoacidosis (DKA) — a life-threatening condition that has often developed by the time T1D is first recognized in a child,” said Dr. Kurt Griffin, principal investigator of the PLEDGE Study and the Todd and Linda Broin Chair of the Sanford Project. “Children with T1D who are treated with insulin early enough to prevent DKA have better glycemic control for years afterwards. We expect results from PLEDGE will help support inclusion of these tests among those that are standard for all children.”

PLEDGE Study benefits for children

Children found to have markers related to T1D through the PLEDGE Study are offered education, ongoing monitoring, and appropriate early intervention to prevent serious illness at the time of diagnosis. When applicable, Sanford will also offer participation in clinical trials seeking to delay or stop the progression to clinical T1D.

Children with markers of celiac disease are referred to pediatric gastroenterologists for treatment. A similar number of children are now under treatment for celiac disease.

Since its launch, the PLEDGE Study has expanded to 126 clinics across Sanford’s footprint in the Dakotas, Minnesota, Iowa, and Nebraska. More than 5,000 patients have signed up for PLEDGE. To date, close to 20 patients with persistent T1D antibodies have been identified and are undergoing periodic monitoring.

“The Helmsley Charitable Trust’s Type 1 Diabetes Program is committed to supporting screening for early stages of T1D to improve clinical care and outcomes for affected children,” said Dr. Anne Koralova, Program Officer at the Helmsley Charitable Trust.

Parents can enroll their children in the study if their child:

  • Is between the ages of 0-5 or 9-16 years
  • Has not been diagnosed with clinical T1D
  • Receives routine care at Sanford Health
  • Has a My Sanford Chart account

Children ages 6-17 who have a sibling with T1D or T1D antibodies may also join the study.

To learn more or to enroll in PLEDGE, talk with your child’s primary care physician or visit sanfordhealth.org/pledge.

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Posted In Children's, Digestive Health, Research