Objective
The primary objective of the Autoimmunity Screening for Kids (ASK) program, initiated in January 2017, is to screen 50,000 general population children 1-17 year old age living in the United States for pre-symptomatic T1D and celiac disease (CD). Through February 2024, ASK has screened 35,000 children for autoantibodies for these two most frequent autoimmune disease of childhood. The ASK program has assessed practical ways of screening in the U.S. and offers clinical trials to intercept at the earliest stage of disease initiation aimed at preventing chronic disease and delaying complications. Participants found to be at increased risk of T1D are invited to participate in follow-up education and monitoring study to prevent complications associated with delayed diagnosis of disease.
ASK is building momentum working in close partnership with additional stakeholders who are invested in offering screening as standard of care by using established hospital infrastructure, electronic health systems such as EPIC, and fostering relationships with primary care providers and their patients who have screened positive for T1D and CD autoantibodies to offer effective, efficient, and accessible care and monitoring.
Background Rationale
Type 1 diabetes (T1D) or celiac disease (CD) affect at least 2% of the general population children. Patients often experience delay in care and complications because 90% have no family history of these diseases. While excellent tests exist allowing early detection of disease-specific autoimmunity, screening for pre-T1D is currently available only in context of research studies or offered to those with a family history of T1D. Screening for CD-specific autoimmunity is limited to high-risk groups, e.g., first-degree relatives of CD patients or patients with T1D. The benefit of early detection of CD is beyond doubt. Fortunately, in November of 2023, the Federal Drug Administration in the U.S. approved a new treatment, Teplizumab (Tzield), which has shown to be effective at delaying the onset of T1D by two years or more. Furthermore, prospective studies have documented significant reduction of illness associated with the diagnosis of T1D among children screened for islet autoantibodies. Teaching parents of screening-detected children minimal home blood glucose monitoring and use of continuous glucose monitors (CGMs) can prevent ~80% of hospitalizations for diabetic ketoacidosis (DKA), including life- threatening complications, e.g., cerebral edema Prevention of DKA at diagnosis improves long-term glycemic control, lowers the risk of vascular complications, and has beneficial effects on patient’s memory.
To increase education and awareness regarding T1D symptoms and prevalence of DKA and complications at diagnosis, we have expanded our community education and social media campaign to reach all U.S. children and adults. ASK strives to tailor the screening program to the individual needs of the practice or organization and offers multiple ways to participate in the ASK screening program including ease of online electronic consent, payment for lab support, and available training and support for providers on implementation of screening and monitoring through ASK and in collaboration with our national monitoring program, Ask the Experts. Through our partnerships with JDRF and Helmsley Charitable Trust, we have been able to increase access to screening, support monitoring, and foster the engagement of providers and other stakeholders who are helping make T1D screening standard of care in the U.S.
Description of Project
T1D or celiac disease (CD) affect at least 2% of the general population children. Patients often experience delay in care and complications because 90% have no family history of these diseases. The ASK Program strives to provide the U.S. community, including the American Diabetes Association, the American Academy of Pediatrics, the US Preventive Services Task Force, and health care organizations with evidence for a universal screening for pre-symptomatic T1D. In our current phase of ASK, we aim to address current evidence gaps related to routine screening for childhood presymptomatic T1D. Over the next three years we will continue ASK screening at a national level with a heightened focus on reaching diverse groups in the U.S. to help us better understand the prevalence of early stage T1D in minority groups, including an emphasis on children of African American and Asian American ancestry.
In addition, ASK will closely examine barriers faced by primary care providers as they implement screening into routine clinical care. We will develop new as well as build upon current innovative approaches to overcome these barriers, including further establishment of adding T1D screening to lead and anemia screening conducted as part of wellness visits at 1-2 years of age and adding T1D screening to dyslipidemia screening, which is currently recommended by the American Academy of Pediatrics between age 9-11.
As part of this effort, we will also develop a comprehensive manual to support health care providers and their patients with understanding of T1D screening results and ensuring best practice advisories are adequately captured in the patient’s medical electronic health record for optimal monitoring and education.
With ongoing national expansion of screening initiatives, we will take a closer look at anxiety that may come with screening and caregiver satisfaction with the ASK screening process to ensure we are meeting the needs of our study participants. This effort will include evaluation of anxiety at initial screening encounter and again when results are shared and confirmed. This data will guide future screening adaptations of ASK and will provide useful information for other screening initiatives.
Anticipated Outcome
This research will provide evidence of both the benefits and potential harm of general pediatric population screening for pre-symptomatic T1D and CD. This research will also increase community awareness of T1D and likely reduce the rate of DKA at diagnosis in childrento less than 5% in participating children. Vitally, this project translates recent advances in the immunology/epidemiology of T1D to public health, towards prevention of T1D and associated morbidity. Furthermore, ASK is working in tandem with other programs like ASK the Experts, which helps monitor at risk children nation-wide in partnership with T1Detect as well as with TrialNet. In addition, ASK partners with new projects, including the Early-Stage T1D Education and Support study, or ESTES, offering early diagnosis, education and monitoring, including CGM-guided insulin treatment for those in stage 2/3 T1D. The ASK Program will provide the American Diabetes Association, the American Academy of Pediatrics, the US Preventive Services Task Force, and health care organizations with the evidence for inclusion of universal screening for pre-symptomatic T1D in clinical screening guidelines and approved preventive services.
Relevance to T1D
This research will provide evidence of both the benefits and potential harm of general pediatric population screening for pre-symptomatic T1D and CD. This research will also increase community awareness of T1D and likely reduce the rate of DKA at diagnosis in children to less than 5% in participating children. Vitally, this project translates recent advances in the immunology/epidemiology of T1D to public health, towards prevention of T1D and associated morbidity. Furthermore, ASK is working in tandem with other programs like ASK the Experts, which helps monitor at risk
children nation-wide in partnership with T1Detect as well as with TrialNet. ASK will continue to support new screening initiatives and clinical trials such as the new Early-Stage T1D Education and Support (ESTES) study, which offers early diagnosis, education and monitoring, including CGM-guided insulin treatment in stage 2/3 T1D. The ASK Program will provide the American Diabetes Association, the American Academy of Pediatrics, the US Preventive Services Task Force, and health care organizations with the evidence for inclusion of universal screening for pre-symptomatic T1D in clinical screening guidelines and approved preventive services.