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ASK: Autoimmunity Screening for Kids (Colorado)

A free, general-population program at Colorado's Barbara Davis Center that blood-tests children for the autoantibodies of early type 1 diabetes (and celiac disease), aiming to catch T1D years before symptoms and prevent dangerous ketoacidosis at diagnosis. Not registered on ClinicalTrials.gov; a key US counterpart to Germany's Fr1da.

Primary endpoints

  • Proportion of children identified with early-stage (stage 1/2) type 1 diabetes before symptoms
  • Reduction in diabetic ketoacidosis (DKA) at clinical diagnosis among screened children
  • Prevalence and confirmation of celiac-disease autoimmunity (transglutaminase autoantibodies)
  • Performance/specificity of the multiplex ECL screening assay in the general population

Results so far

Through February 2024 ASK had screened about 35,000 children. Roughly 3.25% had one or more islet autoantibodies and about 0.58% had multiple islet autoantibodies, which carry a ~70% 10-year risk of T1D. For celiac, among the first 9,973 children, 242 were antibody-positive and 149 confirmed. The central public-health payoff: in Colorado about 60% of children present in diabetic ketoacidosis at T1D diagnosis, but that falls below 10% when families already know the child carries islet autoantibodies — ASK aims to push it under 5% in participants.

The full picture

What is being tested, and why it matters

ASK (Autoimmunity Screening for Kids) is a free public-health program run by the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus that blood-tests children from the general population — not just those with a relative who has diabetes — for the early warning signs of type 1 diabetes (T1D) and celiac disease.12 It started in January 2017 and is one of the largest US general-population screening efforts of its kind, a counterpart to Germany's Fr1da study.23

Type 1 diabetes does not appear overnight. The immune system attacks the insulin-making cells over months to years, and that attack can be detected early by measuring "islet autoantibodies."3 Catching it early matters because, in Colorado, roughly 60% of children are already in life-threatening diabetic ketoacidosis (DKA) by the time T1D is diagnosed — but that rate drops below 10% when the family already knows the child carries these antibodies and is watching for it.4 ASK's stated goal is to cut DKA at diagnosis to under 5% in screened children.4

Who it's for

Any US child aged 1-17 (and adults) can be screened, at no cost, regardless of family history.1 This is the key design choice: about 90% of children who turn out to be at risk have no relative with the disease, so screening only relatives would miss most cases.4

How it works (design)

ASK is an observational screening program, not a randomized drug trial.2 A blood sample is tested for four islet autoantibodies (to insulin, GAD65, IA-2 and ZnT8) for T1D and for transglutaminase autoantibodies for celiac disease, using an efficient multiplex "6-Plex" electrochemiluminescence (ECL) assay that runs all the tests in a single well.5 Children who screen positive return within a month for a confirmation draw and are then followed every 6 months.6 Notably, ASK is not registered on ClinicalTrials.gov — it operates under University of Colorado IRB approval (COMIRB #14-0553) rather than an NCT number.1

Key results so far

Through February 2024, ASK had screened about 35,000 children.2 Around 3.25% had one or more islet autoantibodies, and about 0.58% had multiple islet autoantibodies — a group whose 10-year risk of developing T1D is roughly 70%.7 For celiac disease, among the first 9,973 children screened, 242 tested positive and 149 were confirmed, revealing a high burden of previously undiagnosed celiac autoimmunity.6 Researchers also showed the multiplex ECL assay matches the older standard test for the children who actually progress to T1D while flagging far fewer non-predictive low-level positives, making it practical and cost-effective for mass screening.5

What it means and what's next

ASK provides US evidence that general-population screening is feasible, finds early-stage T1D and celiac disease that would otherwise be missed, and — by warning families in advance — sharply reduces DKA at diagnosis.43 Cost-effectiveness analyses suggest the investment is justified by avoided complications, especially if pairing it with celiac screening and with new therapies that can delay T1D in early-stage patients.3 Children found at high risk can be referred to monitoring and to prevention trials, including those evaluating teplizumab, the first therapy shown to delay clinical T1D.3

References

  1. ASK Research Program (Barbara Davis Center, University of Colorado). About / home pages (free screening, ages 1-17, all US children, COMIRB #14-0553, PI Marian Rewers). askhealth.org (accessed 2026). https://www.askhealth.org/about-us ↩ ↩2 ↩3

  2. Breakthrough T1D (JDRF). Autoimmunity Screening for Kids (ASK) grant page (started January 2017; ~35,000 children screened through February 2024; target 50,000; ~90% no family history). breakthrought1d.org (accessed 2026). https://www.breakthrought1d.org/grants/united-states/colorado/autoimmunity-screening-for-kids-ask/ ↩ ↩2 ↩3 ↩4

  3. Rewers M. Health economic considerations of screening for early type 1 diabetes. Diabetes, Obesity & Metabolism (2025). https://doi.org/10.1111/dom.16522 ↩ ↩2 ↩3 ↩4 ↩5

  4. Breakthrough T1D (JDRF). ASK grant page — DKA outcomes (~60% present in DKA in Colorado; <10% when islet-autoantibody status is known; goal <5% in participants). breakthrought1d.org (accessed 2026). https://www.breakthrought1d.org/grants/united-states/colorado/autoimmunity-screening-for-kids-ask/ ↩ ↩2 ↩3 ↩4

  5. He L, Jia X, Rasmussen CG, et al. High-Throughput Multiplex Electrochemiluminescence Assay Applicable to General Population Screening for Type 1 Diabetes and Celiac Disease. Diabetes Technology & Therapeutics (2022). https://doi.org/10.1089/dia.2021.0517 ↩ ↩2

  6. Stahl MG, Geno Rasmussen C, Dong F, et al. Mass Screening for Celiac Disease: The Autoimmunity Screening for Kids Study. American Journal of Gastroenterology (2021). https://doi.org/10.14309/ajg.0000000000000751 ↩ ↩2

  7. ASK Research Program / type1strong summary of ASK data (e.g., ~3.25% with one or more islet autoantibodies; ~0.58% with multiple islet autoantibodies, ~70% 10-year T1D risk). type1strong.org (accessed 2026). https://www.type1strong.org/blog-post/autoimmunity-screening-for-kids-ask-program ↩