T1Detect (Breakthrough T1D at-home autoantibody screening)

What T1Detect is

T1Detect is an at-home screening program run by Breakthrough T1D (formerly JDRF) that looks for the early immune signs of type 1 diabetes (T1D) before any symptoms appear.¹ You request a kit online, prick a finger at home, place drops of blood on a card, and mail it to the lab Enable Biosciences, which measures islet autoantibodies using its antibody-detection-by-agglutination-PCR (ADAP) assay.¹² It is open to people of all ages (1 year and older), with or without a family member who has T1D, and kits ship within the United States and Puerto Rico.¹ The kit is low-cost and financial assistance is offered.¹

SCREENING: what is measured and why it matters

T1D begins years before diagnosis, when the immune system makes islet autoantibodies against insulin-producing cells. T1Detect tests for autoantibodies to GAD (GADA), islet antigen-2 (IA-2A) and insulin (IAA), with zinc-transporter-8 (ZnT8A) also part of the wider panel.³ Researchers describe T1D in stages: stage 1 is two or more autoantibodies with normal blood sugar; stage 2 adds abnormal ("dysglycemic") blood sugar; stage 3 is clinical diabetes with symptoms.⁴

The number of autoantibodies is a powerful predictor. In a landmark pooled study, children with two or more islet autoantibodies had a ~70% risk of clinical T1D within 10 years and ~84% within 15 years — effectively a near-certain lifetime risk — whereas a single autoantibody carried ~15% 10-year risk and none carried ~0.4%.⁵ This is why finding multiple autoantibodies is so meaningful, and why reach beyond families matters: roughly 85-90% of people who develop T1D have no relative with it, so relative-only screening misses most cases.¹

Why screen at all? The biggest immediate payoff is avoiding diabetic ketoacidosis (DKA), a dangerous and sometimes fatal way T1D often announces itself. In Germany's Fr1da public-health screening of 90,632 young children, DKA at diagnosis fell to under ~5%, versus ~20% in unscreened German children and historically ~60% in the US.⁶ Early knowledge also enables glucose monitoring, education, and access to clinical trials and therapy.⁶

The home dried-blood-spot approach is the practical breakthrough. Validation studies show capillary blood spots perform comparably to a clinic venous draw — sensitivity ~85-89% and specificity ~97-100% against serum — and participants find self-collection easier and less painful than a needle in the arm.⁷⁸ Australia's national Type1Screen program found home blood-spot sampling reached younger and more rural people and detected the expected prevalence of presymptomatic T1D, supporting feasibility at scale.⁹

THERAPY: what a positive result unlocks

T1Detect is a gateway, not a treatment. A positive result is confirmed with standard testing and triggers monitoring and referral. For people who reach stage 2, there is now an approved disease-modifying drug: teplizumab (Tzield), an anti-CD3 monoclonal antibody. In the pivotal TN-10 trial (76 participants, age 8-49), a single 14-day course delayed progression to clinical (stage 3) T1D by a median of roughly two years versus placebo, and the FDA approved it on 17 November 2022 to delay stage 3 T1D in people aged 8 and older with stage 2 disease.¹⁰¹¹ Screening is what makes a person eligible to benefit, since you can only be treated at stage 2 if you have been found.

What's coming

The direction of travel is toward broader, earlier, cheaper detection. General-population (not just relative) screening is being modeled and piloted internationally, multiplexed home blood-spot assays continue to be validated, and major guidelines increasingly endorse autoantibody screening for at-risk individuals.⁷⁹ On the therapy side, the FDA extended teplizumab's stage-2 delay indication down to age 1 in 2026, which — paired with programs like T1Detect — widens the window in which early detection changes outcomes.¹¹

References

1. Breakthrough T1D (JDRF). JDRF Launches First Mass Screening Program for Early-Stage Type 1 Diabetes (T1D) Detection. Breakthrough T1D press release (2020). https://www.breakthrought1d.org/for-the-media/press-releases/jdrf-launches-first-mass-screening-program-for-early-stage-type-1-diabetes-t1d-detection/ ↩ ↩² ↩³ ↩⁴ ↩⁵

2. Cortez FJ, Gebhart D, Robinson PV, et al. Sensitive detection of multiple islet autoantibodies in type 1 diabetes using small sample volumes by agglutination-PCR. PLoS One (2020). https://doi.org/10.1371/journal.pone.0242049 ↩

3. Breakthrough T1D. T1Detect — autoantibodies tested (IAA, GAD, IA-2A, ZnT8). breakthrought1d.org (2024). https://www.breakthrought1d.org/t1detect/ ↩

4. Insel RA, Dunne JL, Atkinson MA, et al. Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care (2015). https://doi.org/10.2337/dc15-1419 ↩

5. Ziegler AG, Rewers M, Simell O, et al. Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children. JAMA (2013). https://doi.org/10.1001/jama.2013.6285 ↩

6. Ziegler AG, Kick K, Bonifacio E, et al. Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany (Fr1da). JAMA (2020). https://doi.org/10.1001/jama.2019.21565 ↩ ↩²

7. Faustini SE, Quinn LM, Hoque M, et al. Establishing the performance and acceptability of dried blood spot sampling to screen for islet-specific autoantibodies. Diabet Med (2025). https://doi.org/10.1111/dme.70071 ↩ ↩²

8. Sing ABE, Naselli G, Huang D, et al. Feasibility and Validity of In-Home Self-Collected Capillary Blood Spot Screening for Type 1 Diabetes Risk. Diabetes Technol Ther (2024). https://doi.org/10.1089/dia.2023.0345 ↩

9. Wentworth JM, Sing ABE, Naselli G, et al. Islet Autoantibody Screening Throughout Australia Using In-Home Blood Spot Sampling: 2-Year Outcomes of Type1Screen. Diabetes Care (2025). https://doi.org/10.2337/dc24-2443 ↩ ↩²

10. U.S. Food and Drug Administration. FDA approves first drug that can delay onset of type 1 diabetes (FDA Update, Jan 1, 2023; original approval Nov 17, 2022). https://www.fda.gov/media/164864/download ↩

11. U.S. Food and Drug Administration. TZIELD (teplizumab-mzwv) Prescribing Information (2026 label; stage-2 delay indication in adults and pediatric patients 1 year and older). https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s013lbl.pdf ↩ ↩²