The autoimmune response in individuals with T1D occurs months to years before symptoms become apparent. We can measure this by the formation of auto-antibodies (Aab) in the blood, which are an important indicator for development and progression of T1D. T1D is divided into different stages, ranging from presymptomatic (stage 1-2: at least 2 AAb combined with normal or disturbed glycemia, respectively) to symptomatic (stage 3). The presence of 2 or more Aab indicates an increased risk of progression to symptomatic T1D by more than 80% within 20 years. Scientific research further shows that early diagnosis of presymptomatic T1D in children, followed by education and follow-up in the hospital, efficiently reduces complications such as diabetic ketoacidosis (DKA).
Do the advantages outweigh the harm?
When a child tests positive for multiple AAb, the psychological impact on the parents cannot be underestimated. Questionnaires are integrated in various screening studies to study the effect on anxiety and depression, also in the EDENT1FI project. Research shows that parents of children at risk for T1D are more anxious. However, anxiety decreases with time and proper education about the condition. When we move towards population screening, psychological support to families should be available.
Is there a simple, sensitive and specific test available?
Screening for T1D is possible with a simple blood test. Today, this test can be done with a finger prick, but results must be confirmed with a larger blood sample. In addition, the test must be repeated at different ages to ensure sensitivity and specificity. These can create barriers for the population and healthcare system. When we move towards population screening, we need a test that is minimally invasive, and there should be clarity on how often and at what age the test should be repeated. This is being studied in the EDENT1FI project.
Is there a treatment that is effective in the early stages of T1D?
Early detection of T1D dramatically reduces the risk of DKA and results in better beta cell function at the time of clinical diagnosis. In other words, T1D is milder when symptoms arise, which ensures a better quality of life. This is due to better 'preparation' for T1D and – if needed – starting insulin therapy earlier. Although teplizumab has not yet been approved in the EU, there are already some countries, including Germany, where 'use in exceptional cases' is permitted (i.e. 'Compassionate Use Program'). However, before we move towards population screening, more studies in the general population – such as the EDENT1FI project – are needed to demonstrate that benefits outweigh the harms.
Conclusion
It is time to roll out screening for early stages of T1D, especially in family members and possibly in the general population. As scientists, we must remain critical and recognize that more research is needed within the general population. However, we believe EDENT1FI is crucial in this matter. Research will continue to improve: better and cheaper tests will be available, teplizumab will one day be approved in the EU and new therapies will be developed. The population and healthcare systems should be ready when we (scientists) are.